K. R. Singhal
Many organizations may find some confusion in outsourcing and exclusion concepts while implementing ISO 9001:2008 QMS.
Clause 4.1 (General requirements) in ISO 9001:2008 QMS Standard includes the outsourcing concept to highlight the fact that special attention is required when obtaining products and services from others that impact the product provided to customer. The requirements in this clause specially refer to outsourced processes to indicate that the organization must ensure control over such outsourced processes. It also requires that the type and extent of control to be applied to outsourced processes must be defined within the quality management system.
Some people may think that the requirement in clause 4.1 (General requirements) regarding outsourcing is not necessary to follow because requirements mentioned in clause 7.1 (Planning of product realization), clause 7.4 (Purchasing), and clause 7.5 (Production and service provision) contain adequate requirements to ensure the integrity provided to the customer.
An organization can’t exclude outsourcing requirements of clause 4.1 (General requirements), if it chooses to outsource any process that affects product conformity to requirements.
If we see the exclusion concept mentioned in clause 1.2 (Application), it states that exclusions are limited to requirements within clause 7 (Product realization). The requirements related to outsourcing concept are mentioned in clause 4.1 (General requirements) that relate to those activities that are essential to the quality management system of your organization, if you choose to outsource any process. When an organization may choose to outsource processes for management activities (related to clause 5), provision of resources (related to clause 6), product realization (related to clause 7), and measurement, analysis and improvement (related to clause 8) may be outsourced.
Who perform the outsourced process? Note 2 at the end of clause 4.1 (General requirements) provides the answer. It clarifies that an outsourced process is identified that process, which is needed for the quality management system, but the same process is performed by a party external to the organization.
Note 3 at the end of clause 4.1 (General requirements) clarifies points with regard to the responsibility of the organization to fulfill all customer, statutory and regulatory requirements and ensuring control over outsourced processes does not absolve the organization of such responsibility to fulfill all customer, statutory and regulatory requirements. This note also clarifies that there are various factors that may influence the type and extent of control on the outsourced process, such as – (i) potential impact of the outsourced process on the capability of the organization to provide product that conforms to requirements, (ii) the degree to which the control for the process is shared (between the organization and the party performing the process), (iii) the capability of achieving the necessary control through the application of clause 7.4 (Purchasing).
If we carefully read the exclusion requirements in clause 1.2 (Application), it also put the condition that such exclusion do not affect the ability or responsibility of the organization to provide product that meets customer and applicable statutory and regulatory requirements.
An organization, taking the benefit of exclusion provision mentioned in clause 1.2 (Application) that exclusions are limited to requirements within clause 7 (Product realization), must remember that when the organization outsource any process then according to clause 4.1 (General requirements), it is the duty of the organization to control such outsourced processes. Further the type and control to be applied to outsourced processes need to be defined.
Let us have following examples:
(i) An organization claimed exclusion from the requirements of clause 7.4 (Purchasing) since the purchasing activity of the unit (implementing ISO 9001:2008 QMS) is done at corporate level.
(ii) An organization claimed exclusion from the requirements of clause 7.1 (Planning of product realization) and clause 7.5 (Production and service provision) since the unit (implementing ISO 9001:2008 QMS) does not carry out any production process and same has been contracted to another organization.
(iii) An organization claimed exclusion from the requirements of clause 7.3 (Design and development) since the designing of the product is carried out at another unit of the organization.
In the above examples, the organization claimed exclusion on the basis that the related process not being carried out by the unit (implementing ISO 9001:2008 QMS). But if look to clause 4.1 (General requirements) then the unit can not ignore control over the processes of (i) purchasing carried out at corporate level, (ii) planning of product realization, and production and service provision, and, (iii) design and development carried out at another unit.
The process approach is having the central approach to ISO 9001:2008 QMS Standard and we have observed that during the last few years outsourcing activities in organizations have increased tremendously, so the new version has clarified its requirements by adding notes in clause 4.1 (General requirements).
Please have you comments to the above.
With kind regards,
K. R. Singhal
Thursday, June 18, 2009
Friday, January 23, 2009
Upgrading the existing QMS to ISO 9001:2008 Standard
Upgrading the existing QMS to ISO 9001:2008 Standard
ISO 9001:2008 QMS Standard has been published on 15 November 2008 by the International Organization for Standardization (ISO). Organizations having the ISO 9001:2000 QMS certifications will upgrade their quality management system as per 2008 version. As per implementation plan jointly announced by International Organization for Standardization (ISO) and International Accreditation Forum (IAF), organizations should upgrade their ISO 9001:2000 QMS to ISO 9001:2008 QMS before 15 November 2010 (within two years from the data of publication of ISO 9001:2008 Standard). However, efforts of many management representatives will be to upgrade their quality management system and obtain certification as per ISO 9001:2008 QMS Standard as early as possible.
It’s good to upgrade the system, but how you can do it in an effective manner. The quality management system of your organization should be able to demonstrate continual improvement as well as changes as per new version. Following steps may be useful.
Step 1 – Get acquainted with ISO 9001:2008 QMS Standard
Nothing can be done without knowing the changes, so please obtain a copy of ISO 9001:2008 Standard. You can obtain the same from the ISO Central Secretariat or from the sales counter of the National Standards Body in your country. ‘Bureau of Indian Standards’ is the national standards body in India, from which you can obtain the equivalent Indian Standard to ISO 9001:2008 QMS. Read ISO 9001:2008 Standard carefully. You should also refer to other reading materials (such as books, articles) on ISO 9001:2008 QMS.
Start ISO 9001:2008 QMS Awareness Programme in your organization. Members of task force, members of steering committee and people, actively involved in ISO 9001 QMS implementation, should be encouraged to attend ISO 9001:2008 Awareness Programme.
Step 2 – Action Plan
Please prepare an action plan for up-gradation to ISO 9001:2008 from the 2000 version. The action plan should indicate the responsibilities of different departments and personnel and set target dates for completion of activities (such as target dates for completion of documentation, training of internal auditors, internal audit, management review etc.).
Step 3 – Revision of QMS Documentation
A few people should be selected for revision of QMS documentation as per ISO 9001:2008 QMS Standard. The Management Representative should be the coordinator of the QMS documentation revision task. Revision in documentation should be done and revised documents should be issued.
Step 4 – Implementation
Implementation should be carried out immediately upon issue of revised documentation as per ISO 9001:2008 QMS Standard.
Step 5 – Training of internal auditors
Internal auditors should be aware of ISO 9001:2008 QMS Standard, so please provide training to your internal auditors, so that they may be able to carry out value added internal audit as per ISO 9001:2008 QMS Standard.
Step 6 – Internal Audit
After implementation as per revised documentation, please carry out internal audit as per ISO 9001:2008 QMS Standard. Take corrective action for the nonconformity or nonconformities observed during the internal audit.
Step 7 – Management Review
After conduct of internal audit, carry out management review of the quality management system of your organization as per ISO 9001:2008 QMS Standard.
Step 8 – Inform Certification Body
After successfully completing all above steps, you should inform your certification body about the up-gradation of your quality management system as per ISO 9001:2008 QMS Standard, so that they may assess your quality management system and upgrade their certificate.
Support from NCQM Ajmer Centre
You can have following support from NCQM Ajmer Centre for up-gradation of your QMS:
Literatures in Hindi and English on ISO 9001:2008 QMS
Training programmes
Guidance for implementation
ISO 9001:2008 QMS Standard has been published on 15 November 2008 by the International Organization for Standardization (ISO). Organizations having the ISO 9001:2000 QMS certifications will upgrade their quality management system as per 2008 version. As per implementation plan jointly announced by International Organization for Standardization (ISO) and International Accreditation Forum (IAF), organizations should upgrade their ISO 9001:2000 QMS to ISO 9001:2008 QMS before 15 November 2010 (within two years from the data of publication of ISO 9001:2008 Standard). However, efforts of many management representatives will be to upgrade their quality management system and obtain certification as per ISO 9001:2008 QMS Standard as early as possible.
It’s good to upgrade the system, but how you can do it in an effective manner. The quality management system of your organization should be able to demonstrate continual improvement as well as changes as per new version. Following steps may be useful.
Step 1 – Get acquainted with ISO 9001:2008 QMS Standard
Nothing can be done without knowing the changes, so please obtain a copy of ISO 9001:2008 Standard. You can obtain the same from the ISO Central Secretariat or from the sales counter of the National Standards Body in your country. ‘Bureau of Indian Standards’ is the national standards body in India, from which you can obtain the equivalent Indian Standard to ISO 9001:2008 QMS. Read ISO 9001:2008 Standard carefully. You should also refer to other reading materials (such as books, articles) on ISO 9001:2008 QMS.
Start ISO 9001:2008 QMS Awareness Programme in your organization. Members of task force, members of steering committee and people, actively involved in ISO 9001 QMS implementation, should be encouraged to attend ISO 9001:2008 Awareness Programme.
Step 2 – Action Plan
Please prepare an action plan for up-gradation to ISO 9001:2008 from the 2000 version. The action plan should indicate the responsibilities of different departments and personnel and set target dates for completion of activities (such as target dates for completion of documentation, training of internal auditors, internal audit, management review etc.).
Step 3 – Revision of QMS Documentation
A few people should be selected for revision of QMS documentation as per ISO 9001:2008 QMS Standard. The Management Representative should be the coordinator of the QMS documentation revision task. Revision in documentation should be done and revised documents should be issued.
Step 4 – Implementation
Implementation should be carried out immediately upon issue of revised documentation as per ISO 9001:2008 QMS Standard.
Step 5 – Training of internal auditors
Internal auditors should be aware of ISO 9001:2008 QMS Standard, so please provide training to your internal auditors, so that they may be able to carry out value added internal audit as per ISO 9001:2008 QMS Standard.
Step 6 – Internal Audit
After implementation as per revised documentation, please carry out internal audit as per ISO 9001:2008 QMS Standard. Take corrective action for the nonconformity or nonconformities observed during the internal audit.
Step 7 – Management Review
After conduct of internal audit, carry out management review of the quality management system of your organization as per ISO 9001:2008 QMS Standard.
Step 8 – Inform Certification Body
After successfully completing all above steps, you should inform your certification body about the up-gradation of your quality management system as per ISO 9001:2008 QMS Standard, so that they may assess your quality management system and upgrade their certificate.
Support from NCQM Ajmer Centre
You can have following support from NCQM Ajmer Centre for up-gradation of your QMS:
Literatures in Hindi and English on ISO 9001:2008 QMS
Training programmes
Guidance for implementation
Monday, January 19, 2009
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter 9
DOCUMENTED PROCEDURES AND RECORDS REQUIRED BY ISO 9001:2008
Documented procedures required by ISO 9001:2008 are:
Control of documents (see clause 4.2.3)
Control of records (see clause 4.2.4)
Internal audit (see clause 8.2.2)
Control of nonconforming product (see clause 8.3)
Corrective action (see clause 8.5.2)
Preventive action (see clause 8.5.3)
However, in addition to above the organization may have documented procedures determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.
Records required by ISO 9001:2008 are:
Clause 5.6 (Management review) – Records from management reviews
Clause 6.2.2 (Competence, training and awareness) – Appropriate records of education, training, skills and experience
Clause 7.1 (Planning of product realization) – Records to provide evidence that the realization processes and resulting product meet requirements
Clause 7.2.2 (Review of requirements related to the product) – Records of the result of the review and actions arising from the review
Clause 7.3.2 (Design and development inputs) – Records of inputs relating to product requirements
Clause 7.3.4 (Design and development review) – Records of the results of the reviews and any necessary actions
Clause 7.3.5 (Design and development verification) – Records of the results of the verification and any necessary actions
Clause 7.3.6 (Design and development validation) – Records of the results of validation and any necessary actions
Clause 7.3.7 (Control of design and development changes) – Records of the results of the review of changes and any necessary actions
Clause 7.4.1 (Purchasing process) – Records of the results of supplier evaluations and any necessary actions arising from the evaluation
Clause 7.5.2 (Validation of processes for production and service provision) – Records as per requirements according to established arrangements
Clause 7.5.3 (Identification and traceability) –Where traceability is a requirement, record of unique identification of product
Clause 7.5.4 (Customer property) – Records of reporting to the customer, if any customer property is lost, damaged or otherwise found to be unsuitable for use
Clause 7.6 (Control of monitoring and measuring equipment) – (i) Records of the basis used for calibration or verification, where no international / national measurement standards exist (ii) Records of the results of calibration and verification (iii) Validity of the previous measuring results when equipment is found not to conform requirements
Clause 8.2.2 (Internal audit) – Records of the audits and their results
Clause 8.2.4 (Monitoring and measurement of product) – Records indicating the person(s) authorizing release of product for delivery to the customer
Clause 8.3 (Control of nonconforming product) – Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained
Clause 8.5.2 (Corrective action) – Records of the results of action taken
Clause 8.5.3 (Preventive action) – Records of the results of action taken
However, in addition to above the organization may have records determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.
If we go through the above list and requirements of ISO 9001:2000 QMS Standard, we find that there is no change in the requirements for documented procedures and records needed to keep as per ISO 9001:2008.
Questions
What are the documented procedures and records required as per clause 4 (Quality management system) of ISO 9001:2008?
What are the documented procedures and records required as per clause 5 (Management responsibility) of ISO 9001:2008?
What are the documented procedures and records required as per clause 6 (Resource management) of ISO 9001:2008?
What are the documented procedures and records required as per clause 7 (Product realization) of ISO 9001:2008?
What are the documented procedures and records required as per clause 8 (Measurement, analysis and improvement) of ISO 9001:2008?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter 9
DOCUMENTED PROCEDURES AND RECORDS REQUIRED BY ISO 9001:2008
Documented procedures required by ISO 9001:2008 are:
Control of documents (see clause 4.2.3)
Control of records (see clause 4.2.4)
Internal audit (see clause 8.2.2)
Control of nonconforming product (see clause 8.3)
Corrective action (see clause 8.5.2)
Preventive action (see clause 8.5.3)
However, in addition to above the organization may have documented procedures determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.
