Aligning Quality Policy and Quality Objectives

Article for review – Comments and suggestions invited

ISO 9001:2008 QMS Standard mentions that an organization's quality policy must provide a framework for establishing and reviewing the company's quality objectives. The quality policy should give an overall direction for the organization, and its quality objectives should flow in that direction. The top management of the organization needs to establish quality objectives. Top management of the organization must ensure that quality objectives (including those needed to meet requirements for the product) are established at relevant functions and levels within the organization. The quality objectives must be measurable and consistent with the quality policy of the organization.

Clause 7.1 (a) of ISO 9001:2008 QMS Standard lays down that in planning product realization, the organization must determine quality objectives and requirements for the product. It is evident from this clause that the ISO 9001:2008 Standard now calls for objectives not only for the quality management system but also for the product. Many factors (such as changes in customer requirements, market conditions, business compulsions) may often put such situation where the organization have to think to change the policy and/or objectives, which may lead to weakening in the alignment between quality policy and quality objectives. To deal such situation continually, ISO 9001:2008 QMS standard requires that top management periodically review changes to both the policy and objectives. An organization's objectives must be measurable and its quality management system processes designed to meet those objectives.

Just after the publication of ISO 9001:2000 QMS Standard (earlier version of the standard), John E. (Jack) West (a famous quality excellence business consultant from USA) stated in an article ‘Three strategies for aligning quality policies, objectives and processes’ published in the Quality Digest (USA) that aligning the quality policy, quality objectives and QMS processes should further top management's intent with regard to quality. There's only one small, potential difficulty: ISO 9001 standard doesn't address aligning the quality policy and objectives with other business goals. Here it is important to mention that organization's overall business goals, quality objectives and quality policy are all interrelated and must work together to achieve business improvement. The purpose of quality management system is to create such management system where an organization is able to consistently provide product that meet customer and applicable legal requirements with aim to enhance customer satisfaction.

Clause 5.4.2 of ISO 9001:2008 QMS standard requires that an organization plan its quality management system to meet both the quality objectives and the general requirements of quality management system as mentioned in clause 4.1. Here it is important to note that clause 4.1 of ISO 9001:2008 QMS standard requires an organization to determine its quality management system processes and their application. The organization also needs to determine how processes interact, determine the criteria and methods needed for effectively operating and controlling the processes, and provide the resources to do so. The organization needs to monitor and, where applicable, measure the processes. And this information must also be analyzed to determine further actions needed to achieve planned results and improvement.

On the basis of the requirements mentioned in clause 5.4.1, some people may think that establishing quality objectives at relevant functions and levels within the organization is a one-time activity; however it is now clear that such thinking opposes the intent of the quality management system. There is also a need to integrate continual improvement activities in the quality management system. ISO 9001:2008 QMS standard requires continually improve the effectiveness of the quality management system through the use of the quality policy, objectives, audit results, data analysis, corrective and preventive actions, and management review. Accordingly, there is a need to continually review alignment between the quality policy and quality objectives and take necessary steps.

- Divya Singhal and Keshav Ram Singhal

(Please send your comments to divyagim@gmail.com and keshavsinghalajmer@gmail.com)

हिंदी में आईएसओ ९००१ गुणवत्ता प्रबंध प्रणाली पर जानकारी वाला पहला ब्लॉग

Please see the link
http://iso9001awareness.blogspot.com/

Thanks,

Keshav Ram Singhal

Control of documents and control of records

Dr. Divya Singhal and Keshav Ram Singhal

First, it is necessary to understand the difference between records and documents. A document provides information in written, printed, or electronic form. A record relates to an activity or transaction that has happened in the past; it is a record of history. A record can consist of one or more documents, which all relate to a single event in time. The difference between a document and a record is that a document can change over time, while a record should not change.

Clause 4.2.3 of ISO 9001:2008 QMS Standard deals with control of documents, and clause 4.2.4 deals with control of records. Now we give below details regarding control of documents and control of records.

Control of documents

All documents required by the quality management system of the organization need to be controlled. Records are also required to be controlled as per requirements mentioned in clause 4.2.4 of the ISO 9001:2008 standard. This is separately addressed in this article under the heading „Control of records‟. For control of documents, a procedure is required to be documented. The documented procedure needs to define the controls needed:

- To approve documents for adequacy prior to issue
- To review and update as necessary and re-approve documents
- To ensure that changes and the current revision status of documents are identified
- To ensure that relevant versions of applicable documents are available at points of use
- To ensure that documents remain legible (clearly readable) and readily identifiable
- To ensure that documents of external origins are determined (which are necessary for the planning and operation of the quality management system)
- To ensure that distribution of determined external origin documents are controlled
- To prevent the unintended use of obsolete documents
- To apply suitable identification to obsolete documents if they retained for any purpose

Approval of document for adequacy prior to issue means that some authority (with responsibility to manage and direct quality management system affairs of the organization) has agreed the document before being made available for use (i.e. approval before the document is distributed, or published or made available to the users).

Reviewing document means another look at the document and this is a task, which should be carried out at the time following the issue of the document by the management representative or by the person, who is linked with the affairs mentioned in the document. Review of documents may be carried out randomly or periodically. Periodic review is proactive action and it is better if the management representative carries out periodic review (at least once in a year) of the issued document. If a document is updated with any change, then the same is required to be approved for adequacy prior to issue.

Changes to documents may be identified by mentioning a change record within the document that denotes the nature of change. Current revision status of document may be identified by issue number, revision number or date of the document.
To ensure that document is available at the point of use, the organization needs to establish who needs which document at what time. The document access should be available to persons who need it for better work performance. To ensure that documents remain legible and readily identifiable, it is required that contents of the documents are readable and documents can be identified easily. Document identification can be done by classification, titles or identification numbers of documents.

In order to control the distribution of external documents, the organization should establish appropriate process or mechanism for identification, classification, distribution and availability of such external documents.

Obsolete documents should not be available at the point of use. Use of obsolete documents may lead to errors, failures or hazards, which become an evidence of nonconformity. Sometime superseded or obsolete documents need to be retained by the organization for a variety of reasons (e.g. legal or reference purpose) and for this the organization must have a method of identifying the status of such documents to prevent their accidental use in place of current documents. In practice, organizations put stamp as „OBSOLETE DOCUMENT‟ in red ink on the face of the obsolete document.

For effective document control, following points should also be taken due care:

- The documents (manual, procedures, and work-instructions) should be written as a value-added proposition, not only as required step in the compliance process of the ISO 9001:2008 standard.
- The documents style, format, vocabulary and language should be easy to understand.
- The process owners should be included in writing relevant procedures or in reviewing the documents. Make sure that the people who use the document are involved in writing and reviewing them.
- The change (revision of documentation) process should be accessible to the people most affected by document inadequacies.
- Developing an effective value-added controlled document requires planning and regular monitoring.
- Write processes as they exist.
- Developing reliable and consistent process execution is critical for effective production planning.
- Make sure that documents are available at the point of use. Providing electronic access to documents at the point of use may be one good solution.
- Manage document changes efficiently.
- Documents should be reviewed regularly for accuracy. Failing to review documents for accuracy is one of the bigger mistakes organization does.
- Keep documents content current and accurate.


