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.
