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1、BRITISH STANDARD BS EN ISO 13485:2003 Incorporating corrigenda June 2007 and February 2008 Medical devices Quality management systems Requirements for regulatory purposes ICS 03.120.10; 11.040.01 ? BS EN ISO 13485:2003 This British Standard was published under the authority of the Standards Policy a
2、nd Strategy Committee on 24 July 2003 BSI 2008 ISBN 978 0 580 61991 5 National foreword This British Standard is the UK implementation of EN ISO 13485:2003, incorporating corrigendum June 2007. It is identical with ISO 13485:2003. It supersedes BS EN ISO 13485:2001, BS EN ISO 13488:2001 and BS EN 46
3、003:1999 which are withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/210, Quality management and corresponding general aspects for medical devices, to Subcommittee CH/210/1, Quality systems for medical devices. A list of organizations represented on this subc
4、ommittee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda is
5、sued since publication DateComments 31 January 2008Implementation of CEN corrigendum June 2007 29 February 2008Missing text reinstated to Introduction: subclauses 0.3 and 0.3.1 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13485 July 2003 ICS 03.120.10; 11.040.01Supersedes EN 46003:1999,
6、EN ISO 13485:2000 and EN ISO 13488:2000 English version Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) Dispositifs mdicaux - Systmes de manegement de la qualit - Exigences des fins rglementaires (ISO 13485:2003) Qualittssicherungssysteme - Medizi
7、nprodukte - Systemanforderungen zur Erfllung gesetzlicher Anforderungen (ISO 13485:2003) This European Standard was approved by CEN on 16 June 2003. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status o
8、f a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version
9、 in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, G
10、ermany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1
11、050 Brussels 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13485:2003 E Incorporating corrigendum June 2007 -,-,- Foreword The text of the International Standard ISO 13485:2003 has been prepared by Technical Committee ISO
12、/TC 210 “Quality management and corresponding general aspects for medical devices, Working Group 1“. The transposition into a European Standard has been managed by the CEN Management Centre (CMC) with the assistance of the CEN/CENELEC Co-ordinating Working Group on quality supplements for medical de
13、vices. 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 January 2004, and conflicting national standards shall be withdrawn at the latest by July 2009. This document has been prepared under a manda
14、te given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this document. NOTE The following is specifically intended for org
15、anisations that need to comply with one or more of the “New Approach” European Directives for medical devices (90/385/EEC, 93/42/EEC, and 98/79/EC) in order to affix CE marking on their products and to other parties involved in that process. The publication of EN ISO 13485:2003 has implications for
16、Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives. It is important to note that the
17、 modules used in individual technical harmonization directives may vary in some respects compared to those described in Council Decision 93/465/EEC. In all cases, it is the annex of the applicable directive(s) which is legally binding. The principles set out in this foreword remain valid regardless
18、of these variations. Three of the modules cited in Council decision, i.e. modules E, D and H, require that “the manufacturer must operate an approved quality system“. The scope of the quality systems required by these modules addresses: - Final product inspection and testing (module E), - Design man
19、ufacture and final product inspection and testing (module H). Where organizations wish to implement quality management systems in conformance with modules E, D or H, they may use EN ISO 13485:2003. In seeking compliance with modules E, D or H organizations may exclude specific requirements. This Eur
20、opean Standard supersedes EN 46003:1999, EN ISO 13485:2000 and EN ISO 13488:2000. - Production, final inspection and testing (module D), BS EN ISO 13485:2003 -,-,- It should be noted that EN ISO 13485:2003 is a Quality Management System for medical devices specifically for regulatory purposes. It is
21、 based on EN ISO 9001:2000 but in particular the requirements for “customer satisfaction” and “continual improvement” have been modified. Therefore, while EN ISO 13485:2003 has the same format as EN ISO 9001:2000 and most of the same requirements, compliance with EN ISO 13485:2003 does not provide c
22、onformity with EN ISO 9001:2000. It should be noted that where the exclusions described in sub-clause 1.2 of EN ISO 13485:2003 are exceeded, conformity to EN ISO 13485:2003 shall not be claimed. According to CEN/CENELEC Internal Regulations, the national standards organizations of the following coun
