UNITED NATIONS INDUSTRIAL DEVELOPMENT ORGANIZATION (UNIDO) has published a survey report 'ISO 9001 — Its relevance and impact in Asian Developing Economies' in 2012. The report is available online at the website of UNIDO at www.unido.org.
Thanks,
Keshav Ram Singhal
Tuesday, June 26, 2012
Saturday, June 23, 2012
Quality Objectives
An exercise to the readers of this blog
Quality objectives are the basis of improvement and growth. ISO 9001:2008 QMS standard requires organization to establish measurable quality objectives at relevant functions and levels (i.e., just everywhere) in the organization. The quality objectives must be consistent with the quality policy of the organization.
We wish our readers to suggest a few quality objectives that should be specific, measurable, achievable, realistic and time-bound. You can mention the same in the comments of this post.
With best wishes,
Keshav Ram Singhal
Example - Quality objectives for a school - (i) 90%+ examination result, (ii) Minimum 25% students getting 75% or more marks.
Quality objectives are the basis of improvement and growth. ISO 9001:2008 QMS standard requires organization to establish measurable quality objectives at relevant functions and levels (i.e., just everywhere) in the organization. The quality objectives must be consistent with the quality policy of the organization.
We wish our readers to suggest a few quality objectives that should be specific, measurable, achievable, realistic and time-bound. You can mention the same in the comments of this post.
With best wishes,
Keshav Ram Singhal
Example - Quality objectives for a school - (i) 90%+ examination result, (ii) Minimum 25% students getting 75% or more marks.
Friday, June 22, 2012
Auditing Purchasing in ISO 9001:2008 QMS
Purchasing is a general process that every organization carries out and it is that activity of an organization that has an effect on the product the organization produces. Purchasing is a formal process of buying goods and services. The purchasing process can vary from one organization to another, but there are some common key elements. The process usually starts with a demand and ends with the fulfillment of that demand. ISO 9001:2008 QMS standard specifies its requirements for purchasing under clause 7.4, which is sub-divided as under:
7.4.1 – Purchasing process
7.4.2 – Purchasing information
7.4.3 – Verification of purchased product
Auditing purchasing in an organization requires certain objective evidences to look for and in this regard the auditor involved should be well prepared and vigilant in auditing purchasing activities in the organization.
According to the requirements of ISO 9001:2008 QMS standard, the organization needs to ensure that purchased product conforms to specified purchase requirements. To ascertain whether the organization ensures that purchased product conforms to specified purchase requirements, an auditor should look for relevant evidences. In the beginning, the auditor should ask people involved in the purchasing process:
- How the purchasing process is being carried out in the organization? What is the established process? Whether the organization follows centralized purchasing or individual departments carry out purchases?
- How the purchasing order is given to supplier?
- How the conformity of the purchased product is checked? What are the types and extent of controls applied to the supplier and the purchased product?
It is also required as per ISO 9001:2008 QMS standard to evaluate and select suppliers for which the organization needs to establish criteria for selection, evaluation and re-evaluation of suppliers. It means that the organization should purchase product from its selected suppliers. Selection and ongoing evaluation of suppliers are important activities in an organization. So inquire from people involved in purchasing the established criteria for selection, evaluation and re-evaluation of suppliers and ask for the records showing results of evaluation, and any necessary action arising from such evaluation. The suitability of suppliers plays an integral role in organization’s success. So, obtain evidences that only approved suppliers are used for purchasing.
ISO 9001:2008 QMS standard requires an organization to communicate purchasing information describing appropriate details of the product to be purchased and other requirements including approval of product, procedures, processes, equipment, qualification of the personnel to the supplier. The organization is also required to ensure the adequacy of specified purchased requirements prior to their communication to the supplier. Therefore, ascertain from people involved in purchasing activities:
- How the organization ensures adequacy of specified purchase requirements prior to their communication to the supplier?
- How the organization communicates purchasing information to the supplier?
The auditor should look for the supporting evidences for the above.
As per ISO 9001:2008 QMS standard, it is necessary that the organization must establish and implement the inspection and other activities necessary to ensure that purchased product meets specified purchase requirements. So it for the auditor to ascertain the following:
- What methods have been established to check the product?
- How the established methods used in the organization to check the product?
In case the auditor observes that verification activities are performed at the supplier’s premises, then he should inquire whether such arrangement is mentioned in the purchasing information.
Any observations or nonconformance to the requirements of ISO 9001:2008 QMS standard should be reported as ‘corrective action request’ (CAR) that will provide an opportunity to the organization to improve its process and implementation.
Keshav Ram Singhal
How you like the article? Please make your comments. Thanks.
Saturday, June 2, 2012
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Thanking you,
Keshav Ram Singhal
Wednesday, May 23, 2012
Validation of Processes
ISO 9001:2008 QMS standard requires validation of processes only where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequent deficiencies (incompleteness or inadequacy) in the product become apparent (known) only after the product is in use or the service has been delivered. The relevant clause in this regard is clause 7.5.2 of ISO 9001:2008 QMS standard that mentions requirements. This clause is for those processes where an organization is not able to easily measure the resulting output. The normal example is how do you test a gun-bullet or tear-shell? If you try and test a gun-bullet or tear-shell, then you will destroy the gun-bullet or tear-shell. So there is a need of the system for validating the processes that the gun-bullet or tear-shell was manufactured correctly and the gun-bullet or tear-shell will not fail.
Validation must demonstrate the ability of such process to achieve planned results. An organization must establish effective arrangements, for such process, including:
- Defining acceptance criteria for review and approval of the process
- Approval of appropriate equipment
- Approval of qualification of personnel, so that trained and qualified personnel are able to handle the process
- Use of specific methods and procedures
- Requirements for records
- Requirements for re-validation
So an organization needs a standard operating procedure (SOP) for that process where the organization is not able to measure the resulting output. And the organization needs to establish effective arrangements, how the organization validates such processes and what records will be kept. Keeping a documented procedure for such standard operating procedure (SOP) is not a mandatory requirement, however the organization may think of determining a documented procedure for such SOP to ensure the effective planning, operation and control of the process included in the SOP. Without having a documented procedure for such SOP, the organization has to prove that the organization has such processes in place.
