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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 45011:1998 The Euro
2、pean Standard EN 45011:1998 has the status of a British Standard ICS 03.120.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW General requirements for bodies operating product certification systems This British Standard, having been prepared under the direction of the Managem
3、ent Systems Sector Board, was published under the authority of the Standards Board and comes into effect on 15 July 1998 BSI 1998 ISBN 0 580 29415 3 BS EN 45011:1998 Amendments issued since publication Amd. No.DateText affected National foreword This British Standard is identical with EN 45011, Gene
4、ral requirements for bodies operating product certification systems. It is a revision of BS 7511:1989, which is withdrawn. The EN 45000 series of standards will assist the process of mutual recognition between bodies engaged in conformity assessment, the development of national accreditation on a ha
5、rmonized basis and the notification of such bodies by Governments to perform the relevant functions under European Community directives. The UK participation in its preparation was entrusted to Technical Committee QS/3, Assessment, testing, certification and inspection, which has the responsibility
6、to: aid enquirers to understand the text; present to the responsible European committee 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. A list of organizations rep
7、resented 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 Standards Catalogue under the section entitled International Standards Correspond
8、ence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of its
9、elf confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 10, an inside back cover and a back cover. CEN/CENELEC CEN Central Secreariat rue de Stassart 36, B-1050 Brussels CENELEC Central Secretariat rue d
10、e Stassart 35, B-1050 Brussels 1998 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 45011:1998 E EUROPEAN STANDARDEN 45011 NORME EUROPE ENNE EUROPA ISCHE NORM February 1998 ICS 03.120.20Supersedes EN
11、 45011:1989 Descriptors: Testing laboratories, certification, approval organizations, specifications English version General requirements for bodies operating product certification systems (ISO/IEC Guide 65:1996) Exigences ge ne rales relatives aux organismes proce dant a la certification de produit
12、s (Guide ISO/IEC 65:1996) Allgemeine Anforderungen an Stellen, die Produktertifizierungssysteme betreiben (ISO/IEC Guide 65:1996) This European Standard was approved by CEN/CENELEC on 8 August 1997. CEN/CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the
13、 conditions for giving this European Standard the status ofanationalstandardwithoutanyalteration.Up-to-datelistsand bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN/CENELEC member. This European Standard exists in t
14、hree official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN/CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN/CENELEC members are the national stan
15、dards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Page 2 EN 45011:1998 BSI 1998 Foreword The text of the ISO/IEC Guide 65:1996 of the Commitee
16、 on Conformity Assessment (CASCO) has been taken over as a European Standard by Technical Committee CEN/CLC/TC 1, Criteria for conformity assessment bodies, the secretariat of which is held by NSF, and approved by CEN and CENELEC. This European Standard supersedes EN 45011:1989. This European Standa
17、rd shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 1998, and conflicting national standards shall be withdrawn at the latest by August 1998. According to the CEN/CENELEC Internal Regulations, the national standar
18、ds organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. NOTENormative
19、 references to International Standards are listed in annex ZA (normative). Contents Page Foreword2 Introduction3 1Scope3 2References3 3Definitions3 4Certification body4 4.1General provisions4 4.2Organization4 4.3Operations5 4.4Subcontracting5 4.5Quality system5 4.6Conditions and procedures for grant
20、ing, maintaining, extending, suspending and withdrawing certification6 4.7Internal audits and management reviews6 4.8Documentation6 4.9Records6 4.10 Confidentiality7 5Certification body personnel7 5.1General7 5.2Qualification criteria7 6Changes in the certification requirements7 7Appeals, complaints
21、 and disputes7 8Application for certification7 8.1Information on the procedure7 8.2The application8 9Preparation for evaluation8 10Evaluation8 11Evaluation report8 12Decision on certification8 13Surveillance9 14Use of licences, certificates and marks of conformity9 15Complaints to suppliers9 Annex Z
22、A (normative) Normative references to international publications with their relevant European publications10 Page 3 EN 45011:1998 BSI 1998 Introduction Certification of a product (a term used to include a process or service) is a means of providing assurance that it complies with specified standards
23、 and other normative documents. Some product certification systems may include initial testing of a product and assessment of its suppliers quality systems, followed by surveillance that takes into account the factory quality system and the testing of samples from the factory and the open market. Ot
24、her systems rely on initial testing and surveillance testing, while still others comprise type testing only. This standard specifies requirements, the observance of which is intended to ensure that certification bodies operate third-party certification systems in a consistent and reliable manner, th
25、ereby facilitating their acceptance on a national and international basis and so furthering international trade. The requirements contained in this standard are written, above all, to be considered as general criteria for organizations operating product certification systems; they may have to be amp
26、lified 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. Assertion of conformity to the appropriate standards or other normative documents will be in the form of certificates or marks of conformity. Sy
27、stems for certifying particular products or product groups to specified standards or other normative documents will, in many cases, require their own explanatory documentation. While this standard is concerned with third-parties providing product certification, many of its provisions may also be use
28、ful in first- and second-party product conformity assessment procedures. The diversity in certification systems may at first seem unnecessary and even confuse newcomers in the field, clients and operators alike. The ISO/IEC publication Certification and related activities is available for background