23、tries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The te
24、xt of ISO 13485:2003 has been approved by CEN as EN ISO 13485:2003 without any modifications. Module D Permissible exclusions Module E Permissible exclusions for conformity of “product quality assurance“ Module H Permissible exclusions Sub-clause 7.3: design and development Sub-clause 7.3: design an
25、d development Sub-clause 7.5.1: control of production and service provision Sub-clause 7.5.2: validation of processes for production and service provision NO exclusions permitted Module D is the basis for annex V of 93/42/EEC Directive and the basis for annex VII of 98/79/EC Directive. Module E is t
26、he basis for annex VI of Directive 93/42/EEC. Module H is the basis for annex 2 of Directive 90/385/EEC, for annex II of Directive 93/42/EEC and for annex IV of Directive 98/79/EC. BS EN ISO 13485:2003 blank -,-,- Reference number ISO 13485:2003(E) INTERNATIONAL STANDARD ISO 13485 Second edition 200
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32、aF 74 90 947 22 14 + E-mailc oirypthgiso.o gr Wew bww.is.o gro ii iii Contents Page Forewordiv 0 Introduction .v 0.1 General.v 0.2 Process approach.v 0.3 Relationship with other standards v 0.4 Compatibility with other management systems .vi 1 Scope1 1.1 General.1 1.2 Application.1 2 Normative refer
33、ences .2 3 Terms and definitions.2 4 Quality management system .4 4.1 General requirements.4 4.2 Documentation requirements4 5 Management responsibility6 5.1 Management commitment6 5.2 Customer focus.6 5.3 Quality policy.6 5.4 Planning.7 5.5 Responsibility, authority and communication.7 5.6 Manageme
34、nt review8 6 Resource management.8 6.1 Provision of resources.8 6.2 Human resources9 6.3 Infrastructure.9 6.4 Work environment.9 7 Product realization10 7.1 Planning of product realization .10 7.2 Customer-related processes10 7.3 Design and development11 7.4 Purchasing.13 7.5 Production and service
35、provision.14 7.6 Control of monitoring and measuring devices17 8 Measurement, analysis and improvement17 8.1 General.17 8.2 Monitoring and measurement18 8.3 Control of nonconforming product.19 8.4 Analysis of data.19 8.5 Improvement20 Annex A (informative) Correspondence between ISO 13485:2003 and I
36、SO 13485:1996.21 Annex B (informative) Explanation of differences between ISO 13485:2003 and ISO 9001:2000 25 Bibliography .57 BS EN ISO 13485:2003 -,-,- iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). T
37、he work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-go
38、vernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
39、 The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a v
40、ote. Attention is drawn to the possibility that some of the elements 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 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding g
41、eneral aspects for medical devices. This second edition cancels and replaces the first edition (ISO 13485:1996), which has been technically revised. It also cancels and replaces ISO 13488:1996. Those organizations which have used ISO 13488 in the past may use this International Standard by excluding
42、 certain requirements in accordance with 1.2. This edition of ISO 13485 has a revised title and addresses quality assurance of product, customer requirements, and other elements of quality system management. BS EN ISO 13485:2003 v 0 Introduction 0.1 General This International Standard specifies requ
43、irements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. It can also be used by internal and external parties, including cert
44、ification bodies, to assess the organizations ability to meet customer and regulatory requirements. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. It is emphasized that the quality management system requirements specified in this International St
45、andard are complementary to technical requirements for products. The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by varying needs, particular objectives, the produ
46、cts provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. There is a wide variety of medical devices and some of the parti
47、cular requirements of this International Standard only apply to named groups of medical devices. These groups are defined in Clause 3. 0.2 Process approach This International Standard is based on a process approach to quality management. Any activity that receives inputs and converts them to outputs
48、 can be considered as a process. For an organization to function effectively, it has to identify and manage numerous linked processes. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identifica
49、tion and interactions of these processes, and their management, can be referred to as the “process approach”. 0.3 Relationship with other standards 0.3.1 Relationship with ISO 9001 While this is a stand-alone standard, it is based on ISO 9001. Those clauses or subclauses that are quoted directly and unchanged from ISO 9001 are in norm