1、BRITISH STANDARD BS EN ISO/IEC 17040:2005 Conformity assessment General requirements for peer assessment of conformity assessment bodies and accreditation bodies The European Standard EN ISO/IEC 17040:2005 has the status of a British Standard ICS 03.120.20 BS EN ISO/IEC 17040:2005 This British Stand
2、ard was published under the authority of the Standards Policy and Strategy Committee on 1 February 2005 BSI 1 February 2005 ISBN 0 580 45432 0 National foreword This British Standard is the official English language version of EN ISO/IEC 17040:2005. It is identical with ISO/IEC 17040:2005. The UK pa
3、rticipation in its preparation was entrusted to Technical Committee QS/3, Conformity assessment, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or
4、 European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to incl
5、ude all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enqui
6、ries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO/IEC title page, the EN ISO/IEC for
7、eword page, the ISO/IEC title page, pages ii to vi, pages 1 to 13 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO/IEC
8、 17040 January 2005 ICS 03.120.20 English version Conformity assessment - General requirements for peer assessment of conformity assessment bodies and accreditation bodies (ISO/IEC 17040:2005) Evaluation de la conformit - Exigences gnrales relatives lvaluation par des pairs des organismes dvaluation
9、 de la conformit et des organismes daccrditation (ISO/IEC 17040:2005) Konformittsbewertung - Allgemeine Anforderungen an die Begutachtung unter gleichrangigen Konformittsbewertungsstellen und Akkreditierungsstellen (ISO/IEC 17040:2005) This European Standard was approved by CEN/CENELEC on 10 Decembe
10、r 2004. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations 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
11、may be obtained on application to the CEN Management Centre or to any CEN or 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 or CENELEC member into its own langua
12、ge and notified to the CEN Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece
13、, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CEN Management Centre: CENELEC Central Secretariat: rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Bruss
14、els 2005 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17040:2005 E Foreword This document (EN ISO/IEC 17040:2005) has been prepared by CASCO “Committee on Conformity Assessment“ in collabo
15、ration with Technical Committee CEN/CLC/TC 1 “Criteria for conformity assessment bodies“, the secretariat of which is held by SN. 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 July 2005, and con
16、flicting national standards shall be withdrawn at the latest by July 2005. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Fin
17、land, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 17040:2005 has been approved by CEN and CENELEC as EN IS
18、O/IEC 17040:2005 without any modifications. ENISO/IEC17040:2005 Reference number ISO/IEC 17040:2005(E)INTERNATIONAL ADNATSDR ISO/IEC 10407 tide tsriFino -500251-10 Conformity assessment General requirements for peer assessment of conformity assessment bodies and accreditation bodies valuation de la
19、conformit Exigences gnrales relatives lvaluation par des pairs des organismes dvaluation de la conformit et des organismes daccrditation Referecne unbmer OSICEI/ 407102:0)E(50INTERNATIONAL STANDARD ISO/IEC 17040 First edition 2005-01-15 noCfrotimy sasemssen t eGnelar eriuqernemtf sossessa reep rmtne
20、 fo fnocimroty ssaenemssb tidose dna tiderccaoitab nseido vulaitano ed c alnofromit xE icnegse ngrlase rlevitase vllataunoi rap dse apris dse ronagsisem dvulaitano ed c alnofromit sed te ronagsisem dcacrtatidino ENISO/IEC17040:2005 ii ENISO/IEC17040:2005 iiiContents Page Foreword iv Introduction v 1
21、 Scope 1 2 Normative references. 1 3 Terms and definitions. 2 4 Structural requirements. 2 5 Human resource requirements 3 5.1 Qualifications and selection 3 5.2 Languages translation . 3 6 Information and documentation 3 7 Peer assessment process requirements 4 7.1 General. 4 7.2 Application for pe
22、er assessment or an extension of scope. 5 7.3 Review and acceptance of the application. 5 7.4 Preparation for the peer assessment process. 5 7.5 Appointment of peer assessment team 6 7.6 Documentation review 7 7.7 On-site assessment 7 7.8 Analysis of findings 7 7.9 Peer assessment report. 7 7.10 Rev
23、iew of the peer assessment report . 8 7.11 Peer assessment in support of continuing membership of agreement group. 8 7.12 Notification of changes 9 8 Confidentiality. 9 9 Complaints. 9 Annex A (informative) Financial aspects . 10 Annex B (informative) Assessment techniques for use by peer assessment
24、 teams 11 Annex C (normative) Information to be included in the peer assessment report . 12 Bibliography . 13 ENISO/IEC17040:2005iv Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide stan
25、dardization. National bodies that are members of ISO or IEC participate in the development 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 o
26、f mutual interest. Other international organizations, governmental and non-governmental, 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 an
27、d Guides. International Standards are drafted in accordance with the rules given in the 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 casti
28、ng a vote. 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. ISO/IEC 17040 was prepared by the ISO Committee on conformity assessment (CASCO). It was c
29、irculated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. ENISO/IEC17040:2005 vIntroduction Peer assessment has been used for many years as a means of deciding upon whom to admit to a particular group of equals or peers. Membership of a professional ins
