BS EN ISO IEC 17065-2012 Conformity assessment Requirements for bodies certifying products processes and services《合格评定 产品 过程和服务认证机构要求》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationConformity assessment Requirements for bodies certifying products, processes and servicesBS EN ISO/IEC 17065:2012National forewordThis British Standard is the UK implementation o

2、f EN ISO/IEC 17065:2012. It supersedes BS EN 45011:1998 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CAS/1, Conformity assessment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does

3、 not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012Published by BSI Standards Limited 2012 ISBN 978 0 580 78472 9 ICS 03.120.20Compliance with a British Standard cannot confer immunity from lega

4、l obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO/IEC 17065:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO/IEC 17065 Sept

5、ember 2012 ICS 03.120.20 Supersedes EN 45011:1998 English version Conformity assessment - Requirements for bodies certifying products, processes and services (ISO/IEC 17065:2012) valuation de la conformit - Exigences pour les organismes certifiant les produits, les procds et les services (ISO/IEC 17

6、065:2012) Konformittsbewertung - Anforderungen an Stellen, die Produkte, Prozesse und Dienstleistungen zertifizieren (ISO/IEC 17065:2012) This European Standard was approved by CEN on 18 August 2012. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulat

7、e 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 member. This E

8、uropean 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 versions.

9、 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, Latvia, Lit

10、huania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre Avenue Marnix 17, B-1000 Brussels 2012 CEN/CENELEC All rights of exploitation in any form and by any means reserved worl

11、dwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17065:2012 EBS EN ISO/IEC 17065:2012EN ISO/IEC 17065:2012 (E) 2 Contents Page Foreword 3g3BS EN ISO/IEC 17065:2012EN ISO/IEC 17065:2012 (E) 3 Foreword This document (EN ISO/IEC 17065:2012) has been prepared by Technical Comm

12、ittee ISO/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 BSI. This European Standard shall be given the status of a national standard, either by publication of an identi

13、cal text or by endorsement, at the latest by March 2013, and conflicting national standards shall be withdrawn at the latest by March 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held respo

14、nsible for identifying any or all such patent rights. This document supersedes EN 45011:1998. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus,

15、 Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Ki

16、ngdom. Endorsement notice The text of ISO/IEC 17065:2012 has been approved by CEN as a EN ISO/IEC 17065:2012 without any modification. BS EN ISO/IEC 17065:2012ISO/IEC 17065:2012(E) ISO 2012 All rights reserved iiiContents Page Introduction . vg31g3 Scope 1g32g3 Normative references 1g33g3 Terms and

17、definitions . 1g34g3 General requirements . 4g34.1g3 Legal and contractual matters . 4g34.2g3 Management of impartiality 6g34.3g3 Liability and financing . 7g34.4g3 Non-discriminatory conditions 7g34.5g3 Confidentiality 7g34.6g3 Publicly available information 8g35g3 Structural requirements 8g35.1g3

18、Organizational structure and top management . 8g35.2g3 Mechanism for safeguarding impartiality . 9g36g3 Resource requirements 10g36.1g3 Certification body personnel 10g36.2g3 Resources for evaluation 11g37g3 Process requirements . 12g37.1g3 General . 12g37.2g3 Application . 13g37.3g3 Application rev

19、iew . 13g37.4g3 Evaluation 14g37.5g3 Review 15g37.6g3 Certification decision 15g37.7g3 Certification documentation . 16g37.8g3 Directory of certified products . 16g37.9g3 Surveillance . 17g37.10g3 Changes affecting certification 17g37.11g3 Termination, reduction, suspension or withdrawal of certific

20、ation . 18g37.12g3 Records 18g37.13g3 Complaints and appeals . 19g38g3 Management system requirements . 19g38.1g3 Options . 19g38.2g3 General management system documentation (Option A) . 20g38.3g3 Control of documents (Option A) 20g38.4g3 Control of records (Option A) 21g38.5g3 Management review (Op

21、tion A) 21g38.6g3 Internal audits (Option A) . 22g38.7g3 Corrective actions (Option A) 22g38.8g3 Preventive actions (Option A) 23g3Annex A (informative) Principles for product certification bodies and their certification activities 24g3Annex B (informative) Application of this International Standard

22、 for processes and services . 26g3Bibliography 27g3BS EN ISO/IEC 17065:2012ISO/IEC 17065:2012(E) ISO 2012 All rights reserved vIntroduction The overall aim of certifying products, processes or services is to give confidence to all interested parties that a product, process or service fulfils specifi

23、ed requirements. The value of certification is the degree of confidence and trust that is established by an impartial and competent demonstration of fulfilment of specified requirements by a third party. Parties that have an interest in certification include, but are not limited to: a) the clients o

24、f the certification bodies; b) the customers of the organizations whose products, processes or services are certified; c) governmental authorities; d) non-governmental organizations; and e) consumers and other members of the public. Interested parties can expect or require the certification body to

25、meet all the requirements of this International Standard as well as when relevant, those of the certification scheme. Certification of products, processes or services is a means of providing assurance that they comply with specified requirements in standards and other normative documents. Some produ

26、ct, process or service certification schemes may include initial testing or inspection and assessment of its suppliers quality management systems, followed by surveillance that takes into account the quality management system and the testing or inspection of samples from the production and the open