Control of records

Records established must be controlled. The purpose to maintain records is to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records must remain:
- Legible
- Readily identifiable
- Retrievable

For control of records, a procedure is required to be documented. The documented procedure needs to define the controls needed for the:
- Identification of records
- Storage of records
- Protection of records
- Retrievable of records
- Retention of records
- Disposition of records

Why managing and controlling records necessary? Records exist in every organization. Records provide with information to help people to manage processes of the organization effectively. Records are the evidence of the past performance. Records provide with information of results achieved or evidence of activities performed.

Appropriate ways to control records include indexing, filing, proper keeping so that the risk of deterioration, damage or loss of record is minimized. It is better to decide who will have access to which records and how readily available and identifiable. Proper indexing, filing and safe keeping facilitate retrieval of records. It is better that records are not destroyed or disposed of before the end of their usefulness. While deciding the retention time of a particular record, also look into the legal requirements in this regard, so as to avoid forthcoming problems. Control on disposition of records should ensure that records are not destroyed prior authorization and organization should specify the method of disposal.

Records serve three purposes: (i) Records provide evidence of conformity with the requirements of the ISO 9001:2008 standard, (ii) Records demonstrate that the organization has an effective quality management system, and (iii) Records document continual improvement.

DS & KRS

Small changes having opportunities for improvement

Article for review – Comments and suggestions invited

Transition to ISO 9001:2008 QMS – Small changes having opportunities for improvement
Dr. Divya Singhal
and
Keshav Ram Singhal


ISO 9001 QMS standard has been popular among organizations all over the world during the last two decades. ISO 9000 QMS family standards were first published in 1987 and thereafter there was a revision in 1994. In the year 2000, there had been a major revision in the QMS standards and revised ‘ISO 9001:2000, Quality management systems – Requirements’ standard was published on 15 December 2000. On 15 November 2008, fourth edition – ISO 9001:2008 has been issued and published. Changes in the revised standard, ISO 9001:2008, are mostly editorial giving more clarity to the right interpretation of requirements. Users, such as organizations implementing ISO 9001 QMS, QMS auditors, etc., will find the new standard useful for right interpretation of standard’s requirements.

On careful reading of the revised ISO 9001:2008 standard and the earlier ISO 9001:2000 standard, we find that both standards used same numbering system to organize the standard and also there is no change in the intent, but the meaning is more clarified by the revision. On reading the standard at the macro level, we find no new requirements, but reading the same at micro-level, we find changes to the wording of a few clauses and additions of notes at the end of requirements. As such, organizations have opportunity to review their quality management system and to check the need for any change. Although the changes in the standard are small, but changes to the wording of the clauses (without adding any new requirements) provide great opportunity for organizations to review their quality management system for its better effectiveness.

We may apply three approaches to the revision. First, there are no new requirements in ISO 9001:2008 standard, so we do not need to do anything or change the documentation. Second, we will look to the changes in ISO 9001:2008 and compare our quality management system whether we need any revision or modification in QMS documentation to remain in compliance with the new standard. Third, we have a big opportunity and we must critically review our quality management system and thus make improvements. The first approach is incorrect or sleepy approach, second one can be termed as minimalist approach, an approach that only to revise quality management system documentation and other efforts. The third approach is a proactive approach that provides real benefits. So, we need to have a proactive approach.

Objective of ISO 9001:2008 standard is to provide consistent and conforming product. Clause 1.1 mentions scope of the standard on the basis of a performance-based objective that ISO 9001:2008 standard specifies quality management system requirements to:
• demonstrate ability to consistently provide product that meets customer and applicable legal (= statutory and regulatory) requirements, and
• enhance customer satisfaction

What are we looking for, while implementing ISO 9001:2008 standard? We must look to the evidence how we are planning our management system to meet the (i) customers requirements, (ii) applicable legal requirements, (iii) standard’s requirements, and (iv) any additional requirements determined in the organization’s quality manual. It is always better to concentrate on the processes, not more on documents. Think cause and effect of every process employed in the organization. Look at the results for which we should critically review system effectiveness and apply PDCA (Plan-do-check-act) approach. If this approach is applied by the internal auditors during their internal audit process then this proactive approach will bring good results for improvement.

There have been three objectives of the revision (i.e., development of ISO 9001:2008 standard):
• to improve the existing standard (i.e., ISO 9001:2000),
• to provide more clarity to the interpretation to requirements to enable ease of use, and
• to improve compatibility with ISO 14001:2004 standard

Now a few important points related to the changes are as under:

1. Clause 0.1 (introduction – general) now refers to organizational environment, changes in that environment and associated risks. Here is an opportunity to the user to check to ensure that the quality management system continues to be relevant to the changing business environment in which the organization is operating.
2. Clause 0.1 (introduction – general) confirms that the intent of the standard is not to imply uniformity in the structure of the QMS or uniformity of documentation. Here is an opportunity to the user to become the owner of its quality management system and its documentation.
3. Clause 0.1 (introduction – general) mentions meeting applicable statutory and regulatory requirements. Here is an opportunity to the user to determine which statutory and regulatory requirements are applicable to the quality management system of the organization.
4. Editorial change and text added to clause 0.2 (process approach) emphasizes the importance of processes of being capable of achieving desired outcome. Here is an opportunity to the user to apply process approach in achieving consistent and conforming product and review whether the system is producing desired results. In case answer to the review come in negative then the user has an opportunity to look at the why and what needs to be changed.
5. Clause 0.3 (relationship with ISO 9004) speaks about the relationship with ISO 9004. New ISO 9004:2009 standard has also been published, as such there is an opportunity to the user to read the latest version of ISO 9004 and get a sense how it might apply to its quality management system to manage the sustained success.
6. Some editorial changes to clause 0.4 (compatibility with other management systems) have introduced for the better alignment with other management systems. Here is an opportunity to the user to think for an integrated approach, if implementing other management systems (such as ISO 14001 EMS, OHSAS etc).
7. Clause 1.1 (scope – general) re-emphasizes that the objective of the quality management system should be to provide confidence in the organization’s ability to consistently provide conforming product (product that meet customer and applicable legal requirements). Here is an opportunity to the user to always keep in mind the objective mentioned in clause 1.1.
8. Throughout the new standard (ISO 9001:2008), the text has been modified to address statutory and regulatory requirements (which can be expressed as legal requirements as per note 2 added to clause 1.1). Here is an opportunity to the user to ensure to think what legal requirements are applicable to the organization.
9. Note 1 in clause 1.1 (scope – general) clarifies that the term ‘product’ refers to any intended output resulting from the product realization processes. Here is an opportunity to the user to ensure that organization’s system addresses the requirements of purchased product, intermediate product (resulting from different realization processes) and the final product. This will help eliminate nonconforming product during realization process.
10. Clause 1.1 (scope – general) reminds to think the scope of the organization’s quality management system and application of ISO 9001:2008 requirements in the organization. Here is an opportunity to the user to check and make sure that the requirements of the standard are properly applied and exclusions to any requirements have valid reasons.
11. Clause 1.2 (application) has been edited by adding statutory to applicable regulatory requirements. Here is an opportunity to the user to think the exclusions that do not affect resulting product meeting customer and applicable statutory and regulatory requirements.
12. Clause 2 (normative reference) now refers to ISO 9000:2005 standard as a normative reference document. Here is an opportunity to the user to consult quality management principles and terminology given in ISO 9000:2005 standard to understand the requirements of ISO 9001:2008 standard more clearly.
13. Clause 3 (terms and definitions) refers to ISO 9000 for terms and definitions and also confirms that the term ‘product’ also mean ‘service’.
14. Note 1 to clause 4.1 (QMS – general requirements) clarifies that the processes needed for the quality management system include processes for management activities, provision of resources, product realization, measurement, analysis and improvement. Processes for analysis and improvement have been added in the note of the revised standard (although necessary earlier also in clause 8 requirements), as such there is an opportunity to the user to check and make sure to manage analysis and improvement processes along with other processes.
15. Clause 4.1 (e) now clarifies that measurement process may not be applicable in all cases, however monitoring all processes being necessary. Here is an opportunity to the user to re-evaluate the need for measurement.
16. Notes have been added to clause 4.1 (QMS – general requirements) that explain more about outsourcing – (i) meaning of ‘outsourced process’, (ii) responsibility of conformity, and (iii) ensuring control to outsourced process. Here is an opportunity to the user to review and define the type and extent of control to be applied to the outsourced process.
17. Note to clause 4.2.1 (QMS – documentation requirements – general) now clarifies that a single document may address the requirements for one or more procedures. Also, a requirement (of ISO 9001:2008 standard) may be covered by more than one document. Accordingly, here is an opportunity to the user to re-evaluate quality management system documentation. The user may choose to address, for example, - (i) ‘Control of document’ and ‘control of records’ in a single procedure, provided that the procedure covers all requirements of clause 4.2.3 and 4.2.4, and (ii) ‘control of nonconforming product’, ‘corrective action’ and ‘preventive action’ in a single procedure , provided that the procedure covers all requirements of clause 8.3, 8.5.2 and 8.5.3.
18. Clause 4.2.1 (c) and (d) include records as a type of documentation required for the quality management system. Here is an opportunity to the user to re-evaluate the need for any new records to ensure effective planning, operation and control of processes.
19. Clause 4.2.3 (control of documents) explains that external origin documents determined by the organization are identified and their distribution controlled. Hence, distribution control not required to all external documents that are used in the organization. Here is an opportunity to the user to be flexible in controlling documents of external origin.
20. Sequence of clause 4.2.4 (control of records) has been changed for more clarity and better alignment with ISO 14001 EMS standard. There is no change in requirements of this clause, however, here is an opportunity to the user to achieve better integration of records generated by quality management system, environmental management system and other management systems (such as OHSAS 18001).
21. No change in the requirements of clause 5.1 (management commitment), clause 5.2 (customer focus), clause 5.3 (quality policy) and clause 5.4 (Planning).
22. Clause 5.5.2 (management representative) clarifies that the management representative has to be a member of organization’s management. Where an organization has appointed outside part-time personnel (such as consultant) as management representative, there is an opportunity to the user to remove such personnel as management representative and appoint organization’s own management member as management representative to take the ownership of the quality management system of the organization.
23. There is no change in the requirements of clause 5.6 (management review).
24. There is no change in the requirements of clause 6.1 (provision of resources).
25. There is editorial change in clause 6.2.1 and addition of a new note, which clarifies that competence requirements relate to personnel whose work directly affects conformity to product requirements and also where it indirectly affects conformity to product requirements. If an organization has limited its attention to competence requirements for personnel directly involved in production (or service delivery) processes, then there is an opportunity to the user to assess competence requirements for personnel involved in other activities (such as purchasing, supplier evaluation, internal audit etc.).
26. In clause 6.2.2 (competence, training and awareness), there is change in sequence of the title to bring the title in line with the similar clause in ISO 14001 EMS standard.
27. There is no new requirement in clause 6.3 (infrastructure), however this clause has now recognized information technology as an example of infrastructure, so there is an opportunity to the user to review dependence on information technology and its maintenance.
28. Although there is addition of a new note to clause 6.4 (work environment) that explains the term ‘work environment’, but this does not change any requirements of this clause. However, there is an opportunity to the user to consider the conditions under which work is performed.
29. Clause 7.1 (planning of product realization) has been reframed being editorial change and there is an addition of the word ‘measurement’, accordingly, there is an opportunity to the user during product realization planning to think and determine measurement activities to ensure proper control.
30. Requirements in clause 7.2.1 (determination of requirements related to the product) have been slightly reworded and a new note has been added that clarifies the post delivery activities to include actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling or final disposal). Here is an opportunity to the user to think about post delivery activities that can enhance customer satisfaction.
31. There is no change in the requirements of clause 7.2.2 (review of requirements related to the product).
32. There is no change in the requirements of clause 7.2.3 (customer communication).
33. A note has been added to clause 7.3.1 (design and development planning) explaining that design and development review, verification and validation have distinct purposes. As such, they may be conducted and recorded separately or in any combination as suitable for the product and the organization. Here is an opportunity to the user to have flexibility in addressing design and development review, verification and validation. For complex design and development process, distinct activities for review, verification and validation are recommended and for simple design and development process, all activities for review, verification and validation may be carried out at the same time.
34. There is editorial change in the wording of the requirements in clause 7.3.2 (design and development inputs), however there is no change in the requirements.
35. There are editorial changes in clause 7.3.3 (design and development outputs) and also a new note has been added explaining that design and development output can include details for the preservation of products. Here is an opportunity to the user to look to design outputs that addresses product packaging and handling information.
36. There is no change in the requirements of clause 7.3.4 (design and development review).
37. There is no change in the requirements of clause 7.3.5 (design and development verification).
38. There is no change in the requirements of clause 7.3.6 (design and development validation).
39. There is no change in the requirements of clause 7.3.7 (design and development changes), no text change, however Paras now merged.
40. There is no change in the requirements of clause 7.4 (purchasing).
41. There are editorial changes in clause 7.5.1 (control of production and service provision) that the word ‘equipment’ has been used instead of ‘devices’ and the word ‘product’ has been added prior to the word ‘release’. Hence, there are no changes in the requirements of this clause.
42. There are editorial changes in clause 7.5.2 (validation of processes for production and service provision), however no changes in the requirements of this clause.
43. The wording in clause 7.5.3 (identification and traceability) has been changed to clarify that identification may be needed throughout the product realization process – not only for the final product. Here is an opportunity to the user to identify the product by suitable means throughout product realization process.
44. There are editorial changes in clause 7.5.4 (customer property) and a new note has been added to this clause explaining that both intellectual property and personal data of the customer are customer property. Here is an opportunity to the user to also think and take care with the intellectual property and personal data of the customer.
45. The wording in clause 7.5.5 (preservation of product) has been changed to clarify the requirements in a better way; however there is no change in requirements of this clause.
46. There are a number of minor editorial changes in clause 7.6 (control of monitoring and measuring equipment), the word ‘devices’ has been replaced by ‘equipment’. An additional note has been added regarding the use of computer software that states verification and configuration management as typical methods to satisfy intended application and maintain suitability for use. The editorial changes in this clause will have no impact, however, here is an opportunity to the user to look and consider the extent to which computer software is used during monitoring and measuring activities. The user should be able to know the impact of computer software on the accuracy of results. The software should be up-to-date and suitably protected against virus, system crash etc.
47. There is minor editorial change in clause 8.1 (measurement, analysis and improvement – general), however this does not change the intent of the requirements.
48. A note has been added to clause 8.2.1 (customer satisfaction) explaining that monitoring customer perception can include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealers report. There is no new requirement in this clause, however, here is an opportunity to the user to review the way top monitor customer perception.
49. There are editorial changes in clause 8.2.2 (internal audit) and this clause now expects management responsible for the area being audited to ensure that correction and corrective actions are addressed without undue delay as appropriate with respect to detected nonconformities. Here is an opportunity to the user to do a root cause analysis and correction of detected nonconformity without loss of time.
50. A note has been added to clause 8.2.3 (monitoring and measurement of processes), which clarifies that when deciding on appropriate monitoring and measurement methods, consider both impact on product conformity and on the effectiveness of the quality management system of the organization. Here is an opportunity to the user to look to all processes of the organization.
51. There are editorial changes in clause 8.2.4 (monitoring and measurement of product), but no new requirements.
52. There are editorial changes in clause 8.3 (control of nonconforming product), but no new requirements.
53. There are editorial changes in clause 8.4 (analysis of data), but no new requirements.
54. There is no change in the requirements of clause 8.5.1 (continual improvement).
55. Clause 8.5.2 (corrective action) now makes it clear that effectiveness of the corrective action must also be reviewed. Here is an opportunity to the user to look carefully at the corrective actions that they are achieving desired results.
56. Clause 8.5.3 (preventive action) now makes it clear that effectiveness of the preventive action must also be reviewed. Here is an opportunity to the user to look carefully at the preventive actions that they are achieving desired results.

