TC176/IAF ISO 9001:2000

1. TC176/IAFISO 9001:2000 Auditing Practices Group

2. The ISO 9000 Advisory Group identified auditor competence as a critical issue when ensuring the credibility of ISO 9001:2000 certification. Auditing Practices Group established in February 2003.

3. Participants Experts nominated by:- • IAF (CRBs, ABs, Industry) • ISO TC/176(WG Int, SC1, SC2, SC3) • ISO CASCO • IATCA

4. Aims of the Group • Development of examples of good auditing practices related to requirements of ISO9001: 2000 and guidelines of ISO19011: 2002 • Development of a website where papers and examples of auditing practice against the requirements of ISO 9001:2000 are posted and available to the public without charge. • The information provided by the Group does not constitute IAF or ISO endorsed benchmarks or interpretations of the preferred way conformance to ISO 9001:2000 is audited.

5. Topics • The need for a 2-stage approach to auditing • Measuring QMS effectiveness and improvements • Identification of processes • Understanding the process approach • Determination of the “where appropriate” processes • Auditing the “where appropriate” requirements • Demonstrating conformity to the standard • Linking an audit of a particular task, activity or process to the overall system • Auditing continual improvement

6. Topics • Auditing a QMS which has minimum documentation • How to audit top management processes • The role and value of the audit checklist  • Scope of ISO 9001:2000, scope of quality management system and defining scope of certification • How to add value • Auditing competence of personnel and the effectiveness of actions taken • Auditing customer feedback processes

7. Topics • Effective use of ISO 19011:2002 • Auditing statutory and regulatory requirements • Documenting a Nonconformity • Review of actions in response to a nonconformity • Auditing quality policy and quality objectives • Auditing the control of monitoring and measuring devices

8. The need for a 2 stage approach to auditing • Auditing to ISO 9001:2000 requires a good understanding of the business and QMS • The primary purpose of the 1st stage audit • Activities performed during the 1st stage audit

9. Measuring QMS effectiveness and improvements (Open presentation)

10. Identification of Processes • Can the auditee distinguish between processes and activities? • Be able to adapt to the auditee’s situation • Determine if there is a problem with difference in terminology • Determine if there is a real lack of implementation of the process approach

11. Understanding the process approach The Auditor should realise several steps are needed • Determine the processes and responsibilities needed to attain objectives • Determine and provide adequate resources and information • Establish and apply methods to monitor and analyse processes • Establish and apply a process for continual improvement

12. Understanding the process approach The Auditor also needs to:- • Be aware that application of the process approach will be different from organisation to organisation • Understand the process approach to a level beyond the terminology of the standard • Consider small & medium enterprises who may not need many processes • Ensure that misunderstandings are identified and resolved during the 1st stage audit

13. Understanding the process approach The Auditee needs to consider:- • Establishment of process objectives • Process planning • Availability of suitable records Redefinition of processes during the 1st stage audit can identify activities incorrectly described as processes

14. Determination of the “where appropriate” processes • Terminology • Definition of process • Exclusions

15. Auditing “where appropriate” requirements • Determine the application of ISO 9001:2000 • Ensure “where appropriate” requirements are appropriate • Does the requirement add value? • Does it increase the risk of not meeting customer requirements?

16. Auditing “where appropriate” requirements Need for experience to make a judgement on a technical issue • Sector knowledge • Competence • Auditing skills • Knowledge of the processes • Objective evidence

17. Demonstrating conformity to the standard • Auditing processesversus auditing to the standard's clauses • Audit checklists may not be sufficient • What is adequate sampling?

18. Linking an audit of a particular task, activity or process to the overall system • Overall direction of the audit • Interaction of processes • Importance of processes • Take samples

19. Auditing continual improvement • How much improvement is “enough”? • What sort of information is relevant and where can we find it? • Improvement of the process or improvement of the QMS?

20. Auditing a QMS which has minimum documentation The necessity for any documentation should be evaluated in the light of: • the observed need for consistency • the role that any documentation could play in avoiding any significant, identified risks.

21. How to audit top management processes • Identifying top management processes • Conducting the audit • Audit reporting

22. The role and value of the audit checklist • Need for checklists • The use of audit checklists • Advantages • Disadvantages • Conclusion

23. Scope of ISO 9001:2000, Scope of Quality Management System (QMS) and Defining Scope of Certification • ISO 9001:2000 clause 1 Scope defines the scope of the standard, not to be confused with QMS scope • The scope of a QMS should be based on the: • nature of products and realization processes • result of risk assessment • commercial considerations • contractual, statutory and regulatory requirements • ISO 9001:2000 clause 1.2 Application • Scope of registration/certification

24. How to add value • “Value-added” quality management systems • Value-added auditing

25. How to add value Some tips for Value-added auditing • Audit planning • Audit technique • Analysis and decision • Report and follow-up

26. Auditing 'competence' and 'effectiveness of actions taken' An organization will need to: • Identify what competencies are required • Identify which personnel already are competent • Decide what additional competencies are required • Decide how these are to be obtained • Train, hire or reassign personnel • review competence of personnel

27. Auditing 'competence' and 'effectiveness of actions taken' Auditor would seek evidence of: • Identification of competencies required • Assignment of competent personnel • Evaluation of the effectiveness of actions taken • Maintenance of competence

28. Auditing customer feedback processes • What are the requirements? • What should be addressed when auditing customer feedback processes? • Prior to the audit of the customer feedback process (preparation stage) • During the process assessment

29. Effective use of ISO19011:2002 The standard contains guidance on:- • The principles of auditing • Managing an audit programme • Audit activities • Competence and evaluation of auditors

30. Documenting a nonconformity • What is a nonconformity? • Identify and document the audit evidence • Determine the requirement • Write the statement of nonconformity

31. Review of actions in response to a nonconformity Auditors not only write nonconformities but are also responsible for the review of the response to the nonconformity • Correction • Determination of cause • Corrective action • Objective evidence

32. Auditing statutory and regulatory requirements • An organization must identify and control the statutory and regulatory requirements applicable to its products (including services). • Evidence should be obtained that these requirements are being satisfied

33. Auditing quality policy and objectives Auditing quality policy • Interview top management to verify that the organisation’s overall quality objectives have been defined • Evaluate commitment and involvement • Have management disseminated the policy throughout the organisation? • Determine awareness among personnel at all levels

34. Auditing quality policy and objectives Auditing quality objectives • Verify that the organization’s overall quality objectives have been defined • Do they reflect the quality policy? • Are they coherent, aligned and compatible with the overall business objectives, including customer expectations?

35. Auditing the control of monitoring and measuring devices It is important for the auditor to understand the differences between:- • “monitoring” and “measurement”, and • “equipment” and “devices”. The different sub-clauses of the standard refer to all of these in isolation and together so clause 7.6 should be read carefully.

36. Copies of the guidance documents referred to in this presentation can be obtained from: www.iaf.nu www.iso.org/tc176/ISO9001AuditingPracticesGroup Comments on the papers or presentations can be sent to the following email address: charles.corrie@bsi-global.com Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised.

37. Disclaimer These papers have not been subject to an endorsement process by the International Organization for Standardization (ISO), ISO Technical Committee 176, or the International Accreditation Forum (IAF).The information contained within them is available for educational and communication purposes. The ISO 9001 Auditing Practices Group does not take responsibility for any errors, omissions or other liabilities that may arise from the provision or subsequent use of such information.

38. TC176/IAFISO 9001:2000 Auditing Practices Group