Records required by ISO 9001:2008 are:
Clause 5.6 (Management review) – Records from management reviews
Clause 6.2.2 (Competence, training and awareness) – Appropriate records of education, training, skills and experience
Clause 7.1 (Planning of product realization) – Records to provide evidence that the realization processes and resulting product meet requirements
Clause 7.2.2 (Review of requirements related to the product) – Records of the result of the review and actions arising from the review
Clause 7.3.2 (Design and development inputs) – Records of inputs relating to product requirements
Clause 7.3.4 (Design and development review) – Records of the results of the reviews and any necessary actions
Clause 7.3.5 (Design and development verification) – Records of the results of the verification and any necessary actions
Clause 7.3.6 (Design and development validation) – Records of the results of validation and any necessary actions
Clause 7.3.7 (Control of design and development changes) – Records of the results of the review of changes and any necessary actions
Clause 7.4.1 (Purchasing process) – Records of the results of supplier evaluations and any necessary actions arising from the evaluation
Clause 7.5.2 (Validation of processes for production and service provision) – Records as per requirements according to established arrangements
Clause 7.5.3 (Identification and traceability) –Where traceability is a requirement, record of unique identification of product
Clause 7.5.4 (Customer property) – Records of reporting to the customer, if any customer property is lost, damaged or otherwise found to be unsuitable for use
Clause 7.6 (Control of monitoring and measuring equipment) – (i) Records of the basis used for calibration or verification, where no international / national measurement standards exist (ii) Records of the results of calibration and verification (iii) Validity of the previous measuring results when equipment is found not to conform requirements
Clause 8.2.2 (Internal audit) – Records of the audits and their results
Clause 8.2.4 (Monitoring and measurement of product) – Records indicating the person(s) authorizing release of product for delivery to the customer
Clause 8.3 (Control of nonconforming product) – Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained
Clause 8.5.2 (Corrective action) – Records of the results of action taken
Clause 8.5.3 (Preventive action) – Records of the results of action taken
However, in addition to above the organization may have records determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.
If we go through the above list and requirements of ISO 9001:2000 QMS Standard, we find that there is no change in the requirements for documented procedures and records needed to keep as per ISO 9001:2008.
Questions
What are the documented procedures and records required as per clause 4 (Quality management system) of ISO 9001:2008?
What are the documented procedures and records required as per clause 5 (Management responsibility) of ISO 9001:2008?
What are the documented procedures and records required as per clause 6 (Resource management) of ISO 9001:2008?
What are the documented procedures and records required as per clause 7 (Product realization) of ISO 9001:2008?
What are the documented procedures and records required as per clause 8 (Measurement, analysis and improvement) of ISO 9001:2008?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter 8
ANNEX, BIBLIOGRAPHY AND OTHER INFORMATION (including implementation plan for ISO 9001:2008 QMS Standard)
Annex A and Annex B have been updated.
Annex A provides informative details of correspondence between ISO 9001:2008 and ISO 14001:2004 For more details, reader should refer to the Standard document ISO 9001:2008.
Annex B provides informative details of changes between ISO 9001:2000 and ISO 9001:2008 in a Table form. For more details, reader should refer to the Standard document ISO 9001:2008.
Bibliography is also updated to reflect new standards and new editions of standards. For more details, reader should refer to the Standard document ISO 9001:2008.
In short, from the study of ISO 9001:2008, we come to a conclusion that ISO 9001:2008 will be an international standard with minor revision to ISO 9001: 2000 and changes are more as clarifications to the requirements.
There will be little impact of the revision. Only a few changes in the requirements may require revision in documentation and implementation. International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Details are mentioned below.
Implementation Plan for ISO 9001:2008 QMS Standard
International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Both organizations have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008 QMS Standard.
The ISO 9001:2008 QMS Standard has been published on 15 November 2008. ISO 9001:2008 QMS Standard replaces the year 2000 version of the Standard. Certification is not a requirement of the standard, however the quality management system (QMS) of about one million organizations have been audited and certified by independent certification bodies to existing ISO 9001:2000 QMS Standard. ISO 9001 certification is frequently used in both private and public sectors to increase confidence in the products and services provided by certified organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts.
International Organization for Standardization (ISO) is the developer and publisher of ISO 9001 Standard. ISO does not itself carry out auditing and certification to ISO 9001 Standard. These services are performed independently of ISO by certification bodies. ISO does not control such bodies. But ISO has developed voluntary International Standards to encourage good practice in their activities on a worldwide basis. ISO/IEC 17021:2006, developed and published by ISO, specifies the requirements for certification bodies carrying out auditing and certification of management systems.
Certification bodies that wish to provide further confidence in their services generally apply to be "accredited" as competent by an International Accreditation Forum (IAF) recognized national accreditation body। In India, National Accreditation Board of Certification Bodies (NABCB) is the IAF recognized national accreditation body। ISO/IEC 17011:2004, developed and published by ISO, specifies the requirements for carrying out such accreditation. International Accreditation Forum (IAF) is an international association, having membership of national accreditation bodies of 49 countries/economies. International Organization for Standardization (ISO) has a technical committee, known as ISO/TC 176, Quality management and quality assurance. This committee is responsible for the ISO 9000 family of standards. This committee is preparing a number of support documents explaining the differences between ISO 9001:2008 (forthcoming new version) and ISO 9001:2000 (the year 2000 version), why and what they mean for users. On getting approval, these documents will be posted on the ISO Web site – probably in October 2008.
International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001:2008 QMS Standard, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services. ISO 9001:2008 does not contain any new requirements. As such, ISO and IAF have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 QMS Standard. It also introduces changes intended to improve consistency with ISO14001:2004 EMS Standard. The implementation plan and validity of certification to ISO 9001 QMS, as agreed by ISO and IAF, in relation to accredited certification is as under:(i) Accredited certification to the ISO 9001:2008 QMS Standard shall not be granted until the publication of ISO 9001:2008 QMS Standard as an International Standard. ISO 9001:2008 QMS Standard has since been published as International Standard on 15 November 2008.
(ii) Certification of conformity to ISO 9001:2008 QMS Standard and/or national equivalents (such as, IS/ISO 9001:2008 QMS Standard, in India) shall only be issued after official publication of ISO 9001:2008 (i.e after 15 November 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.
(iii) One year after publication of ISO 9001:2008 QMS Standard all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008 QMS Standard.
(iv) Twenty four months after publication by ISO of ISO 9001:2008 QMS Standard, any existing certification issued to ISO 9001:2000 shall not be valid.
Questions
1. What is your conclusion with regard to ISO 9001 revision?
2. What is the implementation plan for ISO 9001:2008 QMS Standard announced by International Organization for Standardization (ISO) and International Accreditation Forum (IAF)?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter 8
ANNEX, BIBLIOGRAPHY AND OTHER INFORMATION (including implementation plan for ISO 9001:2008 QMS Standard)
Annex A and Annex B have been updated.
Annex A provides informative details of correspondence between ISO 9001:2008 and ISO 14001:2004 For more details, reader should refer to the Standard document ISO 9001:2008.
Annex B provides informative details of changes between ISO 9001:2000 and ISO 9001:2008 in a Table form. For more details, reader should refer to the Standard document ISO 9001:2008.
Bibliography is also updated to reflect new standards and new editions of standards. For more details, reader should refer to the Standard document ISO 9001:2008.
In short, from the study of ISO 9001:2008, we come to a conclusion that ISO 9001:2008 will be an international standard with minor revision to ISO 9001: 2000 and changes are more as clarifications to the requirements.
There will be little impact of the revision. Only a few changes in the requirements may require revision in documentation and implementation. International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Details are mentioned below.
Implementation Plan for ISO 9001:2008 QMS Standard
International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Both organizations have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008 QMS Standard.
The ISO 9001:2008 QMS Standard has been published on 15 November 2008. ISO 9001:2008 QMS Standard replaces the year 2000 version of the Standard. Certification is not a requirement of the standard, however the quality management system (QMS) of about one million organizations have been audited and certified by independent certification bodies to existing ISO 9001:2000 QMS Standard. ISO 9001 certification is frequently used in both private and public sectors to increase confidence in the products and services provided by certified organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts.
International Organization for Standardization (ISO) is the developer and publisher of ISO 9001 Standard. ISO does not itself carry out auditing and certification to ISO 9001 Standard. These services are performed independently of ISO by certification bodies. ISO does not control such bodies. But ISO has developed voluntary International Standards to encourage good practice in their activities on a worldwide basis. ISO/IEC 17021:2006, developed and published by ISO, specifies the requirements for certification bodies carrying out auditing and certification of management systems.
Certification bodies that wish to provide further confidence in their services generally apply to be "accredited" as competent by an International Accreditation Forum (IAF) recognized national accreditation body। In India, National Accreditation Board of Certification Bodies (NABCB) is the IAF recognized national accreditation body। ISO/IEC 17011:2004, developed and published by ISO, specifies the requirements for carrying out such accreditation. International Accreditation Forum (IAF) is an international association, having membership of national accreditation bodies of 49 countries/economies. International Organization for Standardization (ISO) has a technical committee, known as ISO/TC 176, Quality management and quality assurance. This committee is responsible for the ISO 9000 family of standards. This committee is preparing a number of support documents explaining the differences between ISO 9001:2008 (forthcoming new version) and ISO 9001:2000 (the year 2000 version), why and what they mean for users. On getting approval, these documents will be posted on the ISO Web site – probably in October 2008.
International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001:2008 QMS Standard, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services. ISO 9001:2008 does not contain any new requirements. As such, ISO and IAF have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 QMS Standard. It also introduces changes intended to improve consistency with ISO14001:2004 EMS Standard. The implementation plan and validity of certification to ISO 9001 QMS, as agreed by ISO and IAF, in relation to accredited certification is as under:(i) Accredited certification to the ISO 9001:2008 QMS Standard shall not be granted until the publication of ISO 9001:2008 QMS Standard as an International Standard. ISO 9001:2008 QMS Standard has since been published as International Standard on 15 November 2008.
(ii) Certification of conformity to ISO 9001:2008 QMS Standard and/or national equivalents (such as, IS/ISO 9001:2008 QMS Standard, in India) shall only be issued after official publication of ISO 9001:2008 (i.e after 15 November 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.
(iii) One year after publication of ISO 9001:2008 QMS Standard all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008 QMS Standard.
(iv) Twenty four months after publication by ISO of ISO 9001:2008 QMS Standard, any existing certification issued to ISO 9001:2000 shall not be valid.
Questions
1. What is your conclusion with regard to ISO 9001 revision?
2. What is the implementation plan for ISO 9001:2008 QMS Standard announced by International Organization for Standardization (ISO) and International Accreditation Forum (IAF)?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Wednesday, January 14, 2009
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter 7
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Author – K. R. Singhal
There are following clauses under this section:
8.1 – General
8.2 – Monitoring and measurement
8.3 – Control of nonconforming product
8.4 – Analysis of data
8.5 – Improvement
General
(Please refer to clause 8.1 of ISO 9001:2008)
The organization must plan and implement the monitoring, measurement, analysis and improvement processes needed for the following:
to demonstrate conformity to product requirements,
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality management system.
The organization must determine applicable methods (including statistical techniques) and extent of their use.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement, however there is editorial change in the wordings. As per ISO 9001:2008, monitoring, measurement, analysis and improvement processes needed ‘to demonstrate conformity to product requirements’, instead of ‘to demonstrate conformity of the product’ (as mentioned in ISO 9001:2000 QMS Standard).
Monitoring and measurement
(Please refer to clause 8.2 of ISO 9001:2008)
There are following clauses under this clause:
8.2.1 – Customer satisfaction
8.2.2 – Internal audit
8.2.3 – Monitoring and measurement of processes
8.2.4 – Monitoring and measurement of product
Customer satisfaction
(Please refer to clause 8.2.1 of ISO 9001:2008)
The organization must monitor information relating to customer perception to know whether the organization has met customer requirements. The organization must determine methods for obtaining and using information relating to customer satisfaction. This monitoring must be done by the organization as one of the measurements of the performance of organization’s quality management system.
Note at the end of this clause clarifies that monitoring customer satisfaction can include obtaining inputs from various sources, such as:
customer satisfaction surveys,
customer data on delivered product quality,
user opinion surveys,
lost business analysis,
compliments,
warranty claims, and
dealer reports.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.1 (Customer satisfaction), a note has been added that monitoring customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports.
Internal audit
(Please refer to clause 8.2.2 of ISO 9001:2008)
The organization must conduct internal audits at planned intervals. Conducting internal audits must be done to determine whether the quality management system of the organization:
conforms to the planned arrangements,
conforms to the requirements of ISO 9001:2008 Standard,
conforms to the quality management system requirements established by the organization, and
is effectively implemented and maintained.
The organization must plan an audit programme by considering the status and importance of the processes, areas to be audited and results of previous audits. The organization must define audit criteria, scope, frequency and methods of internal audit. The organization must ensure objectivity and impartiality of the audit process in selecting internal auditors and conducting internal audits. Auditors must not audit their own work.
The organization must establish a documented procedure to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
The organization must maintain records of the audits and their results.
The management (of the area or department being audited) must ensure that any necessary corrections and corrective actions are taken promptly (without undue delay) to eliminate detected nonconformities and their causes.
The organization must carry out follow-up activities including verification of the actions taken and the reporting of verification results.
Note at the end of this clause states to refer to ISO 19011 for guidance.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that the requirements of this clause reworded to give more clarity. The requirements in ISO 9001:2008 is very clear that a documented procedure must be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. It also requires that records of the audits and their results must be maintained. In Para 4 of sub-clause 8.2.2 of ISO 9001:2000 QMS Standard, before the word ‘actions’ phrase ‘any necessary corrections and corrective’ has been added in ISO 9001:2008 to give more clarity .A note at the end of sub clause 8.2.2 now refers to ISO 19011 for guidance in ISO 9001:2008, instead of ISO 10011-1, ISO 10011-2 and ISO 10011-3 as mentioned in ISO 9001:2000 QMS Standard.
Monitoring and measurement of processes
(Please refer to clause 8.2.3 of ISO 9001:2008)
The organization must apply:
suitable methods for monitoring of the quality management system processes, and
where applicable, measurement of quality management system processes.
Such suitable methods must demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, the organization must take correction and corrective action, as appropriate.
Note at the end of this clause suggests that organization should consider the type and extent of monitoring or measurement appropriate to each of its processes, when determining suitable methods, in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.3 the phrase ‘to ensure conformity of the product’ has been removed as was mentioned in ISO 9001:2000. A note added at the end of sub-clause 8.2.3 now clarifies that when deciding on appropriate methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and effectiveness of the quality management system.
Monitoring and measurement of product
(Please refer to clause 8.2.4 of ISO 9001:2008)
The organization must monitor and measure the characteristics of the product to verify that product requirements have been met. This must be carried out at appropriate stages of the product realization process in accordance with the planned arrangement. The organization must maintain evidence of conformity with the accepted criteria.
The organization must maintain records indicating the person(s) authorizing release of product for delivery to the customer.
