BS EN ISO IEC 17050-1-2010 Conformity assessment - Supplier-s declaration of conformity - General requirements《合格评定 供应商的符合标准声明 一般要求》.pdf

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1、BS EN ISO/IEC17050-1:2010ICS 03.120.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDConformity assesment Suppliersdeclaration ofconformityPart 1: General requirements (ISO/IEC 17050-1:2004, corrected version2007-06-15)This British Standardwas published under t

2、heauthority of the StandardsPolicy and StrategyCommittee on 31 May 2010 BSI 2010ISBN 978 0 580 70040 8Amendments/corrigenda issued since publicationDate CommentsBS EN ISO/IEC 17050-1:2010National forewordThis British Standard is the UK implementation of EN ISO/IEC17050-1:2010. It is identical to ISO

3、/IEC 17050-1:2004, corrected version2007-06-15. It supersedes BS EN ISO/IEC 17050-1:2004 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CAS/1, Conformity assessment.A list of organizations represented on this committee can be obtained onrequest to its s

4、ecretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO/IEC 17050-1 Apri

5、l 2010 ICS 03.120.20 Supersedes EN ISO/IEC 17050-1:2004 English version Conformity assessment - Suppliers declaration of conformity - Part 1: General requirements (ISO/IEC 17050-1:2004, corrected version 2007-06-15) valuation de la conformit - Dclaration de conformit du fournisseur - Partie 1: Exige

6、nces gnrales (ISO/IEC 17050-1:2004, version corrige 2007-06-15) Konformittsbewertung - Konformittserklrung von Anbietern - Teil 1: Allgemeine Anforderungen (ISO/IEC 17050-1:2004, korrigierte Fassung 2007-06-15) This European Standard was approved by CEN on 13 March 2010. CEN and CENELEC members are

7、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 may be obtained on application to th

8、e CEN Management Centre or to any CEN and 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 and CENELEC member into its own language and notified to the CEN Managem

9、ent Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, I

10、taly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels 2010 CEN/CENELEC All r

11、ights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17050-1:2010 EBS EN ISO/IEC 17050-1:2010EN ISO/IEC 17050-1:2010 (E) 3 Foreword The text of ISO/IEC 17050-1:2004, corrected version 2007-06-15 has been prepared

12、by Committee on conformity assessment (CASCO) of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) and has been taken over as EN ISO/IEC 17050-1:2010 by Technical Committee CEN/CLC/TC 1 “Criteria for conformity assessment bodies” the sec

13、retariat of which is held by BSI. 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 October 2010, and conflicting national standards shall be withdrawn at the latest by October 2010. Attention is dr

14、awn 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 responsible for identifying any or all such patent rights. This document supersedes EN ISO/IEC 17050-1:2004. According to the CEN/CENELEC Internal Regulations,

15、the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Neth

16、erlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO/IEC 17050-1:2004, corrected version 2007-06-15 has been approved by CEN as a EN ISO/IEC 17050-1:2010 without any modification. BS EN ISO/IEC 17050-1:2

17、010ISO/IEC 17050-1:2004(E) ISO 2004 All rights reserved iiiForeword 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 participate i

18、n 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 of mutual interest. Other international organizations, governmental and no

19、n-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 rule

20、s 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 casting a vote. Attention is drawn to the possibility that some of the element

21、s 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 17050-1 was prepared by the ISO Committee on conformity assessment (CASCO). It was circulated for voting to the national bodies of both ISO and IEC, and wa

22、s approved by both organizations. This first edition of ISO/IEC 17050-1, together with ISO/IEC 17050-2, cancels and replaces the second edition of ISO/IEC Guide 22:1996, General criteria for suppliers declaration of conformity. ISO/IEC 17050 consists of the following parts, under the general title C

23、onformity assessment Suppliers declaration of conformity: Part 1: General requirements Part 2: Supporting documentation This corrected version of ISO/IEC 17050-1:2004 incorporates the correction of the numbering of the list in 10.2, and an updated Bibliography. BS EN ISO/IEC 17050-1:2010ISO/IEC 1705

24、0-1:2004(E) iv ISO 2004 All rights reservedIntroduction This part of ISO/IEC 17050 has been developed with the objective of providing general requirements for a suppliers declaration of conformity. It addresses one of the three types of attestation of conformity, namely attestation undertaken by the

25、 first party (e.g. the supplier of a product). Other types are second-party attestation (e.g. where a user issues an attestation for the product the user is using) or third-party attestation. Each of these three types is used in the market in order to increase confidence in the conformity of an obje

26、ct. This part of ISO/IEC 17050 specifies requirements applicable when the individual or organization responsible for fulfilment of specified requirements (supplier) provides a declaration that a product (including service), process, management system, person or body is in conformity with specified r

27、equirements, which can include normative documents such as standards, guides, technical specifications, laws and regulations. Such a declaration of conformity can also make reference to the results of assessments by one or more first, second or third parties. Such references are not to be interprete

28、d as reducing the responsibility of the supplier in any way. These general requirements are applicable to all sectors. However, these requirements might need to be supplemented for specific purposes, for example for use in connection with regulations. A suppliers declaration of conformity of a produ