Please post your comments. With best wishes,
Keshav Ram Singhal
Tuesday, May 22, 2012
Quality Policy
Clause 4.2.1 of ISO 9001:2008 QMS standard includes documented statement of quality policy as part of the organization's QMS documentation. Clause 5.3 of ISO 9001:2008 QMS standard mentions requirements for quality policy. It is the responsibility of the top management of the organization to ensure framing of quality policy of the organization.
What is in a quality policy?
Quality policy is a QMS documentation that provides a commitment to comply with requirements and continually improve the effectiveness of the quality management system and also to have a framework for establishing and reviewing quality policy. ISO 9000:2005 standard defines quality policy as overall intentions and direction of an organization related to quality that is formally expressed by the top management of the organization.
What are the requirements related to quality policy in ISO 9001:2008 QMS standard?
As per requirements mentioned in clause 5.3 of ISO 9001:2008 QMS standard the top management of the organization must ensure that:
(i) - the quality policy is appropriate to the purpose of the organization
(ii)- a commitment to comply with requirements of the quality management system is included in the quality policy
(iii)- a commitment to continually improve the effectiveness of the quality management system is included in the quality policy
(iv)- a framework for establishing quality objectives is provided in the quality policy
(v) - a framework for reviewing quality objectives is provided in the quality policy
(vi)- the quality policy is communicated within the organization
(vii)- the quality policy is understood within the organization
(viii)- the quality policy is reviewed for continuing suitability
The requirements as mentioned in (i) to (v) above are useful in developing or framing a quality policy.
First Sample 'Quality Policy'
"Our organization is committed to enhance customer satisfaction by achieving our organization's quality objectives through the effective application, review and continual improvement of our quality management system."
Second Sample 'Quality Policy'
"We, the employees of ABC Organization, are committed to meet customer requirements as well as applicable legal requirements by achieving our quality objectives through the application, review and continual improvement of our management systems."
With best wishes,
Keshav Ram Singhal
What is in a quality policy?
Quality policy is a QMS documentation that provides a commitment to comply with requirements and continually improve the effectiveness of the quality management system and also to have a framework for establishing and reviewing quality policy. ISO 9000:2005 standard defines quality policy as overall intentions and direction of an organization related to quality that is formally expressed by the top management of the organization.
What are the requirements related to quality policy in ISO 9001:2008 QMS standard?
As per requirements mentioned in clause 5.3 of ISO 9001:2008 QMS standard the top management of the organization must ensure that:
(i) - the quality policy is appropriate to the purpose of the organization
(ii)- a commitment to comply with requirements of the quality management system is included in the quality policy
(iii)- a commitment to continually improve the effectiveness of the quality management system is included in the quality policy
(iv)- a framework for establishing quality objectives is provided in the quality policy
(v) - a framework for reviewing quality objectives is provided in the quality policy
(vi)- the quality policy is communicated within the organization
(vii)- the quality policy is understood within the organization
(viii)- the quality policy is reviewed for continuing suitability
The requirements as mentioned in (i) to (v) above are useful in developing or framing a quality policy.
First Sample 'Quality Policy'
"Our organization is committed to enhance customer satisfaction by achieving our organization's quality objectives through the effective application, review and continual improvement of our quality management system."
Second Sample 'Quality Policy'
"We, the employees of ABC Organization, are committed to meet customer requirements as well as applicable legal requirements by achieving our quality objectives through the application, review and continual improvement of our management systems."
With best wishes,
Keshav Ram Singhal
Saturday, May 19, 2012
Newly released book on 'Implementing ISO 9001:2008 Quality Management System - A Reference Guide'
Wednesday, April 25, 2012
Steps to Implement ISO 9001:2008 QMS Without Seeking Consultant’s Help
- Dr. Divya Singhal & Keshav Ram Singhal
A few days back one of the authors of this write-up received a phone call from an executive of an organization stating that his organization wishes to implement ISO 9001:2008 QMS standard and asked whether engaging a consultant was necessary to implement the standard and how his organization could implement ISO 9001:2008 standard without engaging a consultant.
Due to high cost involved in implementing any of the management systems standards, organizations generally hesitate to implement management systems standards. Although appointing a consultant may be worthwhile investment for an organization, however appointing a consultant to implement any management systems standards is not necessary. Many organizations in the world have implemented ISO 9001 QMS standard without engaging consultants and successfully got ISO 9001 certification. However, many organizations find it difficult to implement the standard without consultant. It depends on the level of competency available in the organization. An organization, wish to implement any management systems standards, should determine whether a consultant is required. Why organizations generally engage consultants? We find, there may be following reasons:
1. Consultants have the experience, expertise and time that employees may not. Organizations generally engage consultants to fill the knowledge and time gaps.
2. Consultants provide flexibility of time. Consultants work any time, including nights, weekends and holidays.
3. Consultants offer the latest and objective point of view. Consultants bring the latest and unbiased ideas from their vide experience.
4. Consultants are more efficient and focus on assigned project with sincerity. So they help you fast track your way to an effective QMS.
If competency level in the organization is adequate and people are well aware of the organization’s systems, then organization can think implementing ISO 9001:2008 QMS standard without consultant. One should be very clear that ISO 9001:2008 standard is a generic standard in terms of its requirements, but not generic in terms of its implementation. So, while implementing the standard, the emphasis should be on the objectives and processes of the organization.
When organization plans to implement ISO 9001:2008 QMS Standard without consultant, the top management of the organization has important and relevant role in implementation. Through leadership and their actions, the top management is able to create an environment in the organization – (i) where people are fully involved, and (ii) in which a quality management system can operate effectively. The top management should demonstrate its commitment and determination to implement ISO 9001:2008 QMS Standard by involving themselves actively in the following tasks –
(i) Ensuring people in the organization understand the importance of meeting customer requirements and also statutory and regulatory requirements.
(ii) Defining organization’s quality objectives and commitment to quality and ensuring that everyone in the organization understands the ‘quality policy’ and how it applies to their work.
(iii) Performing ‘management reviews’ regularly to see the continuing suitability, adequacy and effectiveness of the quality management system.
(iv) Providing necessary resources to all quality activities.