ISO 9001:2008 Implementation Policy
International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have agreed an implementation plan to ensure smooth migration of accredited certification to ISO 9001:2008, which is summarized as under:
• 15 November 2008 – date of publication of ISO 901:2008. Before this date, no accredited certificates to ISO 9001:2008 were allowed.
• On or after 15 November 2008, new certificates only after a routine surveillance or recertification audit against ISO 9001:2008.
• Up to 15 November 2009, certification and renewal to ISO 9001:2000 (old version) were permitted.
• Beginning 15 November 2009, no new certificates to ISO 9001:2000 (old version) are allowed. All audits to be conducted to ISO 9001:2008.
• From 15 November 2010, ISO 9001:2000 (old version) certificates will no longer be valid.

Transition to ISO 9001:2008
If we look to the changes in ISO 9001:2008 standard, there are no new requirements, so the transition to ISO 9001:2008 is simple, but not automatic. Organizations should take advantage of the changes to re-assess the value of their quality management system and accordingly, they should revise their quality management system documentation. Internal auditors need to be aware of the changes. They should use ISO 9001:2008 Annex B. Time is running fast, so ISO 9001:2000 certified organizations are required to act fast.

What is needed from existing internal auditor trained for ISO 9001:2000 QMS auditing?
The internal auditor should undergo a training to understand the underlying philosophy and principles, concepts and requirements of ISO 9001:2008 standard, and how to apply them within an audit context and also understand the key differences between the revised series of standards and the 2000 and 2008 versions, and understand the implications of these differences for effective auditing against the revised standard.


Do not forget
Consistent, conforming product (meeting customer and applicable statutory and regulatory requirements) and also enhancement of customer satisfaction and that should be the aim of your quality management system.

Thanks

The END ???
Learning is a process that never ends.

Publication Series प्रबंध प्रणाली बोध 'MANAGEMENT SYSTEMS AWARENESS'

Please see details on publication series being published by National Centre for Quality Management, Ajmer Centre. Please click the photo attached and see details. We seek your publication support contribution. Thanks.

INCREASING THE POWER OF YOUR QMS – ACHIEVE PERFORMANCE EXCELLENCE THROUGH CONTINUAL IMPROVEMENT

K. R. Singhal

Hariharan Jairam once writes in the ‘Quality World’ – “Quality! Call it a concept, an approach, a way of life, a tool for achievement or merely a word. Whatever definition you give or whatever approach you take, this subject has made people think and think in a big way.” Girdhar J. Gyani says, “Quality today has many dimensions. Gone are the days when quality was identified with product alone.” Dr. R. H. G. Rau opines, “Management of quality is not a one-shot affair. It covers all transactions. Continuous creation of value addition is possible only when we manage change; that too proactively.” Continuous creation of value addition has now become the expectation of consumers. Presently ‘constant’ quality is no longer good enough and ‘continual improvement’ is needed.

There is a need of continual improvement in the effectiveness of the quality management system because:
- ‘Continual improvement’ is needed by customers because of their changing expectations
- ‘Continual improvement’ is one of the quality management principles on which your quality management system is based
- ‘Continual improvement’ is one of the requirements of ISO 9001:2008 QMS Standard and you are required to comply with it. Organizations, implementing ISO 9001:2008 QMS, must understand that continual improvement is a must requirement of the Standard.

‘Continual improvement’ is a recurring (step-by-step) activity followed by: (i) identifying opportunities for improvement and their justification, (ii) deciding how to improve on the available resources, and (iii) implementing (carrying out) improvement.

We need to improve the effectiveness of the quality management system, but how can we do such improvement, that’s a relevant question. In this regard ISO 9001:2008 QMS Standard mentions use of quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review to continually improve the effectiveness of the quality management system. Clause 8.5 of the ISO 9001:2008 QMS Standard specially deals with the requirements for improvement. Continual improvement is a defined requirement of the Standard. (Clause 8.5.1)

If you wish to improve the power of your quality management system, achieve performance excellence through continual improvement.

General requirements (Clause 4.1) of ISO 9001:2008 QMS Standard stipulate that the organization must continually improve the effectiveness of its QMS in accordance with the requirements of the Standard. The Standard also stipulates to ensure top management to include a commitment to comply with requirements and continually improve the effectiveness of the quality management system. (Clause 5.3)

Clause 5.5.2 of ISO 9001:2008 stipulates responsibility and authority of the management representative to report to the top management on the performance of the quality management system and any need for improvement. The requirements for management review (Clause 5.6.1) stipulate that management review must include assessing opportunities for improvement and need for changes to the quality management system, including the quality policy and quality objectives. Review input requirements (Clause 5.6.2) include information on recommendations for improvement. Review output requirements (Clause 5.6.3) include any decisions and actions related to improvement of the following:
- the effectiveness of the quality management system,
- the effectiveness of the processes, and
- product related to customer requirements.

ISO 9001:2008 QMS Standard takes care to determine and provide resources needed to continually improve the effectiveness of the quality management system. (Clause 6.1) The Standard also stipulates the requirements (Clause 8.1) for the organization to plan and implement monitoring, measurement, analysis and improvement processes. This is required to demonstrate conformity of the product, to ensure conformity of the quality management system and to continually improve the effectiveness of the quality management system.

Clause 8.5 of ISO 9001:2008 Standard specially deals with requirements for improvement. Continual improvement is a defined requirement of the standard (Clause 8.5.1). Accordingly, the organization is required to improve the effectiveness of the quality management system through the use of quality policy, quality objectives, audit results, analysis of data, corrective action, preventive action and management review.

Use of Quality Policy and Quality Objectives: Quality policy must include a commitment to comply with requirements and continually improve the effectiveness of the quality management system. It must also provide a framework for establishing and reviewing quality objectives. Quality objectives must be measurable and consistent with the quality policy of the organization. The organization must also ensure to review quality policy for continuing suitability. Framework for reviewing provides a way for improvement as review include assessing opportunities for changes to the quality management system, including quality policy and quality objectives. (Relevant Clauses of ISO 9001:2008 QMS Standard – 5.3, 5.4.1, 8.5.1)

Use of audit results: QMS audit is a systematic process and conducted at defined intervals. Audit evidences are input to QMS audit process and audit results are its output. Audit results become the input to management review process, which provides opportunities for improvement. When any nonconformity are detected during QMS audit, ISO 9001:2008 QMS Standard requires to eliminate such nonconformities and their causes. (Relevant Clauses of ISO 9001:2008 QMS Standard – 5.6.2, 8.2.2, 8.5.1)

Use of analysis of data: One purpose of analysis of data is to evaluate where continual improvement in the quality management system can be made. The organization is required to determine, collect and analyze appropriate data relating to customer satisfaction, conformity to product requirements, characteristics and trends of processes and products (including opportunities for preventive action), and suppliers. Analysis of data helps organization to solve problems and also helps to improve effectiveness and efficiency. Analysis of data can help organizations to determine the root cause of existing and potential problems, and therefore guide decisions about corrective and preventive actions needed for improvement. (Relevant Clauses of ISO 9001:2008 QMS Standard – 8.4, 8.5.1)

Use of corrective action: ISO 9001:2008 QMS Standard requires to take action eliminate the causes of nonconformities in order to prevent recurrence. Corrective action is a major tool in the quality management system to achieve improvement. It should be noted that corrective action is agenda item for management review. (Relevant Clauses of ISO 9001:2008 QMS Standard – 8.5.1, 8.5.2)

Use of preventive action: ISO 9001:2008 QMS Standard requires to take action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive action is a major improvement tool in the quality management system. (Relevant Clauses of ISO 9001:2008 QMS Standard – 8.5.1, 8.5.3)

Use of management review: Management review is conducted at defined intervals to ensure continuing suitability, adequacy and effectiveness of the quality management system. Management review includes assessing opportunities for improvement and need for changes to the quality management system. Output to management review to include any decisions and actions relating to – (i) improvement of the effectiveness of the quality management system, (ii) improvement of the effectiveness of the processes of the organization, (iii) improvement of product related to customer requirements, and (iv) resources needs of the organization. (Relevant Clauses of ISO 9001:2008 QMS Standard – 5.6, 8.5.1)

ISO 9000:2005, Quality management systems – Fundamental and vocabulary, identifies eight quality management principles to be used by the top management of the organization in order to lead the organization towards improved performance. Among eight principles stated in this fundamentals and vocabulary standard, continual improvement is one of the quality management principles. It states that continual improvement of the organization’s overall performance should be a permanent objective of the organization.

What is the aim of continual improvement? ISO 9000:2005 provides the answer. According to Clause 2.9 of ISO 9000:2005, the aim of continual improvement of the quality management system is to increase the probability of enhancing customer satisfaction and also satisfaction of other interested parties. Following actions are needed for improvement:
- Identifying areas of improvement through analysis and evaluation of the existing situation
- Establishing objectives for improvement
- Searching for and evaluating possible solutions to achieve the objectives
- Making a selection from the possible solutions and implementing the selected solution
- Measuring, verifying, analyzing and evaluating results of the implementation to determine whether the objectives have been met, and
- Formalizing changes

Results should be reviewed to determine further opportunities for improvement. Accordingly, improvement is a continual activity to be undertaken by the organization and the top management has the important role to play in this regard. To identify opportunities for improvement, following actions may be useful:
- Obtaining feedback from customers and other interested parties
- Audit results, and
- Review of the quality management system

Process for continual improvement is given in Annex B of ISO 9004:2000, a QMS guidelines Standard for performance improvement. It briefly describes the distinction between breakthrough improvement and small-step ongoing improvement. The distinction between the two may be understood as under:
(i) In small-step ongoing improvement there remains involvement of people working in the process, while in breakthrough improvement there remains involvement of cross-functional teams outside routine operation (such as managers, engineers, consultants)
(ii) In small-step ongoing improvement size of changes remain small, while these are big in breakthrough improvement.
(iii) In small-step ongoing improvement results show small improvements, while the results show big jump in performance in breakthrough improvement.
(iv) Cost is low (within operating budget) in small-step ongoing improvement, while cost is high (may involve additional capital investment) in breakthrough improvement.
(v) Types of changes in small-step ongoing improvement include modification in practices, procedures, equipment, elimination and simplification of activities, while types of changes in breakthrough improvement include process reengineering, major process upgrades, change in technology and addition of new equipment.

ISO 9004:2000 Standards provides steps involved in the method of continual improvement that include:
- Identification of a process problem
- Selection of area of improvement
- Noting the reason for improvement
- Evaluating effectiveness and efficiency of the existing process
- Collecting relevant data
- Analyzing relevant data to discover the generally occurring problems
- Selecting a specific problem
- Setting objective for improvement for such specific problem
- Identifying and verifying the root causes of the problem
- Identifying possible solutions as well as exploring alternative solutions
- Evaluating effects to conform that the problem and its root causes have been eliminated or their effects reduced
- Implementing and standardizing new solutions by replacing old process with improved process as a preventive action
- Evaluating effectiveness and efficiency of the process

Since the above steps provide improvement solution to a specific process problem, so the above steps should be repeated on remaining other identified problems, thereby making the improvement as real and effective.

John E. (Jack) West in his article ‘Continuous Improvement and Your QMS’ says, “Piecemeal improvements are no improvements at all.” He also suggests, “First, let’s review what continual improvement is and what it’s not. Continual improvement isn’t necessarily improving everything in the organization. However, it does not entail identifying and planning changes to those products, processes or systems that will improve the organization performance.”

John E. (Jack) West correctly opines, “Sometimes sustained improvement isn’t achievable unless several processes are changed. In the case of improving a product design, it might be necessary to change not only the design and development process but also the process for hiring designer’s, the capital allocation process and the process for understanding customer requirements. In such a case, overall systems changes are needed; just starting a new product design project may be the organization’s worst approach.”

It is necessary to create people awareness in the organization on continual improvement and this may be created by forming small groups, selecting their group leaders, allowing people to control and improve their workplace and developing people’s knowledge, experience and skills.

The role of the top management and management representative are important in continual improvement of the effectiveness of the quality management system and they should take effective steps to do so.


Courtesy Source References

- ISO 9001:2008 QMS Standard
- ISO 9004:2000
- ISO 9001 for small businesses – What to do (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001:2000 – A workbook for service organizations (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001 Fitness Checker – A practical, easy to use checklist designed to help SMEs assess their readiness for ISO 9001 certification
- Implementing ISO 9001:2000 Quality Management System – A Reference Guide, Dr. Divya Singhal and K. R. Singhal (Publication from PHI Learning Pvt. Ltd., New Delhi)
- Article ‘Standard Approach – Continuous Improvement and Your QMS’, John E. (Jack) West, Quality Digest, USA, April 2006
- Article ‘Increasing the power of quality management system: Performance excellence through continual improvement’, Publication series ‘Management Systems Awareness’ – Issue 5, August 2006
- Quality World, New Delhi
- Quality Striving for Excellence, NCQM, Mumbai

Note

Author’s profile may be seen at http://www.linkedin.com/in/krsinghal

INTERNAL AUDIT OF QUALITY MANAGEMENT SYSTEM

K. R. Singhal

Conducting internal audit is a vital tool to assess organization’s quality management system. The organization gets information in a planned way by conducting internal audit from a variety of sources. The purpose of conducting internal audit is to find out the answers to following questions:
- Is quality management system of the organization conformed to the planning of product realization carried out in the organization?
- Is the quality management system of the organization conformed to the requirements of ISO 9001:2008 QMS Standard?
- Is the quality management system of the organization conformed to the quality management system requirements established by the organization?
- Is the quality management system of the organization effectively implemented and maintained?

An internal audit is a tool to monitor and determine the health of the quality management system of the organization. For an organization, a properly conducted audit is beneficial and we need to conduct value added internal audit that is useful to the organization, auditee department, management representative and top management.

Clause 8.2.2 of ISO 9001:2008 QMS Standard deals with internal audit requirements. As per requirements of ISO 9001:2008 QMS Standard, an organization needs to conduct internal audit at planned intervals. An audit process should include the following aspects:
- Planning of internal audit – such as planning of audit schedule, assignment of auditors, auditee area, and scope of audit, status and importance of processes, results of previous audits.
- Examining and reviewing the quality management system documentation of the organization,
- Examining and reviewing other relevant information of the organization, such as production reports, failure trends, customer complaints, customer survey reports etc.
- Examining and reviewing the quality management system procedures and processes by visiting the audit area spot, interviewing relevant personnel and looking to relevant processes.
- Reporting the internal audit results (including corrective action requests from auditors).
- Verifying corrective actions taken.

An organization should have a documented procedure for conducting internal audit that define and narrate the following aspects:
- Audit criteria
- Scope of the audit
- Frequency of audit
- Audit methods
- Responsibilities and requirements for planning and conducting internal audit
- Relevant audit records (including results of audit) to be established and maintained
- Reporting results of the audit.


Chandrakant Agrawal, Manager (Risk and Compliance team), points out the following to add the value of internal audit:
(i) One more item that would be added is usage of checklist as a tool to make sure all aspects are covered. Also focus on documentation and continuous improvement should be there.
(ii) The Corrective action log would be the most valuable source to support the focus on Quality from the team's perspective.
(iii) The team awareness on policies and procedures and the feel of Quality should also be part of the audit process.
(iv) Sharing of Best practices should also be output of audit so that all involved are benefited.



Does ISO 9001:2008 QMS Standard mention specific frequency of internal audit? How frequently does an organization need to perform internal audits? Is it fair to conduct internal audit once in two years?
ISO 9001:2008 QMS Standard does not mention specific frequency of internal audit. Requirements of ISO 9001:2008 QMS Standard say conducting internal audit at planned intervals. As such the Standard binds the organization to conduct internal audit at planned intervals. It is up to the organization to decide the frequency of internal audit.

How frequently does an organization need to perform internal audits? It is very relevant question. Internal audits need to be performed to cover all quality management system activities the organization undertake and all the ISO 9001:2008 Standard requirements. In deciding the frequency of internal audits, the organization should consider following factors:
- Complexity of procedures and processes
- Maturity level of the organization’s quality management system
- Nature of business activity
- Problematic aspects and areas as per history
- Organization approach for monitoring and improvement
- Frequency of management review

Jan A. de Ridder, Senior Consultant, QA en Lean professional, says, “Frequency depends on many things. In my opinion it is fair to audit Clause 5.5 every two years, unless there are changes in the organization. Clause 8.3 should be audited more or less continuously. When requirements are not met, frequency should increase. I used to audit the whole system and every area in a 3 year cycle. Some places were visited more often than others. One should wonder how audits can be performed effectively, but also efficiently. I used to discuss frequency with the responsible manager. Is he/she happy with the outcome and the number of audits? After all he is the internal customer of the auditor.”

Richard Sledgister, an Engineer, says, “The frequency of a company’s internal audits should accomplish the following goals: 1) assess standard conformance, 2) drive RCCA (Root Cause Corrective Action) and 3) drive continuous improvement. Audits should measure the overall effectiveness of a QMS (Quality Management System) in a company and or a specific facility within a company. Audits should also focus on specific areas in which the planned method (standard work) is not being executed properly, high warranty costs are being incurred, a high scrap rate exists, processes are not in statistical control and or other performance metrics are not being achieved. These are all signs of poor quality. The audit frequency should be adjusted to focus on areas needing continuous improvement as this is an efficient use of resources. The cost of poor quality will be reduced and profitability will be enhanced.”

Sandeep Sharma, a Quality engineer, says, “I think it must be finished just before the external audit, if we will get the NC's, there will be time to resolve all the issues.”


On considering above points, it is now clear that it will be unfair to conduct internal audit once in two years as the time gap between two internal audits will be too long.

What should be done after getting results of internal audit?
The organization gets information about the areas which need correction and/or improvement from the results of internal audit. The information from internal audit results becomes input for the management review.

Who should perform internal audits?
Internal QMS auditors should perform internal audits. ISO 9001:2008 QMS Standard has two relevant important requirements:
- Selection of auditors must ensure objectivity and impartiality of the audit process
- An auditor must not audit his/her own work.