27、market. Other schemes rely on initial testing and surveillance testing, while still others comprise type testing only. This International Standard specifies requirements, the observance of which is intended to ensure that certification bodies operate certification schemes in a competent, consistent

28、and impartial manner, thereby facilitating the recognition of such bodies and the acceptance of certified products, processes and services on a national and international basis and so furthering international trade. This International Standard can be used as a criteria document for accreditation or

29、peer assessment or designation by governmental authorities, scheme owners and others. The requirements contained in this International Standard are written, above all, to be considered as general criteria for certification bodies operating product, process or service certification schemes; they may

30、have to be amplified when specific industrial or other sectors make use of them, or when particular requirements such as health and safety have to be taken into account. Annex A contains principles relating to certification bodies and certification activities that they provide. This International St

31、andard does not set requirements for schemes and how they are developed and is not intended to restrict the role or choice of scheme owners, however scheme requirements should not contradict or exclude any of the requirements of this International Standard. Statements of conformity to the applicable

32、 standards or other normative documents can be in the form of certificates and/or marks of conformity. Schemes for certifying particular products or product groups, processes and services to specified standards or other normative documents will, in many cases, require their own explanatory documenta

33、tion. While this International Standard is concerned with third parties providing product, process or service certification, many of its provisions may also be useful in first- and second-party product conformity assessment procedures. BS EN ISO/IEC 17065:2012ISO/IEC 17065:2012(E) vi ISO 2012 All ri

34、ghts reservedIn this International Standard, the following verbal forms are used: g127 “shall” indicates a requirement; g127 “should” indicates a recommendation; g127 “may” indicates a permission; g127 “can” indicates a possibility or a capability. Further details can be found in the ISO/IEC Directi

35、ves, Part 2. BS EN ISO/IEC 17065:2012INTERNATIONAL STANDARD ISO/IEC 17065:2012(E) ISO 2012 All rights reserved 1Conformity assessment Requirements for bodies certifying products, processes and services 1 Scope This International Standard contains requirements for the competence, consistent operation

36、 and impartiality of product, process and service certification bodies. Certification bodies operating to this International Standard need not offer all types of products, processes and services certification. Certification of products, processes and services is a third-party conformity assessment a

37、ctivity (see ISO/IEC 17000:2004, definition 5.5). In this International Standard, the term “product” can be read as “process” or “service”, except in those instances where separate provisions are stated for “processes” or “services” (see Annex B). 2 Normative references The following referenced docu

38、ments 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, Conformity assessment Vocabulary and general principles ISO/IEC

39、 17020, Conformity assessment Requirements for the operation of various types of bodies performing inspection ISO/IEC 17021, Conformity assessment Requirements for bodies providing audit and certification of management systems ISO/IEC 17025, General requirements for the competence of testing and cal

40、ibration laboratories 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC 17000 and the following apply. 3.1 client organization or person responsible to a certification body for ensuring that certification requirements (3.7), including product requi

41、rements (3.8), are fulfilled NOTE Whenever the term “client” is used in this International Standard, it applies to both the “applicant” and the “client”, unless otherwise specified. 3.2 consultancy participation in a) the designing, manufacturing, installing, maintaining or distributing of a certifi

42、ed product or a product to be certified, or BS EN ISO/IEC 17065:2012ISO/IEC 17065:2012(E) 2 ISO 2012 All rights reservedb) the designing, implementing, operating or maintaining of a certified process or a process to be certified, or c) the designing, implementing, providing or maintaining of a certi

43、fied service or a service to be certified NOTE In this International Standard, the term “consultancy” is used in relation to activities of certification bodies, personnel of certification bodies and organizations related or linked to certification bodies. 3.3 evaluation combination of the selection

44、and determination functions of conformity assessment activities NOTE The selection and determination functions are specified in ISO/IEC 17000:2004, Clauses A.2 and A.3. 3.4 product result of a process NOTE 1 Four generic product categories are noted in ISO 9000:2005: g127 services (e.g. transport) (

45、see definition in 3.6); g127 software (e.g. computer program, dictionary); g127 hardware (e.g. engine, mechanical part); g127 processed materials (e.g. lubricant). Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software,

46、 hardware or processed material depends on the dominant element. NOTE 2 Products include results of natural processes, such as growth of plants and formation of other natural resources. NOTE 3 Adapted from ISO/IEC 17000:2004, definition 3.3. 3.5 process set of interrelated or interacting activities

47、which transforms inputs into outputs EXAMPLES Welding engineering processes; heat treatment processes; manufacturing processes requiring confirmation of process capability (e.g. operating or producing product within specified tolerances); food production processes; plant growth processes. NOTE Adapt

48、ed from ISO 9000:2005, definition 3.4.1. 3.6 service result of at least one activity necessarily performed at the interface between the supplier and the customer, which is generally intangible NOTE 1 Provision of a service can involve, for example, the following: g127 an activity performed on a cust

49、omer-supplied tangible product (e.g. automobile to be repaired); g127 an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); g127 the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); g127 the creation of ambience for the customer (e.g. in hotels and restaurants). NOTE 2 Adapted from ISO 9000:2005, definition 3.4.2. BS EN ISO/IEC 17065:2012ISO/IEC 17065:2012(E) ISO 2012 All rights reserved 33.7 certificatio