The following step-by-step approach may be useful in implementing ISO 9001:2008 QMS Standard –
Step 1 – Appointing management representative
Management representative is important personnel in quality management system structure, who should have responsibility and authority to (i) implement the requirements of ISO 9001:2008 QMS, (ii) report back to the top management on the performance of the quality management system, and (iii) promote awareness of customer requirements throughout the organization. ISO 9001:2008 QMS Standard also requires appointment of a management representative (clause 5.2.2). Accordingly, the top management should appoint a member of organization’s management as management representative. It should be noted that the responsibility and authority of management representative cannot be assigned to an outside person.
Step 2 – Setting up a steering committee
When organization is thinking to implement ISO 9001:2008 QMS without consultant, it is better if the top management set up a steering committee. The chief executive or a senior officer of the organization should head the steering committee. Functional heads and management representative should be the members of the steering committee. The committee should be responsible for the overall planning of ISO 9001:2008 QMS implementation process, giving directions and allocating resources. The committee should also decide the scope for ISO 9001:2008 QMS.
Step 3 – Setting up a task force
The top management or steering committee should set up a task force. The management representative should be the coordinator of the task force. Persons having good knowledge of the organization’s processes and good communication-writing skills should be included as members of the task force. The task force should be allocated the timeframe task of developing documentation, such as, quality manual, procedures, work instructions etc.
Step 4 – Obtaining information about ISO 9001 QMS
The management representative should collect information about ISO 9001:2008 QMS and related standards. For general information, it is better to visit ISO website and IAF website. Purchase of the following may be useful –
• ISO 9000:2005 Quality management systems – Fundamental and vocabulary,
• ISO 9001:2008 Quality management systems – Requirements,
• ISO 9004:2009, Managing for the sustained success of an organization – A quality management approach,
• ISO 19011:2002, Guidelines on quality and/or environmental management systems auditing,
• Various others publications / literatures providing knowledge on ISO 9001:2008 QMS.
Internet is useful source for obtaining information on ISO 9001:2008 QMS for which various websites and blogs may be visited.
Step 5 – Organizing awareness programme
ISO 9001:2008 QMS awareness programme should be organized to communicate to the employees the aim of ISO 9001:2008 QMS, the advantage it offers (to employees, customers and the organization), how it will work, and employees’ roles and responsibilities within the system. This programme may be conducted by the management representative, any of the task force members or outside faculty.
Step 6 – Training
Training is important for improving the competency level of employees. Training programmes should be organized for different categories of employees – senior managers, supervisors and workers. It will be better if the top management also attend ISO 9001:2008 QMS related training, seminar or presentation.
The training should cover the basic concepts of quality management systems and their overall impact on the strategic goals of an organization, quality management principles, the processes, requirements and the likely work culture implications of the system.
Initial training may also be necessary on developing documentation, QMS auditing, laboratory management techniques, statistical tools, calibration, measurement and testing procedures etc.
The steering committee can decide organizing such trainings as in-house programmes or alternatively personnel may be nominated to external training programmes.
It is suggested that a few people of the organization (including the management representative) should undergo Lead Auditor Training. A few people selected as internal auditors should be provided internal audit or lead auditor training.
Step 7 – Formulating action plan
The steering committee should formulate a timeframe action plan for implementation of ISO 9001:2008 QMS. The action plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities.
Step 8 – Carrying out initial status survey
It is better to know the gaps between the systems of the organization and the requirements of the ISO 9001:2008 QMS Standard. A self-assessment initial status survey may be carried out by the management representative or any other personnel who have undergone QMS auditor training or lead auditor training. After conducting initial status survey, the organization will be in a position to know the gaps and what is required to do for implementation.
Step 9 – Developing documentation
ISO 9001:2008 QMS Standard requires developing QMS documentation and developing documentation is the most important activity in the implementation process. Members of the task force should be given training on developing documentation. It will be better if a few of them are trained as lead auditors. They should be well versed with the requirements of ISO 9001:2008 QMS Standard and also with the processes of the organization. As earlier pointed out, members of the task force involved in developing documentation should have good communication-writing skill. While developing documentation, reference to ISO 9001:2008 QMS, ISO 19011:2002 (on auditing) and ISO 10013 (on documentation) Standards would be better.
Organizations implementing ISO 9001:2008 QMS need to develop and establish documentation (including quality policy, quality objectives, quality manual, procedures etc.) and also to keep records of information that is useful in operation and assessment of the organization’s quality management system.
The quality management system documentation of the organization needs to include the following documents:
i. Documented statement of quality policy,
ii. Documented statements of quality objectives,
iii. A quality manual,
iv. Documented procedures required by the Standard,
v. Documents (= including documented procedures, work instructions, forms) determined by the organization,
vi. Records required by the Standard,
vii. Records determined by the organization.
Out of the above first five types of documents are required to be developed and rest two types are records of information that is useful in operation and assessment of the organization’s quality management system.
For developing organization’s quality policy, quality objectives and quality manual, compliance to requirements mentioned in clauses 4.2, 5.3 and 5.4.1 of ISO 9001:2008 QMS Standard should be adhered to.
QMS documentation is the basis for establishment, implementation and maintenance of the quality management system of the organization. An organization can combine all documentation in one manual or can have more manuals.
As stated earlier developing QMS documentation is the most important activity in the implementation process. A list of documents to be prepared should be drawn up and the the responsibility for writing the documents should be assigned to members of the task force concerned with various functional departments. This will lead to better understanding of requirements and also provide a sense of responsibility (including the involvement and ownership by personnel involved in developing documentation). The responsibility to develop QMS documentation (for example: procedures, work instructions) should be given to those persons, who are involved in the processes and activities. This will lead to ownership of documents and better understanding of the organization’s processes.
As the coordinator of the task force, the management representative should follow following steps –
• Make a list of all existing QMS related documents and obtain a copy of each documents for reference,
• Study each process and prepare a flow chart of activities,
• Examine interfaces and lack of interfaces between the processes,
• Review the process flow charts and identify duplication or omissions in the information or process flow,
• Map out what is to be written,
• Verify the presence of all the required elements (requirements) of ISO 9001:2008 QMS Standard in the current system,
• Allocate responsibilities for preparing drafts of relevant parts to various members of the task force,
• Circulate the completed drafts to persons concerned for comments,
• Consider comments received and incorporate necessary corrections,
• Take action to prepare final manuscript of the documentation
Step 10 – Implementation
The organization needs to close the gaps as identified in step 8 (initial status survey), the steering committee should allocate resources to perform actions and implementation, assign responsibilities and establish a final time-frame to complete the needed actions.
