1、BRITISH STANDARD BS EN ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies The European Standard EN ISO/IEC 17011:2004 has the status of a British Standard ICS 03.120.20 BS EN ISO/IEC 17011:2004 This British Standard was pub
2、lished under the authority of the Standards Policy and Strategy Committee on 14 October 2004 BSI 14 October 2004 ISBN 0 580 44583 6 National foreword This British Standard is the official English language version of EN ISO/IEC 17011:2004. It is identical with ISO/IEC 17011:2004. It supersedes BS EN
3、45003:1995, BS EN 45010:1998 and PD 6642:1999 which are withdrawn. NOTE ISO/IEC 17011 cancels and replaces ISO/IEC Guide 58, ISO/IEC Guide 61 and ISO/IEC TR 17010. The UK participation in its preparation was entrusted to Technical Committee QS/3, Conformity assessment, which has the responsibility t
4、o: 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 European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International
5、 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 include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British St
6、andard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and Euro
7、pean 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 foreword page, the ISO/IEC title page, pages ii to vi, pages 1 to 21 and a back cover. The BSI copyright notice displayed in this
8、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 17011 September 2004 ICS 03.120.20 English version Conformity assessment - General requirements for accreditation bodies accre
9、diting conformity assessment bodies (ISO/IEC 17011:2004) valuation de la conformit - Exigences gnrales pour les organes daccrditation procdant laccrditation des organes dvaluation de la conformit (ISO/IEC 17011:2004) Konformittsbewertung - Allgemeine Anforderungen an Akkreditierungsstellen, die Konf
10、ormittsbewertungsstellen akkreditieren (ISO/IEC 17011:2004) This European Standard was approved by CEN and CENELEC on 1 July 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 na
11、tional standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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).
12、A version in any other language made by translation under the responsibility of a CEN or CENELEC member into its own language 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 electrotechnica
13、l committees, respectively, of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdo
14、m. CEN Management Centre: CENELEC Central Secretariat: rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Brussels 2004 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 17011:2004
15、ENE IS/OIEC 11107:200)E( 4 2 Foreword This document (EN ISO/IEC 17011:2004) has been prepared by CASCO “Committee on Conformity Assessment“ in collaboration with Technical Committee CEN/CLC/TC 1 “Criteria for conformity assessment bodies“, the secretariat of which is held by SN. This European Standa
16、rd shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2005, and conflicting national standards shall be withdrawn at the latest by March 2005. According to the CEN/CENELEC Internal Regulations, the national standards
17、 organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovak
18、ia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO/IEC 17011:2004 has been approved by CEN and CENELEC as EN ISO/IEC 17011:2004 without any modifications. ENISO/IEC17011:2004 Reference number ISO/IEC 17011:2004(E) OSI 4002INTERNATIONAL STANDARD ISO/IEC 17
19、011 First edition 2004-09-01 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies valuation de la conformit Exigences gnrales pour les organes daccrditation procdant laccrditation des organes dvaluation de la conformit ENISO/IEC17011:2004IS/OIE
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25、 Page Foreword iv Introduction v 1 Scope 1 2 Normative references. 1 3 Terms and definitions. 1 4 Accreditation body 4 4.1 Legal responsibility 4 4.2 Structure 4 4.3 Impartiality. 5 4.4 Confidentiality. 6 4.5 Liability and financing 6 4.6 Accreditation activity 6 5 Management 6 5.1 General. 6 5.2 Ma
26、nagement system. 7 5.3 Document control. 7 5.4 Records 7 5.5 Nonconformities and corrective actions 8 5.6 Preventive actions 8 5.7 Internal audits 8 5.8 Management reviews 9 5.9 Complaints. 9 6 Human resources 10 6.1 Personnel associated with the accreditation body . 10 6.2 Personnel involved in the
27、 accreditation process 10 6.3 Monitoring 10 6.4 Personnel records. 11 7 Accreditation process 11 7.1 Accreditation criteria and information 11 7.2 Application for accreditation . 12 7.3 Resource review 12 7.4 Subcontracting the assessment 12 7.5 Preparation for assessment. 13 7.6 Document and record
28、 review. 14 7.7 On-site assessment 14 7.8 Analysis of findings and assessment report . 14 7.9 Decision-making and granting accreditation. 15 7.10 Appeals 16 7.11 Reassessment and surveillance 17 7.12 Extending accreditation. 17 7.13 Suspending, withdrawing or reducing accreditation 17 7.14 Records o
29、n CABs 18 7.15 Proficiency testing and other comparisons for laboratories . 18 8 Responsibilities of the accreditation body and the CAB 18 8.1 Obligations of the CAB. 18 8.2 Obligations of the accreditation body 19 8.3 Reference to accreditation and use of symbols 19 Bibliography . 21 ENISO/IEC17011