The organization must not proceed to release product and delivery of service to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority of the organization and, where applicable, by the customer.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there are editorial changes, some additions and deletions. Requirement to maintain evidence of conformity with the accepted criteria is in Para 2 of ISO 9001:2000 QMS Standard, and this requirement has been deleted from this Para and added to Para 1 of this sub-clause in ISO 9001:2008. In Para 2 of this sub-clause in ISO 9001:2000 requires records to indicate the person(s) authorizing release of product, and this has been made more specific now in ISO 9001:2008 and records must indicate the person(s) authorizing release of product for delivery to the customer. The phrase ‘Product release and service delivery’ in Para 3 of this sub-clause (as mentioned in ISO 9001:2000 QMS Standard) has been substituted by the phrase ‘The release of product and delivery of service to the customer’ (in ISO 9001:2008).
Control of nonconforming product
(Please refer to clause 8.3 of ISO 9001:2008)
The organization must ensure that nonconforming product (the product which does not conform to product requirements) is identified and controlled to prevent its unintended use or delivery. The organization must establish a documented procedure to define the controls and related responsibilities and authorities for dealing with nonconforming product.
Where applicable, the organization must deal with nonconforming product by one or more of the following ways:
by taking action to eliminate the detected nonconformity,
by authorizing its use, release or acceptance under concession by relevant authority and, where applicable, by the customer,
by taking action to preclude its original intended use or application,
by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.
When organization carries out correction in nonconforming product, such correction must be subject to re-verification to demonstrate conformity to the requirements.
The organization must main records of the nature of nonconformities and any subsequent actions taken, including concessions obtained.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that Para 1 of this clause has been reframed to provide more clarity. The term ‘where applicable’ is added in the beginning in Para 2 of this clause. The requirements of Para 3 and Para 4 of this clause (in ISO 9001:2000 QMS Standard) have been interchanged as Para 4 and Para 3 in ISO 9001:2008 without any change in wordings. The requirement mentioned in Para 5 of this clause (mentioned in ISO 9001:2000 QMS Standard) has been shifted in Para 3 Bullet d) with appropriate reframing of wordings (in ISO 9001:2008).
Analysis of data
(Please refer to clause 8.4 of ISO 9001:2008)
The organization must determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This must include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data must provide information relating to:
customer satisfaction,
conformity to product requirements,
characteristics and trends of processes and products, including opportunities for preventive action, and
suppliers.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of this clause, however, reference to clause has been changed or added. In clause 8.4 (b), reference to ‘(see 8.2.4)’ has been mentioned in ISO 9001:2008 instead of ‘(see 7.2.1)’ as mentioned in ISO 9001:2000 QMS Standard. In clause 8.4 (c), after ‘… preventive action’ the words ‘(see 8.2.3 and 8.2.4)’ have been added. In clause 8.4 (d), after suppliers the words ‘(see 7.4)’ added.
Improvement
(Please refer to clause 8.5 of ISO 9001:2008)
There are following clauses under this clause:
8.5.1 – Continual improvement
8.5.2 – Corrective action
8.5.3 – Preventive action
Continual improvement
(Please refer to clause 8.5.1 of ISO 9001:2008)
The organization must continually improve the effectiveness of the organization’s quality management system. This must be done through the use of the following:
quality policy,
quality objectives,
audit results,
analysis of data,
corrective action,
preventive action, and
management review.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of sub-clause 8.5.1 (Continual improvement).
Corrective action
(Please refer to clause 8.5.2 of ISO 9001:2008)
The organization must take corrective action, appropriate to the effects of the nonconformities encountered, to eliminate the causes of nonconformities in order to prevent recurrence.
The organization must establish a documented procedure that defines requirements for the following:
reviewing nonconformities,
determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities do not recur,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the corrective action taken.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.2 (Corrective action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. The word ‘cause’ (as mentioned in Para 1 of sub-clause 8.5.2 in ISO 9001:2000 QMS Standard) has been substituted by the word ‘causes’ (in ISO 9001:2008). Instead of ‘reviewing the corrective action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the corrective action taken’ (in ISO 9001:2008).
Preventive action
(Please refer to clause 8.5.3 of ISO 9001:2008)
The organization must determine preventive action, appropriate to the effects of the potential problems, to eliminate the causes of potential nonconformities in order to prevent their occurrence.
The organization must establish a documented procedure to define requirements for:
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the preventive action taken.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.3 (Preventive action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. Instead of ‘reviewing the preventive action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the preventive action taken’ (in ISO 9001:2008).
Questions
What are the key changes in clause 8.1 (measurement, analysis and improvement – General) in ISO 9001?
What are the key changes in clause 8.2.1 (Customer satisfaction) in ISO 9001?
What are the key changes in clause 8.2.2 (Internal Audit) in ISO 9001?
What are the key changes in clause 8.2.3 (Monitoring and measurement of processes) in ISO 9001?
What are the key changes in clause 8.2.4 (Monitoring and measurement of product) in ISO 9001?
What are the key changes in clause 8.3 (Control of nonconforming product) in ISO 9001?
What are the key changes in clause 8.4 (Analysis of data) in ISO 9001?
What are the key changes in clause 8.5 (Improvement) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter 7
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Author – K. R. Singhal
There are following clauses under this section:
8.1 – General
8.2 – Monitoring and measurement
8.3 – Control of nonconforming product
8.4 – Analysis of data
8.5 – Improvement
General
(Please refer to clause 8.1 of ISO 9001:2008)
The organization must plan and implement the monitoring, measurement, analysis and improvement processes needed for the following:
to demonstrate conformity to product requirements,
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality management system.
The organization must determine applicable methods (including statistical techniques) and extent of their use.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement, however there is editorial change in the wordings. As per ISO 9001:2008, monitoring, measurement, analysis and improvement processes needed ‘to demonstrate conformity to product requirements’, instead of ‘to demonstrate conformity of the product’ (as mentioned in ISO 9001:2000 QMS Standard).
Monitoring and measurement
(Please refer to clause 8.2 of ISO 9001:2008)
There are following clauses under this clause:
8.2.1 – Customer satisfaction
8.2.2 – Internal audit
8.2.3 – Monitoring and measurement of processes
8.2.4 – Monitoring and measurement of product
Customer satisfaction
(Please refer to clause 8.2.1 of ISO 9001:2008)
The organization must monitor information relating to customer perception to know whether the organization has met customer requirements. The organization must determine methods for obtaining and using information relating to customer satisfaction. This monitoring must be done by the organization as one of the measurements of the performance of organization’s quality management system.
Note at the end of this clause clarifies that monitoring customer satisfaction can include obtaining inputs from various sources, such as:
customer satisfaction surveys,
customer data on delivered product quality,
user opinion surveys,
lost business analysis,
compliments,
warranty claims, and
dealer reports.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.1 (Customer satisfaction), a note has been added that monitoring customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports.
Internal audit
(Please refer to clause 8.2.2 of ISO 9001:2008)
The organization must conduct internal audits at planned intervals. Conducting internal audits must be done to determine whether the quality management system of the organization:
conforms to the planned arrangements,
conforms to the requirements of ISO 9001:2008 Standard,
conforms to the quality management system requirements established by the organization, and
is effectively implemented and maintained.
The organization must plan an audit programme by considering the status and importance of the processes, areas to be audited and results of previous audits. The organization must define audit criteria, scope, frequency and methods of internal audit. The organization must ensure objectivity and impartiality of the audit process in selecting internal auditors and conducting internal audits. Auditors must not audit their own work.
The organization must establish a documented procedure to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
The organization must maintain records of the audits and their results.
The management (of the area or department being audited) must ensure that any necessary corrections and corrective actions are taken promptly (without undue delay) to eliminate detected nonconformities and their causes.
The organization must carry out follow-up activities including verification of the actions taken and the reporting of verification results.
Note at the end of this clause states to refer to ISO 19011 for guidance.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that the requirements of this clause reworded to give more clarity. The requirements in ISO 9001:2008 is very clear that a documented procedure must be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. It also requires that records of the audits and their results must be maintained. In Para 4 of sub-clause 8.2.2 of ISO 9001:2000 QMS Standard, before the word ‘actions’ phrase ‘any necessary corrections and corrective’ has been added in ISO 9001:2008 to give more clarity .A note at the end of sub clause 8.2.2 now refers to ISO 19011 for guidance in ISO 9001:2008, instead of ISO 10011-1, ISO 10011-2 and ISO 10011-3 as mentioned in ISO 9001:2000 QMS Standard.
Monitoring and measurement of processes
(Please refer to clause 8.2.3 of ISO 9001:2008)
The organization must apply:
suitable methods for monitoring of the quality management system processes, and
where applicable, measurement of quality management system processes.
Such suitable methods must demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, the organization must take correction and corrective action, as appropriate.
Note at the end of this clause suggests that organization should consider the type and extent of monitoring or measurement appropriate to each of its processes, when determining suitable methods, in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.3 the phrase ‘to ensure conformity of the product’ has been removed as was mentioned in ISO 9001:2000. A note added at the end of sub-clause 8.2.3 now clarifies that when deciding on appropriate methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and effectiveness of the quality management system.
Monitoring and measurement of product
(Please refer to clause 8.2.4 of ISO 9001:2008)
The organization must monitor and measure the characteristics of the product to verify that product requirements have been met. This must be carried out at appropriate stages of the product realization process in accordance with the planned arrangement. The organization must maintain evidence of conformity with the accepted criteria.
The organization must maintain records indicating the person(s) authorizing release of product for delivery to the customer.
The organization must not proceed to release product and delivery of service to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority of the organization and, where applicable, by the customer.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there are editorial changes, some additions and deletions. Requirement to maintain evidence of conformity with the accepted criteria is in Para 2 of ISO 9001:2000 QMS Standard, and this requirement has been deleted from this Para and added to Para 1 of this sub-clause in ISO 9001:2008. In Para 2 of this sub-clause in ISO 9001:2000 requires records to indicate the person(s) authorizing release of product, and this has been made more specific now in ISO 9001:2008 and records must indicate the person(s) authorizing release of product for delivery to the customer. The phrase ‘Product release and service delivery’ in Para 3 of this sub-clause (as mentioned in ISO 9001:2000 QMS Standard) has been substituted by the phrase ‘The release of product and delivery of service to the customer’ (in ISO 9001:2008).
Control of nonconforming product
(Please refer to clause 8.3 of ISO 9001:2008)
The organization must ensure that nonconforming product (the product which does not conform to product requirements) is identified and controlled to prevent its unintended use or delivery. The organization must establish a documented procedure to define the controls and related responsibilities and authorities for dealing with nonconforming product.
Where applicable, the organization must deal with nonconforming product by one or more of the following ways:
by taking action to eliminate the detected nonconformity,
by authorizing its use, release or acceptance under concession by relevant authority and, where applicable, by the customer,
by taking action to preclude its original intended use or application,
by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.
When organization carries out correction in nonconforming product, such correction must be subject to re-verification to demonstrate conformity to the requirements.
The organization must main records of the nature of nonconformities and any subsequent actions taken, including concessions obtained.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that Para 1 of this clause has been reframed to provide more clarity. The term ‘where applicable’ is added in the beginning in Para 2 of this clause. The requirements of Para 3 and Para 4 of this clause (in ISO 9001:2000 QMS Standard) have been interchanged as Para 4 and Para 3 in ISO 9001:2008 without any change in wordings. The requirement mentioned in Para 5 of this clause (mentioned in ISO 9001:2000 QMS Standard) has been shifted in Para 3 Bullet d) with appropriate reframing of wordings (in ISO 9001:2008).
Analysis of data
(Please refer to clause 8.4 of ISO 9001:2008)
The organization must determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This must include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data must provide information relating to:
customer satisfaction,
conformity to product requirements,
characteristics and trends of processes and products, including opportunities for preventive action, and
suppliers.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of this clause, however, reference to clause has been changed or added. In clause 8.4 (b), reference to ‘(see 8.2.4)’ has been mentioned in ISO 9001:2008 instead of ‘(see 7.2.1)’ as mentioned in ISO 9001:2000 QMS Standard. In clause 8.4 (c), after ‘… preventive action’ the words ‘(see 8.2.3 and 8.2.4)’ have been added. In clause 8.4 (d), after suppliers the words ‘(see 7.4)’ added.
Improvement
(Please refer to clause 8.5 of ISO 9001:2008)
There are following clauses under this clause:
8.5.1 – Continual improvement
8.5.2 – Corrective action
8.5.3 – Preventive action
Continual improvement
(Please refer to clause 8.5.1 of ISO 9001:2008)
The organization must continually improve the effectiveness of the organization’s quality management system. This must be done through the use of the following:
quality policy,
quality objectives,
audit results,
analysis of data,
corrective action,
preventive action, and
management review.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of sub-clause 8.5.1 (Continual improvement).
Corrective action
(Please refer to clause 8.5.2 of ISO 9001:2008)
The organization must take corrective action, appropriate to the effects of the nonconformities encountered, to eliminate the causes of nonconformities in order to prevent recurrence.
The organization must establish a documented procedure that defines requirements for the following:
reviewing nonconformities,
determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities do not recur,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the corrective action taken.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.2 (Corrective action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. The word ‘cause’ (as mentioned in Para 1 of sub-clause 8.5.2 in ISO 9001:2000 QMS Standard) has been substituted by the word ‘causes’ (in ISO 9001:2008). Instead of ‘reviewing the corrective action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the corrective action taken’ (in ISO 9001:2008).
Preventive action
(Please refer to clause 8.5.3 of ISO 9001:2008)
The organization must determine preventive action, appropriate to the effects of the potential problems, to eliminate the causes of potential nonconformities in order to prevent their occurrence.
The organization must establish a documented procedure to define requirements for:
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the preventive action taken.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.3 (Preventive action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. Instead of ‘reviewing the preventive action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the preventive action taken’ (in ISO 9001:2008).
Questions
What are the key changes in clause 8.1 (measurement, analysis and improvement – General) in ISO 9001?
What are the key changes in clause 8.2.1 (Customer satisfaction) in ISO 9001?
What are the key changes in clause 8.2.2 (Internal Audit) in ISO 9001?
What are the key changes in clause 8.2.3 (Monitoring and measurement of processes) in ISO 9001?
What are the key changes in clause 8.2.4 (Monitoring and measurement of product) in ISO 9001?
What are the key changes in clause 8.3 (Control of nonconforming product) in ISO 9001?
What are the key changes in clause 8.4 (Analysis of data) in ISO 9001?
What are the key changes in clause 8.5 (Improvement) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Sunday, December 21, 2008
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter – 6
PRODUCT REALIZATION
Author – K. R. Singhal
There are following clauses under this section:
7.1 – Planning of product realization
7.2 – Customer-related processes
7.3 – Design and development
7.4 – Purchasing
7.5 – Production and service provision
7.6 – Control of monitoring and n measuring equipment
Planning of product realization
(Please refer to Clause 7.1 of ISO 9001:2008)
The organization must plan the processes needed for product realization and the organization must develop such processes.