Clause 6.2.1 of ISO 9001:2008 QMS Standard mentions the requirement of competent personnel performing work affecting conformity to product requirements on the basis of appropriate education, training, skills and experience. Accordingly, the personnel conducting internal audit must be competent to audit for which the organization should refer to the relevant guidelines as mentioned in ISO 19011 Standard and take appropriate steps to provide appropriate training to personnel selected as auditors for internal audit.

Suggested Reading: Chapter 12 – Value Added Audit, Implementing ISO 9001:2000 Quality Management System – A Reference Guide, Dr. Divya Singhal and K. R. Singhal (Published by PHI Learning Pvt. Ltd., New Delhi – 110001, India)

Courtesy Source References
- ISO 9001:2008 QMS Standard
- ISO 9004:2000
- ISO 9001 for small businesses – What to do (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001:2000 – A workbook for service organizations (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001 Fitness Checker – A practical, easy to use checklist designed to help SMEs assess their readiness for ISO 9001 certification
- Implementing ISO 9001:2000 Quality Management System – A Reference Guide, Dr. Divya Singhal and K. R. Singhal (Publication from PHI Learning Pvt. Ltd., New Delhi)
- Discussion at Linkedin.com Groups



Note
Author’s profile may be seen at http://www.linkedin.com/in/krsinghal

QUALITY POLICY AND QUALITY OBJECTIVES IN ISO 9001:2008

K. R. Singhal

QUALITY POLICY

Let us begin with the concept of quality policy in QMS. The quality policy of an organization shapes approach of the organization to its customers. A quality policy establishes: (i) a commitment to quality, (ii) a commitment to continual improvement of the quality management system, (iii) the context for quality objectives, and (iv) how the organization’s objectives relate to customers’ requirements.

A quality policy of an organization must meet the following minimum criteria:
(a) It should be linked to overall organizational goals,
(b) It should be relevant to the needs and expectations of the customers of the organization.

Accordingly, the quality policy of an organization must provide a framework for establishing and reviewing organization’s quality objectives.

A quality policy should also include explicit commitments to customer satisfaction and continual improvement. Quality policy of an organization should have a clear statement of outcomes. The policy should have understood by the staff of the organization.

Product quality depends both on perceived customer satisfaction and on well motivated staff. Here it should be noted that the term ‘customer satisfaction’ could refer to both types of customers: (a) internal customers (staff of the organization), and (b) external customers (who buy product from the organization by paying the value).

There may be a situation that your organization may not have a quality policy, then you should try to develop a quality policy for your organization. It is often useful to first develop the overall organization’s policy, including policies for marketing, sales, production, finance etc. This exercise could make the quality policy easier to prepare. Organization’s commitment to quality should describe organization’s overall vision of what quality means to organization’s business and its customers. Clause 4.2.1 of ISO 9001:2008 Standard requires organization to document quality policy statement.

Clause 5.3 of ISO 9001:2008 Standard frames requirements with regard to quality policy, which include to ensure that quality policy is (i) appropriate to the purpose of the organization, (ii) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, (iii) provides a framework for establishing and reviewing quality objectives, (iv) is communicated and understood within the organization, and (v) is reviewed for continuing suitability.

Tony Johnston (AJ Quality Management Consulting, Ireland) describes his three fold approach to writing a quality policy – (i) Write quality policy in a language that anyone can understand, (ii) Quality policy should be relative to the organization and believe by its employees when they read it, and (iii) It should make reference to the eight quality management principles, namely customer focus, leadership (management commitment), process approach, continual improvement, factual approach to decision making, mutually beneficial supplier relationship, system approach to management, and involvement of people. The quality policy should be endorsed by the managing director and it should be reviewed at least annually for suitability and updated if necessary.

While the John’s approach is good for writing quality policy and in addition to his approach if a reference for establishing and reviewing quality objectives is given in the quality policy, then it will be better.

If your organization has a quality policy, then you should evaluate your quality policy. Evaluate, whether your quality policy clearly linked to your overall organizational goals. If quality policy of your organization is not linked to your organizational goals, then you need to re-examine your policy and goals. Also find out answers to following questions:
- Does the quality policy include commitment to customer satisfaction?
- Does the quality policy include commitment to continual improvement?
- Does the quality policy include aspects of service quality that are to be emphasized?
- Does the quality policy include benefits for customers (quality outcomes)?
- Is the quality policy focused on maximizing customer satisfaction with the services received?
- Is the quality policy focused on maximizing customer satisfaction with the service received?
- Is the quality policy focused on maximizing staff morale in providing client services?

On the basis of answers to above questions, you may wish to revise the quality policy of your organization.

An illustration of a Quality Policy

…. (name of the organization) …. is committed in achieving customer satisfaction by providing … (the quality characteristics of product provided by the organization) …. For our customers, in context of continual improvement, so that our customers will … (outcomes in relation to customers’ needs / expectations to be met) ….


Another illustration of Quality Policy

We, … (name of the organization) …, manufactures … (name of the products) …. We manufacture and market these products both for domestic and abroad markets. Our purpose is to produce products to satisfy needs of our customers. We continually improve our products and services to satisfy needs of our customers better. Our quality management system is designed to ensure the maintenance of the product quality through evaluation, inspection and verification processes at all stages of production.

We are committed to comply with customer as well as legal requirements and also committed to continually improve the effectiveness of our quality management system. Our organization has decided to achieve quality objectives as set in the documented statement of quality objectives. The top management of our organization in the meeting of board of directors, at least once in every six months, reviews the quality management system of our organization.


QUALITY OBJECTIVES

ISO 9001:2008 QMS Standard requires that organization develop measurable quality objectives, consistent with the quality policy of the organization. Internal and external auditors review quality objectives at each audit to see if they are being met. For planning of the quality management system, it is necessary to establish measurable quality objectives. Requirements with respect to quality objectives are mentioned in clause 5.4.1 of ISO 9001:2008 Standard.

The top management of the organization needs to establish quality objectives. Top management of the organization must ensure that quality objectives (including those needed to meet requirements for the product) are established at relevant functions and levels within the organization. The quality objectives must be measurable and consistent with the quality policy of the organization. Clause 7.1 (a) of ISO 9001:2008 QMS Standard lays down that in planning product realization, the organization must determine quality objectives and requirements for the product. It is evident from this clause that the ISO 9001:2008 Standard now calls for objectives not only for the quality management system but also for the product.

Now questions arise:
- How to set or develop quality objectives?
- How to monitor quality objectives?


Developing Quality Objectives

Developing quality objectives provides the organization with the opportunity to identify areas of inefficiency. The organization can address such areas to improve customer satisfaction. The Management Representative of the organization should frame a committee (with the approval of the top management) for developing quality objectives. This committee should have members from all departments of the organization. The committee members should have conceptual knowledge on ISO 9001:2008 QMS Standard and also on eight quality management principles.

