1、AMERICAN NATIONAL STANDARDGuidelines for management systems auditingU.S. Version with supplemental guidance added AMERICAN SOCIETY FOR QUALITY P.O. BOX 3005 MILWAUKEE, WI 53201-3005 ANSI/ISO/ASQ QE19011S-2008(This page intentionally left blank)AMERICAN NATIONAL STANDARD Guidelines for management sys
2、tems auditing U.S. Version with supplemental guidance added Approved as an American National Standard by: ASC Z1 Subcommities on Quality Management and Environmental Management May 19, 2008 American National Standards: An American National Standard implies a consensus of those substantially concerne
3、d with is scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether he or she has approved the standard or not, from manufac
4、turing, purchasing, or using products, processes, or procedures not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition. Caution Notice: This American National Standard may be revised or withdrawn at any time. Th
5、e procedures of the American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Purchasers of American National Standards may receive current information on all standards by calling of writin
6、g the American National Standards Institute. ANSI/ISO/ASQ QE19011S-2008iii 2008 by ASQCopyright Protection Notice for the ANSI/ISO/ASQ QE19011S-2008 Standard.This standard is subject to copyright claims of ISO, ANSI, and ASQ. Not for resale. No part of this publication may be reproduced in any form,
7、 including an electronic retrieval system, without the prior written permission of ASQ. All requests pertaining to the ANSI/ISO/ASQ QE19011S-2008Standard should be submitted to ASQ.Note: As used in this document, the term “International Standard” refers to the American National Standard adoption of
8、this and other International Standards.ASQ will consider requests for change and information on the submittal of such requests regarding this Standard. All requests should be in writing to the attention of the Standards administrator at the address below.ASQ Mission: The American Society for Quality
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12、se inform ASQ at the address below.ANSI/ISO/ASQ QE19011S-2008ivAlso available from ASQ Quality Press: The Internal Auditing Pocket Guide: Preparing, Performing, Reporting, and Follow-Up, Second Edition J.P. Russell The Management System Auditors Handbook Joe Kausek The ASQ Auditing Handbook, Third E
13、dition J.P. Russell, editing director The Process Auditing Techniques Guide J.P. Russell Quality Audits for Improved Performance, Third Edition Dennis R. Arter The Quality Toolbox, Second Edition Nancy R. Tague Managing the Customer Experience: A Measurement-Based Approach Morris Wilburn Lean Kaizen
14、: A Simplified Approach to Process Improvements George Alukal and Anthony Manos Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bjrn Andersen and Tom Fagerhaug The Certified Manager of Quality/Organizational Excellence Handbook, Third Edition Russell T. Westcott, editor Enabling
15、 Excellence: The Seven Elements Essential to Achieving Competitive Advantage Timothy A. Pine To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at http:/www.asq.org/quality-press. ANSI/ISO/ASQ QE19011S-2008v(This page intentionally left bla
16、nk)Contents Page Foreword .viii Introduction.ix 1 Scope .1 2 Normative references.1 3 Terms and definitions 2 4 Principles of auditing .4 5 Managing an audit program 5 5.1 General 5 5.2 Audit program objectives and extent .8 5.3 Audit program responsibilities, resources, and procedures.10 5.4 Audit
17、program implementation .12 5.5 Audit program records.13 5.6 Audit program monitoring and reviewing14 6 Audit activities 15 6.1 General 15 6.2 Initiating the audit.17 6.3 Conducting document review .21 6.4 Preparing for on-site activities22 6.5 Conducting on-site activities 24 6.6 Preparing, approvin
18、g and distributing the audit report .33 6.7 Completing the audit34 6.8 Conducting audit follow-up.35 7 Competence and evaluation of auditors 36 7.1 General 36 7.2 Personal attributes .39 7.3 Knowledge and skills .40 7.4 Education, work experience, auditor training and audit experience 47 7.5 Mainten
19、ance and improvement of competence 51 7.6 Auditor evaluation 52 ANSI/ISO/ASQ QE19011S-2008viiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried
20、 out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
21、 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International standards are drafted in accordance with the rules given in the ISO/IEC Directives, part 3. The main task of technical committees is to prepare Internation
22、al Standards. Draft international standards accepted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75% of the members casting a vote. ISO 19011:2002 was prepared jointly by Technical Committee ISO/TC
23、 176, Quality management and quality assurance, Subcommittee SC 3, Supporting technologies, and Technical Committee ISO/TC 207, Environmental management, Subcommittee SC 2, Environmental auditing and related environmental investigations. Attention is drawn to the possibility that some of the element
24、s of ISO 19011 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. The first edition of ISO 19011:2002 canceled and replaced ISO 10011-1:1990, ISO 10011-2:1991, ISO 10011-3:1991, ISO 14010:1996, ISO 14011:1996, and ISO 14012:1996. The
25、 American National Standard ANSI/ISO/ASQ QE19011-2002 contains the same text as the ISO version. This Supplement, ANSI/ISO/ASQ QE19011S-2008, is modeled after ISO 9004:2004; that is, the verbatim text of QE19011 (ISO 19011) is given and is followed by supplemental guidance for first-party (internal)
26、 audits, second-party (supplier) audits, occupational health and safety audits, and for use by small organizations for the full range of audit activities. ANSI/ISO/ASQ QE19011S-2008viiiIntroduction The ISO 9000 and ISO 14000 series of International Standards emphasize the importance of audits as a m
27、anagement tool for monitoring and verifying the effective implementation of an organizations quality and/or environmental policy. ANSI/AIHA Z10-2005 includes audits as an integral part of managing the effective implementation of an occupational health and safety management system (OHSMS). Audits are
28、 also an essential part of conformity assessment activities such as external certification/registration and of supply chain evaluation and surveillance. The ISO 19011:2002 International Standard provides guidance on the management of audit programs, the conduct of internal or external audits of qual