It will be good practice to implement the procedures being documented, as the documentation is developed, although this may be more effective in larger organizations. In small size organizations, the implementation of the QMS documentation is done at once throughout the organization. When phased implementation takes place, the effectiveness of the system in selected area can be evaluated. It would be a good idea initially to evaluate areas where the chances of positive evaluation are high, to main confidence of both management and staff in the merits of implementing the quality management system as per ISO 9001:2008 QMS Standard. Make efforts for effective implementation and make sure that what has been written in QMS documentation is being carried out.
Step 11 – Internal audit
As per the requirement of ISO 9001:2008 QMS Standard, the organization needs to conduct internal audits at planned intervals. The purpose is to ensure that the quality management system of the organization conforms to the planned arrangements, to the requirements of the ISO 9001:2008 QMS Standard and to the requirements established by the organization. A few staff members should be trained to carry out internal auditing. Even after the system stabilizes and start functioning, internal audits should be planned and performed as a regular strategy.
Make sure that non-conformances pointed out in the internal audit are resolved by ensuring corrective actions and turned to conformances. Make sure to maintain records of the audit and its results.
Step 12 – Management Review
When implementation of the documented QMS has been operating for three to six months and an internal audit has been conducted, a management review should be conducted by the top management of the organization by considering following inputs:
• Internal audit results,
• Customer feedback,
• Process performance,
• Product conformity,
• Status of corrective and preventive actions,
• Changes that could affect the QMS and recommendations for improvement.
Management review forms an integral part of the quality management system and it should be conducted at planned intervals. Make sure to maintain records from the management review.
Conclusion
Accordingly, by carrying out above steps an organization can implement ISO 9001:2008 QMS Standard without seeking consultant’s help, however, it is important to note that the training and awareness is very important in implementing management systems standards.
Certification is not a requirement of ISO 9001:2008 QMS Standard and many organizations in the world are implementing the standard without obtaining certification. However, if an organization wishes to obtain certification, then a pre-assessment audit should be arranged with an independent and qualified auditor that would provide a degree of confidence in the implementation. When the quality management system as per ISO 9001:2008 QMS Standard has been in operation for a few months and has stabilized, the organization can go for the process of third party certification.
Courtesy - Quality World, New Delhi - November 2010
Where can I get more articles?
This article is included in ‘Awareness Series on QMS’ containing more than 50 articles edited by KESHAV RAM SINGHAL. You can get this series by sending your subscription that is very nominal. You should send an email to keshavsinghalajmer@gmail.com asking subscription details of the Awareness Series on QMS.
I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.
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A few days back one of the authors of this write-up received a phone call from an executive of an organization stating that his organization wishes to implement ISO 9001:2008 QMS standard and asked whether engaging a consultant was necessary to implement the standard and how his organization could implement ISO 9001:2008 standard without engaging a consultant.
Due to high cost involved in implementing any of the management systems standards, organizations generally hesitate to implement management systems standards. Although appointing a consultant may be worthwhile investment for an organization, however appointing a consultant to implement any management systems standards is not necessary. Many organizations in the world have implemented ISO 9001 QMS standard without engaging consultants and successfully got ISO 9001 certification. However, many organizations find it difficult to implement the standard without consultant. It depends on the level of competency available in the organization. An organization, wish to implement any management systems standards, should determine whether a consultant is required. Why organizations generally engage consultants? We find, there may be following reasons:
1. Consultants have the experience, expertise and time that employees may not. Organizations generally engage consultants to fill the knowledge and time gaps.
2. Consultants provide flexibility of time. Consultants work any time, including nights, weekends and holidays.
3. Consultants offer the latest and objective point of view. Consultants bring the latest and unbiased ideas from their vide experience.
4. Consultants are more efficient and focus on assigned project with sincerity. So they help you fast track your way to an effective QMS.
If competency level in the organization is adequate and people are well aware of the organization’s systems, then organization can think implementing ISO 9001:2008 QMS standard without consultant. One should be very clear that ISO 9001:2008 standard is a generic standard in terms of its requirements, but not generic in terms of its implementation. So, while implementing the standard, the emphasis should be on the objectives and processes of the organization.
When organization plans to implement ISO 9001:2008 QMS Standard without consultant, the top management of the organization has important and relevant role in implementation. Through leadership and their actions, the top management is able to create an environment in the organization – (i) where people are fully involved, and (ii) in which a quality management system can operate effectively. The top management should demonstrate its commitment and determination to implement ISO 9001:2008 QMS Standard by involving themselves actively in the following tasks –
(i) Ensuring people in the organization understand the importance of meeting customer requirements and also statutory and regulatory requirements.
(ii) Defining organization’s quality objectives and commitment to quality and ensuring that everyone in the organization understands the ‘quality policy’ and how it applies to their work.
(iii) Performing ‘management reviews’ regularly to see the continuing suitability, adequacy and effectiveness of the quality management system.
(iv) Providing necessary resources to all quality activities.
The following step-by-step approach may be useful in implementing ISO 9001:2008 QMS Standard –
Step 1 – Appointing management representative
Management representative is important personnel in quality management system structure, who should have responsibility and authority to (i) implement the requirements of ISO 9001:2008 QMS, (ii) report back to the top management on the performance of the quality management system, and (iii) promote awareness of customer requirements throughout the organization. ISO 9001:2008 QMS Standard also requires appointment of a management representative (clause 5.2.2). Accordingly, the top management should appoint a member of organization’s management as management representative. It should be noted that the responsibility and authority of management representative cannot be assigned to an outside person.
Step 2 – Setting up a steering committee
When organization is thinking to implement ISO 9001:2008 QMS without consultant, it is better if the top management set up a steering committee. The chief executive or a senior officer of the organization should head the steering committee. Functional heads and management representative should be the members of the steering committee. The committee should be responsible for the overall planning of ISO 9001:2008 QMS implementation process, giving directions and allocating resources. The committee should also decide the scope for ISO 9001:2008 QMS.
