EN ISO IEC 17065-2012 en Conformity assessment - Requirements for bodies certifying products processes and services《合格评定机构认证要求产品 流程和服务(取代 CEN EN 45011)》.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 It supersedes BS EN 45011:1998 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CAS/1, Conformity assessment.A list of organizations represented on this committee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 3BS EN ISO/IEC 17065:2012EN ISO/IEC 17065:2012 (E) 3 Foreword This document (EN ISO/IEC 17065:2012) has been prepared by Technical Commit

12、tee 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 identica

13、l 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 respons

14、ible 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, C

15、zech 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 King

16、dom. 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 . v 1 Scope 1 2 Normative references 1 3 Terms and definitions

17、 . 1 4 General requirements . 4 4.1 Legal and contractual matters . 4 4.2 Management of impartiality 6 4.3 Liability and financing . 7 4.4 Non-discriminatory conditions 7 4.5 Confidentiality 7 4.6 Publicly available information 8 5 Structural requirements 8 5.1 Organizational structure and top manag

18、ement . 8 5.2 Mechanism for safeguarding impartiality . 9 6 Resource requirements 10 6.1 Certification body personnel 10 6.2 Resources for evaluation 11 7 Process requirements . 12 7.1 General . 12 7.2 Application . 13 7.3 Application review . 13 7.4 Evaluation 14 7.5 Review 15 7.6 Certification dec

19、ision 15 7.7 Certification documentation . 16 7.8 Directory of certified products . 16 7.9 Surveillance . 17 7.10 Changes affecting certification 17 7.11 Termination, reduction, suspension or withdrawal of certification . 18 7.12 Records 18 7.13 Complaints and appeals . 19 8 Management system requir

20、ements . 19 8.1 Options . 19 8.2 General management system documentation (Option A) . 20 8.3 Control of documents (Option A) 20 8.4 Control of records (Option A) 21 8.5 Management review (Option A) 21 8.6 Internal audits (Option A) . 22 8.7 Corrective actions (Option A) 22 8.8 Preventive actions (Op

21、tion A) 23 Annex A (informative) Principles for product certification bodies and their certification activities 24 Annex B (informative) Application of this International Standard for processes and services . 26 Bibliography 27 BS EN ISO/IEC 17065:2012ISO/IEC 17065:2012(E) ISO 2012 All rights reserv

22、ed 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 specified requirements. The value of certification is the degree of confidence and trust that is established by an impartial and c

23、ompetent 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 of the certification bodies; b) the customers of the organizations whose products, processes or services are certified; c) g

24、overnmental authorities; d) non-governmental organizations; and e) consumers and other members of the public. Interested parties can expect or require the certification body to meet all the requirements of this International Standard as well as when relevant, those of the certification scheme. Certi

25、fication of products, processes or services is a means of providing assurance that they comply with specified requirements in standards and other normative documents. Some product, process or service certification schemes may include initial testing or inspection and assessment of its suppliers qual

26、ity 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 market. Other schemes rely on initial testing and surveillance testing, while still others comprise type testing only. This

27、 International Standard specifies requirements, the observance of which is intended to ensure that certification bodies operate certification schemes in a competent, consistent and impartial manner, thereby facilitating the recognition of such bodies and the acceptance of certified products, process

28、es 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 peer assessment or designation by governmental authorities, scheme owners and others. The requirements contained in this In

29、ternational Standard are written, above all, to be considered as general criteria for certification bodies operating product, process or service certification schemes; they may have to be amplified when specific industrial or other sectors make use of them, or when particular requirements such as he

30、alth and safety have to be taken into account. Annex A contains principles relating to certification bodies and certification activities that they provide. This International Standard does not set requirements for schemes and how they are developed and is not intended to restrict the role or choice

31、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 standards or other normative documents can be in the form of certificates and/or marks of conformity. Schemes for certifyi

32、ng particular products or product groups, processes and services to specified standards or other normative documents will, in many cases, require their own explanatory documentation. While this International Standard is concerned with third parties providing product, process or service certification

33、, 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 rights reservedIn this International Standard, the following verbal forms are used: “shall” indicates a requirement; “should”

34、 indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability. Further details can be found in the ISO/IEC Directives, Part 2. BS EN ISO/IEC 17065:2012INTERNATIONAL STANDARD ISO/IEC 17065:2012(E) ISO 2012 All rights reserved 1Conformity assessment Requireme

35、nts for bodies certifying products, processes and services 1 Scope This International Standard contains requirements for the competence, consistent operation and impartiality of product, process and service certification bodies. Certification bodies operating to this International Standard need not

36、offer all types of products, processes and services certification. Certification of products, processes and services is a third-party conformity assessment activity (see ISO/IEC 17000:2004, definition 5.5). In this International Standard, the term “product” can be read as “process” or “service”, exc

37、ept in those instances where separate provisions are stated for “processes” or “services” (see Annex B). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the

38、 latest edition of the referenced document (including any amendments) applies. ISO/IEC 17000, Conformity assessment Vocabulary and general principles ISO/IEC 17020, Conformity assessment Requirements for the operation of various types of bodies performing inspection ISO/IEC 17021, Conformity assessm

39、ent Requirements for bodies providing audit and certification of management systems ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC 17000 and the follo

40、wing apply. 3.1 client organization or person responsible to a certification body for ensuring that certification requirements (3.7), including product requirements (3.8), are fulfilled NOTE Whenever the term “client” is used in this International Standard, it applies to both the “applicant” and the

41、 “client”, unless otherwise specified. 3.2 consultancy participation in a) the designing, manufacturing, installing, maintaining or distributing of a certified 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, imple

42、menting, operating or maintaining of a certified process or a process to be certified, or c) the designing, implementing, providing or maintaining of a certified service or a service to be certified NOTE In this International Standard, the term “consultancy” is used in relation to activities of cert

43、ification bodies, personnel of certification bodies and organizations related or linked to certification bodies. 3.3 evaluation combination of the selection and determination functions of conformity assessment activities NOTE The selection and determination functions are specified in ISO/IEC 17000:2

44、004, 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: services (e.g. transport) (see definition in 3.6); software (e.g. computer program, dictionary); hardware (e.g. engine, mechanical part); processed materials (e.g. lubricant).

45、 Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, 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 ot

46、her natural resources. NOTE 3 Adapted from ISO/IEC 17000:2004, definition 3.3. 3.5 process set of interrelated or interacting activities which transforms inputs into outputs EXAMPLES Welding engineering processes; heat treatment processes; manufacturing processes requiring confirmation of process ca

47、pability (e.g. operating or producing product within specified tolerances); food production processes; plant growth processes. NOTE Adapted 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,

48、which is generally intangible NOTE 1 Provision of a service can involve, for example, the following: an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired); an activity performed on a customer-supplied intangible product (e.g. the income statement needed to pr

49、epare a tax return); the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); 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 certification requirement specified requirement, including product requirements (3.8), that is fulfilled by the client (3.1) as a condition of establishing or maintainin