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1、 Reference number ISO/IEC 17021:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO/IEC 17021 First edition 2006-09-15 Conformity assessment Requirements for bodies providing audit and certification of management systems valuation de la conformit Exigences pour les organismes procdant laudit et la certifica
2、tion de systmes de management Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:38:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO/IEC 17021:200
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6、SO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in th
7、e country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved Copyright International Organization for Standardization Provided by IHS un
8、der license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:38:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO/IEC 17021:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative re
9、ferences. 1 3 Terms and definitions. 1 4 Principles. 2 4.1 General. 2 4.2 Impartiality. 3 4.3 Competence 3 4.4 Responsibility . 3 4.5 Openness. 3 4.6 Confidentiality. 4 4.7 Responsiveness to complaints. 4 5 General requirements. 4 5.1 Legal and contractual matters. 4 5.2 Management of impartiality .
10、 4 5.3 Liability and financing 6 6 Structural requirements. 6 6.1 Organizational structure and top management. 6 6.2 Committee for safeguarding impartiality 6 7 Resource requirements 7 7.1 Competence of management and personnel. 7 7.2 Personnel involved in the certification activities 7 7.3 Use of i
11、ndividual external auditors and external technical experts 8 7.4 Personnel records 9 7.5 Outsourcing. 9 8 Information requirements 9 8.1 Publicly accessible information 9 8.2 Certification documents. 10 8.3 Directory of certified clients 10 8.4 Reference to certification and use of marks 10 8.5 Conf
12、identiality. 11 8.6 Information exchange between a certification body and its clients 12 9 Process requirements 13 9.1 General requirements. 13 9.2 Initial audit and certification 15 9.3 Surveillance activities 17 9.4 Recertification. 18 9.5 Special audits 19 9.6 Suspending, withdrawing or reducing
13、the scope of certification . 19 9.7 Appeals 20 9.8 Complaints 20 9.9 Records of applicants and clients 21 10 Management system requirements for certification bodies. 22 10.1 Options 22 10.2 Option 1: Management system requirements in accordance with ISO 9001 22 10.3 Option 2: General management syst
14、em requirements. 23 Bibliography. 26 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:38:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO/IEC 17
15、021:2006(E) iv ISO 2006 All rights reserved Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the developme
16、nt of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental,
17、 in liaison with ISO and IEC, also take part in the work. In the field of conformity assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of International Standards and Guides. International Standards are drafted in accordance with the rules given in the
18、ISO/IEC Directives, Part 2. Draft International Standards are circulated to the national bodies for voting. Publication as an International Standard requires approval by at least 75 % of the national bodies casting a vote. Attention is drawn to the possibility that some of the elements of this docum
19、ent may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/IEC 17021 was prepared by the ISO Committee on conformity assessment (CASCO). It was circulated for voting to the national bodies of both ISO and IEC, and was approved by bot
20、h organizations. This first edition of ISO/IEC 17021 cancels and replaces ISO/IEC Guide 62:1996 and ISO/IEC Guide 66:1999, which have been combined and technically revised. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standar
21、ds 1/9972545001 Not for Resale, 04/12/2007 20:38:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO/IEC 17021:2006(E) ISO 2006 All rights reserved v Introduction Certification of a management system, such as a quality or environmental management system of an organizatio
22、n, is one means of providing assurance that the organization has implemented a system for the management of the relevant aspects of its activities, in line with its policy. This International Standard specifies requirements for certification bodies. Observance of these requirements is intended to en
23、sure that certification bodies operate management system certification in a competent, consistent and impartial manner, thereby facilitating the recognition of such bodies and the acceptance of their certifications on a national and international basis. This International Standard serves as a founda
24、tion for facilitating the recognition of management system certification in the interests of international trade. Certification of a management system provides independent demonstration that the management system of the organization a) conforms to specified requirements, b) is capable of consistentl
25、y achieving its stated policy and objectives, and c) is effectively implemented. Conformity assessment such as certification of a management system thereby provides value to the organization, its customers and interested parties. In this International Standard, Clause 4 describes the principles on w
26、hich credible certification is based. These principles help the reader to understand the essential nature of certification and they are a necessary prelude to Clauses 5 to 10. These principles underpin all the requirements in this International Standard, but such principles are not auditable require
27、ments in their own right. Clause 10 describes two alternative ways of supporting and demonstrating the consistent achievement of the requirements in this International Standard through the establishment of a management system by the certification body. This International Standard is intended for use
