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1、BRITISH STANDARD BS EN 45004: 1995 General criteria for the operation of various types of bodies performing inspection The European Standard EN 45004:1995 has the status of a British Standard Licensed Copy: Institute Of Technology Tallaght, Institute of Technology, Sun Jul 15 09:03:16 GMT+00:00 2007
2、, Uncontrolled Copy, (c) BSI BS EN 45004:1995 This British Standard, having been prepared under the direction of the Management Systems Sector Board, was published under the authority of the Standards Board and comes into effect on 15 August 1995 BSI 11-1998 The following BSI references relate to th
3、e work on this standard: Committee reference QS/3 Draft for comment 92/89493 DC ISBN 0 580 24538 1 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee QS/3, Assessment, testing, certification and inspection, upon which the fo
4、llowing bodies were represented: Associated Offices TechnicalElectricity Association CommitteeEnergy Industries Council Association of British CertificationEngineering Equipment and BodiesMaterials Users Association Association of Consulting ScientistsFederation of the Electronics Automated Material
5、 HandlingIndustry Systems AssociationFederation of Manufacturers of BEAMA Ltd.Construction Equipment and British Chemical EngineeringCranes Contractors AssociationFederation of Small Businesses British Compressed Air SocietyFederation of Wire Rope British Gas plcManufacturers of Great Britain Britis
6、h Industrial Truck AssociationFork Truck Hire Association British Iron and Steel ProducersHealth and Safety Executive AssociationInstitute of Quality Assurance British Materials Handling Institute of Trading Standards FederationAdministration British Measurement and TestingInstitution of Mechanical
7、Engineers AssociationLifting Equipment Engineers British Quality FoundationAssociation British Railways BoardLloyd s Register of Shipping Ceramic Industry CertificationManufacturing Science Finance Scheme Ltd.Medical Sterile Products Association Chemical Industries AssociationNational Accreditation
8、Council of Committee of User InspectoratesCertification Bodies Confederation of British IndustryNational Association of Leisure Consumers AssociationIndustry Certification (NAFLIC) Construction Plant-hire AssociationNational Association of Lift Makers Council of Independent InspectingNational Indust
9、ries Liaison Group on AuthoritiesQuality Assurance Department of Trade and IndustrySociety of British Aerospace (NAMAS Executive)Companies Limited Department of Trade and IndustryCoopted members (Standards Policy Unit) Amendments issued since publication Amd. No.DateComments Licensed Copy: Institute
10、 Of Technology Tallaght, Institute of Technology, Sun Jul 15 09:03:16 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 45004:1995 BSI 11-1998i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 450043 Licensed Copy: Institute Of Technology Tallaght, Insti
11、tute of Technology, Sun Jul 15 09:03:16 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 45004:1995 ii BSI 11-1998 National foreword This British Standard was prepared by Technical Committee QS/3 and is the English language version of EN 45004:1995 General criteria for the operation of various types
12、 of bodies performing inspection published by the joint European Standards Institution (CEN/CENELEC). EN 45004 is a significant addition to the EN 45000 series of standards that were designed to provide the basis for confidence in the various kinds of body engaged in conformity assessment; and which
13、 did not until now provide for those bodies engaged in inspection. 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 harmonized basis and the notification of such bodies by Go
14、vernments to perform the relevant functions under European Community directives. NOTEThroughout this standard the use of the pronouns he, him and his is intended to be non-gender specific. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Sta
15、ndards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 9 and a back cover. This st
16、andard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: Institute Of Technology Tallaght, Institute of Technology, Sun Jul 15 09:03:16 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUR
17、OPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 45004 March 1995 ICS 03.120.20 Descriptors: Certification, accreditation, quality, inspection bodies, approved organizations, specifications English version General criteria for the operation of various types of bodies performing inspection Critres g
18、nraux pour le fonctionnement de diffrents types d organismes procdant l inspection Allgemeine Kriterien fr den Betrieb verschiedener Typen von Stellen, die Inspektionen durchfhren This European Standard was approved by CEN on 1995-03-06. CEN members are bound to comply with the CEN/CENELEC Internal
19、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 the Central Secretariat or to any CEN/CENELEC me
20、mber. The European Standards exist in three 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. CE
21、N/CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European
22、Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1995 All rights of reproduction and communication in any form and by any means reserved in all countries to CEN/CENELEC and its members. Ref. No. EN 45
23、004:1995 E Licensed Copy: Institute Of Technology Tallaght, Institute of Technology, Sun Jul 15 09:03:16 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 45004:1995 2 BSI 11-1998 Foreword This European Standard has been drawn up by CEN/CENELEC/TC1, Criteria for conformity assessment bodies, whose Secre
24、tariat is held by the CEN Central Secretariat. 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 September 1995, and conflicting national standards shall be withdrawn at the latest by September 1995
25、. According to the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Con
26、tents Page Foreword2 Introduction3 1Scope3 2Definitions3 3Administrative requirements4 4Independence, impartiality and integrity4 5Confidentiality4 6Organization and management4 7Quality system5 8Personnel5 9Facilities and equipment6 10Inspection methods and procedures6 11Handling inspection samples
27、 and items7 12Records7 13Inspection reports and inspection certificates7 14Sub-contracting7 15Complaints and appeals8 16Co-operation8 Annex A (normative) Independence criteria for Type A inspection body9 Annex B (normative) Independence criteria for Type B inspection body9 Annex C (normative) Indepe
28、ndence criteria for Type C inspection body9 Annex D (informative) Information to be included or referenced in the quality manual9 Licensed Copy: Institute Of Technology Tallaght, Institute of Technology, Sun Jul 15 09:03:16 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 45004:1995 BSI 11-19983 Introd
