Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

ISO 13485:2016 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.
If applicable 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 regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)

Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, das durch eine Organisation angewendet werden kann, die an einer oder mehreren Stufen des Lebenszyklus eines Medizinprodukts beteiligt ist, einschließlich Entwicklung, Produktion, Lagerung und Vertrieb, Installation, Instandhaltung und endgültige Außerbetriebnahme und Entsorgung von Medizinprodukten sowie Entwicklung oder Bereitstellung von damit zusammenhängenden Tätigkeiten (z. B. technischer Support). Die Anforderungen nach dieser Internationalen Norm können auch von Lieferanten oder anderen externen Parteien angewendet werden, die Produkte (z. B. Rohstoffe, Bauteile, Baugruppen, Medizinprodukte, Sterilisationsdienstleistungen, Kalibrierdienstleistungen, Vertriebsdienstleistungen, Instandhaltungsdienstleistungen) für derartige Organisationen bereitstellen. Der Lieferant oder die externe Partei kann die Anforderungen dieser Internationalen Norm entweder freiwillig erfüllen oder kann vertraglich dazu aufgefordert werden.
In verschiedenen Zuständigkeitsbereichen gelten regulatorische Anforderungen an die Anwendung von Qualitätsmanagementsystemen durch Organisationen mit unterschiedlichen Rollen in der Lieferkette für Medizinprodukte. Aus diesem Grund erwartet diese Internationale Norm von der Organisation, dass
—   sie ihre Rolle(n) unter anwendbaren regulatorischen Anforderungen identifiziert;
—   sie die regulatorischen Anforderungen identifiziert, die für ihre Tätigkeiten unter diesen Rollen gelten;
—   sie diese anwendbaren regulatorischen Anforderungen in ihr Qualitätsmanagementsystem einbindet.

Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)

L'ISO 13485:2016 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. Ces organismes peuvent être impliqués dans une ou plusieurs étapes du cycle de vie incluant la conception et le développement, la production, le stockage et la distribution, l'installation ou les prestations associées d'un dispositif médical, ainsi que la conception, le développement ou la prestation d'activités associées (par exemple support technique). L'ISO 13485:2016 peut également être utilisée par les fournisseurs ou les parties externes qui fournissent des produits, notamment des services associés au système de management de la qualité à de tels organismes.
Les exigences de L'ISO 13485:2016 s'appliquent aux organismes, indépendamment de leur taille ou de leur nature, à l'exception des cas où cela est clairement indiqué. Lorsque les exigences s'appliquent effectivement aux dispositifs médicaux, elles s'appliquent également aux services associés fournis par l'organisme.
Les processus requis par l'ISO 13485:2016, qui sont applicables à l'organisme, mais non mis en ?uvre par celui-ci, relèvent de la responsabilité de ce dernier qui en tient compte dans son système de management de la qualité en surveillant, en tenant à jour et en maîtrisant les processus.
Le fait que des exigences réglementaires applicables 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 exigences réglementaires peuvent prévoir d'autres approches qu'il faut appliquer dans le système de management de la qualité. Il incombe à l'organisme de s'assurer que ses demandes de conformité à l'ISO 13485:2016 correspondent à toute exclusion des systèmes de contrôle de conception et de développement.
Lorsqu'une exigence définie à l'Article 6, 7 ou 8 de l'ISO 13485:2016 ne peut être appliquée en raison des activités entreprises par l'organisme ou de la nature du dispositif médical auquel s'applique le système de management de la qualité, l'organisme n'est pas tenu d'inclure cette exigence dans son système de management de la qualité. Pour les paragraphes apparaissant comme non applicables, l'organisme enregistre la justification comme cela est décrit en 4.2.2.

Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2016)