30、:2004IS/OIE11071 C:(4002E) iv I SO/IE 4002 C All irhgts seredevrForeword 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 particip
31、ate in the development of International Standards through technical committees established by the respective organization to deal with particular fields or technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other International Organization, governmental an
32、d 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 and Guides. International Standards are drafted in accordance with the
33、rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by
34、at least 75 % of the member bodies casting 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 17011 was prepared by the ISO, Committee o
35、n conformity assessment (CASCO). This first edition of ISO/IEC 17011 cancels and replaces ISO/IEC Guide 58, ISO/IEC Guide 61, and ISO/IEC/TR 17010. Many accreditation bodies requested this revision because, for quite similar activities, they have had to comply with three sets of largely repetitious
36、but slightly differing, requirements for the same attributes. ENISO/IEC17011:2004IS/OIE11071 C:(4002E) I SO/IE 4002 C All irhgts seredevr vIntroduction In the regulatory sector, government authorities implement laws covering the approval of products (including services) for reasons of safety, health
37、, environmental protection, fraud prevention or market fairness. In the voluntary sector, many lines of industry have, both within an economy as well as globally, set up systems for conformity assessment and approval, aiming at achieving a minimum technical level, enabling comparability, and also en
38、suring competition on equal terms. A prerequisite for trade on equal terms is that any product (including services), accepted formally in one economy, must also be free to circulate in other economies without having to undergo extensive re-testing, re- inspection, re-certification, etc. This should
39、be the case regardless of whether the product (including services) falls wholly or partly under the regulatory sector. In todays society it is often required to state objectively conformity of products (including services) to specified requirements. Conformity assessment bodies (CABs) can objectivel
40、y state such conformity. These CABs perform conformity assessment activities that include certification, inspection, testing and, in the context of this International Standard, calibration. It is important for the purchaser, regulator and the public to know that these CABs are competent to perform t
41、heir tasks. For that reason there is an increasing demand for impartial verification of their competence. Such verification is done by authoritative accreditation bodies that are impartial in relation to both the CABs and their clients, and which normally operate in a non-profit distributing manner
42、(see Figure 1). A system to accredit CAB conformity assessment services should provide confidence to the purchaser and regulator. Such a system should facilitate cross-border trade, as pursued by trade authorities and organizations. The ultimate goal is to achieve one-stop accreditation and one-stop
43、 conformity assessment. A “cross border” trade facilitating system can work well if accreditation bodies and CABs all operate to globally accepted requirements in an equivalent manner and take into account the interests of all parties concerned. This International Standard specifies the general requ
44、irements for accreditation bodies. Peer evaluation mechanisms have been created at regional and international levels, through which assurance is provided that accreditation bodies are operating in accordance with this International Standard. Those who have passed such an evaluation can become member
45、s of mutual recognition arrangements. Through regular re-evaluations, the continued adherence to this International Standard is assured. These mutual recognition arrangement members facilitate the one-stop process, through recognition, promotion and acceptance of each others accredited conformity as
46、sessments. This means that a CAB in an economy should not need to be accredited more than once for the same scope by different accreditation bodies. ENISO/IEC17011:2004IS/OIE11071 C:(4002E) vi I SO/IE 4002 C All irhgts seredevrNOTE The word supplier is used to mean provider of products (including se
47、rvices). Figure 1 Flowchart ENISO/IEC17011:2004INTENRATIONAL TSANDADR IS/OIE11071 C:(4002E)I SO/IE 4002 C All irhgts seredevr 1Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies 1 Scope This International Standard specifies general requiremen
48、ts for accreditation bodies assessing and accrediting conformity assessment bodies (CABs). It is also appropriate as a requirements document for the peer evaluation process for mutual recognition arrangements between accreditation bodies. Accreditation bodies operating in accordance with this Intern
49、ational Standard do not have to offer accreditation to all types of CABs. For the purposes of this International Standard, CABs are organizations providing the following conformity assessment services: testing, inspection, management system certification, personnel certification, product certification and, in the context of this International Standard, calibration. NOTE General requirements for these bodies have been established, for ex