29、ct (including service), process, management system, person or body to specified requirements can be substantiated by supporting documentation under the responsibility of the supplier. In cases where this is desirable, or necessary, reference is made to ISO/IEC 17050-2. BS EN ISO/IEC 17050-1:2010INTE

30、RNATIONAL STANDARD ISO/IEC 17050-1:2004(E) ISO 2004 All rights reserved 1Conformity assessment Suppliers declaration of conformity Part 1: General requirements 1 Scope This part of ISO/IEC 17050 specifies general requirements for a suppliers declaration of conformity in cases where it is desirable,

31、or necessary, that conformity of an object to the specified requirements be attested, irrespective of the sector involved. For the purposes of this part of ISO/IEC 17050, the object of a declaration of conformity can be a product, process, management system, person or body. This part of ISO/IEC 1705

32、0 does not define any particular object for the declaration of conformity. Instead of “suppliers declaration of conformity”, the term “declaration of conformity” can be used when appropriate. 2 Normative references The following referenced documents are indispensable for the application of this docu

33、ment. 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 principles 3 Terms and definitions For the purposes of this document,

34、 the terms and definitions given in ISO/IEC 17000 apply. NOTE 1 “Suppliers declaration of conformity” is a “declaration” as defined in ISO/IEC 17000, i.e. first-party attestation. NOTE 2 To avoid any confusion with attestation by certification bodies, the term “self-certification” is deprecated and

35、should not be used. 4 Purpose of the declaration of conformity The purpose of the declaration is to give assurance of conformity of the identified object to specified requirements to which the declaration refers, and to make clear who is responsible for that conformity and declaration. A suppliers d

36、eclaration of conformity may be used alone or in conjunction with another conformity assessment procedure for regulatory or non-regulatory purposes. BS EN ISO/IEC 17050-1:2010ISO/IEC 17050-1:2004(E) 2 ISO 2004 All rights reserved5 General requirements The issuer (issuing organization or person) of a

37、 declaration of conformity shall be responsible for issuing, maintaining, extending, reducing, suspending or withdrawing the declaration and the conformity of the object to the specified requirements. The declaration of conformity shall be based on results of an appropriate type of conformity assess

38、ment activity (e.g. testing, measurement, auditing, inspection or examination) carried out by one or more first, second or third parties. Conformity assessment bodies involved, where applicable, should consult relevant International Standards, Guides and other normative documents. Where a declaratio

39、n of conformity is for a group of products of a similar type, it shall cover each individual product of the group. Where a declaration of conformity is for similar products delivered over a period of time, it shall cover each product as delivered or accepted. It is recommended, as good conformity as

40、sessment practice, that the person reviewing the conformity assessment results be different from the signatory. 6 Contents of the declaration of conformity 6.1 The issuer of the declaration of conformity shall ensure that the declaration contains sufficient information to enable the recipient of the

41、 declaration of conformity to identify the issuer of the declaration, the object of the declaration, the standards or other specified requirements with which conformity is declared, and the person signing for and on behalf of the issuer of the declaration of conformity. As a minimum, the declaration

42、 of conformity shall contain the following: a) unique identification of the declaration of conformity; b) the name and contact address of the issuer of the declaration of conformity; c) the identification of the object of the declaration of conformity (e.g. name, type, date of production or model nu

43、mber of a product, description of a process, management system, person or body, and/or other relevant supplementary information); d) the statement of conformity; e) a complete and clear list of standards or other specified requirements, as well as the selected options, if any; f) the date and place

44、of issue of the declaration of conformity; g) the signature (or equivalent sign of validation), name and function of the authorized person(s) acting on behalf of the issuer; h) any limitation on the validity of the declaration of conformity. 6.2 Additional supporting information may be provided to r

45、elate the declaration to the conformity assessment results on which it is based, for example: a) the name and address of any conformity assessment body involved (e.g. testing or calibration laboratory, inspection body, certification body); b) reference to relevant conformity assessment reports, and

46、the date of the reports; c) reference to any management systems involved; BS EN ISO/IEC 17050-1:2010ISO/IEC 17050-1:2004(E) ISO 2004 All rights reserved 3d) reference to the accreditation documents of conformity assessment bodies involved where the scope of accreditation is relevant to the declarati

47、on of conformity; e) reference to the existence of associated supporting documentation, such as that described in ISO/IEC 17050-2; f) additional information regarding certificates, registrations or marks that have been obtained; g) other activities or programmes of the conformity assessment body (e.

48、g. membership in an agreement group). References in the documentation to conformity assessment results shall not misrepresent their applicability nor mislead the recipient of the declaration of conformity. 7 Form of declaration of conformity See Annex A for an example of a declaration of conformity.

49、 The declaration of conformity may be in hardcopy, electronic media, or any other suitable medium. 8 Accessibility A copy of the declaration of conformity may be included in other documentation, such as a statement, catalogue, invoice, users instructions or website, relevant to the object of the declaration of conformity. 9 Product marking If any marking is placed on the product to indicate the existence of a declaration of conformity, such marking shall be in such a format that it will not be confused with any cer