Step 3 – Setting up a task force
The top management or steering committee should set up a task force. The management representative should be the coordinator of the task force. Persons having good knowledge of the organization’s processes and good communication-writing skills should be included as members of the task force. The task force should be allocated the timeframe task of developing documentation, such as, quality manual, procedures, work instructions etc.
Step 4 – Obtaining information about ISO 9001 QMS
The management representative should collect information about ISO 9001:2008 QMS and related standards. For general information, it is better to visit ISO website and IAF website. Purchase of the following may be useful –
• ISO 9000:2005 Quality management systems – Fundamental and vocabulary,
• ISO 9001:2008 Quality management systems – Requirements,
• ISO 9004:2009, Managing for the sustained success of an organization – A quality management approach,
• ISO 19011:2002, Guidelines on quality and/or environmental management systems auditing,
• Various others publications / literatures providing knowledge on ISO 9001:2008 QMS.
Internet is useful source for obtaining information on ISO 9001:2008 QMS for which various websites and blogs may be visited.
Step 5 – Organizing awareness programme
ISO 9001:2008 QMS awareness programme should be organized to communicate to the employees the aim of ISO 9001:2008 QMS, the advantage it offers (to employees, customers and the organization), how it will work, and employees’ roles and responsibilities within the system. This programme may be conducted by the management representative, any of the task force members or outside faculty.
Step 6 – Training
Training is important for improving the competency level of employees. Training programmes should be organized for different categories of employees – senior managers, supervisors and workers. It will be better if the top management also attend ISO 9001:2008 QMS related training, seminar or presentation.
The training should cover the basic concepts of quality management systems and their overall impact on the strategic goals of an organization, quality management principles, the processes, requirements and the likely work culture implications of the system.
Initial training may also be necessary on developing documentation, QMS auditing, laboratory management techniques, statistical tools, calibration, measurement and testing procedures etc.
The steering committee can decide organizing such trainings as in-house programmes or alternatively personnel may be nominated to external training programmes.
It is suggested that a few people of the organization (including the management representative) should undergo Lead Auditor Training. A few people selected as internal auditors should be provided internal audit or lead auditor training.
Step 7 – Formulating action plan
The steering committee should formulate a timeframe action plan for implementation of ISO 9001:2008 QMS. The action plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities.
Step 8 – Carrying out initial status survey
It is better to know the gaps between the systems of the organization and the requirements of the ISO 9001:2008 QMS Standard. A self-assessment initial status survey may be carried out by the management representative or any other personnel who have undergone QMS auditor training or lead auditor training. After conducting initial status survey, the organization will be in a position to know the gaps and what is required to do for implementation.
Step 9 – Developing documentation
ISO 9001:2008 QMS Standard requires developing QMS documentation and developing documentation is the most important activity in the implementation process. Members of the task force should be given training on developing documentation. It will be better if a few of them are trained as lead auditors. They should be well versed with the requirements of ISO 9001:2008 QMS Standard and also with the processes of the organization. As earlier pointed out, members of the task force involved in developing documentation should have good communication-writing skill. While developing documentation, reference to ISO 9001:2008 QMS, ISO 19011:2002 (on auditing) and ISO 10013 (on documentation) Standards would be better.
Organizations implementing ISO 9001:2008 QMS need to develop and establish documentation (including quality policy, quality objectives, quality manual, procedures etc.) and also to keep records of information that is useful in operation and assessment of the organization’s quality management system.
The quality management system documentation of the organization needs to include the following documents:
i. Documented statement of quality policy,
ii. Documented statements of quality objectives,
iii. A quality manual,
iv. Documented procedures required by the Standard,
v. Documents (= including documented procedures, work instructions, forms) determined by the organization,
vi. Records required by the Standard,
vii. Records determined by the organization.
Out of the above first five types of documents are required to be developed and rest two types are records of information that is useful in operation and assessment of the organization’s quality management system.
For developing organization’s quality policy, quality objectives and quality manual, compliance to requirements mentioned in clauses 4.2, 5.3 and 5.4.1 of ISO 9001:2008 QMS Standard should be adhered to.
QMS documentation is the basis for establishment, implementation and maintenance of the quality management system of the organization. An organization can combine all documentation in one manual or can have more manuals.
As stated earlier developing QMS documentation is the most important activity in the implementation process. A list of documents to be prepared should be drawn up and the the responsibility for writing the documents should be assigned to members of the task force concerned with various functional departments. This will lead to better understanding of requirements and also provide a sense of responsibility (including the involvement and ownership by personnel involved in developing documentation). The responsibility to develop QMS documentation (for example: procedures, work instructions) should be given to those persons, who are involved in the processes and activities. This will lead to ownership of documents and better understanding of the organization’s processes.
As the coordinator of the task force, the management representative should follow following steps –
• Make a list of all existing QMS related documents and obtain a copy of each documents for reference,
• Study each process and prepare a flow chart of activities,
• Examine interfaces and lack of interfaces between the processes,
• Review the process flow charts and identify duplication or omissions in the information or process flow,
• Map out what is to be written,
• Verify the presence of all the required elements (requirements) of ISO 9001:2008 QMS Standard in the current system,
• Allocate responsibilities for preparing drafts of relevant parts to various members of the task force,
• Circulate the completed drafts to persons concerned for comments,
• Consider comments received and incorporate necessary corrections,
• Take action to prepare final manuscript of the documentation
Step 10 – Implementation
The organization needs to close the gaps as identified in step 8 (initial status survey), the steering committee should allocate resources to perform actions and implementation, assign responsibilities and establish a final time-frame to complete the needed actions.
It will be good practice to implement the procedures being documented, as the documentation is developed, although this may be more effective in larger organizations. In small size organizations, the implementation of the QMS documentation is done at once throughout the organization. When phased implementation takes place, the effectiveness of the system in selected area can be evaluated. It would be a good idea initially to evaluate areas where the chances of positive evaluation are high, to main confidence of both management and staff in the merits of implementing the quality management system as per ISO 9001:2008 QMS Standard. Make efforts for effective implementation and make sure that what has been written in QMS documentation is being carried out.
Step 11 – Internal audit
As per the requirement of ISO 9001:2008 QMS Standard, the organization needs to conduct internal audits at planned intervals. The purpose is to ensure that the quality management system of the organization conforms to the planned arrangements, to the requirements of the ISO 9001:2008 QMS Standard and to the requirements established by the organization. A few staff members should be trained to carry out internal auditing. Even after the system stabilizes and start functioning, internal audits should be planned and performed as a regular strategy.