Planning of product realization must be consistent with the requirements of the other processes of the QMS. In this connection, a reference to clause 4.1 of ISO 9001:2008 is needed.
In planning product realization, the organization must (as appropriate) determine the following:
quality objectives for the product
requirements for the product
the need to establish processes
the need to establish documents
the need to provide resources specific to the product
required verification activity specific to the product
required validation activity specific to the product
required monitoring activity specific to the product
required measurement activity specific to the product
required inspection activity specific to the product
required test activity specific to the product
the criteria for product acceptance
records needed to provide evidence that the realization processes and resulting product meet requirements
A reference to clause 4.2.4 of ISO 9001:2008 is needed for control of records.
The output of planning of product realization must be in a form suitable for method of operations of the organization.
There are two notes at the end of clause 7.1 of ISO 9001:2008.
Note 1 clarifies the term quality plan. A quality plan is a document specifying:
the process of the quality management system (including the product realization processes), and
the resources to be applied to a specific product, project or contract.
Note 2 clarifies that those requirements given in clause 7.3 (design and development) to the development of product realization processes may be applied by the organization.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that the requirement in clause 7.1 (b) has been reframed being editorial change. In clause 7.1 (c), the word ‘measurement’ has been added, accordingly, the organization needs to also determine required measurement activities, as appropriate, specific to the product and the criteria for product acceptance.
Customer-related processes
(Please refer to Clause 7.2 of ISO 9001:2008)
There are following clauses under this clause:
7.2.1 – Determination of requirements related to the product
7.2.2 – Review of requirements related to the product
7.2.3 – Customer communication
Determination of requirements related to the product
(Please refer to Clause 7.2.1 of ISO 9001:2008)
The organization must determine:
customer requirements,
requirements for delivery and post-delivery activities,
requirements, necessary for specified or intended use of the product, although not stated by the customer,
applicable legal (statutory and regulatory) requirements related to the product,
any other requirements, that are considered necessary by the organization.
Note at the end of this clause clarifies the term post-delivery activities. Actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling, final disposal) are part of post delivery activities.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that requirement has been slightly re-worded. The word ‘related’ has been changed to ‘applicable’. The wordings of clause 7.2.1 (d) that ‘any additional requirements determined by the organization’ (in ISO 9001:2000 Standard) have been changed to ‘any additional requirements considered necessary by the organization’ (in ISO 9001:2008). Accordingly, now the organization must determine any additional requirements considered necessary by the organization.
A note has been added at the end of sub clause 7.2.1 in ISO 9001:2008 clarifying the post delivery activities to include actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling and final disposal). Old version did not clarify what post delivery meant; now the new version has clarified the same.
Review of requirements related to the product
(Please refer to Clause 7.2.2 of ISO 9001:2008)
The organization must review, the requirements related to the product, prior to the organization’s commitment to supply a product to the customer. Accordingly, the organization must review the requirements related to the product before submission of tenders, acceptance of contracts, acceptance of orders, acceptance of changes to the contracts, or acceptance of changes to orders.
The organization must also ensure the following:
to define product requirements,
to resolve contract or order requirements differing from those previously expressed,
the organization has the ability to meet requirements that are defined.
The organization must maintain following records:
results of the review, and
actions arising from the review.
Sometimes customer provides its requirements verbally (not written requirements), in such situation, the organization must confirm such customer requirements before acceptance to supply the product to the customer.
There may be instances when product requirements are changed, in such situation, the organization must ensure that relevant documents are amended and information about the changed requirements is made aware to relevant personnel.
A note at the end of the clause provides clarification that a formal review of requirements is impractical for organization and customer in some situations, as in the case of internet sales. In such cases, the review of requirements can cover relevant product information, such as catalogues and adverting material.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.2.2.
Customer communication
(Please refer to clause 7.2.3 of ISO 9001:2008)
The organization must determine and implement effective arrangements for communicating with customers in relation to:
product information,
enquiries,
contracts or order handling,
amendments, if any,
customer feedback,
customer complaints, if any.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.2.3.
Design and development
(Please refer to clause 7.3 of ISO 9001:2008)
There are following clauses under this clause:
7.3.1 – Design and development planning
7.3.2 – Design and development inputs
7.3.3 – Design and development outputs
7.3.4 – Design and development review
7.3.5 – Design and development verification
7.3.6 – Design and development validation
7.3.7 – Control of design and development changes
Design and development planning
(Please refer to clause 7.3.1 of ISO 9001:2008)
The organization must plan and control the design and development of product.
During the planning of design and development, the organization must determine:
the stages of design and development,
the review, verification and validation (appropriate to each design and development stage), and
responsibilities and authorities for design and development.
The organization must manage the interfaces between different groups involved in design and development. The purpose is to ensure effective communication and clear assignment of responsibility.
During the progress of design and development, planning must be updated, as appropriate.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) a note added in the sub-clause 7.3.1 (Design and development planning) in ISO 9001:2008 clarifies that design and development review, verification and validation are separate activities having distinct purposes and these may be conducted and recorded separately or in combination as suitable for the product and the organization.
Design and development inputs
(Please refer to clause 7.3.2 of ISO 9001:2008)
The organization must determine design and development inputs relating to product requirements and maintain records. The design and development inputs must contain:
functional requirements,
performance requirements,
applicable legal (statutory and regulatory) requirements,
other requirements necessary for design and development.
The organization must review design and development inputs for adequacy. Requirements must be:
complete,
unambiguous, and
not in conflict with each other.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is editorial change in the wordings of sub-clause 7.3.2 (Design and development inputs), no change in the requirement.
Design and development outputs
(Please refer to clause 7.3.3 of ISO 9001:2008)
The outputs of design and development must be such that are suitable for verification against the design and development inputs and outputs must be approved prior to release.
Design and development outputs must:
meet input requirements for design and development,
provide appropriate information for purchasing,
provide appropriate information for production and service provision,
contain product acceptance criteria or its reference, and
specify characteristics (essential for safe and proper use) of the product.
Note at the end of the clause clarify that information for production and service provision may include details for preservation of product.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), in this clause, the word ‘provided’ mentioned in old version has been removed and the phrase ‘suitable for’ (in new version) replaces ‘that enables’ (of the old version). The word ‘for’ (service provision) has been removed. A new note (added in ISO 9001:2008) in the sub clause 7.3.3 clarifies that information for production and service provision may include details for the preservation of product.
The old version requires making sure that design and development process generate outputs information that must have to meet certain thing, but the new version also requires that design and development outputs could include information that must explain how product to be preserved during production and service provision..
Design and development review
(Please refer to clause 7.3.4 of ISO 9001:2008)
The organization must perform systematic design and development review at suitable stages in accordance with planned arrangements:
to evaluate the ability of the results of design and development to meet requirements, and
to identify any problems, and
to propose necessary actions.
Participants in such reviews must be from the functions concerned with the design and development stage / stages that are being reviewed. The organization must maintain records of the results of the reviews and any necessary actions.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.4.
Design and development verification
(Please refer to clause 7.3.5 of ISO 9001:2008)
The organization must perform design and development verification in accordance with planned arrangement to ensure that the design and development outputs have met the design and development input requirements. The organization must maintain records of the results of the verification and any necessary actions.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.5.
Design and development validation
(Please refer to clause 7.3.6 of ISO 9001:2008)
The organization must perform design and development validation in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use of the product, where known. Where it is possible (practicable), design and development validation must be completed prior to the delivery or implementation of the product. The organization must maintain records of the result of validation and any necessary action.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.6.
Control of design and development changes
(Please refer to clause 7.3.7 of ISO 9001:2008)
The organization must identify design and development changes and maintain records. The organization must review, verify and validate design and development changes, as appropriate, and approve such changes before implementation. The design and development changes’ review must include evaluation of the effect of the changes on constituent parts and product already delivered. The organization must maintain results of the review of changes and any necessary actions.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.7. There is editorial change, no text change. Two Para of old version merged to one Para in new version.
Purchasing
(Please refer to clause 7.4 of ISO 9001:2008)
There are following clauses under this clause:
7.4.1 – Purchasing process
7.4.2 – Purchasing information
7.4.3 – Verification of purchased product
Purchasing process
(Please refer to clause 7.4.1 of ISO 9001:2008)
The organization must ensure that purchased product conforms to specified purchase requirements. The type and extent of control (on the supplier and the purchased product)must be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization must evaluate and select supplier. Such evaluation and selection must be based on the ability of suppliers to supply product in accordance with the organization’s requirements. The organization must establish:
criteria for selection,
criteria for evaluation, and
criteria for re-evaluation.
The organization must maintain records of the results of evaluations and any necessary actions arising from the evaluation.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.4.1.
Purchasing information
(Please refer to clause 7.4.2 of ISO 9001:2008)
Organization’s purchasing information must describe the product to be purchased. Where appropriate, following must be included in the purchasing information:
requirements for approval of product,
requirements for approval of procedures,
requirements for approval of processes,
requirements for approval of equipment,
requirements for qualification of personnel, and
any other quality management system requirements.
The organization must ensure adequacy of specified purchase requirements prior to their communication to the supplier.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.4.2.
Verification of purchased product
(Please refer to clause 7.4.3 of ISO 9001:2008)
The organization must establish and implement the inspection and other activities necessary to ensure that purchased product meets specified purchase requirements.
Where the organization or its customer wishes to perform verification at supplier’s premises, the organization must state the intended verification arrangements and method of product release in the purchasing information.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.4.3.
Production and service provision
(Please refer to clause 7.5 of ISO 9001:2008)
There are following clauses under this clause:
7.5.1 – Control of production and service provision
7.5.2 – Validation of processes for production and service provision
7.5.3 – Identification and traceability
7.5.4 – Customer property
7.5.5 – Preservation of product
Control of production and service provision
(Please refer to clause 7.5.1 of ISO 9001:2008)
The organization must plan and carry out production and service provision under controlled conditions. Controlled condition must include, as applicable, the following:
the availability of information about the product characteristics,
the availability of work instructions, as necessary,
the use of suitable equipment,
the availability and use of monitoring and measuring equipment,
the implementation of monitoring and measurement, and
the implementation of product release, delivery and post-delivery activities.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), the term ‘monitoring and measuring devices’ (mentioned in ISO 9001:2000 QMS Standard) has been replaced by the term ‘monitoring and measuring equipment’ (in ISO 9001:2008). It is now clearly mentioned in the new standard that release (mentioned in old version) is product release.
Validation of processes for production and service provision
(Please refer to clause 7.5.2 of ISO 9001:2008)
The organization must validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
Validation must demonstrate the ability of these processes to achieve planned results.
The organization must establish arrangements for these processes including, as applicable, the following:
defined criteria for review of the processes,
defined criteria for approval of the processes,
approval of equipment,
approval of qualification of personnel,
use of specific methods and procedures,
requirements for records, and
revalidation.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), in clause requirement, there is editorial change and accordingly as per new version, the organization must validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement and as a consequences deficiencies are known only after the product is in use or service has been delivered.
Identification and traceability
(Please refer to clause 7.5.3 of ISO 9001:2008)
Where appropriate, the organization must identify the product by suitable means throughout product realization process.
The organization must identify the product status with respect to monitoring and measurement requirements throughout product realization.
Where traceability is a requirement, the organization must control the unique identification of the product. The organization must also maintain such records.
Note at the end of the clause clarifies that in some industry sectors identification and traceability are maintained by configuration management.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), Para 2 of this sub-clause has been modified and organization needs to identify the product status with respect to monitoring and measurement requirements throughout product realization. In Para 3 of this sub-clause, there is slight modification in wordings and maintaining records is a requirement instead of just recording the unique identification of the product (as mentioned in ISO 9001:2000 QMS Standard). There is no change in the requirement to control the unique identification of the product, where traceability is a requirement.
Customer property
(Please refer to clause 7.5.4 of ISO 9001:2008)
The organization must exercise care with customer property while the customer property is under the control of the organization or being used by the organization. The organization must identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization must report this to the customer and maintain records.
Note at the end of this clause clarifies that the customer property can include intellectual property and personal data.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), there is no change in the requirement and maintaining records has been made clearer in this sub-clause. There is editorial change in this sub-clause. A note at the end of sub clause 7.5.4 has been made clearer to include ‘personal data’ as customer property.
Preservation of product
(Please refer to clause 7.5.5 of ISO 9001:2008)
In order to maintain conformity to requirements, the organization must preserve the product during:
internal processing, and
delivery to the intended destination.
As applicable, preservation must include:
identification,
handling,
packaging,
storage, and
protection.
Preservation must apply to the constituent parts of a product.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), the terms ‘conformity to requirements’ and ‘as applicable’ have been added to provide more clarity. Accordingly, now as per ISO 9001:2008, the organization needs to preserve the product (earlier ISO 9001:2000 QMS Standard mentioned ‘the conformity of product’) during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation must include identification, handling, packaging, storage and protection. Preservation must also apply to the constituent parts of a product.
Control of monitoring and measuring equipment
(Please refer to clause 7.6 of ISO 9001:2008)
The organization must determine:
the monitoring and measurement to be undertaken, and
the monitoring and measuring equipment needed,
to provide evidence of conformity of product to determined requirements.
To ensure performing monitoring and measurement consistent with requirements the organization must establish processes.
Where necessary to ensure valid results, measuring equipment must:
be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards,
be adjusted or re-adjusted as necessary,
have identification in order to determine its calibration status, be safeguarded from adjustments that would invalidate the measurement results,
be protected from damage and deterioration during handling, maintenance and storage.
Where no international or national standards exist, the basis used for calibration or verification must be recorded.
The organization must also assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization must take appropriate action on the equipment and any product affected.
The organization must maintain the results of calibration and verification.
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application must be confirmed. This must be undertaken prior to initial use and reconfirmed as necessary.
Note at the end of this clause clarifies that confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that the term ‘devices’ (of the old version) has been replaced by the term ‘equipment’ (in the new version). Thus the title of this clause is also revised. The requirement of this clause has been reworded to bring in more clarity. Reference to see 7.2.1 has been deleted. The words ‘or both,’ have been added after the words ‘be calibrated or verified,’ in clause 7.6 (a). In 7.6 (c), instead of ‘be identified to enable the calibration status to be determined’ (mentioned in ISO 9001:2000 QMS Standard) the requirement now says ‘have identification in order to determine its calibration status’ (in ISO 9001:2008). A new Para 5 in this clause has been made (in ISO 9001:2008) from the Para 4 of this clause (in ISO 9001:2000 QMS Standard), this Para 4 of ISO 9001:2000 QMS Standard is converted in two Para (Para 4 and Para 5) in ISO 9001:2008. Para 5 of this clause (in ISO 9001:2000 QMS Standard) is now Para 6 of this clause (in ISO 9001:2008). The note at the end of this clause (in ISO 9001:2000 QMS Standard) ‘See ISO 10012-1 and ISO 10012-2 for guidance’ has been deleted. Explanatory notes have been added at the end of this clause regarding the use of computer ‘software to satisfy the intended application typically includes its verification and configuration management to maintain its suitability for use.
