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)

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Standards Content (Sample)

SIST EN ISO 13485:2003
SIST EN ISO 13485:2002
SIST EN ISO 13488:2002
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
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
SIST EN ISO 13485:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EN ISO 13485
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
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
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.

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EN ISO 13485:2003 (E)
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
For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this
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

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