Make sure that non-conformances pointed out in the internal audit are resolved by ensuring corrective actions and turned to conformances. Make sure to maintain records of the audit and its results.
Step 12 – Management Review
When implementation of the documented QMS has been operating for three to six months and an internal audit has been conducted, a management review should be conducted by the top management of the organization by considering following inputs:
• Internal audit results,
• Customer feedback,
• Process performance,
• Product conformity,
• Status of corrective and preventive actions,
• Changes that could affect the QMS and recommendations for improvement.
Management review forms an integral part of the quality management system and it should be conducted at planned intervals. Make sure to maintain records from the management review.
Conclusion
Accordingly, by carrying out above steps an organization can implement ISO 9001:2008 QMS Standard without seeking consultant’s help, however, it is important to note that the training and awareness is very important in implementing management systems standards.
Certification is not a requirement of ISO 9001:2008 QMS Standard and many organizations in the world are implementing the standard without obtaining certification. However, if an organization wishes to obtain certification, then a pre-assessment audit should be arranged with an independent and qualified auditor that would provide a degree of confidence in the implementation. When the quality management system as per ISO 9001:2008 QMS Standard has been in operation for a few months and has stabilized, the organization can go for the process of third party certification.
Courtesy - Quality World, New Delhi - November 2010
Where can I get more articles?
This article is included in ‘Awareness Series on QMS’ containing more than 50 articles edited by KESHAV RAM SINGHAL. You can get this series by sending your subscription that is very nominal. You should send an email to keshavsinghalajmer@gmail.com asking subscription details of the Awareness Series on QMS.
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Monday, April 16, 2012
Let us learn from a Quality Guru - Philip Crosby
Philip Crosby
18 June 1926 – 18 August 2001)
American Quality Guru Philip Crosby contributed to management theory and quality management principles. He was the person, who initiated ‘Zero Defects’ programme at the plant of Martin Company, Florida, USA. He was the person, who put the belief among the industrial world that quality is free. ‘Doing it right the first time’ is his principle to respond to any quality crisis.
Education – Graduated (1944) from Triadelpha High School, Honorary Law Degree from Wheeling College, Honorary Law Degree from Rollins College, Honorary Doctor of Corporate Management from the University of Findlay
Crosby work life details
Crosby served in World War II and the Korean War. After serving in WWII and the Korean War, he worked for Closley, Martin-Marietta and ITT. He was the corporate vice president of ITT for 14 years. In the Korean War he served as a Marine Medical Corpsman.
1952 – Crosby started his career as a quality professional. Joined Croseley Corporation (Richmond, Indiana) as a junior electronic test technician, where he was directed to join the American Society for Quality Control and thus he entered in to the field of quality.
1955 – Moved to South Bend, Indiana and joined Bendix Corporation as a reliability technician, where he was associated with the work to investigate defects found by the testers and inspectors
1957 – Joined Martin Marietta Company in Orlando, Florida as a senior quality engineer and worked there for eight years. During this period, he developed his ‘Zero Defects’ concepts and also wrote many articles for various journals. He also started his speaking career.
1965 – He joined International Telephone and Telegraph as a vice president in charge of corporate quality.
1979 – Started a management consultancy organization ‘Philip Crosby Associates Inc.’ He published his first book ‘Quality is Free’.
1991 – Retired from Philip Crosby Associates and founded a new company named ‘Career IV, Inc.’ helping people to grow.
Crosby in Indian context
Philip Crosby visited India in 1996 and he talked with a few software folks at NIIT. As a nonexecutive chairman of ‘India Quality Management Foundation’, Crosby wrote a story about the eighth grade and quality management.
Crosby books
• Cutting the Cost of Quality (1967)
• Quality is Free: The Art of Making Quality Certain (1979)
• Quality Without Tears: The Art of Hassle-Free Management (!984)
• Running Things: The Art of Making Things Happen (1986)
• The Eternally Successful Organization (1988)
• Let’s Talk Quality (1989)
• Leading: The Art of Becoming an Executive (1990)
• Completeness: Quality for the 21st Century (1992)
• Reflections on Quality (1995)
• Quality IS Still Free (1996)
• The Absolutes of Leadership (1997)
• Quality and Me : Lessons of an Evolving Life (1999)
The Principle – ‘Doing it right the first time’
‘Doing it right the first time’ is Crosby’s principle to respond to any quality crisis. He defined following four quality absolutes:
i. Quality is conformance to requirements (requirements meaning both product requirements and customer’s requirements), not as ‘goodness’ or ‘elegence’
ii. The system of quality is prevention, not appraisal
iii. The performance standard must be zero defects (relative to requirements), not ‘that’s close enough’
iv. The measurement of quality is the price of nonconformance (PONC), not by indices
The above four absolutes originally coined by Crossby in his famous book ‘Quality is Free’. Four years after the death of Philip Crosby, Pilip Crosby Associates, a consulting organization founded by Philip Crosby, added another absolute, which states – “The purpose of quality is to ensure customer success, not customer satisfaction.”
Philip Crosby’s 14-Step Quality Improvement Process
Step 1 – Management commitment
Step 2 – Quality improvement teams
Step 3 – Measurement
Step 4 – Cost of quality
Step 5 – Quality awareness
Step 6 – Corrective action
Step 7 – Zero defects planning
Step 8 – Education
Step 9 – Zero Defects Day
Step 10 – Goal setting
Step 11 – Error cause removal
Step 12 – Recognition
Step 13 – Quality councils
Step 14 – Do it over again
‘Quality is Free’
‘Quality is Free’ communicates powerful messages
i. Senior management must commit to quality if things are to change
ii. Doing things right the first time adds absolutely nothing to the cost of a product or service
iii. Quality is free, but it is not a gift
iv. An organization that established a quality programme will see savings more than pay off cost of the quality programme.
With best wishes,
Keshav Ram Singhal
18 June 1926 – 18 August 2001)
American Quality Guru Philip Crosby contributed to management theory and quality management principles. He was the person, who initiated ‘Zero Defects’ programme at the plant of Martin Company, Florida, USA. He was the person, who put the belief among the industrial world that quality is free. ‘Doing it right the first time’ is his principle to respond to any quality crisis.