Questions
What are the key changes in clause 7.1 (Planning of product realization) in ISO 9001?
What are the key changes in clause 7.2 (Customer related processes) in ISO 9001?
What are the key changes in clause 7.3 (Design and development) in ISO 9001?
What are the key changes in clause 7.4 (Purchasing) in ISO 9001?
What are the key changes in clause 7.5 (Production and service provision) in ISO 9001?
What are the key changes in clause 7.6 (Control of monitoring and measuring devices) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter – 6
PRODUCT REALIZATION
Author – K. R. Singhal
There are following clauses under this section:
7.1 – Planning of product realization
7.2 – Customer-related processes
7.3 – Design and development
7.4 – Purchasing
7.5 – Production and service provision
7.6 – Control of monitoring and n measuring equipment
Planning of product realization
(Please refer to Clause 7.1 of ISO 9001:2008)
The organization must plan the processes needed for product realization and the organization must develop such processes.
Planning of product realization must be consistent with the requirements of the other processes of the QMS. In this connection, a reference to clause 4.1 of ISO 9001:2008 is needed.
In planning product realization, the organization must (as appropriate) determine the following:
quality objectives for the product
requirements for the product
the need to establish processes
the need to establish documents
the need to provide resources specific to the product
required verification activity specific to the product
required validation activity specific to the product
required monitoring activity specific to the product
required measurement activity specific to the product
required inspection activity specific to the product
required test activity specific to the product
the criteria for product acceptance
records needed to provide evidence that the realization processes and resulting product meet requirements
A reference to clause 4.2.4 of ISO 9001:2008 is needed for control of records.
The output of planning of product realization must be in a form suitable for method of operations of the organization.
There are two notes at the end of clause 7.1 of ISO 9001:2008.
Note 1 clarifies the term quality plan. A quality plan is a document specifying:
the process of the quality management system (including the product realization processes), and
the resources to be applied to a specific product, project or contract.
Note 2 clarifies that those requirements given in clause 7.3 (design and development) to the development of product realization processes may be applied by the organization.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that the requirement in clause 7.1 (b) has been reframed being editorial change. In clause 7.1 (c), the word ‘measurement’ has been added, accordingly, the organization needs to also determine required measurement activities, as appropriate, specific to the product and the criteria for product acceptance.
Customer-related processes
(Please refer to Clause 7.2 of ISO 9001:2008)
There are following clauses under this clause:
7.2.1 – Determination of requirements related to the product
7.2.2 – Review of requirements related to the product
7.2.3 – Customer communication
Determination of requirements related to the product
(Please refer to Clause 7.2.1 of ISO 9001:2008)
The organization must determine:
customer requirements,
requirements for delivery and post-delivery activities,
requirements, necessary for specified or intended use of the product, although not stated by the customer,
applicable legal (statutory and regulatory) requirements related to the product,
any other requirements, that are considered necessary by the organization.
Note at the end of this clause clarifies the term post-delivery activities. Actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling, final disposal) are part of post delivery activities.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that requirement has been slightly re-worded. The word ‘related’ has been changed to ‘applicable’. The wordings of clause 7.2.1 (d) that ‘any additional requirements determined by the organization’ (in ISO 9001:2000 Standard) have been changed to ‘any additional requirements considered necessary by the organization’ (in ISO 9001:2008). Accordingly, now the organization must determine any additional requirements considered necessary by the organization.
A note has been added at the end of sub clause 7.2.1 in ISO 9001:2008 clarifying the post delivery activities to include actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling and final disposal). Old version did not clarify what post delivery meant; now the new version has clarified the same.
Review of requirements related to the product
(Please refer to Clause 7.2.2 of ISO 9001:2008)
The organization must review, the requirements related to the product, prior to the organization’s commitment to supply a product to the customer. Accordingly, the organization must review the requirements related to the product before submission of tenders, acceptance of contracts, acceptance of orders, acceptance of changes to the contracts, or acceptance of changes to orders.
The organization must also ensure the following:
to define product requirements,
to resolve contract or order requirements differing from those previously expressed,
the organization has the ability to meet requirements that are defined.
The organization must maintain following records:
results of the review, and
actions arising from the review.
Sometimes customer provides its requirements verbally (not written requirements), in such situation, the organization must confirm such customer requirements before acceptance to supply the product to the customer.
There may be instances when product requirements are changed, in such situation, the organization must ensure that relevant documents are amended and information about the changed requirements is made aware to relevant personnel.
A note at the end of the clause provides clarification that a formal review of requirements is impractical for organization and customer in some situations, as in the case of internet sales. In such cases, the review of requirements can cover relevant product information, such as catalogues and adverting material.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.2.2.
Customer communication
(Please refer to clause 7.2.3 of ISO 9001:2008)
The organization must determine and implement effective arrangements for communicating with customers in relation to:
product information,
enquiries,
contracts or order handling,
amendments, if any,
customer feedback,
customer complaints, if any.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.2.3.
Design and development
(Please refer to clause 7.3 of ISO 9001:2008)
There are following clauses under this clause:
7.3.1 – Design and development planning
7.3.2 – Design and development inputs
7.3.3 – Design and development outputs
7.3.4 – Design and development review
7.3.5 – Design and development verification
7.3.6 – Design and development validation
7.3.7 – Control of design and development changes
Design and development planning
(Please refer to clause 7.3.1 of ISO 9001:2008)
The organization must plan and control the design and development of product.
During the planning of design and development, the organization must determine:
the stages of design and development,
the review, verification and validation (appropriate to each design and development stage), and
responsibilities and authorities for design and development.
The organization must manage the interfaces between different groups involved in design and development. The purpose is to ensure effective communication and clear assignment of responsibility.
During the progress of design and development, planning must be updated, as appropriate.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) a note added in the sub-clause 7.3.1 (Design and development planning) in ISO 9001:2008 clarifies that design and development review, verification and validation are separate activities having distinct purposes and these may be conducted and recorded separately or in combination as suitable for the product and the organization.
Design and development inputs
(Please refer to clause 7.3.2 of ISO 9001:2008)
The organization must determine design and development inputs relating to product requirements and maintain records. The design and development inputs must contain:
functional requirements,
performance requirements,
applicable legal (statutory and regulatory) requirements,
other requirements necessary for design and development.
The organization must review design and development inputs for adequacy. Requirements must be:
complete,
unambiguous, and
not in conflict with each other.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is editorial change in the wordings of sub-clause 7.3.2 (Design and development inputs), no change in the requirement.
Design and development outputs
(Please refer to clause 7.3.3 of ISO 9001:2008)
The outputs of design and development must be such that are suitable for verification against the design and development inputs and outputs must be approved prior to release.
Design and development outputs must:
meet input requirements for design and development,
provide appropriate information for purchasing,
provide appropriate information for production and service provision,
contain product acceptance criteria or its reference, and
specify characteristics (essential for safe and proper use) of the product.
Note at the end of the clause clarify that information for production and service provision may include details for preservation of product.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), in this clause, the word ‘provided’ mentioned in old version has been removed and the phrase ‘suitable for’ (in new version) replaces ‘that enables’ (of the old version). The word ‘for’ (service provision) has been removed. A new note (added in ISO 9001:2008) in the sub clause 7.3.3 clarifies that information for production and service provision may include details for the preservation of product.
The old version requires making sure that design and development process generate outputs information that must have to meet certain thing, but the new version also requires that design and development outputs could include information that must explain how product to be preserved during production and service provision..
Design and development review
(Please refer to clause 7.3.4 of ISO 9001:2008)
The organization must perform systematic design and development review at suitable stages in accordance with planned arrangements:
to evaluate the ability of the results of design and development to meet requirements, and
to identify any problems, and
to propose necessary actions.
Participants in such reviews must be from the functions concerned with the design and development stage / stages that are being reviewed. The organization must maintain records of the results of the reviews and any necessary actions.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.4.
Design and development verification
(Please refer to clause 7.3.5 of ISO 9001:2008)
The organization must perform design and development verification in accordance with planned arrangement to ensure that the design and development outputs have met the design and development input requirements. The organization must maintain records of the results of the verification and any necessary actions.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.5.
Design and development validation
(Please refer to clause 7.3.6 of ISO 9001:2008)
The organization must perform design and development validation in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use of the product, where known. Where it is possible (practicable), design and development validation must be completed prior to the delivery or implementation of the product. The organization must maintain records of the result of validation and any necessary action.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.6.
Control of design and development changes
(Please refer to clause 7.3.7 of ISO 9001:2008)
The organization must identify design and development changes and maintain records. The organization must review, verify and validate design and development changes, as appropriate, and approve such changes before implementation. The design and development changes’ review must include evaluation of the effect of the changes on constituent parts and product already delivered. The organization must maintain results of the review of changes and any necessary actions.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.7. There is editorial change, no text change. Two Para of old version merged to one Para in new version.
Purchasing
(Please refer to clause 7.4 of ISO 9001:2008)
There are following clauses under this clause:
7.4.1 – Purchasing process
7.4.2 – Purchasing information
7.4.3 – Verification of purchased product
Purchasing process
(Please refer to clause 7.4.1 of ISO 9001:2008)
The organization must ensure that purchased product conforms to specified purchase requirements. The type and extent of control (on the supplier and the purchased product)must be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization must evaluate and select supplier. Such evaluation and selection must be based on the ability of suppliers to supply product in accordance with the organization’s requirements. The organization must establish:
criteria for selection,
criteria for evaluation, and
criteria for re-evaluation.
The organization must maintain records of the results of evaluations and any necessary actions arising from the evaluation.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.4.1.
Purchasing information
(Please refer to clause 7.4.2 of ISO 9001:2008)
Organization’s purchasing information must describe the product to be purchased. Where appropriate, following must be included in the purchasing information:
requirements for approval of product,
requirements for approval of procedures,
requirements for approval of processes,
requirements for approval of equipment,
requirements for qualification of personnel, and
any other quality management system requirements.
The organization must ensure adequacy of specified purchase requirements prior to their communication to the supplier.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.4.2.
Verification of purchased product
(Please refer to clause 7.4.3 of ISO 9001:2008)
The organization must establish and implement the inspection and other activities necessary to ensure that purchased product meets specified purchase requirements.
Where the organization or its customer wishes to perform verification at supplier’s premises, the organization must state the intended verification arrangements and method of product release in the purchasing information.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.4.3.
Production and service provision
(Please refer to clause 7.5 of ISO 9001:2008)
There are following clauses under this clause:
7.5.1 – Control of production and service provision
7.5.2 – Validation of processes for production and service provision
7.5.3 – Identification and traceability
7.5.4 – Customer property
7.5.5 – Preservation of product
Control of production and service provision
(Please refer to clause 7.5.1 of ISO 9001:2008)
The organization must plan and carry out production and service provision under controlled conditions. Controlled condition must include, as applicable, the following:
the availability of information about the product characteristics,
the availability of work instructions, as necessary,
the use of suitable equipment,
the availability and use of monitoring and measuring equipment,
the implementation of monitoring and measurement, and
the implementation of product release, delivery and post-delivery activities.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), the term ‘monitoring and measuring devices’ (mentioned in ISO 9001:2000 QMS Standard) has been replaced by the term ‘monitoring and measuring equipment’ (in ISO 9001:2008). It is now clearly mentioned in the new standard that release (mentioned in old version) is product release.
Validation of processes for production and service provision
(Please refer to clause 7.5.2 of ISO 9001:2008)
The organization must validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
Validation must demonstrate the ability of these processes to achieve planned results.
The organization must establish arrangements for these processes including, as applicable, the following:
defined criteria for review of the processes,
defined criteria for approval of the processes,
approval of equipment,
approval of qualification of personnel,
use of specific methods and procedures,
requirements for records, and
revalidation.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), in clause requirement, there is editorial change and accordingly as per new version, the organization must validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement and as a consequences deficiencies are known only after the product is in use or service has been delivered.
Identification and traceability
(Please refer to clause 7.5.3 of ISO 9001:2008)
Where appropriate, the organization must identify the product by suitable means throughout product realization process.
The organization must identify the product status with respect to monitoring and measurement requirements throughout product realization.
Where traceability is a requirement, the organization must control the unique identification of the product. The organization must also maintain such records.
Note at the end of the clause clarifies that in some industry sectors identification and traceability are maintained by configuration management.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), Para 2 of this sub-clause has been modified and organization needs to identify the product status with respect to monitoring and measurement requirements throughout product realization. In Para 3 of this sub-clause, there is slight modification in wordings and maintaining records is a requirement instead of just recording the unique identification of the product (as mentioned in ISO 9001:2000 QMS Standard). There is no change in the requirement to control the unique identification of the product, where traceability is a requirement.
Customer property
(Please refer to clause 7.5.4 of ISO 9001:2008)
The organization must exercise care with customer property while the customer property is under the control of the organization or being used by the organization. The organization must identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization must report this to the customer and maintain records.
Note at the end of this clause clarifies that the customer property can include intellectual property and personal data.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), there is no change in the requirement and maintaining records has been made clearer in this sub-clause. There is editorial change in this sub-clause. A note at the end of sub clause 7.5.4 has been made clearer to include ‘personal data’ as customer property.
Preservation of product
(Please refer to clause 7.5.5 of ISO 9001:2008)
In order to maintain conformity to requirements, the organization must preserve the product during:
internal processing, and
delivery to the intended destination.
As applicable, preservation must include:
identification,
handling,
packaging,
storage, and
protection.
Preservation must apply to the constituent parts of a product.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), the terms ‘conformity to requirements’ and ‘as applicable’ have been added to provide more clarity. Accordingly, now as per ISO 9001:2008, the organization needs to preserve the product (earlier ISO 9001:2000 QMS Standard mentioned ‘the conformity of product’) during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation must include identification, handling, packaging, storage and protection. Preservation must also apply to the constituent parts of a product.
Control of monitoring and measuring equipment
(Please refer to clause 7.6 of ISO 9001:2008)
The organization must determine:
the monitoring and measurement to be undertaken, and
the monitoring and measuring equipment needed,
to provide evidence of conformity of product to determined requirements.
To ensure performing monitoring and measurement consistent with requirements the organization must establish processes.
Where necessary to ensure valid results, measuring equipment must:
be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards,
be adjusted or re-adjusted as necessary,
have identification in order to determine its calibration status, be safeguarded from adjustments that would invalidate the measurement results,
be protected from damage and deterioration during handling, maintenance and storage.