29、ity and/or environmental management systems, as well as competence and evaluation of auditors. It is intended to apply to a broad range of potential users, including auditors, organizations implementing quality and/or environmental management systems, organizations needing to conduct audits of quali
30、ty and/or environmental management systems for contractual reasons, and organizations involved in auditor certification or training, in certification/registration of management systems, in accreditation or in standardization in the area of conformity assessment. The guidance in the ISO 19011:2002 In
31、ternational Standard is intended to be flexible. As indicated at various points in the text, the use of the guidelines can differ according to the size, nature and complexity of the organizations, as well as on the objectives and scopes of the audits to be conducted. Throughout the International Sta
32、ndard, supplementary guidance and examples on specific topics are provided in the form of practical help in boxed text. However, the U.S. determined that additional guidance was needed to apply the International Standard to the full range of audit activities, specifically first-party (internal) audi
33、ts and second-party (supplier) audits, occupational health and safety management system (OHSMS) audits, and use by small organizations. Since the definition of small organizations may vary, the concept of a small organization in this Supplement does not only relate to the size of the organization bu
34、t also to the complexity of the management system, complexity of the product and processes, the organizations regulatory environment, and the effectiveness of communications within the organization. Therefore, the guidance given for small organizations may also apply to larger organizations with sim
35、ple management systems, simple products and processes, little regulatory impact, and good communications processes among the personnel, functions and management levels. It is up to the organizations top management and the audit program manager to determine the application of ISO 19011:2002 and this
36、Supplement to their organization and to the various types of audits they use. Accordingly, this Supplement has been developed to provide the needed additional guidance. The format includes the complete text of ANSI/ISO/ASQ QE19011-2002 in boxed text followed by supplemental text as needed. No change
37、s to the boxed text from ANSI/ISO/ASQ QE19011-2002 are made in this document. Where no supplemental text is needed, this is stated at the end of the boxed text. When additional text is needed, it is presented for first-party audits, second-party audits, OHSMS audits and use by small organizations as
38、 applicable. In some cases, the supplemental text provided for first-party and second-party audits may be also useful for small organizations. Clause 4 describes the principles of auditing. These principles help the user to appreciate the essential nature of auditing and they are a necessary prelude
39、 to clauses 5, 6 and 7. Clause 5 provides guidance on managing audit programs and covers such issues as assigning responsibility for managing audit programs, establishing the audit program objectives, coordinating auditing activities and providing sufficient audit team resources. Clause 6 contains g
40、uidance on conducting audits of quality and/or environmental management systems, including the selection of audit teams. This Supplement uses a graded approach to ANSI/ISO/ASQ QE19011S-2008ixapply the guidance from the International Standard to all audit situations. Clause 7 provides guidance on the
41、 competence needed by an auditor and describes a process for evaluating auditors. The guidance provided in the International Standard may be more appropriately suited for third-party audits, including certification/registration audits. This Supplement provides an alternative approach to determining
42、and evaluating the competence of auditors. Rather than emphasizing one set of levels of work experience, education, and audit experience as provided in the International Standard, this Supplement focuses on defining the needed competence for auditors depending on the scope of the audit program. Also
43、 included in this Supplement is guidance on the competence needed by those auditing occupational health and safety management systems, a subject that is not addressed in the International Standard. Where quality, environmental or occupational health and safety (OH however, users can apply them to de
44、velop their own audit-related requirements. In addition, any other individual or organization with an interest in monitoring conformance to requirements, such as product specifications or laws and regulations, may find the guidance in the International Standard and this Supplement useful. ANSI/ISO/A
45、SQ QE19011S-2008xGuidelines for management systems auditing U.S. Version with supplementary guidance added 1 Scope QE19011 Text: This International Standard provides guidance on the principles of auditing, managing audit programs, conducting quality management system audits and environmental managem
46、ent system audits as well as the competence of quality and environmental management system auditors. It is applicable to all organizations having a need to conduct internal or external quality and/or environmental management system audits or manage an audit program. The application of this Internati
47、onal Standard to other types of audits is possible in principle but special consideration should be paid to identifying the competence needed by the audit team members in such cases. S1 Scope The supplemental text contained in this document provides additional guidance to users to augment the Intern
48、ational Standard. In particular, additional guidance is provided for small organizations that may wish to consider its application to the full range of audit activities (i.e., first, second, and third-party audits) and for any users that wish to apply the standard to internal (first-party) audits an
49、d external supplier (second-party) audits. Since the definition of small organizations may vary, the concept of a small organization in this Supplement relates not only to the size of the organization but also to the complexity of the management system, the complexity of the product and processes, the organizations regulatory environment, and the effectiveness of communications within the organization. Therefore, the guidance given for small organizations may also apply to larger organizations with simple management systems, simple products and processes, little regulatory