29、 reading and will help to answer questions regarding the practices of the worldwide conformity assessment community. 1 Scope 1.1 This European Standard specifies general requirements that a third-party operating a product certification system shall meet if it is to be recognized as competent and rel
30、iable. In this European Standard the term certification body is used to cover any body operating a product certification system. The word product is used in its widest sense and includes processes and services; the word standard is used to include other normative documents such as specifications or
31、technical regulations. 1.2 The certification system used by the certification body may include one or more of the following, which could be coupled with production surveillance or assessment and surveillance of the suppliers quality system or both, as described in ISO/IEC Guide 53: type testing or e
32、xamination; testing or inspection of samples taken from the market or from suppliers stock or from a combination of both; testing or inspection of every product or of a particular product, whether new or already in use; batch testing or inspection; design appraisal. NOTE 1ISO/IEC Guide 28 may be con
33、sulted for a model of one form of a third-party product certification system. 2 References ISO 8402:1994, Quality management and quality assurance Vocabulary. ISO 10011-1:1990, Guidelines for auditing quality systems Part 1: Auditing. ISO/IEC Guide 2:1996, Standardization and related activities Gene
34、ral vocabulary. ISO/IEC Guide 7:1994, Guidelines for drafting of standards suitable for use for conformity assessment. ISO/IEC Guide 23:1982, Methods of indicating conformity with standards for third-party certification systems. ISO/IEC Guide 25:1990, General requirements for the competence of calib
35、ration and testing laboratories. ISO/IEC Guide 27:1983, Guidelines for corrective action to be taken by a certification body in the event of misuse of its mark of conformity. ISO/IEC Guide 28:1982, General rules for a model third-party certification system for products. ISO/IEC Guide 39:1988, Genera
36、l requirements for the acceptance of inspection bodies. ISO/IEC Guide 53:1988, An approach to the utilization of a suppliers quality system in third-party product certification. ISO/IEC Guide 62:1996, General requirements for bodies operating assessment and certification/registration of quality syst
37、ems. 3 Definitions For the purposes of this standard, the relevant definitions given in ISO/IEC Guide 2 and ISO 8402 apply, together with the following definition. 3.1 supplier the party that is responsible for ensuring that products meet and, if applicable, continue to meet, the requirements on whi
38、ch the certification is based Page 4 EN 45011:1998 BSI 1998 4 Certification body 4.1 General provisions 4.1.1 The policies and procedures under which the certification body operates and their administration shall be non-discriminatory and shall be administered in a non-discriminatory manner. Procedu
39、res shall not be used to impede or inhibit access by applicants, other than as provided for in this standard. 4.1.2 The certification body shall make its services accessible to all applicants whose activities fall within its declared field of operation. There shall not be undue financial or other co
40、nditions. Access shall not be conditional upon the size of the supplier or membership of any association or group, nor shall certification be conditional upon the number of certificates already issued. 4.1.3 The criteria against which the products of a supplier are evaluated shall be those outlined
41、in specified standards. Requirements for standards suitable for this purpose are contained in ISO/IEC Guide 7. If explanation is required as to the application of these documents for a specific certification system, it shall be formulated by relevant and impartial committees or persons possessing th
42、e necessary technical competence, and published by the certification body. 4.1.4 The certification body shall confine its requirements, evaluation and decision on certification to those matters specifically related to the scope of the certification being considered. 4.2 Organization The structure of
43、 the certification body shall be such as to foster confidence in its certifications. In particular, the certification body shall: a) be impartial; b) be responsible for decisions relating to its granting, maintaining, extending, suspending and withdrawing of certification; c) identify the management
44、 (committee, group or person) which shall have overall responsibility for all of the following: 1) performance of testing, inspection, evaluation and certification as defined in this standard; 2) formulation of policy matters relating to the operation of the certification body; 3) decisions on certi
45、fication; 4) supervision of the implementation of its policies; 5) supervision of the finances of the body; 6) delegation of authority to committees or individuals as required to undertake defined activities on its behalf; 7) technical basis for granting certification; d) have documents which demons
46、trate it is a legal entity; e) have a documented structure which safeguards impartiality including provisions to ensure the impartiality of the operations of the certification body; this structure shall enable the participation of all parties significantly concerned in the development of policies an
47、d principles regarding the content and functioning of the certification system; f) ensure that each decision on certification is taken by a person(s) different from those who carried out the evaluation; g) have rights and responsibilities relevant to its certification activities; h) have adequate ar
48、rangements to cover liabilities arising from its operations and/or activities; i) have the financial stability and resources required for the operation of a certification system; j) employ a sufficient number of personnel having the necessary education, training, technical knowledge and experience f
49、or performing certification functions relating to the type, range and volume of work performed, under a responsible senior executive; k) have a quality system giving confidence in its ability to operate a certification system for products; l) have policies and procedures that distinguish between product certification and any other activities in which the certification body is engaged; m) together with its senior executive and staff, be free from any commercial, financial and other pressures which might influence the results of the