Where no international or national standards exist, the basis used for calibration or verification must be recorded.
The organization must also assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization must take appropriate action on the equipment and any product affected.
The organization must maintain the results of calibration and verification.
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application must be confirmed. This must be undertaken prior to initial use and reconfirmed as necessary.
Note at the end of this clause clarifies that confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that the term ‘devices’ (of the old version) has been replaced by the term ‘equipment’ (in the new version). Thus the title of this clause is also revised. The requirement of this clause has been reworded to bring in more clarity. Reference to see 7.2.1 has been deleted. The words ‘or both,’ have been added after the words ‘be calibrated or verified,’ in clause 7.6 (a). In 7.6 (c), instead of ‘be identified to enable the calibration status to be determined’ (mentioned in ISO 9001:2000 QMS Standard) the requirement now says ‘have identification in order to determine its calibration status’ (in ISO 9001:2008). A new Para 5 in this clause has been made (in ISO 9001:2008) from the Para 4 of this clause (in ISO 9001:2000 QMS Standard), this Para 4 of ISO 9001:2000 QMS Standard is converted in two Para (Para 4 and Para 5) in ISO 9001:2008. Para 5 of this clause (in ISO 9001:2000 QMS Standard) is now Para 6 of this clause (in ISO 9001:2008). The note at the end of this clause (in ISO 9001:2000 QMS Standard) ‘See ISO 10012-1 and ISO 10012-2 for guidance’ has been deleted. Explanatory notes have been added at the end of this clause regarding the use of computer ‘software to satisfy the intended application typically includes its verification and configuration management to maintain its suitability for use.
Questions
What are the key changes in clause 7.1 (Planning of product realization) in ISO 9001?
What are the key changes in clause 7.2 (Customer related processes) in ISO 9001?
What are the key changes in clause 7.3 (Design and development) in ISO 9001?
What are the key changes in clause 7.4 (Purchasing) in ISO 9001?
What are the key changes in clause 7.5 (Production and service provision) in ISO 9001?
What are the key changes in clause 7.6 (Control of monitoring and measuring devices) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Wednesday, December 17, 2008
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter – 5
RESOURCE MANAGEMENT
Author – K. R. Singhal
There are following clauses under this section:
6.1 – Provision of resources
6.2 – Human resources
6.3 – Infrastructure
6.4 – Work environment
Provision of resources
(Please refer to Clause 6.1 of ISO 9001:2008)
The organization must (i) determine, and (ii) provide the following:
resources needed to implement the QMS,
resources needed to continually improve the QMS, and
resources needed to enhance customer satisfaction by meeting customer requirements
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 6.1.
Human resources
(Please refer to Clause 6.2 of ISO 9001:2008)
There are following sub-clauses in this clause:
6.2.1 – General
6.2.2 – Competence, training and awareness
General
(Please refer to Clause 6.2.1 of ISO 9001:2008)
In an organization, personnel perform work affecting conformity to product requirements, and such personnel must be competent on the basis of appropriate education, training, skills and experience.
Note mentioned at the end of clause 6.2.1 of ISO 9001:2008 clarifies that conformity to product requirements can be affected directly or indirectly by personnel performing any task within the QMS.
Competence, training and awareness
(Please refer to Clause 6.2.2 of ISO 9001:2008)
The organization must:
determine the necessary competence for personnel (who perform work affecting conformity to product requirements),
provide training to personnel or take other actions, where applicable, so that such personnel achieve the necessary competence,
evaluate the effectiveness of the actions taken,
ensure that the personnel of the organization are aware of the relevance and importance of the activities of the organization,
ensure that how personnel of the organization contribute to the achievement of the quality objectives, and
maintain appropriate records of education, training, skills and experience
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that in sub clause 6.2.1 and 6.2.2, the words ‘product quality’ have been replaced by ‘conformity to product requirements.’ Although the old version also requires the importance of competence, but now new version makes it more clear that the personnel performing work affecting conformity to product requirements must be competent and the organization needs to determine the necessary competence for personnel performing work affecting conformity to product requirements. Sub-clause 6.2.2 (b) now states that ‘where applicable’ training needs to be provided to achieve the ‘necessary competence’. The wordings of clause title of sub-clause 6.2.2 ‘Competence, awareness and training’ (in ISO 9001:2000 Standard) has been reframed as ‘Competence, training and awareness’ in ISO 9001:2008.
A note is added after sub clause 6.2.1 mentioning that product requirement may be affected directly or indirectly by personnel performing any task within the quality management system.
Infrastructure
(Please refer to Clause 6.3 of ISO 9001:2008)
The organization must determine the infrastructure needed to achieve conformity to product requirements and the organization must provide and maintain such infrastructure as determined.
Infrastructure (as applicable) includes the following:
buildings,
workspace,
associated utilities,
hardware process equipment,
software process, and
supporting services
Supporting services include transport, communication and information systems.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that in sub clause 6.3 (c), information systems has been included in the supporting services in the new version. In the old version, the term infrastructure includes building, workspaces, equipment, software, utilities, and support services such as transportation and communication. The new version has added information systems to the previous list of support services.
Work environment
(Please refer to Clause 6.4 of ISO 9001:2008)
The organization must determine the work environment needed to achieve conformity to product requirement and the organization must manage such work environment.
Note mentioned at the end of clause 6.4 of ISO 9001:2008 clarifies that the term ‘work environment’ relates to those conditions under which work is performed. Such conditions include physical, environmental and other factors, such as noise, temperature, humidity, lighting or weather.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that there is no change in the requirement of this clause; however a note has been added to make clearer the conditions under which the work is performed. The new version states that the term work environment refers to working conditions. These working conditions include physical, environmental and other factors such as noise, temperature, humidity, lighting, weather.
Questions
What are the key changes in clause 6.1 (Provision of resources) in ISO 9001?
What are the key changes in clause 6.2 (Human resources) in ISO 9001?
What are the key changes in clause 6.3 (Infrastructure) in ISO 9001?
What are the key changes in clause 6.4 (Work environment) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter – 5
RESOURCE MANAGEMENT
Author – K. R. Singhal
There are following clauses under this section:
6.1 – Provision of resources
6.2 – Human resources
6.3 – Infrastructure
6.4 – Work environment
Provision of resources
(Please refer to Clause 6.1 of ISO 9001:2008)
The organization must (i) determine, and (ii) provide the following:
resources needed to implement the QMS,
resources needed to continually improve the QMS, and
resources needed to enhance customer satisfaction by meeting customer requirements
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 6.1.
Human resources
(Please refer to Clause 6.2 of ISO 9001:2008)
There are following sub-clauses in this clause:
6.2.1 – General
6.2.2 – Competence, training and awareness
General
(Please refer to Clause 6.2.1 of ISO 9001:2008)
In an organization, personnel perform work affecting conformity to product requirements, and such personnel must be competent on the basis of appropriate education, training, skills and experience.
Note mentioned at the end of clause 6.2.1 of ISO 9001:2008 clarifies that conformity to product requirements can be affected directly or indirectly by personnel performing any task within the QMS.
Competence, training and awareness
(Please refer to Clause 6.2.2 of ISO 9001:2008)
The organization must:
determine the necessary competence for personnel (who perform work affecting conformity to product requirements),
provide training to personnel or take other actions, where applicable, so that such personnel achieve the necessary competence,
evaluate the effectiveness of the actions taken,
ensure that the personnel of the organization are aware of the relevance and importance of the activities of the organization,
ensure that how personnel of the organization contribute to the achievement of the quality objectives, and
maintain appropriate records of education, training, skills and experience
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that in sub clause 6.2.1 and 6.2.2, the words ‘product quality’ have been replaced by ‘conformity to product requirements.’ Although the old version also requires the importance of competence, but now new version makes it more clear that the personnel performing work affecting conformity to product requirements must be competent and the organization needs to determine the necessary competence for personnel performing work affecting conformity to product requirements. Sub-clause 6.2.2 (b) now states that ‘where applicable’ training needs to be provided to achieve the ‘necessary competence’. The wordings of clause title of sub-clause 6.2.2 ‘Competence, awareness and training’ (in ISO 9001:2000 Standard) has been reframed as ‘Competence, training and awareness’ in ISO 9001:2008.
A note is added after sub clause 6.2.1 mentioning that product requirement may be affected directly or indirectly by personnel performing any task within the quality management system.
Infrastructure
(Please refer to Clause 6.3 of ISO 9001:2008)
The organization must determine the infrastructure needed to achieve conformity to product requirements and the organization must provide and maintain such infrastructure as determined.
Infrastructure (as applicable) includes the following:
buildings,
workspace,
associated utilities,
hardware process equipment,
software process, and
supporting services
Supporting services include transport, communication and information systems.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that in sub clause 6.3 (c), information systems has been included in the supporting services in the new version. In the old version, the term infrastructure includes building, workspaces, equipment, software, utilities, and support services such as transportation and communication. The new version has added information systems to the previous list of support services.
Work environment
(Please refer to Clause 6.4 of ISO 9001:2008)
The organization must determine the work environment needed to achieve conformity to product requirement and the organization must manage such work environment.
Note mentioned at the end of clause 6.4 of ISO 9001:2008 clarifies that the term ‘work environment’ relates to those conditions under which work is performed. Such conditions include physical, environmental and other factors, such as noise, temperature, humidity, lighting or weather.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that there is no change in the requirement of this clause; however a note has been added to make clearer the conditions under which the work is performed. The new version states that the term work environment refers to working conditions. These working conditions include physical, environmental and other factors such as noise, temperature, humidity, lighting, weather.
Questions
What are the key changes in clause 6.1 (Provision of resources) in ISO 9001?
What are the key changes in clause 6.2 (Human resources) in ISO 9001?
What are the key changes in clause 6.3 (Infrastructure) in ISO 9001?
What are the key changes in clause 6.4 (Work environment) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Tuesday, December 16, 2008
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter – 4
MANAGEMENT RESPONSIBILITY
Author – K. R. Singhal
There are following clauses under this section:
5.1 – Management commitment
5.2 – Customer focus
5.3 – Quality policy
5.4 – Planning
5.5 – Responsibility, authority and communication
5.6 – Management review
Management commitment
(Please refer to Clause 5.1 of ISO 9001:2008)
Top management must provide evidence of its commitment to the following:
development of the QMS
implementation of the QMS, and
continually improving the effectiveness of the QMS
Top management must provide such evidence of the above by the following:
communicating the importance of meeting customer and legal requirements to the organization (employees and people working on behalf of the organization)
establishing the quality policy (please refer to clause 5.3 of ISO 9001:2008 for requirements of quality policy)
ensuring that quality objectives are established (please refer to clause 5.4.1 of ISO 9001:2008 for requirements of quality objectives)
conducting management reviews (please refer to clause 5.6 of ISO 9001:2008 for requirements of management review), and
ensuring the availability of resources (please refer to clause 6 of ISO 9001:2008 for requirements of resource management
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.1.
Customer focus
(Please refer to Clause 5.2 of ISO 9001:2008)
Top management must ensure the following with the aim of enhancing customer satisfaction:
that customer requirements are determined, and
that customer requirements are met
In this connection, please refer to clause 7.2.1 of ISO 9001:2008 for determination of requirements related to the product and clause 8.2.1 of ISO 9001:2008 for requirements of customer satisfaction.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.2.
Quality policy
(Please refer to Clause 5.3 of ISO 9001:2008)
Top management must ensure the following:
The quality policy is appropriate to the purpose of the organization,
The quality policy includes a commitment to comply with requirements,
The quality policy includes a commitment to continually improve the effectiveness of the QMS,
The quality policy provides a framework for establishing quality objectives.
The quality policy provides a framework for reviewing quality objectives.
The quality policy is communicated within the organization.
The quality policy is understood within the organization.
The quality policy is reviewed for continuing suitability.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.3.
Planning
(Please refer to Clause 5.4 of ISO 9001:2008)
There are following two sub-clauses in this clause:
1.4.1 – Quality objectives
1.4.2 – Quality management system planning
Quality objectives
(Please refer to Clause 5.4.1 of ISO 9001:2008)
Top management must ensure that quality objectives (including those objectives needed to meet requirements for product) are established within the organization at (i) relevant functions, and (ii) relevant levels.
The quality objectives must be:
measurable, and
consistent with quality policy
Quality management system planning
(Please refer to Clause 5.4.2 of ISO 9001:2008)
Top management must ensure the following:
That the planning of the QMS is carried out in order to meet the general requirements mentioned in clause 4.1 of ISO 9001:2008.
That the planning of the QMS is carried out in order to meet the quality objectives.
That the integrity of the QMS is maintained when changes to the QMS are planned.
That the integrity of the QMS is maintained when planned changes to QMS are implemented.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.4.1 and clause 5.4.2.
Responsibility, authority and communication
(Please refer to Clause 5.5 of ISO 9001:2008)
There are following three sub-clauses in this clause:
5.5.1 – Responsibility and authority
5.5.2 – Management representative
5.5.3 – Internal communication
Responsibility and authority
(Please refer to Clause 5.5.1 of ISO 9001:2008)
Top management must ensure to define responsibilities and authorities. Top management must ensure to communicate the defined responsibilities and authorities within the organization.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.5.1.
Management representative
(Please refer to Clause 5.5.2 of ISO 9001:2008)
Top management must appoint a member of the organization’s management as management representative. The management representative, irrespective of other responsibilities, must have responsibility and authority including the following:
to ensure that processes needed for the QMS are established
to ensure that processes needed for the QMS are implemented
to ensure that processes needed for the QMS are maintained
to report to the top management of the organization on the performance of the QMS
to report to the top management of the organization on any need for improvement in the QMS
to ensure promotion of awareness of customer requirements throughout the organization
It has been clarified in the note given at the end of this clause that the responsibility a management representative can include liaison with external parties on matters relating to the QMS.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), clause 5.5.2 is modified with clarity that member of the organization’s own management must be appointed as a management representative. The old version allowed organization to appoint any member of management to manage organization’s quality management system. It did not clearly mention that the management representative must be a member of the organization’s own management; as such there were instances where organizations had appointed outsiders as management representatives. Now this is clear that the management representative must be member of organization’s own management.
Internal communication
(Please refer to Clause 5.5.3 of ISO 9001:2008)
Top management must ensure that appropriate communication processes are established within the organization. Top management must ensure that communication takes place within the organization regarding the effectiveness of the QMS.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.5.3.
