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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 ? Licensed Copy: London South Bank University, London
2、South Bank University, Thu Mar 01 06:26:07 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO/IEC 17011:2004 This British Standard was published 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 Briti
3、sh 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 It supersedes BS EN 45003:1995, BS EN 45010:1998 and PD 6642:1999 which are withdrawn. NOTEISO/IEC 17011 cancels and replaces ISO/IEC Guide 58, ISO/IEC Guide 61 and ISO/IEC TR 1701
4、0. The UK participation 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 inte
5、rnational or 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 pur
6、port to include 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 committ
7、ee any enquiries 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
8、 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 document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, Lond
9、on South Bank University, Thu Mar 01 06:26:07 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 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 accrediting conformity assess
10、ment 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 Konformittsbewertungsstellen
11、 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 national standard without
12、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). A version in any other l
13、anguage 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 electrotechnical committees, respective
14、ly, 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 Kingdom. CEN Management Centre
15、: 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 E Licensed Copy: London
16、South Bank University, London South Bank University, Thu Mar 01 06:26:07 GMT+00:00 2007, Uncontrolled Copy, (c) BSI NE 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
17、/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 March 2005, and conflicting national standards shall
18、be withdrawn at the latest by March 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, Finland, France, Germany, Greece, Hu
19、ngary, 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/IEC 17011:2004 has been approved by CEN and CENELEC as EN ISO/IEC 17011:2004 without any
20、modifications. EN ISO/IEC 17011:2004 Licensed Copy: London South Bank University, London South Bank University, Thu Mar 01 06:26:07 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO/IEC 17011:2004(E) OSI 4002 INTERNATIONAL STANDARD ISO/IEC 17011 First edition 2004-09-01 Conformity asse
21、ssment 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 EN ISO/IEC 17011:2004 Licensed Copy: London South Bank University, Lo
22、ndon South Bank University, Thu Mar 01 06:26:07 GMT+00:00 2007, Uncontrolled Copy, (c) BSI IS/OIE11071 C:(4002E) DPlcsid Fremia ihTs PDF file mya ctnoian emdebt dedyfepcaes. In ccacnadrow eitA hebods licnesilop gnic,y tihs file mirp eb yatnde iv roweb detu slahl ton ide ebtlnu deess teh typfecaes wi
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27、tsser edevr EN ISO/IEC 17011:2004 Licensed Copy: London South Bank University, London South Bank University, Thu Mar 01 06:26:07 GMT+00:00 2007, Uncontrolled Copy, (c) BSI IS/OIE11071 C:(4002E) I SO/IE 4002 C All irhgts seredevr iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative refere
28、nces .1 3 Terms and definitions.1 4 Accreditation body4 4.1 Legal responsibility 4 4.2 Structure 4 4.3 Impartiality.5 4.4 Confidentiality .6 4.5 Liability and financing6 4.6 Accreditation activity6 5 Management 6 5.1 General.6 5.2 Management system.7 5.3 Document control .7 5.4 Records7 5.5 Nonconfo
29、rmities and corrective actions8 5.6 Preventive actions 8 5.7 Internal audits8 5.8 Management reviews9 5.9 Complaints.9 6 Human resources10 6.1 Personnel associated with the accreditation body .10 6.2 Personnel involved in the accreditation process10 6.3 Monitoring10 6.4 Personnel records.11 7 Accred
30、itation process 11 7.1 Accreditation criteria and information11 7.2 Application for accreditation .12 7.3 Resource review12 7.4 Subcontracting the assessment12 7.5 Preparation for assessment.13 7.6 Document and record review.14 7.7 On-site assessment14 7.8 Analysis of findings and assessment report
31、.14 7.9 Decision-making and granting accreditation.15 7.10 Appeals 16 7.11 Reassessment and surveillance17 7.12 Extending accreditation .17 7.13 Suspending, withdrawing or reducing accreditation17 7.14 Records on CABs18 7.15 Proficiency testing and other comparisons for laboratories .18 8 Responsibi
32、lities of the accreditation body and the CAB18 8.1 Obligations of the CAB.18 8.2 Obligations of the accreditation body 19 8.3 Reference to accreditation and use of symbols19 Bibliography .21 EN ISO/IEC 17011:2004 Licensed Copy: London South Bank University, London South Bank University, Thu Mar 01 0
33、6:26:07 GMT+00:00 2007, Uncontrolled Copy, (c) BSI IS/OIE11071 C:(4002E) iv I SO/IE 4002 C All irhgts seredevr Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National
34、 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 or technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Ot
35、her International Organization, 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 and Guides. Internationa
36、l Standards are drafted in accordance with the 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
37、an International Standard requires approval by 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
38、/IEC 17011 was prepared by the ISO, Committee on 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
39、 comply with three sets of largely repetitious but slightly differing, requirements for the same attributes. EN ISO/IEC 17011:2004 Licensed Copy: London South Bank University, London South Bank University, Thu Mar 01 06:26:07 GMT+00:00 2007, Uncontrolled Copy, (c) BSI IS/OIE11071 C:(4002E) I SO/IE 4
40、002 C All irhgts seredevr v Introduction In the regulatory sector, government authorities implement laws covering the approval of products (including services) for reasons of safety, health, environmental protection, fraud prevention or market fairness. In the voluntary sector, many lines of industr
41、y 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 ensuring competition on equal terms. A prerequisite for trade on equal terms is that any product (including servi
42、ces), 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 be the case regardless of whether the product (including services) falls wholly or partly under the regulatory
43、sector. In todays society it is often required to state objectively conformity of products (including services) to specified requirements. Conformity assessment bodies (CABs) can objectively state such conformity. These CABs perform conformity assessment activities that include certification, inspec
44、tion, 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 their tasks. For that reason there is an increasing demand for impartial verification of their competence. Such
45、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 (see Figure 1). A system to accredit CAB conformity assessment services should provide confidence to the purcha
46、ser 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 conformity assessment. A “cross border” trade facilitating system can work well if accreditation bodies and CA
47、Bs 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 requirements for accreditation bodies. Peer evaluation mechanisms have been created at regional and international l
48、evels, 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 members of mutual recognition arrangements. Through regular re-evaluations, the continued adherence to this Internati
49、onal Standard is assured. These mutual recognition arrangement members facilitate the one-stop process, through recognition, promotion and acceptance of each others accredited conformity assessments. 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. EN ISO/IEC 17011:2004 Licensed Copy: London South Bank University, London South Bank University, Thu Mar 01 06:26:07 GMT+00: