t410 iso 19011
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Using ANSI/ASQ QE 19011Sfor QMS and EMS Auditing � a
Practitioner�s Perspective
Gary L. JohnsonU.S. EPA
Research Triangle Park, NC 27711
May 2004
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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?
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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.
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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
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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.
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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).
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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
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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.
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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.
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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.
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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
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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.
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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
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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.
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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.
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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
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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.
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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
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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.
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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.
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5 Managing an Audit Program - Example
� Clause 5.2.1 � Objectives of an Audit Program� See Handout 1
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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)
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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
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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.
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6 Audit Activities -Example
� Clause 6.5.1 � Conducting the Opening Meeting� See Handout 2
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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.
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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.
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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.
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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.
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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.
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Maintenance and Improvement of Competence
� Maintaining competence needs:� Continual professional development.� Regular participation in audits.
� Reflects �graded approach� in application.
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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.
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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.
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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.