Management review
(Please refer to Clause 5.6 of ISO 9001:2008)
There are following three sub-clauses in this clause:
5.6.1 – General
5.6.2 – Review input
5.6.3 – Review output
General
(Please refer to Clause 5.6.1 of ISO 9001:2008)
Top management must review the organization’s QMS at planned intervals (as decided by the organization) to ensure:
continuing suitability of the QMS
continuing adequacy of the QMS, and
continuing effectiveness of the QMS
The management review of the QMS must include the following:
assessing opportunities for improvement to the QMS, and
need for changes to the QMS, including the quality policy and quality objectives
The organization must maintain records from management review.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.6.1.
Review input
(Please refer to Clause 5.6.2 of ISO 9001:2008)
The input to management review, carried out by the top management, must include information on the following:
results of audits (external as well as internal)
customer feedback
process performance
product conformity
status of preventive actions
status of corrective actions
follow-up actions from previous management reviews
changes that could affect the QMS, and
recommendations for improvement
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.6.2.
Review output
(Please refer to Clause 5.6.3 of ISO 9001:2008)
The output of the management review, carried out by the top management, must include any decisions and actions related to the following:
Improvement of the effectiveness of the QMS
Improvement of the effectiveness of the processes of the organization
Improvement of product related to customer requirements, and
Resources needs of the organization
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.6.3.
Questions
What are the key changes in clause 5.1 (Management commitment) in ISO 9001?
What are the key changes in clause 5.2 (Customer focus) in ISO 9001?
What are the key changes in clause 5.3 (Quality policy) in ISO 9001?
What are the key changes in clause 5.4 (Planning) in ISO 9001?
What are the key changes in clause 5.5 (Responsibility, authority and communication) in ISO 9001?
What are the key changes in clause 5.6 (Management review) in ISO 9001?
Whether an outside personnel or QMS expert can be appointed Management Representative as per ISO 9001:2008?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter – 4
MANAGEMENT RESPONSIBILITY
Author – K. R. Singhal
There are following clauses under this section:
5.1 – Management commitment
5.2 – Customer focus
5.3 – Quality policy
5.4 – Planning
5.5 – Responsibility, authority and communication
5.6 – Management review
Management commitment
(Please refer to Clause 5.1 of ISO 9001:2008)
Top management must provide evidence of its commitment to the following:
development of the QMS
implementation of the QMS, and
continually improving the effectiveness of the QMS
Top management must provide such evidence of the above by the following:
communicating the importance of meeting customer and legal requirements to the organization (employees and people working on behalf of the organization)
establishing the quality policy (please refer to clause 5.3 of ISO 9001:2008 for requirements of quality policy)
ensuring that quality objectives are established (please refer to clause 5.4.1 of ISO 9001:2008 for requirements of quality objectives)
conducting management reviews (please refer to clause 5.6 of ISO 9001:2008 for requirements of management review), and
ensuring the availability of resources (please refer to clause 6 of ISO 9001:2008 for requirements of resource management
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.1.
Customer focus
(Please refer to Clause 5.2 of ISO 9001:2008)
Top management must ensure the following with the aim of enhancing customer satisfaction:
that customer requirements are determined, and
that customer requirements are met
In this connection, please refer to clause 7.2.1 of ISO 9001:2008 for determination of requirements related to the product and clause 8.2.1 of ISO 9001:2008 for requirements of customer satisfaction.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.2.
Quality policy
(Please refer to Clause 5.3 of ISO 9001:2008)
Top management must ensure the following:
The quality policy is appropriate to the purpose of the organization,
The quality policy includes a commitment to comply with requirements,
The quality policy includes a commitment to continually improve the effectiveness of the QMS,
The quality policy provides a framework for establishing quality objectives.
The quality policy provides a framework for reviewing quality objectives.
The quality policy is communicated within the organization.
The quality policy is understood within the organization.
The quality policy is reviewed for continuing suitability.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.3.
Planning
(Please refer to Clause 5.4 of ISO 9001:2008)
There are following two sub-clauses in this clause:
1.4.1 – Quality objectives
1.4.2 – Quality management system planning
Quality objectives
(Please refer to Clause 5.4.1 of ISO 9001:2008)
Top management must ensure that quality objectives (including those objectives needed to meet requirements for product) are established within the organization at (i) relevant functions, and (ii) relevant levels.
The quality objectives must be:
measurable, and
consistent with quality policy
Quality management system planning
(Please refer to Clause 5.4.2 of ISO 9001:2008)
Top management must ensure the following:
That the planning of the QMS is carried out in order to meet the general requirements mentioned in clause 4.1 of ISO 9001:2008.
That the planning of the QMS is carried out in order to meet the quality objectives.
That the integrity of the QMS is maintained when changes to the QMS are planned.
That the integrity of the QMS is maintained when planned changes to QMS are implemented.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.4.1 and clause 5.4.2.
Responsibility, authority and communication
(Please refer to Clause 5.5 of ISO 9001:2008)
There are following three sub-clauses in this clause:
5.5.1 – Responsibility and authority
5.5.2 – Management representative
5.5.3 – Internal communication
Responsibility and authority
(Please refer to Clause 5.5.1 of ISO 9001:2008)
Top management must ensure to define responsibilities and authorities. Top management must ensure to communicate the defined responsibilities and authorities within the organization.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.5.1.
Management representative
(Please refer to Clause 5.5.2 of ISO 9001:2008)
Top management must appoint a member of the organization’s management as management representative. The management representative, irrespective of other responsibilities, must have responsibility and authority including the following:
to ensure that processes needed for the QMS are established
to ensure that processes needed for the QMS are implemented
to ensure that processes needed for the QMS are maintained
to report to the top management of the organization on the performance of the QMS
to report to the top management of the organization on any need for improvement in the QMS
to ensure promotion of awareness of customer requirements throughout the organization
It has been clarified in the note given at the end of this clause that the responsibility a management representative can include liaison with external parties on matters relating to the QMS.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), clause 5.5.2 is modified with clarity that member of the organization’s own management must be appointed as a management representative. The old version allowed organization to appoint any member of management to manage organization’s quality management system. It did not clearly mention that the management representative must be a member of the organization’s own management; as such there were instances where organizations had appointed outsiders as management representatives. Now this is clear that the management representative must be member of organization’s own management.
Internal communication
(Please refer to Clause 5.5.3 of ISO 9001:2008)
Top management must ensure that appropriate communication processes are established within the organization. Top management must ensure that communication takes place within the organization regarding the effectiveness of the QMS.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.5.3.
Management review
(Please refer to Clause 5.6 of ISO 9001:2008)
There are following three sub-clauses in this clause:
5.6.1 – General
5.6.2 – Review input
5.6.3 – Review output
General
(Please refer to Clause 5.6.1 of ISO 9001:2008)
Top management must review the organization’s QMS at planned intervals (as decided by the organization) to ensure:
continuing suitability of the QMS
continuing adequacy of the QMS, and
continuing effectiveness of the QMS
The management review of the QMS must include the following:
assessing opportunities for improvement to the QMS, and
need for changes to the QMS, including the quality policy and quality objectives
The organization must maintain records from management review.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.6.1.
Review input
(Please refer to Clause 5.6.2 of ISO 9001:2008)
The input to management review, carried out by the top management, must include information on the following:
results of audits (external as well as internal)
customer feedback
process performance
product conformity
status of preventive actions
status of corrective actions
follow-up actions from previous management reviews
changes that could affect the QMS, and
recommendations for improvement
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.6.2.
Review output
(Please refer to Clause 5.6.3 of ISO 9001:2008)
The output of the management review, carried out by the top management, must include any decisions and actions related to the following:
Improvement of the effectiveness of the QMS
Improvement of the effectiveness of the processes of the organization
Improvement of product related to customer requirements, and
Resources needs of the organization
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.6.3.
Questions
What are the key changes in clause 5.1 (Management commitment) in ISO 9001?
What are the key changes in clause 5.2 (Customer focus) in ISO 9001?
What are the key changes in clause 5.3 (Quality policy) in ISO 9001?
What are the key changes in clause 5.4 (Planning) in ISO 9001?
What are the key changes in clause 5.5 (Responsibility, authority and communication) in ISO 9001?
What are the key changes in clause 5.6 (Management review) in ISO 9001?
Whether an outside personnel or QMS expert can be appointed Management Representative as per ISO 9001:2008?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Monday, December 8, 2008
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter – 3
QUALITY MANAGEMENT SYSTEM – GENERAL AND DOCUMENTATION REQUIREMENTS
Author – K. R. Singhal
There are following clauses under this section:
4.1 – General requirements
4.2 – Documentation requirements
General requirements
(Please refer to Clause 4.1 of ISO 9001:2008)
The organization is required to carry out the following in accordance with the requirements of ISO 9001:2008 Standard:
establish a QMS
document a QMS
implement a documented QMS
maintain a established and documented QMS
continually improve effectiveness of the QMS
The organization must determine the processes needed for the QMS and their application throughout the organization. In this connection please see Clause 1.2 of ISO 9001:2008, which deals with the application of ISO 9001:2008.
The word ‘identify’ (mentioned in ISO 9001:2000) has been replaced by the word ‘determine’ in the new version. Accordingly, as per ISO 9001:2008 now the organization needs to determine (instead of identify) the processes needed for the quality management system and their application throughout the organization. After the word ‘measure’ the term ‘(where applicable)’ is added. Accordingly, as per ISO 9001:2008, organization needs to monitor, measure (where applicable), and analyze these processes.
The organization must determine the sequence and interaction of such processes (which are determined by the organization and needed for the QMS).
The organization must determine criteria and methods needed to ensure the effectiveness of operation and control of such determined processes.
The organization must:
monitor such determined processes
measure (where applicable) such determined processes, and
analyze such determined processes
The organization must implement actions necessary to achieve planned results and continual improvement of such determined processes.
Such determined processes must be managed by the organization in accordance with the requirements of ISO 9001:2008.
Where any process that affects product conformity to requirements and an organization chooses to outsource such process, the organization must ensure control over such process. The organization must define within the QMS:
the type of control to be applied to such outsourced processes, and
the extent of control to be applied to such outsourced processes
Three notes have been mentioned at the end of this clause in ISO 9001:2008, clarifying (i) processes needed for the QMS, (ii) an outsourced process, and (iii) responsibility of the organization. Accordingly,
Processes needed for the QMS include (a) processes for management activities, (b) processes for provision of resources, (c) processes for product realization, and (d) processes for measurement, analysis and improvement.
An outsourced process is identified as the process being needed for the QMS of the organization and such process being chosen to be performed by an external party.
Ensuring control over outsourced processes does not absolve the organization of the responsibility to fulfill all customer and legal requirements. The type and extent of control to be applied to the outsourced process may be influenced by various factors and ISO 9001:2008 mentions examples of such factors including (a) the potential impact of the outsourced process on the capability of the organization to provide product. (Here the product is the product that conforms to requirements.) (b) the degree to which the control for the process is shared (c) the capability of achieving the necessary control through the application of clause 7.4. (Clause 7.4 deals with the requirements of purchasing.)
The process approach is having the central approach to ISO 9001:2008 QMS Standard and we have observed that during the last few years, outsourcing activity has increased in organization, so the new version has expanded its requirements for outsourced processes. The new version (ISO 9001:2008 Standard) states a message clearly that an outsourced process is part of organization’s quality management system, even though it is performed by a party external to the organization. The new version (ISO 9001:2008 Standard) also states a message to think carefully about how the organization is going to control outsourced processes.
Additional requirement, the type and extent of control to be applied to outsourced processes need to be defined by the organization within the quality management system, has been added, in the new version. In the first note of this clause, there have been editorial changes. The word ‘should’ (as mentioned in ISO 9001:2000 Standard) has been deleted and after the words ‘…product realization and measurement’ (as mentioned in ISO 9001:2000 Standard), the words ‘, analysis and improvement’ have been added in ISO 9001:2008. Two additional notes (Note 2 and Note 3) have been given in ISO 9001:2008. These additional notes provide more explanation about outsourcing and nature of control to be applied to the outsourced process. According to Note 2 of this clause, an outsourced process is identified as one being needed for the quality management system of the organization, but such process is chosen to be performed by a party external to the organization. Note 3 of this clause clarify the following:
It is the responsibility of the organization to conform to all requirements (related to customer, statutory and regulatory requirements) and ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all such requirements.
The type and extent of control to be applied to the outsourced process may be influenced by many factors.
ISO 9001:2008 mentions the factors that influence the type and extent of control and these include:
The potential impact of the outsourced process on the organization’s capability to provide product. Here product is that which conforms to requirements.
The degree to which the control for the process is shared.
The capability of achieving the necessary control through the application of requirements mentioned in clause 7.4 (Purchasing).
Thus, this clause clarifies requirements with regard to outsourced process clearly and now it is the intention of ISO 9001:2008 that control on outsourced organization and its processes must be included in the quality management system of the organization.
Documentation requirements
(Please refer to Clause 4.2 of ISO 9001:2008)
There are following four sub-clauses in this clause:
4.2.1 – General
4.2.2 – Quality manual
4.2.3 – Control of documents
4.2.4 – Control of records
General
(Please refer to Clause 4.2.1 of ISO 9001:2008)
The QMS documentation must include the following:
documented statement of a quality policy
documented statement(s) of quality objectives
a quality manual
documented procedures required by ISO 9001:2008
records required by ISO 9001:2008
Documents and records (determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization)
Three notes have been mentioned at the end of this clause, clarifying (i) documented procedure (ii) the extent of QMS documentation difference, (iii) medium of documentation. Accordingly,
The term ‘documented procedure’ (in ISO 9001:2008) means that the procedure is established, documented, implemented and maintained. It is also clarified that a single document may address the requirements for one or more procedures. Further clarified that a requirement for a documented procedure may be covered by more than one document.
The extent of QMS documentation may differ from one organization to another organization due to (i) the size of the organization, (ii) type of activities of the organization, (iii) the complexity of the processes of the organization, (iv) the interaction of the processes of the organization, and (v) competence of personnel of the organization.
The QMS documentation may be in any form or type of medium.
This clause wordings (in the new version) are reframed, however, having same meaning as stated in ISO 9001:2000, such as –
(i) Quality management System documentation includes records.
(ii) The documents required may be combined.
(iii) The requirements of the standard (ISO 9001) may be covered by more than one document.
(iv)The organization may have a single document for multiple procedures or multiple documents for various requirements of the document procedures (Note 1 of the sub clause is expanded in ISO 9001:2008)
In this sub-clause the word ‘needed’ (mentioned in ISO 9001:2000 Standard) has been replaced by the word ‘determined’ (in ISO 9001:2008). Accordingly, as per ISO 9001:2008, the quality management system documentation of an organization must include the following:
documented statement of quality policy,
documented statement of quality objectives,
a quality manual,
documented procedures and records required by ISO 9001:2008,
documents, including records, determined by the organization, which are necessary to ensure effective planning, operation and control of processes of the organization.
