EN ISO IEC 17011-2017 en Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Conformity assessment Requirements for accreditation bodies accrediting conformity assessment bodiesBS EN ISO/IEC 17011:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO/IEC 17011 December 2017 ICS 03.120.20

2、Supersedes EN ISO/IEC 17011:2004 English version Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2017) valuation de la conformit - Exigences pour les organismes daccrditation procdant laccrditation dorganismes dvaluation de la con

3、formit (ISO/IEC 17011:2017) Konformittsbewertung - Anforderungen an Akkreditierungsstellen, die Konformittsbewertungsstellen akkreditieren (ISO/IEC 17011:2017) This European Standard was approved by CEN on 10 November 2017. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Re

4、gulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN an

5、d CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status a

6、s the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ire

7、land, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2017 CEN/CENELEC All rights of exploitation in an

8、y form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17011:2017 ENational forewordThis British Standard is the UK implementation of EN ISO/IEC 17011:2017. It is identical to ISO/IEC 17011:2017. It supersedes BS EN ISO/IEC 17011:2004, which

9、is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CAS/1/-/42, Drafting panel ISO/CASCO 17011.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provis

10、ions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 87856 5ICS 03.120.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published

11、 under the authority of the Standards Policy and Strategy Committee on 31 January 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO/IEC 17011:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO/IEC 17011 December 2017 ICS 03.120.20 Supersedes EN

12、ISO/IEC 17011:2004 English version Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2017) valuation de la conformit - Exigences pour les organismes daccrditation procdant laccrditation dorganismes dvaluation de la conformit (ISO/IE

13、C 17011:2017) Konformittsbewertung - Anforderungen an Akkreditierungsstellen, die Konformittsbewertungsstellen akkreditieren (ISO/IEC 17011:2017) This European Standard was approved by CEN on 10 November 2017. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations whic

14、h stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC memb

15、er. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official

16、 versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L

17、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2017 CEN/CENELEC All rights of exploitation in any form and by

18、any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17011:2017 EBS EN ISO/IEC 17011:2017EN ISO/IEC 17011:2017 (E) 3 European foreword This document (EN ISO/IEC 17011:2017) has been prepared by Technical Committee ISO/CASCO “Committee on conformity asses

19、sment“ in collaboration with Technical Committee CEN/CLC/JTC 1 “Criteria for conformity assessment bodies” the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by

20、June 2018 and conflicting national standards shall be withdrawn at the latest by June 2018. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This docu

21、ment supersedes EN ISO/IEC 17011:2004. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugo

22、slav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/IEC 1

23、7011:2017 has been approved by CEN as EN ISO/IEC 17011:2017 without any modification. BS EN ISO/IEC 17011:2017ISO/IEC 17011:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 General requirements . 54.1 Legal entity . 54.2 Accreditation agreement 54.3 Use

24、 of accreditation symbols and other claims of accreditation . 64.4 Impartiality requirements 74.5 Financing and liability 84.6 Establishing accreditation schemes 95 Structural requirements 96 Resource requirements 106.1 Competence of personnel . 106.1.1 General. 106.1.2 Determination of competence c

25、riteria .106.1.3 Competence management 126.2 Personnel involved in the accreditation process 126.3 Personnel records 136.4 Outsourcing. 137 Process requirements 137.1 Accreditation requirements 137.2 Application for accreditation . 147.3 Resource review 147.4 Preparation for assessment 147.5 Review

26、of documented information 157.6 Assessment 157.7 Accreditation decision-making 167.8 Accreditation information 177.9 Accreditation cycle . 197.10 Extending accreditation . 207.11 Suspending, withdrawing or reducing accreditation .207.12 Complaints . 207.13 Appeals . 217.14 Records on conformity asse

27、ssment bodies . 228 Information requirements 228.1 Confidential information . 228.2 Publicly available information 229 Management system requirements .239.1 General 239.2 Management system . 249.3 Document control 249.4 Records control 249.5 Nonconformities and corrective actions 259.6 Improvement .

28、 259.7 Internal audits 259.8 Management reviews . 26Annex A (informative) Knowledge and skills for performing accreditation activities .27Bibliography .29 ISO/IEC 2017 All rights reserved iiiContents PageBS EN ISO/IEC 17011:2017ISO/IEC 17011:2017(E)ForewordISO (the International Organization for Sta

29、ndardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the righ

30、t to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures

31、used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rule

32、s of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identif

33、ied during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on

34、the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword

35、.html.This document was prepared by the ISO Committee on Conformity Assessment (CASCO) and circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations.This second edition cancels and replaces the first edition (ISO/IEC 17011:2004), which has been technica

36、lly revised.The main changes compared to the previous edition are as follows: alignment with the CASCO common structure for standards and incorporation of CASCO common elements in clauses on impartiality, confidentiality, complaints and appeal and management system; recognition of proficiency testin

37、g as an accreditation activity; addition of new definitions for “accreditation scheme” (see 3.8), “flexible scope of accreditation” (see 3.7), “remote assessment” (see 3.26) and “assessment programme” (see 3.27); introduction of the concept of risk; incorporation of competence criteria in the docume

38、nt, including an informative annex on knowledge and skills.iv ISO/IEC 2017 All rights reservedBS EN ISO/IEC 17011:2017ISO/IEC 17011:2017(E)IntroductionThis document specifies the requirements for accreditation bodies accrediting conformity assessment bodies. In the context of this document, activiti

39、es covered by accreditation include but are not limited to testing, calibration, inspection, certification of management systems, persons, products, processes and services, provision of proficiency testing, production of reference materials, validation and verification.It is important for interested

40、 parties to know that conformity assessment bodies are competent to perform their tasks. For that reason, there is an increasing demand for impartial attestation of their competence. Such attestation is done by accreditation bodies that are impartial and independent in relation to the conformity ass

41、essment bodies and the conformity assessment bodies clients. Accreditation bodies normally operate in a non-profit distributing manner and conduct regular assessments of conformity assessment bodies to ensure that conformity assessment bodies conform to relevant international standards and other nor

42、mative documents.A system to accredit conformity assessment bodies is intended to provide for a consistent application of conformity assessment to international consensus based standards and conformity assessment schemes, in order to benefit public health, safety, environment and welfare and support

43、 regulators and end users. It can facilitate national and cross-border trade, as pursued by trade authorities and organizations.This document can be used to support peer evaluation mechanisms which have been created at regional and international levels and through which confidence is provided that a

44、ccreditation bodies are operating in accordance with this document.In this document, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability.Further details can be found in

45、the ISO/IEC Directives, Part 2.For the purposes of research, users are encouraged to share their views on this document and their priorities for changes to future editions. Click on the link below to take part in the online survey:17011_ed2_usersurvey ISO/IEC 2017 All rights reserved vBS EN ISO/IEC

46、17011:2017Conformity assessment Requirements for accreditation bodies accrediting conformity assessment bodies1 ScopeThis document specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.NOTE In t

47、he context of this document, activities covered by accreditation include, but are not limited to, testing, calibration, inspection, certification of management systems, persons, products, processes and services, provision of proficiency testing, production of reference materials, validation and veri

48、fication.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (i

49、ncluding any amendments) applies.ISO/IEC 17000, Conformity assessment Vocabulary and general principles3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO/IEC 17000 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at https:/www.iso.org/obp IEC Electropedia: available at http:/www.electropedia.org/3.1accreditationthird-party attestation related to a conformi