30、titution, for example, can be decided by using a process that the existing members have established, involving the setting of requirements for membership and the assessment of candidates for conformity with those requirements. In the field of conformity assessment, groups of bodies conducting the sa
31、me type of work, for example testing or accreditation, have used peer assessment in order that the work of each body can be assessed and found acceptable to all the other bodies. The global economy has accelerated the need for mutual recognition amongst accreditation and conformity assessment bodies
32、. Each group has developed a form of peer assessment appropriate to its activities. It became apparent when reviewing the methods used by the different groups that there were many aspects in common. It was felt that there would be benefits in creating an International Standard that gave generic requ
33、irements for an effective peer assessment process, while leaving it open to individual groups to adopt specific measures appropriate to their individual fields of activities. This International Standard is intended to be used by groups of peers performing any conformity assessment activity (e.g. con
34、formity assessment bodies, accreditation bodies). Such groups of peers have been described in various ways, and are called agreement groups in ISO/IEC Guide 68. That is not to say that other groups in different fields of work cannot use the peer assessment process. However, such groups would need to
35、 adopt suitable organizational and managerial arrangements to provide the right conditions for the peer assessment process to be carried out to the best effect. As a result, each group can achieve its desired outcomes with the expenditure of less resources. This International Standard is also intend
36、ed to enhance the confidence of those who use or depend upon the results of conformity assessment that the work is being conducted in a competent and proper manner. In this International Standard a generic peer assessment process is illustrated in Figure 1. The model shown in Figure 1 separates aspe
37、cts of the peer assessment process that are covered in this International Standard. It starts with the presumption that there is a prospective applicant to join an agreement group. It is assumed that an agreement group exists, and that this group has some criteria or requirements that have to be met
38、 in order for a body to join. These aspects are not covered by this International Standard but are for the specific agreement group to decide for themselves, as are the decision on membership of the group and any appeal on that decision. The bulk of this International Standard focuses on the steps t
39、o be used within the peer assessment process, and only makes non-process requirements where absolutely necessary. It can be used in conjunction with ISO/IEC Guide 68, and for the peer assessment process that may be required in either regulatory or voluntary fields of conformity assessment. The natur
40、e of a peer assessment is determined by the goal of the agreement group and the use to which the outcome of the peer assessment process will be applied. The goal of the agreement group could be one or more of the following: a) conformity of bodies with specified requirements; b) equivalence of resul
41、ts among bodies; c) acceptance of results from one body by other bodies for use in their conformity assessment activities. ENISO/IEC17040:2005vi Figure 1 Generic peer assessment process ENISO/IEC17040:2005INTENRATIONAL TSANDADR IS/OIE04071 C:(5002E)1Conformity assessment General requirements for pee
42、r assessment of conformity assessment bodies and accreditation bodies 1 Scope 1.1 This International Standard specifies the general requirements for the peer assessment process to be carried out by agreement groups of accreditation bodies or conformity assessment bodies. It addresses the structure a
43、nd operation of the agreement group only insofar as they relate to the peer assessment process. 1.2 This International Standard is not concerned with the wider issues of the arrangements for the formation, organization and management of the agreement group, and does not cover how the group will use
44、peer assessment in deciding membership of the group. Such matters, which could for example include a procedure for applicants to appeal against decisions of the agreement group, are outside the scope of this International Standard. NOTE 1 Further information on the wider issues is contained in ISO/I
45、EC Guide 68. 1.3 This International Standard is applicable to peer assessment of conformity assessment bodies performing activities such as a) testing, b) product certification, c) inspection, d) management system certification (sometimes also called registration), and e) personnel certification. Mo
46、re than one type of activity can be included in a peer assessment process. This can be considered particularly appropriate when the body under assessment conducts combined assessments of multiple conformity assessment activities. This International Standard is also applicable to peer assessment amon
47、gst accreditation bodies, which is also known as peer evaluation. NOTE 2 Bodies that are members of an agreement group might wish to rely on the soundness of the peer assessment process for evaluating the competence of a peer body as a potential subcontractor. 2 Normative references The following re
48、ferenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC 17000:2004, Conformity assessment Vocabulary and general
49、principles ENISO/IEC17040:20052 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 peer assessment assessment of a body against specified requirements by representatives of other bodies in, or candidates for, an agreement group ISO/IEC 17000:2004, definition 4.5 NOTE 1 “Candidates” are included to cater for the situation where a new group is being formed, at which time there would be no