Members of the committee should be advised to frame quality objectives for their respective departments. Management Representative should act as a convener and call a meeting to finalize the quality objectives. Quality objectives finalized in such meeting should be sent to the top management for considering the same in the management review meeting and finalizing them as organization’s quality objectives.

For developing measurable quality objectives for your organization, you may use a worksheet. Worksheet for creating quality objectives may be as under:
- List specific measurable activities that would improve customer satisfaction. Example – Responding to customer’s complaint on the day of its receipt, replying to letters within three days of receipt.
- List specific measurable activities that would improve staff morale. Example – Monthly staff feedback on their performance.
- List specific measurable activities that would improve staff efficiency. Example – Providing computer training to staff.

From the answers that you would have listed for above questions, you may select quality objectives clearly linked to the quality policy of the organization and for each quality objective, you should specify:
- What is to be done?
- How often the organization will achieve the level of performance?
- The date by which the organization will achieve that level of performance.

On careful study of clause 7.1 (a) of ISO 9001:2008 Standard, you will find that the standard calls for quality objectives not only for the quality management system but also for the product. Quality objectives need to be realistic and related to achievable outcomes, such as:
- Meeting agreed customer requirements for delivery or other product characteristics within a certain percentage of time.
- Meeting regulatory and other requirements for product and services.
- Meeting the planned schedule for achieving the quality objectives targets.
- Identifying opportunities for improvement.
- Minimizing the cost of poor quality, rework or scrap.
- Identifying new opportunities.

The Standard also requires that relevant objectives be established at appropriate parts of the organization. For example – Process performance targets, continual improvement targets be established at human resources, production, sales departments.

When setting up quality objectives, look for activities or indicators that employees can relate to and that can be measured. A few examples may be:
- Reducing the production time
- Achieving no failures or defects in production
- Achieving cost reduction
- Improving productivity
- Increasing market share

It is very important point that people in the organization must be aware of how they contribute to the achievement of the quality objectives. Therefore, employees in the organization must know and understand the specific quality objectives that have been set up for their functions and level and how they can achieve them. For awareness of quality objectives, specific training sessions or campaigns may be organized.

At the service delivery, customer interface or at the production line, quality objectives should be very simple and direct.

Think carefully about the quality objectives set by you for the organization and the timeframe you intend to allow for them to be achieved. Keep in mind that quality objectives must be measurable. The organization should be able to check that the organization is achieving the objective and, if not, what the organization is going to do about the quality management system.

Monitoring Quality Objectives

It is the intention of the ISO 9001:2008 QMS Standard that the organization is producing quality product. Monitoring and measurement activities are planned and carried out to carefully improve. Question arises – how to monitor quality objectives? If we carefully read clause 5.6.1 of ISO 9001:2008 QMS Standard, we will come to know that it is the responsibility of the top management to ensure continuing suitability, adequacy and effectiveness of the QMS and to review the organization’s quality management system at planned intervals. Review must include assessing opportunities for improvement and need for changes to the quality management system, including the quality policy and quality objectives.

Quality objectives may be monitored from the input information received from the following:
- Internal and external audits
- Customer feedback
- Process performance reports
- Product conformity reports

A Management Representative (MR) acts a link person between the top management and the organization. His role is very important for maintaining and improving the quality management system in the organization. It is the duty of the Management Representative to report to the top management on the performance of the quality management system and any need for improvement. Accordingly, he should monitor quality objectives from the input information received from various corners.

It is also important to tell employees in the organization regularly how well specified quality objectives are being met and where improvements are required. Quality objectives must be reviewed and revised from time to time as part of the continual improvement process.

Courtesy Source References

- ISO 9001:2008 QMS Standard
- ISO 9004:2000
- ISO 9001 for small businesses – What to do (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001:2000 – A workbook for service organizations (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001 Fitness Checker – A practical, easy to use checklist designed to help SMEs assess their readiness for ISO 9001 certification
- Implementing ISO 9001:2000 Quality Management System – A Reference Guide, Dr. Divya Singhal and K. R. Singhal (Publication from PHI Learning Pvt. Ltd., New Delhi)
- Comments from Mr. Tony Johnston (Ireland)

Note

Author’s profile may be seen at http://www.linkedin.com/in/krsinghal






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CALIBRATION IN ISO 9001:2008

K. R. Singhal

The purpose of this paper is to discuss calibration requirements as per ISO 9001:2008 QMS Standard and related issues.

A monitoring, measuring or testing activity is useful and effective only when measurement results are reliable. Measurement results should be sufficiently accurate with a known degree of uncertainty. For this purpose, there is a need to control monitoring and measuring equipment that have the desired level of accuracy and consistency under condition of actual use.

Clause 7.6 of ISO 9001:2008 QMS Standard deals with control of monitoring and measuring equipment. This clause interalia speaks about calibration of monitoring and measuring equipment. The purpose of requirements in clause 7.6 of ISO 9001:2008 QMS Standard is to ensure suitability of monitoring and measuring equipment.

Requirements of Clause 7.6

The organization must determine (i) what to monitor and measure, and (ii) the monitoring and measuring equipment needed. Monitoring and measuring equipment is helpful in providing evidence of conformity of product to determined requirements.

The organization must establish processes to ensure carrying out monitoring and measurement in consistent with the requirements. As such, it is necessary to have a detailed process system established and maintained for keeping the monitoring and measuring equipment accurate and good operating conditions.

Where necessary to ensure valid results – (i) monitoring and measuring equipment must be calibrated or verified, or both, at specified intervals (decided by the organization), or prior to use, against international or national measurement standard, (ii) monitoring and measuring equipment must be adjusted or re-adjusted as necessary, (iii) monitoring and measuring equipment must have identification in order to determine its calibration status – when the calibration or verification was done and what is the due date for calibration or verification, (iv) monitoring and measuring equipment must be safeguarded from such adjustment that invalidates the measurement result, and (v) monitoring and measuring equipment be protected from damage and deterioration.

Where no international or national standards exist for calibration or verification of the equipment, the basis used for calibration or verification must be recorded. It is better to record the process used and the personnel who carried out calibration and verification.

The organization must assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. In such case, the organization must take appropriate action on the equipment and any product affected.

The organization is required to maintain records of the results of calibration and verification.

Whenever computer software is used in the monitoring or measurement bof specified requirements, it is necessary to conform the ability of the computer software to satisfy the intended application. This must be undertaken prior to initial use and re-conformed as necessary.

Note at the end of clause 7.6 of ISO 9001:2008 clarifies that confirmation of computer software’s ability to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

Finding international or national standard for calibration or verification

To find out relevant international or national standard for calibration or verification, of monitoring and measuring equipment, it is suggested to refer to the latest ISO Catalogue of Standards for international standards and the latest BIS Catalogue for Indian Standards.

Comments may be sent to ncqmajmer@gmail.com

Outsourcing and Exclusion Concepts in ISO 9001:2008 QMS

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