The new version (ISO 9001:2008 Standard) has expanded the definition of documentation to include all QMS processes records.
In Note 1 of this sub-clause (4.2.1), following have been additionally clarified:
That a single document may address the requirements for one procedure or more procedures.
That a requirement for a documented procedure may be covered by more than one document.
Quality manual
(Please refer to Clause 4.2.2 of ISO 9001:2008)
The organization must establish and maintain a quality manual. The quality manual must include:
the scope of the QMS (with details of justification for any exclusions claimed by the organization as per clause 1.2 of ISO 9001:2008)
the documented procedures established for the QMS, or reference to such documented procedures, and
a description of the interaction between the processes of the QMS.
According to Clause 1.2 of ISO 9001:2008, all requirements of ISO 9001:2008 are generic and these requirements are meant to be applicable to all organization regardless of:
type of the organization,
size of the organization, and
product provided by the organization
Where any requirement or requirements of ISO 9001:2008 cannot be applied due to the nature of an organization and product of the organization, such requirement or requirements can be considered for exclusion.
Where exclusion are made, such exclusions are limited to requirements within clause 7 of ISO 9001:2008 and such exclusions must not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable legal requirements, otherwise claims of conformity to ISO 9001:2008 are not acceptable.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 4.2.2.
Control of documents
(Please refer to Clause 4.2.3 of ISO 9001:2008)
The organization must control documents required by the QMS. Records are a special type of document. The organization must control records as per requirements mentioned in clause 4.2.4 (Control of records) of ISO 9001:2008.
The organization must establish a documented procedure to define control of documents. Such documented procedure must include:
controls needed to approve documents for adequacy prior to issue of such documents
controls needed to review documents
controls needed to update documents, as necessary
controls needed to re-approve documents
controls needed to ensure that changes of documents are identified
controls needed to ensure that the current revision status of documents are identified
controls needed to ensure that relevant versions of applicable documents are available at point of use
controls needed to ensure that documents remain legible
controls needed to ensure that documents remain readily identifiable
controls needed to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the QMS are identified
controls needed to ensure distribution control of documents of external origin determined by the organization to be necessary for the planning and operation of the QMS
controls needed to prevent the unintended use of obsolete documents
controls needed to apply suitable identification to obsolete documents if they are retained for any purpose
In this sub clause, the requirements on control of external origin documents have been mentioned to give more clarity. External documents referred to are those needed for use in the quality management system. Now the organization needs to ensure identification and distribution control of documents of external origins determined by the organization to be necessary for the planning and operation of the quality management system. The old version (ISO 9001:2000) had the impression that all external documents needed to be identified and controlled. The new version (ISO 9001:2008 Standard) has clarified that the organization needs to identify and control the distribution of only those external documents that the organization needs to plan and operate organization’s quality management system. We can now say that only relevant external QMS documents need to be controlled, not all of them.
Control of records
(Please refer to Clause 4.2.4 of ISO 9001:2008)
The organization must control records established to provide evidence of conformity to requirements and of the effective operation of the QMS.
The organization must establish a documented procedure to define control of records. Such documented procedure must include:
controls needed for the identification of records
controls needed for storage of records
controls needed for protection of records
controls needed for retrieval of records
controls needed for retention of records
controls needed for disposition of records
The records must remain:
legible
readily identifiable, and
retrievable
There are editorial changes in this clause and requirements of this clause significantly reduced in length but requirements remain unchanged.
Questions
What are the key changes in clause 4.1 (Quality management system – General) in ISO 9001?
How many additional notes have been provided to clause 4.1 (Quality management system – General) in ISO 9001:2008?
What factors influence type and extent of control to be applied to the outsource process as per ISO 9001:2008?
What are the key changes in clause 4.2.1 (Documentation requirements – General) in ISO 9001?
Whether an organization may have a single document for multiple procedures as per ISO 9001:2008?
What are the key changes in clause 4.2.2 (Documentation requirements – Quality manual) in ISO 9001?
What are the key changes in clause 4.2.3 (Documentation requirements – Control of documents) in ISO 9001?
What are the key changes in clause 4.2.4 (Documentation requirements – Control of records) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter – 3
QUALITY MANAGEMENT SYSTEM – GENERAL AND DOCUMENTATION REQUIREMENTS
Author – K. R. Singhal
There are following clauses under this section:
4.1 – General requirements
4.2 – Documentation requirements
General requirements
(Please refer to Clause 4.1 of ISO 9001:2008)
The organization is required to carry out the following in accordance with the requirements of ISO 9001:2008 Standard:
establish a QMS
document a QMS
implement a documented QMS
maintain a established and documented QMS
continually improve effectiveness of the QMS
The organization must determine the processes needed for the QMS and their application throughout the organization. In this connection please see Clause 1.2 of ISO 9001:2008, which deals with the application of ISO 9001:2008.
The word ‘identify’ (mentioned in ISO 9001:2000) has been replaced by the word ‘determine’ in the new version. Accordingly, as per ISO 9001:2008 now the organization needs to determine (instead of identify) the processes needed for the quality management system and their application throughout the organization. After the word ‘measure’ the term ‘(where applicable)’ is added. Accordingly, as per ISO 9001:2008, organization needs to monitor, measure (where applicable), and analyze these processes.
The organization must determine the sequence and interaction of such processes (which are determined by the organization and needed for the QMS).
The organization must determine criteria and methods needed to ensure the effectiveness of operation and control of such determined processes.
The organization must:
monitor such determined processes
measure (where applicable) such determined processes, and
analyze such determined processes
The organization must implement actions necessary to achieve planned results and continual improvement of such determined processes.
Such determined processes must be managed by the organization in accordance with the requirements of ISO 9001:2008.
Where any process that affects product conformity to requirements and an organization chooses to outsource such process, the organization must ensure control over such process. The organization must define within the QMS:
the type of control to be applied to such outsourced processes, and
the extent of control to be applied to such outsourced processes
Three notes have been mentioned at the end of this clause in ISO 9001:2008, clarifying (i) processes needed for the QMS, (ii) an outsourced process, and (iii) responsibility of the organization. Accordingly,
Processes needed for the QMS include (a) processes for management activities, (b) processes for provision of resources, (c) processes for product realization, and (d) processes for measurement, analysis and improvement.
An outsourced process is identified as the process being needed for the QMS of the organization and such process being chosen to be performed by an external party.
Ensuring control over outsourced processes does not absolve the organization of the responsibility to fulfill all customer and legal requirements. The type and extent of control to be applied to the outsourced process may be influenced by various factors and ISO 9001:2008 mentions examples of such factors including (a) the potential impact of the outsourced process on the capability of the organization to provide product. (Here the product is the product that conforms to requirements.) (b) the degree to which the control for the process is shared (c) the capability of achieving the necessary control through the application of clause 7.4. (Clause 7.4 deals with the requirements of purchasing.)
The process approach is having the central approach to ISO 9001:2008 QMS Standard and we have observed that during the last few years, outsourcing activity has increased in organization, so the new version has expanded its requirements for outsourced processes. The new version (ISO 9001:2008 Standard) states a message clearly that an outsourced process is part of organization’s quality management system, even though it is performed by a party external to the organization. The new version (ISO 9001:2008 Standard) also states a message to think carefully about how the organization is going to control outsourced processes.
Additional requirement, the type and extent of control to be applied to outsourced processes need to be defined by the organization within the quality management system, has been added, in the new version. In the first note of this clause, there have been editorial changes. The word ‘should’ (as mentioned in ISO 9001:2000 Standard) has been deleted and after the words ‘…product realization and measurement’ (as mentioned in ISO 9001:2000 Standard), the words ‘, analysis and improvement’ have been added in ISO 9001:2008. Two additional notes (Note 2 and Note 3) have been given in ISO 9001:2008. These additional notes provide more explanation about outsourcing and nature of control to be applied to the outsourced process. According to Note 2 of this clause, an outsourced process is identified as one being needed for the quality management system of the organization, but such process is chosen to be performed by a party external to the organization. Note 3 of this clause clarify the following:
It is the responsibility of the organization to conform to all requirements (related to customer, statutory and regulatory requirements) and ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all such requirements.
The type and extent of control to be applied to the outsourced process may be influenced by many factors.
ISO 9001:2008 mentions the factors that influence the type and extent of control and these include:
The potential impact of the outsourced process on the organization’s capability to provide product. Here product is that which conforms to requirements.
The degree to which the control for the process is shared.
The capability of achieving the necessary control through the application of requirements mentioned in clause 7.4 (Purchasing).
Thus, this clause clarifies requirements with regard to outsourced process clearly and now it is the intention of ISO 9001:2008 that control on outsourced organization and its processes must be included in the quality management system of the organization.
Documentation requirements
(Please refer to Clause 4.2 of ISO 9001:2008)
There are following four sub-clauses in this clause:
4.2.1 – General
4.2.2 – Quality manual
4.2.3 – Control of documents
4.2.4 – Control of records
General
(Please refer to Clause 4.2.1 of ISO 9001:2008)
The QMS documentation must include the following:
documented statement of a quality policy
documented statement(s) of quality objectives
a quality manual
documented procedures required by ISO 9001:2008
records required by ISO 9001:2008
Documents and records (determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization)
Three notes have been mentioned at the end of this clause, clarifying (i) documented procedure (ii) the extent of QMS documentation difference, (iii) medium of documentation. Accordingly,
The term ‘documented procedure’ (in ISO 9001:2008) means that the procedure is established, documented, implemented and maintained. It is also clarified that a single document may address the requirements for one or more procedures. Further clarified that a requirement for a documented procedure may be covered by more than one document.
The extent of QMS documentation may differ from one organization to another organization due to (i) the size of the organization, (ii) type of activities of the organization, (iii) the complexity of the processes of the organization, (iv) the interaction of the processes of the organization, and (v) competence of personnel of the organization.
The QMS documentation may be in any form or type of medium.
This clause wordings (in the new version) are reframed, however, having same meaning as stated in ISO 9001:2000, such as –
(i) Quality management System documentation includes records.
(ii) The documents required may be combined.
(iii) The requirements of the standard (ISO 9001) may be covered by more than one document.
(iv)The organization may have a single document for multiple procedures or multiple documents for various requirements of the document procedures (Note 1 of the sub clause is expanded in ISO 9001:2008)
In this sub-clause the word ‘needed’ (mentioned in ISO 9001:2000 Standard) has been replaced by the word ‘determined’ (in ISO 9001:2008). Accordingly, as per ISO 9001:2008, the quality management system documentation of an organization must include the following:
documented statement of quality policy,
documented statement of quality objectives,
a quality manual,
documented procedures and records required by ISO 9001:2008,
documents, including records, determined by the organization, which are necessary to ensure effective planning, operation and control of processes of the organization.
The new version (ISO 9001:2008 Standard) has expanded the definition of documentation to include all QMS processes records.
In Note 1 of this sub-clause (4.2.1), following have been additionally clarified:
That a single document may address the requirements for one procedure or more procedures.
That a requirement for a documented procedure may be covered by more than one document.
Quality manual
(Please refer to Clause 4.2.2 of ISO 9001:2008)
The organization must establish and maintain a quality manual. The quality manual must include:
the scope of the QMS (with details of justification for any exclusions claimed by the organization as per clause 1.2 of ISO 9001:2008)
the documented procedures established for the QMS, or reference to such documented procedures, and
a description of the interaction between the processes of the QMS.
According to Clause 1.2 of ISO 9001:2008, all requirements of ISO 9001:2008 are generic and these requirements are meant to be applicable to all organization regardless of:
type of the organization,
size of the organization, and
product provided by the organization
Where any requirement or requirements of ISO 9001:2008 cannot be applied due to the nature of an organization and product of the organization, such requirement or requirements can be considered for exclusion.
Where exclusion are made, such exclusions are limited to requirements within clause 7 of ISO 9001:2008 and such exclusions must not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable legal requirements, otherwise claims of conformity to ISO 9001:2008 are not acceptable.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 4.2.2.
Control of documents
(Please refer to Clause 4.2.3 of ISO 9001:2008)
The organization must control documents required by the QMS. Records are a special type of document. The organization must control records as per requirements mentioned in clause 4.2.4 (Control of records) of ISO 9001:2008.
The organization must establish a documented procedure to define control of documents. Such documented procedure must include:
controls needed to approve documents for adequacy prior to issue of such documents
controls needed to review documents
controls needed to update documents, as necessary
controls needed to re-approve documents
controls needed to ensure that changes of documents are identified
controls needed to ensure that the current revision status of documents are identified
controls needed to ensure that relevant versions of applicable documents are available at point of use
controls needed to ensure that documents remain legible
controls needed to ensure that documents remain readily identifiable
controls needed to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the QMS are identified
controls needed to ensure distribution control of documents of external origin determined by the organization to be necessary for the planning and operation of the QMS
controls needed to prevent the unintended use of obsolete documents
controls needed to apply suitable identification to obsolete documents if they are retained for any purpose
In this sub clause, the requirements on control of external origin documents have been mentioned to give more clarity. External documents referred to are those needed for use in the quality management system. Now the organization needs to ensure identification and distribution control of documents of external origins determined by the organization to be necessary for the planning and operation of the quality management system. The old version (ISO 9001:2000) had the impression that all external documents needed to be identified and controlled. The new version (ISO 9001:2008 Standard) has clarified that the organization needs to identify and control the distribution of only those external documents that the organization needs to plan and operate organization’s quality management system. We can now say that only relevant external QMS documents need to be controlled, not all of them.
Control of records
(Please refer to Clause 4.2.4 of ISO 9001:2008)
The organization must control records established to provide evidence of conformity to requirements and of the effective operation of the QMS.
The organization must establish a documented procedure to define control of records. Such documented procedure must include:
controls needed for the identification of records
controls needed for storage of records
controls needed for protection of records
controls needed for retrieval of records
controls needed for retention of records
controls needed for disposition of records
The records must remain:
legible
readily identifiable, and
retrievable
There are editorial changes in this clause and requirements of this clause significantly reduced in length but requirements remain unchanged.
Questions
What are the key changes in clause 4.1 (Quality management system – General) in ISO 9001?
How many additional notes have been provided to clause 4.1 (Quality management system – General) in ISO 9001:2008?
What factors influence type and extent of control to be applied to the outsource process as per ISO 9001:2008?
What are the key changes in clause 4.2.1 (Documentation requirements – General) in ISO 9001?
Whether an organization may have a single document for multiple procedures as per ISO 9001:2008?
What are the key changes in clause 4.2.2 (Documentation requirements – Quality manual) in ISO 9001?
What are the key changes in clause 4.2.3 (Documentation requirements – Control of documents) in ISO 9001?
What are the key changes in clause 4.2.4 (Documentation requirements – Control of records) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
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