EN ISO 13485:2003
(Main)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003)
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation ihre Fähigkeit zur Bereitstellung von Medizinprodukten und zugehörigen Dienstleistungen darzulegen hat, die ständig die Anforderungen der Kunden und die für Medizinprodukte und zugehörige Dienstleistungen zutreffenden gesetzlichen Anforderungen erfüllen.
Das primäre Ziel dieser Internationalen Norm ist die Ermöglichung der Harmonisierung der für Medizinprodukte zutreffenden gesetzlichen Anforderungen an Qualitätsmanagementsysteme. Im Ergebnis dessen enthält sie einige besondere Anforderungen an Medizinprodukte und schließt einige Anforderungen von ISO 9001 aus, die nicht als Anforderungen für gesetzliche Zwecke geeignet sind. Wegen dieser Ausschlüsse können Organisationen, deren Qualitätsmanagementsysteme dieser Internationalen Norm entsprechen, keine Konformität mit ISO 9001 beanspruchen, außer wenn ihr Qualitätsmanagementsystem mit allen Anforderungen von ISO 9001 konform ist (siehe Anhang B).
Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003)
L'ISO 13485:2003 énonce les exigences relatives au système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir régulièrement des dispositifs médicaux et des services associés conformes aux exigences des clients et aux exigences réglementaires applicables aux dispositifs médicaux et aux services associés.
Le principal objectif de l'ISO 13485:2003 est de faciliter la mise en oeuvre d'exigences réglementaires harmonisées en matière de dispositifs médicaux, dans le cadre des systèmes de management de la qualité. Par conséquent, elle comprend certaines exigences particulières concernant les dispositifs médicaux, mais certaines exigences de l'ISO 9001, non appropriées en tant qu'exigences réglementaires, en sont exclues. Du fait de ces exclusions, les organismes dont les systèmes de management de la qualité sont conformes à l'ISO 13485:2003 ne peuvent revendiquer la conformité à l'ISO 9001 que si leurs systèmes de management de la qualité sont conformes à l'ensemble des exigences de l'ISO 9001.
Toutes les exigences de l'ISO 13485:2003 sont spécifiques aux organismes fournissant des dispositifs médicaux, indépendamment du type ou de la taille de l'organisme.
Le fait que des exigences réglementaires autorisent l'exclusion des systèmes de contrôle de conception et de développement peut servir à justifier leur exclusion du système de management de la qualité. Ces réglementations peuvent prévoir d'autres dispositions qui doivent être appliquées dans le système de management de la qualité. Il incombe à l'organisme de s'assurer que ses demandes de conformité à l'ISO 13485:2003 correspondent à l'exclusion des systèmes de contrôle de conception et de développement.
Lorsqu'une ou plusieurs exigences définies à l'Article 7 de l'ISO 13485:2003 ne peuvent être appliquées en raison de la nature du ou des dispositifs médicaux auxquels s'applique le système de management de la qualité, l'organisme n'est pas tenu d'inclure cette (ces) exigence(s) dans son système de management de la qualité.
Les processus requis par l'ISO 13485:2003, qui sont applicables au(x) dispositif(s) médical (médicaux) mais non adoptés par l'organisme, relèvent de la responsabilité de ce dernier qui en tient compte dans son système de management de la qualité.
Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za zakonodajne namene (ISO 13485:2003)
General Information
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Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2003
1DGRPHãþD
SIST EN ISO 13485:2002
SIST EN ISO 13488:2002
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Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2003)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2003)
Dispositifs médicaux - Systemes de manegement de la qualité - Exigences a des fins
réglementaires (ISO 13485:2003)
Ta slovenski standard je istoveten z: EN ISO 13485:2003
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 13485
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2003
ICS 03.120.10; 11.040.01 Supersedes EN ISO 13485:2000 and EN ISO 13488:2000
English version
Medical devices - Quality management systems - Requirements
for regulatory purposes (ISO 13485:2003)
Dispositifs médicaux - Systèmes de manegement de la Qualitätssicherungssysteme - Medizinprodukte -
qualité - Exigences à des fins réglementaires (ISO Systemanforderungen zur Erfüllung gesetzlicher
13485:2003) 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 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 Management Centre or to any CEN 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 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, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13485:2003 E
worldwide for CEN national Members.
Foreword
The text of the International Standard ISO 13485:2003 has been prepared by Technical
Committee ISO/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 devices.
This European Standard supersedes EN ISO 13485:2000 and EN ISO 13488:2000.
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 2006.
This document has been prepared under a mandate 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 organisations 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 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 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 of these variations.
Two of the modules cited in Council Decision, i.e. modules D and H, require that “the
manufacturer must operate an approved quality system”. The scope of the quality systems
required by these modules addresses:
- Production, final inspection and testing (module D),
- Design manufacture and final product inspection and testing (module H).
Where organizations wish to implement quality management systems in conformance with
modules D or H, they may use EN ISO 13485:2003. In seeking compliance with modules D or H
organizations may exclude specific requirements.
Where organizations wish to implement quality management systems in conformance with
module E, they may use EN 46003:1999 (which is in the process of being revised into the format
of EN ISO 13485:2003)
Module D Module H
Permissible exclusions Permissible exclusions
Sub-clause 7.3: design and development 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 H is the basis for annex 2 of 90/385/EEC directive, for annex II of 93/42/EEC directive
and for annex II of 98/79/EC directive.
It should be noted that EN ISO 13485:2003 is a Quality Management System for medical
devices specifically for regulatory purposes. It is 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 conformity 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 countries 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 text of ISO 13485:2003 has been approved by CEN as EN ISO 13485:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications with their corresponding
European publications
This European Standard incorporates, by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text, and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by (mod.),
the relevant EN/HD applies.
Publication Year Title EN/HD Year
ISO 9000 2000 Quality management systems – EN ISO 9000 2000
Fundamentals and vocabulary
Annex ZB
(informative)
Relationship of this document with EC Directives
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association and supports essential requirements of EC
Directive(s) :
- EC Directive 93/42/E(E)C
Compliance with this document provides one means of conforming with the specific essential
requirements of the Directive concerned and associated EFTA regulations.
WARNING: Other requirements and other EC Directives may be applicable to the product(s)
falling within the scope of this document.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
INTERNATIONAL ISO
STANDARD 13485
Second edition
2003-07-15
Medical devices — Quality management
systems — Requirements for regulatory
purposes
Dispositifs médicaux — Systèmes de management de la qualité —
Exigences à des fins réglementaires
Reference number
ISO 13485:2003(E)
©
ISO 2003
ISO 13485:2003(E)
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ISO 13485:2003(E)
Contents Page
Foreword. iv
0 Introduction . v
0.1 General. v
0.2 Process approach . v
0.3 Relationship with other standards . vi
0.4 Compatibility with other management systems . vi
1 Scope. 1
1.1 General. 1
1.2 Application. 1
2 Normative references . 2
3 Terms and definitions. 2
4 Quality management system . 4
4.1 General requirements . 4
4.2 Documentation requirements . 4
5 Management responsibility. 6
5.1 Management commitment. 6
5.2 Customer focus. 6
5.3 Quality policy. 6
5.4 Planning . 7
5.5 Responsibility, authority and communication. 7
5.6 Management review. 8
6 Resource management. 8
6.1 Provision of resources . 8
6.2 Human resources. 9
6.3 Infrastructure. 9
6.4 Work environment. 9
7 Product realization.
...
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