Education – Graduated (1944) from Triadelpha High School, Honorary Law Degree from Wheeling College, Honorary Law Degree from Rollins College, Honorary Doctor of Corporate Management from the University of Findlay
Crosby work life details
Crosby served in World War II and the Korean War. After serving in WWII and the Korean War, he worked for Closley, Martin-Marietta and ITT. He was the corporate vice president of ITT for 14 years. In the Korean War he served as a Marine Medical Corpsman.
1952 – Crosby started his career as a quality professional. Joined Croseley Corporation (Richmond, Indiana) as a junior electronic test technician, where he was directed to join the American Society for Quality Control and thus he entered in to the field of quality.
1955 – Moved to South Bend, Indiana and joined Bendix Corporation as a reliability technician, where he was associated with the work to investigate defects found by the testers and inspectors
1957 – Joined Martin Marietta Company in Orlando, Florida as a senior quality engineer and worked there for eight years. During this period, he developed his ‘Zero Defects’ concepts and also wrote many articles for various journals. He also started his speaking career.
1965 – He joined International Telephone and Telegraph as a vice president in charge of corporate quality.
1979 – Started a management consultancy organization ‘Philip Crosby Associates Inc.’ He published his first book ‘Quality is Free’.
1991 – Retired from Philip Crosby Associates and founded a new company named ‘Career IV, Inc.’ helping people to grow.
Crosby in Indian context
Philip Crosby visited India in 1996 and he talked with a few software folks at NIIT. As a nonexecutive chairman of ‘India Quality Management Foundation’, Crosby wrote a story about the eighth grade and quality management.
Crosby books
• Cutting the Cost of Quality (1967)
• Quality is Free: The Art of Making Quality Certain (1979)
• Quality Without Tears: The Art of Hassle-Free Management (!984)
• Running Things: The Art of Making Things Happen (1986)
• The Eternally Successful Organization (1988)
• Let’s Talk Quality (1989)
• Leading: The Art of Becoming an Executive (1990)
• Completeness: Quality for the 21st Century (1992)
• Reflections on Quality (1995)
• Quality IS Still Free (1996)
• The Absolutes of Leadership (1997)
• Quality and Me : Lessons of an Evolving Life (1999)
The Principle – ‘Doing it right the first time’
‘Doing it right the first time’ is Crosby’s principle to respond to any quality crisis. He defined following four quality absolutes:
i. Quality is conformance to requirements (requirements meaning both product requirements and customer’s requirements), not as ‘goodness’ or ‘elegence’
ii. The system of quality is prevention, not appraisal
iii. The performance standard must be zero defects (relative to requirements), not ‘that’s close enough’
iv. The measurement of quality is the price of nonconformance (PONC), not by indices
The above four absolutes originally coined by Crossby in his famous book ‘Quality is Free’. Four years after the death of Philip Crosby, Pilip Crosby Associates, a consulting organization founded by Philip Crosby, added another absolute, which states – “The purpose of quality is to ensure customer success, not customer satisfaction.”
Philip Crosby’s 14-Step Quality Improvement Process
Step 1 – Management commitment
Step 2 – Quality improvement teams
Step 3 – Measurement
Step 4 – Cost of quality
Step 5 – Quality awareness
Step 6 – Corrective action
Step 7 – Zero defects planning
Step 8 – Education
Step 9 – Zero Defects Day
Step 10 – Goal setting
Step 11 – Error cause removal
Step 12 – Recognition
Step 13 – Quality councils
Step 14 – Do it over again
‘Quality is Free’
‘Quality is Free’ communicates powerful messages
i. Senior management must commit to quality if things are to change
ii. Doing things right the first time adds absolutely nothing to the cost of a product or service
iii. Quality is free, but it is not a gift
iv. An organization that established a quality programme will see savings more than pay off cost of the quality programme.
With best wishes,
Keshav Ram Singhal
Sunday, April 15, 2012
Let us learn from a Quality Guru - Joseph M. Juran
Joseph M. Juran
(24 December 1904 – 28 February 2008)
Joseph Moses Juran, a leading quality guru, who had written several influential books on quality and quality management. Born in Romania, but he spent most of his life in America. He is often known as ‘Father of Quality’.
A few awards received by Juran includes – (i) Second Order of the Sacred Treasure Award from the Emperor of Japan.
Education – B. S. in Electrical Engineering (1925) – University of Minnesota
Juran’s Work Life details
1925 – Started working with Western Electric in the Inspection Department of the Hawthorne Works, Chicago, USA.
1926 – Attended training programme designed to implement new tools and techniques, and thereafter, from a group of 20 trainees, Juran became one of two engineers for the Inspection Statistical Department.
1928 – Juran wrote a paper ‘Statistical Methods Applied to Manufacturing Problems’
1937 – Juran became the Chief of Industrial Engineering at Western Electric in New York. His work involved visiting other organizations and discussing methods of quality management. Juran created the ‘Pareto Principle’ which managers rely on to help separate the ‘vital few’ from the ‘useful many’ in their activities. This is now commonly referred as the 80-20 principle and also referred to as Juran’s Pareto Principle.
During World War II – Juran’s leave of absence from Western Electric for a period of four years, during this time he served as an assistant administrator for the Land-Lease Administration in Washington. By the end of the war, Juran was a well-known and highly-regarded Statistician and industrial engineering theorist in America.
1945 and thereafter – Left Washington and did not join Western Electric. Juran chose to devote the remainder of his life to the study of quality management. Joined New York University as Chairman of the Department of Administrative Engineering, where he taught for many years. He devoted his tome mostly in the development of his management philosophies. The Union of Japanese Scientists and Engineers invited Juran to Japan in 1954, where he taught them the principles of quality management and thus helped Japanese rebuilt their economy. In 1979 he founded Juran Institute.
Juran is famous for his quality management ideas known as Quality Trilogy. Quality Trilogy includes three distinct phases: (i) Quality Planning – Identify your customers, determine needs of your customers, translate their needs in your own language, and develop a product that can respond to customer needs, (ii) Quality Improvement – Develop a process which is able to produce a product, and optimize the process, (iii) Quality Control – Prove that the process can produce the product under operating conditions with minimal inspection, and transfer the process to operation.