29、uction This European Standard has been drawn up with the objective of promoting confidence in those bodies performing inspection which conform to it. It has been drawn up in the light of experience of European bodies performing inspections taking into account requirements and recommendations of Euro
30、pean and international documents such as the ISO 9000 (EN 29000) series of standards and ISO/IEC Guide 39. Inspection bodies have carried out assessments on behalf of private clients, their parent organizations, and/or official authorities with the objective of providing information to those parties
31、 relative to conformity with regulations, standards, or specifications. Inspection parameters may include matters of quantity, quality, safety, fitness for use, and continued safety compliance of plant or systems in operation. The general criteria, with which these bodies are required to comply in o
32、rder that their services be accepted by clients and by supervisory authorities, need to be harmonized in a European Standard. This standard, therefore, covers the functions of bodies whose work may include the examination of materials, products, installations, plant, processes, work procedures, or s
33、ervices, and the determination of their conformity with requirements, and the subsequent reporting of results of these activities to clients and, when required, to supervisory authorities. Inspection of a product, an installation or plant may concern all stages during the lifetime of these items, in
34、cluding the design stage. Such work normally requires the exercise of professional judgement in providing the service, in particular when assessing conformity. The requirement for the independence of inspection bodies varies according to legislation and market needs. This standard therefore includes
35、, in annexes A, B and C, criteria for independence. This standard has also been produced to support the introduction of the conformity assessment procedures specified in the EC Council decision concerning the modules for the various phases of the conformity assessment procedures which are intended t
36、o be used in the technical harmonization directives. The relevant requirements of the EN 29000 series of standards applying to the quality systems for inspection bodies are incorporated in this standard. This standard forms part of the following series of standards covering testing, inspection, cert
37、ification and accreditation: EN 45001, General criteria for the operation of testing laboratories. EN 45002, General criteria for the assessment of testing laboratories. EN 45003, General criteria for the laboratory accreditation bodies. EN 45004, General criteria for the operation of bodies perform
38、ing inspection. EN xxxx1), General criteria for the accreditation of various types of bodies performing inspection. EN 45011, General criteria for certification bodies operating product certification. EN 45012, General criteria for certification bodies operating quality system certification. EN 4501
39、3, General criteria for certification bodies operating certification of personnel. EN 45014, General criteria for suppliers declaration of conformity. EN 45020, General terms and their definitions concerning standardization and related activities. 1 Scope 1.1 This European Standard specifies general
40、 criteria for the competence of impartial bodies performing inspection irrespective of the sector involved. It also specifies independence criteria. 1.2 This standard is intended for the use of inspection bodies and their accreditation bodies as well as other bodies concerned with recognizing the co
41、mpetence of inspection bodies. 1.3 This set of criteria may have to be interpreted when applied to particular sectors, or to in-service inspection. 1.4 This standard does not cover testing laboratories, certification bodies or the suppliers declaration of conformity, the criteria for which are conta
42、ined in other European Standards of the EN 45000 series. 2 Definitions For the purpose of this standard the following definitions apply: 1)In preparation. Licensed Copy: Institute Of Technology Tallaght, Institute of Technology, Sun Jul 15 09:03:16 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 45004
43、:1995 4 BSI 11-1998 2.1 inspection examination of a product design, product, service, process or plant, and determination of their conformity with specific requirements or, on the basis of professional judgement, general requirements NOTE 1Inspection of processes includes personnel, facilities, tech
44、nology and methodology. NOTE 2The results of inspection may be used to support certification. 2.2 inspection body body that performs inspection NOTEA body can be an organization, or part of an organization. for other definitions those given in EN 45020:1993 are applicable 3 Administrative requiremen
45、ts 3.1 The inspection body, or the organization of which it forms a part, shall be legally identifiable. 3.2 An inspection body that is part of an organization involved in functions other than inspection shall be identifiable within that organization. 3.3 The inspection body shall have documentation
46、 which describes its functions and the technical scope of activity for which it is competent. The precise scope of an inspection will be determined by the terms of the individual contract or work order. 3.4 The inspection body shall have adequate liability insurance unless its liability is assumed b
47、y the State in accordance with national laws or by the organization of which it forms a part. 3.5 The inspection body shall have documentation describing the conditions on which it does business unless it is part of an organization and provides inspection services only to that organization. 3.6 The
48、inspection body, or the organization of which it forms a part, shall have independently audited accounts. 4 Independence, impartiality and integrity 4.1 General The personnel of the inspection body shall be free from any commercial, financial and other pressures which might affect their judgement. P
49、rocedures shall be implemented to ensure that persons or organizations external to the inspection body, cannot influence the results of inspections carried out. 4.2 Independence The inspection body shall be independent to the extent that is required with regard to the conditions under which it performs its services. Depending on these conditions it shall meet the minimum criteria stipulated in one of the normative annexes A, B or C. 4.2.1 Type A inspection body The inspection body providing “ third party” services shall meet the criteria of annex A (norm