28、 by bodies that carry out audit and certification of management systems. It gives generic requirements for such certification bodies performing audit and certification in the field of quality, environmental and other forms of management systems. Such bodies are referred to as certification bodies. T
29、his wording should not be an obstacle to the use of this International Standard by bodies with other designations that undertake activities covered by the scope of this document. Certification activities involve the audit of an organizations management system. The form of attestation of conformity o
30、f an organizations management system to a specific management system standard or other normative requirements is normally a certification document or a certificate. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/997
31、2545001 Not for Resale, 04/12/2007 20:38:00 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:38:00 MDT
32、No reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO/IEC 17021:2006(E) ISO 2006 All rights reserved 1 Conformity assessment Requirements for bodies providing audit and certification of management systems 1 Scope This International Standard contains princi
33、ples and requirements for the competence, consistency and impartiality of the audit and certification of management systems of all types (e.g. quality management systems or environmental management systems) and for bodies providing these activities. Certification bodies operating to this Internation
34、al Standard need not offer all types of management system certification. Certification of management systems (named in this International Standard “certification”) is a third-party conformity assessment activity (see ISO/IEC 17000:2004, 5.5). Bodies performing this activity are therefore third-party
35、 conformity assessment bodies (named in this International Standard “certification body/bodies”). NOTE 1 Certification of a management system is sometimes also called “registration”, and certification bodies are sometimes called “registrars”. NOTE 2 A certification body can be non-governmental or go
36、vernmental (with or without regulatory authority). NOTE 3 This International Standard can be used as a criteria document for accreditation or peer assessment or other audit processes. 2 Normative references The following referenced documents are indispensable for the application of this document. Fo
37、r dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005, Quality management systems Fundamentals and vocabulary ISO 19011:2002, Guidelines for quality and/or environmental management s
38、ystems auditing1) ISO/IEC 17000:2004, Conformity assessment Vocabulary and general principles 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000, ISO/IEC 17000 and the following apply. 3.1 certified client organization whose management system has b
39、een certified 1) References in this document to the relevant guidance in ISO 19011 apply to the auditing of all other types of management systems. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Re
40、sale, 04/12/2007 20:38:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO/IEC 17021:2006(E) 2 ISO 2006 All rights reserved 3.2 impartiality actual and perceived presence of objectivity NOTE 1 Objectivity means that conflicts of interest do not exist or are resolved so a
41、s not to adversely influence subsequent activities of the certification body. NOTE 2 Other terms that are useful in conveying the element of impartiality are: objectivity, independence, freedom from conflict of interests, freedom from bias, lack of prejudice, neutrality, fairness, open-mindedness, e
42、ven-handedness, detachment, balance. 3.3 management system consultancy participation in designing, implementing or maintaining a management system EXAMPLES are a) preparing or producing manuals or procedures, and b) giving specific advice, instructions or solutions towards the development and implem
43、entation of a management system. NOTE Arranging training and participating as a trainer is not considered consultancy, provided that, where the course relates to management systems or auditing, it is confined to the provision of generic information that is freely available in the public domain; i.e.
44、 the trainer should not provide company-specific solutions. 4 Principles 4.1 General 4.1.1 These principles are the basis for the subsequent specific performance and descriptive requirements in this International Standard. This International Standard does not give specific requirements for all situa
45、tions that can occur. These principles should be applied as guidance for the decisions that may need to be made for unanticipated situations. Principles are not requirements. 4.1.2 The overall aim of certification is to give confidence to all parties that a management system fulfils specified requir
46、ements. The value of certification is the degree of public confidence and trust that is established by an impartial and competent assessment by a third-party. Parties that have an interest in certification include, but are not limited to a) the clients of the certification bodies, b) the customers o
47、f the organizations whose management systems are certified, c) governmental authorities, d) non-governmental organizations, and e) consumers and other members of the public. 4.1.3 Principles for inspiring confidence include impartiality, competence, responsibility, Copyright International Organizati
48、on for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:38:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO/IEC 17021:2006(E) ISO 2006 All rights reserved 3 openness, confidentiality, and responsiveness to complaints. 4.2 Impartiality 4.2.1 Being impartial, and being perceived to be impartial, is necessary for a certification body to deliver certification tha