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T410 iso 19011

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T410 iso 19011

  1. 1. Using ANSI/ASQ QE 19011S for QMS and EMS Auditing – a Practitioner’s Perspective Gary L. Johnson U.S. EPA Research Triangle Park, NC 27711 May 2004
  2. 2. Today We Will Cover • What is QE 19011S and its benefits? • How will QE 19011S be used? • Why supplemental guidance is needed? • What is the structure of QE 19011S? • What is the status of QE 19011S?
  3. 3. What is QE 19011S? • An consensus-based American National Standard for use with ISO 19011 in auditing management systems. • Provides specific guidelines for auditing: – Quality Management Systems – Environmental Management Systems • Applicable to ISO 9001:2000 QMS and ISO 14001:1996 EMS.
  4. 4. QE 19011S • Supplements ISO standard by addressing full range of auditing activities, including: - Internal audits – first party - Supplier audits – second party - Certification and other third party audits - Use by small organizations
  5. 5. International Standard • ISO published the final approved ISO 19011 standard in October 2002. • U.S. adopted ISO 19011 as American National Standard (QE 19011:2004) in spring 2004. • American National Standard is identical to ISO version.
  6. 6. Benefits of ISO 19011 • Replaced six existing standards with one: – Quality Auditing Standards - ISO 10011 Parts 1, 2, and 3 – Environmental Auditing Standards - ISO 14010, ISO 14011, ISO 14012 • Accepted for registration/certification audits in U.S. (ANSI-RAB NAP).
  7. 7. U.S. Concerns about ISO 19011 Limitations • ISO 19011 guidance on auditor competence was insufficient: – Implied minimum levels – Not based on sound science • ISO standard did not adequately address: - Internal Audits - Supplier Audits - Use by Small Organizations
  8. 8. U.S. Concerns contd. • ISO 19011 text largely reflected 3rd Party and Certification Audits. – ISO 19011 JWG experience was strongest for 3rd Party Audits. – U.S. efforts to broaden guidance were rejected. • ISO 19011 text was often too burdensome for 1st and 2nd Party audits and small organization users.
  9. 9. U.S. Solution • Developed Supplement to ISO 19011:2002 • Added to ISO text to supply needed guidance. • Supplement format is modeled after ISO 9004:2000. • Supplement contains complete ISO text with added guidance.
  10. 10. U.S. Supplement • ANSI/ASQ QE 19011S:2004 was developed by ANSI ASC Z1 Committee Joint Task Group. • Ballot for approval as American National Standard is in progress. • Approval is expected – Summer 2004.
  11. 11. QE 19011S Format • ISO 19011:2002 text presented in boxes. – Unchanged from ISO – Cannot be changed unless standard is revised. JTG had no authority to do so. • When ISO text is inadequate, Supplement text follows to add guidance as needed for: – Internal (1st Party) audits – Supplier (2nd Party) audits – Use by small organizations
  12. 12. QE 19011S Format • When ISO 19011:2002 text needs no change: – Supplement notes that no additional text is needed. • Supplement text generally builds on the ISO text to augment the guidance.
  13. 13. Structure of QE 19011S • 0 Introduction • 1 Scope • 2 Normative References • 3 Terms and Definitions • 4 Principles of Auditing • 5 Managing an Audit Program • 6 Audit Activities • 7 Competence and Evaluation of Auditors
  14. 14. 0 Introduction • Provides background on why the ISO Standard and U.S. Supplement are needed. • Provides a general outline of how the Supplement is structured and how its contents should be used. • Briefly outlines the use of the Supplement for different audit programs.
  15. 15. 1 Scope • Brief statement of the intent and application of the standard, including internal and external audits, and use by small organizations. • Emphasizes flexibility and broad range of users. • Notes that the standard may be applied to other types of audits as well (OHS?). • Few additions made by the Supplement.
  16. 16. 2 Normative References • Identifies other documents whose provisions are included in ISO 19011:2002 by reference and which apply to the Supplement. • There are two normative references: – ISO 9000:2000 QMS Vocabulary – ISO 14050:1998 EMS Vocabulary
  17. 17. 3 Terms and Definitions • Provides for additional definitions not specifically covered in normative references or elsewhere. • Key terms in ISO 19011 include: – Audit criteria – Audit findings – Audit team leader – Audit program – Competence (of Auditors) • No additional terms/definitions were included.