Juran in Indian context
Indian Merchants’ Chamber (IMC) initiated an award named ‘IMC Juran Medal’, which has become a benchmark for quality leaders in India.
Famous work of Juran
• Juran’s Pareto Principle
• Quality Control Handbook (First released in 1951)
• Managerial Breakthrough – A collection of Juran’s lectures (1964)
• Juran’s Quality Trilogy (First published in 1986)
• Foundation of Juran Institute (1979)
Juran’s Pareto Principle
Juran’s Pareto Principle, suggested by Joseph M. Juran, is also known as the ’20-80 Rule’, ‘the law of vital few’ and ‘the principle of factor sparsity’. It emphasizes that for many phenomena 80% of consequences stem from 20% causes. Juran framed this principle after he adopted an idea from the Italian economist Vilfredo Pareto that stated the 80% of property in Italy was owned by 20% of the Italian population. Thus, Juran was able to frame that ‘20% of clients are responsible for 80% of sales volume’. The Juran’s Pareto Principle is helpful in future decision making. The 20-80 Rule means that in anything a few (20%) are vital and many (80%) are trival.
Juran’s definition for quality
Juran defines quality as ‘fitness for use’ (1988). Note: The customer defines the fitness.
Juran offers two definitions of quality in his must-have reference, Juran’s Quality Handbook:
• Quality means those features of products, which meet customer needs and thereby provide customer satisfaction.
• Quality means freedom from deficiencies – freedom from errors that require doing work again (rework) or that result in field failures, customer claim and so on.
Juran’s Quality Improvement Tools
Juran suggests following 10 steps to quality improvement:
i. Build awareness of opportunity to improve
ii. Set your goals for improvement
iii. Organize yourself to reach goals
iv. Provide training
v. Carry out projects to solve problems
vi. Report progress
vii. Give recognition
viii. Communicate results
ix. Keep score
x. Maintain momentum by making annual improvement plan of the regular systems and processes of the organization
With best wishes,
KRS
(24 December 1904 – 28 February 2008)
Joseph Moses Juran, a leading quality guru, who had written several influential books on quality and quality management. Born in Romania, but he spent most of his life in America. He is often known as ‘Father of Quality’.
A few awards received by Juran includes – (i) Second Order of the Sacred Treasure Award from the Emperor of Japan.
Education – B. S. in Electrical Engineering (1925) – University of Minnesota
Juran’s Work Life details
1925 – Started working with Western Electric in the Inspection Department of the Hawthorne Works, Chicago, USA.
1926 – Attended training programme designed to implement new tools and techniques, and thereafter, from a group of 20 trainees, Juran became one of two engineers for the Inspection Statistical Department.
1928 – Juran wrote a paper ‘Statistical Methods Applied to Manufacturing Problems’
1937 – Juran became the Chief of Industrial Engineering at Western Electric in New York. His work involved visiting other organizations and discussing methods of quality management. Juran created the ‘Pareto Principle’ which managers rely on to help separate the ‘vital few’ from the ‘useful many’ in their activities. This is now commonly referred as the 80-20 principle and also referred to as Juran’s Pareto Principle.
During World War II – Juran’s leave of absence from Western Electric for a period of four years, during this time he served as an assistant administrator for the Land-Lease Administration in Washington. By the end of the war, Juran was a well-known and highly-regarded Statistician and industrial engineering theorist in America.
1945 and thereafter – Left Washington and did not join Western Electric. Juran chose to devote the remainder of his life to the study of quality management. Joined New York University as Chairman of the Department of Administrative Engineering, where he taught for many years. He devoted his tome mostly in the development of his management philosophies. The Union of Japanese Scientists and Engineers invited Juran to Japan in 1954, where he taught them the principles of quality management and thus helped Japanese rebuilt their economy. In 1979 he founded Juran Institute.
Juran is famous for his quality management ideas known as Quality Trilogy. Quality Trilogy includes three distinct phases: (i) Quality Planning – Identify your customers, determine needs of your customers, translate their needs in your own language, and develop a product that can respond to customer needs, (ii) Quality Improvement – Develop a process which is able to produce a product, and optimize the process, (iii) Quality Control – Prove that the process can produce the product under operating conditions with minimal inspection, and transfer the process to operation.
Juran in Indian context
Indian Merchants’ Chamber (IMC) initiated an award named ‘IMC Juran Medal’, which has become a benchmark for quality leaders in India.
Famous work of Juran
• Juran’s Pareto Principle
• Quality Control Handbook (First released in 1951)
• Managerial Breakthrough – A collection of Juran’s lectures (1964)
• Juran’s Quality Trilogy (First published in 1986)
• Foundation of Juran Institute (1979)
Juran’s Pareto Principle
Juran’s Pareto Principle, suggested by Joseph M. Juran, is also known as the ’20-80 Rule’, ‘the law of vital few’ and ‘the principle of factor sparsity’. It emphasizes that for many phenomena 80% of consequences stem from 20% causes. Juran framed this principle after he adopted an idea from the Italian economist Vilfredo Pareto that stated the 80% of property in Italy was owned by 20% of the Italian population. Thus, Juran was able to frame that ‘20% of clients are responsible for 80% of sales volume’. The Juran’s Pareto Principle is helpful in future decision making. The 20-80 Rule means that in anything a few (20%) are vital and many (80%) are trival.
Juran’s definition for quality
Juran defines quality as ‘fitness for use’ (1988). Note: The customer defines the fitness.
Juran offers two definitions of quality in his must-have reference, Juran’s Quality Handbook:
• Quality means those features of products, which meet customer needs and thereby provide customer satisfaction.
• Quality means freedom from deficiencies – freedom from errors that require doing work again (rework) or that result in field failures, customer claim and so on.
Juran’s Quality Improvement Tools
Juran suggests following 10 steps to quality improvement:
i. Build awareness of opportunity to improve
ii. Set your goals for improvement
iii. Organize yourself to reach goals
iv. Provide training
v. Carry out projects to solve problems
vi. Report progress
vii. Give recognition
viii. Communicate results
ix. Keep score
x. Maintain momentum by making annual improvement plan of the regular systems and processes of the organization
With best wishes,
KRS
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