EN ISO 13485:2012

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 management 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)

Standard ISO 13485 2003 določa zahteve za sisteme vodenja kakovosti v primerih, ko mora organizacija izkazati svojo zmožnost dobave medicinskih pripomočkov in povezanih storitev, ki dosledno izpolnjujejo zahteve strank ter zakonodajne zahteve, ki se uporabljajo za medicinske pripomočke in povezane storitve.
Glavni cilj standarda ISO 13485:2003 je omogočiti harmonizirane zakonodajne zahteve za medicinske pripomočke za sisteme vodenja kakovosti. Standard zato vključuje nekatere posebne zahteve za medicinske pripomočke in izključuje nekatere zahteve standarda ISO 9001, ki niso primerne kot zakonodajne zahteve. Organizacije, katerih sistemi vodenja kakovosti so skladni s tem mednarodnim standardom, se zaradi teh izključitev ne morejo sklicevati na skladnost s standardom ISO 9001, razen če so njihovi sistemi vodenja kakovosti skladni z vsemi zahtevami standarda ISO 9001.
Vse zahteve standarda ISO 13485:2003 veljajo za organizacije, ki dobavljajo medicinske pripomočke, ne glede na vrsto ali velikost organizacije.
Če zakonodajne zahteve omogočajo izključitve kontrol zasnove in razvoja, se lahko to uporabi kot utemeljitev za njihovo izključitev iz sistema vodenja kakovosti. Ti predpisi lahko zagotovijo nadomestne ureditve, ki se morajo obravnavati v sistemu vodenja kakovosti. Organizacija mora zagotoviti, da sklicevanje na skladnost s standardom ISO 13485:2003 odraža izključitev kontrol zasnove in razvoja.
Če se katera koli zahteva v točki 7 standarda ISO 13485:2003 ne uporablja zaradi narave medicinskega pripomočka, za katerega se sistem vodenja kakovosti uporablja, organizaciji take zahteve ni treba vključiti v svoj sistem vodenja kakovosti.
Postopki, ki jih standard ISO 13485:2003 zahteva in ki se uporabljajo za medicinske pripomočke, vendar jih organizacija ne izvaja, so odgovornost organizacije in so opisani v sistemu vodenja kakovosti organizacije.

General Information

• Status: Withdrawn
• Publication Date: 14-Feb-2012
• Withdrawal Date: 01-Mar-2016
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 02-Mar-2016
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 13485:2012 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

Relations

• Replaces: EN ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
• Effective Date: 22-Feb-2012
• Replaces: EN ISO 13485:2003/AC:2009 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
• Effective Date: 22-Feb-2012
• Replaced By: EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Effective Date: 08-Feb-2012
• Corrected By: EN ISO 13485:2012/AC:2012 - Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13485:2012
01-april-2012
1DGRPHãþD
SIST EN ISO 13485:2003
SIST EN ISO 13485:2003/AC:2009
0HGLFLQVNLSULSRPRþNL6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]D]DNRQRGDMQH
QDPHQH,62
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2003)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2003)
Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins
réglementaires (ISO 13485:2003)
Ta slovenski standard je istoveten z: EN ISO 13485:2012
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 13485:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 13485:2012

---------------------- Page: 2 ----------------------

SIST EN ISO 13485:2012


EUROPEAN STANDARD
EN ISO 13485

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2012
ICS 03.120.10; 11.040.01 Supersedes EN ISO 13485:2003
English version
Medical devices - Quality management systems - Requirements
for regulatory purposes (ISO 13485:2003)
Dispositifs médicaux - Systèmes de manegement de la Medizinprodukte - Qualitätsmanagementsysteme -
qualité - Exigences à des fins réglementaires (ISO Anforderungen für regulatorische Zwecke (ISO
13485:2003) 13485:2003)
This European Standard was approved by CEN on 24 January 2012.

CEN and CENELEC 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 CEN-CENELEC Management Centre or to any CEN and CENELEC
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 and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre
has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.






CEN-CENELEC Management Centre,
Avenue Marnix 17, B-1000 Brussels
© 2012 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13485:2012 E
worldwide for CEN national Members and for CENELEC
Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this European Standard and the Conformity
Assessment Requirements of EU Directive 90/385/EEC .5
Annex ZB (informative)  Relationship between this European Standard and the Conformity
Assessment Requirements of EU Directive 93/42/EEC . 10
Annex ZC (informative)  Relationship between this European Standard and the Conformity
Assessment Requirements of EU Directive 98/79/EC . 17

2

---------------------- Page: 4 ----------------------

SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
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-CENELEC Management Centre
(CCMC) with the assistance of the CEN-CENELEC Technical Committee 3 "Quality Management and
corresponding general aspects for medical devices".
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 August 2012, and conflicting national standards shall be withdrawn at
the latest by August 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared
...