  18. 18. 4 Principles of Auditing • Provides basic auditing principles for auditors, including: – Ethical conduct – Fair Presentation – Due professional care • For audits, including: – Independence – Evidence-based approach
  19. 19. 5 Managing an Audit Program • Provides guidance on establishing and maintaining an effective audit program – For one, few, or many audits, – Includes consideration of internal and external audits, – Introduces guidance on combined or joint audits.
  20. 20. 5 Managing an Audit Program • Key elements include: – Implementing the audit program. – Monitoring and reviewing the audit program. – Establishing the authority for the audit program. – Improving the audit program. – Establishing the audit program. • Expands guidance on audit program performance beyond ISO text, particularly for internal audits.
  21. 21. 5 Managing an Audit Program - Example • Clause 5.2.1 – Objectives of an Audit Program – See Handout 1
  22. 22. 6 Audit Activities • Auditing process includes: – Initiating the audit – Conducting document reviews – Preparing for on-site audit activities – Conducting on-site audit activities – Preparing, approving, and distributing the audit report – Completing the audit – Conducting audit follow-up (if in audit plan)
  23. 23. 6 Audit Activities • Uses “graded approach” in applying activities to particular audits, not “one size fits all.” • Reflects major differences between internal and external audits for: – Opening/closing meetings – Auditor competence needed – Reporting audit results
  24. 24. 6 Audit Activities • Guidance is applicable to auditing the process approach in ISO 9001. – Also applies to ISO 14001 audits. • Guidance applies to combined and joint audits. – Combined - auditing QMS and EMS in one audit. – Joint – two parallel audits at the same time.
  25. 25. 6 Audit Activities - Example • Clause 6.5.1 – Conducting the Opening Meeting – See Handout 2
  26. 26. 7 Competence and Evaluation of Auditors • Auditor – person competent to conduct an audit. • Competence of an auditor is based on: – Personal attributes. – Ability to apply sufficient knowledge and skills gained through education, work experience, auditor training, and audit experience. • Audit team leaders need additional knowledge and skills, work experience, auditor training, and audit experience specific to leadership.
  27. 27. 7 Competence and Evaluation of Auditors • Competence of auditors needed: – Should be left to audit program managers. – Should fit the needs of the audit program. – Should be maintained through appropriate methods. • Guidance is provided on: – Selecting auditors for a particular audit program, – Evaluating auditors and audit team leaders.
  28. 28. Knowledge and Skills • Generic knowledge and skills on: – Audit principles and techniques. – Relevant management systems reference documents. – Organizational situations. – Applicable laws, regulations, and requirements. • Specific knowledge and skills on: – QMS or EMS methods and techniques. – Related processes, science, and technology. – Technical aspects of operations.
  29. 29. Demonstrated Credentials • Demonstrated evidence of: – Education – Work experience – Auditor training – Audit experience • Supplement does not set levels. – Levels should be based on Audit Program needs. – Table 1 in ISO 19001:2002 is specific to registration audits.
  30. 30. Other Considerations • Audit team leader. • Auditor for both QMS and EMS. – What is needed to audit in both disciplines. • 1st, 2nd, and/or 3rd party audit situations. – What differences exist.
  31. 31. Maintenance and Improvement of Competence • Maintaining competence needs: – Continual professional development. – Regular participation in audits. • Reflects “graded approach” in application.
  32. 32. Auditor Evaluation • Evaluation process has four general steps: – Identify needed personal attributes and knowledge and skills. – Set the evaluation criteria. – Select an appropriate evaluation method. – Conduct the evaluation. • Guidance is provided on different evaluation methods and techniques.
  33. 33. Summary • QE 19011S offer a complete, process approach to QMS and EMS auditing. • ISO 19011 as written appears to be best suited for 3rd Party/Certification audits. • QE 19011S provides more complete guidance on 1st and 2nd Party audits.
  34. 34. Summary • ISO 19011 and QE 19011S will be useful to QMS and EMS auditors and audit programs in the U.S. and elsewhere. • ISO 19011:2002 is available now. • QE 19011S should be available this summer.

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