Standard EN ISO 13485 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 zadevne zakonodajne zahteve. Takšne organizacije so lahko vključene v eno ali več faz življenjskega cikla, vključno z načrtovanjem in razvojem, proizvodnjo, skladiščenjem in dobavo, namestitvijo ali servisiranjem medicinskega pripomočka ter z načrtovanjem in razvojem ali zagotavljanjem s tem povezanih dejavnosti (npr. tehnična podpora). Ta mednarodni standard lahko uporabljajo tudi dobavitelji ali zunanje stranke, ki dobavljajo izdelek, vključno s storitvami sistema vodenja kakovosti, povezanimi s takšnimi organizacijami. Zahteve tega mednarodnega standarda veljajo za organizacije ne glede na njihovo velikost ali vrsto, razen kadar je to izrecno navedeno. Kadar je navedeno, da se zahteve nanašajo na medicinske pripomočke, te enakovredno veljajo tudi za z njimi povezane storitve, ki jih zagotavlja organizacija. Postopki, ki jih ta mednarodni standard zahteva in ki se uporabljajo za organizacijo, vendar jih organizacija ne izvaja, so odgovornost organizacije in so opisani v sistemu vodenja kakovosti organizacije v okviru spremljanja, vzdrževanja in nadzora procesov. Če zadevne zakonodajne zahteve omogočajo izključitve kontrol zasnove in razvoja, se lahko to uporabi kot utemeljitev za njihovo izključitev iz sistema vodenja kakovosti. Te zakonodajne zahteve lahko zagotovijo nadomestne ureditve, ki se morajo obravnavati v sistemu vodenja kakovosti. Organizacija mora zagotoviti, da sklicevanje na skladnost s tem mednarodnim standardom odraža morebitno izključitev kontrol zasnove in razvoja. Če se katera koli zahteva v točkah 6, 7 ali 8 tega mednarodnega standarda ne uporablja zaradi dejavnosti, ki jih izvaja organizacija, ali narave medicinskega pripomočka, za katerega se uporablja sistem vodenja kakovosti, organizaciji takšne zahteve ni treba vključiti v svoj sistem vodenja kakovosti. Za vse točke, za katere se ugotovi, da se ne uporabljajo, organizacija zabeleži utemeljitev, kot je opisano v razdelku 4.2.2.

General Information

Status
Published
Publication Date
01-Mar-2016
Withdrawal Date
30-Mar-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
02-Mar-2016
Completion Date
02-Mar-2016

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SLOVENSKI STANDARD
SIST EN ISO 13485:2016
01-maj-2016
1DGRPHãþD
SIST EN ISO 13485:2012
SIST EN ISO 13485:2012/AC:2012
SIST-TP CEN ISO/TR 14969:2010
0HGLFLQVNLSULSRPRþNL6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]D]DNRQRGDMQH
QDPHQH ,62
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO 13485:2016)
Ta slovenski standard je istoveten z: EN ISO 13485:2016
ICS:
03.100.70 Sistemi vodenja Management systems
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
SIST EN ISO 13485:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 13485:2016

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

SIST EN ISO 13485:2016


EUROPEAN STANDARD
EN ISO 13485

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2016
ICS 03.120.10; 11.040.01
Supersedes EN ISO 13485:2012
English version

Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la Medizinprodukte - Qualitätsmanagementsysteme -
qualité - Exigences à des fins réglementaires (ISO Anforderungen für regulatorische Zwecke (ISO
13485:2016) 13485:2016)
This European Standard was approved by CEN on 30 January 2016.

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, Former Yugoslav Republic of Macedonia, 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
© 2016 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 13485:2016 E
reserved worldwide for CEN national Members and for
CENELEC Members.

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

SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC (as amended) . 5
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC (as amended) . 10
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC . 17

2

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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
European foreword
This document (EN ISO 13485:2016) has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices” in collaboration with Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
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 2016, and conflicting national standards
shall be withdrawn at the latest by March 2019.
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 supers
...

SLOVENSKI STANDARD
SIST EN ISO 13485:2016
01-maj-2016
1DGRPHãþD
SIST EN ISO 13485:2012
SIST EN ISO 13485:2012/AC:2012
SIST-TP CEN ISO/TR 14969:2010
0HGLFLQVNLSULSRPRþNL6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]D]DNRQRGDMQH
QDPHQH ,62
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO 13485:2016)
Ta slovenski standard je istoveten z: EN ISO 13485:2016
ICS:
03.100.70 Sistemi vodenja Management systems
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
SIST EN ISO 13485:2016 en,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 13485:2016

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

SIST EN ISO 13485:2016


EUROPÄISCHE NORM
EN ISO 13485

EUROPEAN STANDARD

NORME EUROPÉENNE März 2016
ICS 03.120.10; 11.040.01
Ersatz für EN ISO 13485:2012
Deutsche Fassung

Medizinprodukte - Qualitätsmanagementsysteme -
Anforderungen für regulatorische Zwecke (ISO
13485:2016)
Medical devices - Quality management systems - Dispositifs médicaux - Systèmes de management de la
Requirements for regulatory purposes (ISO qualité - Exigences à des fins réglementaires (ISO
13485:2016) 13485:2016)
Diese Europäische Norm wurde vom CEN am 30. Januar 2016 angenommen.

Die CEN und CENELEC-Mitglieder sind gehalten, die CEN/CENELEC-Geschäftsordnung zu erfüllen, in der die Bedingungen
festgelegt sind, unter denen dieser Europäischen Norm ohne jede Änderung der Status einer nationalen Norm zu geben ist. Auf
dem letzten Stand befindliche Listen dieser nationalen Normen mit ihren bibliographischen Angaben sind beim Management-
Zentrum des CEN-CENELEC oder bei jedem CEN und CENELEC-Mitglied auf Anfrage erhältlich.

Diese Europäische Norm besteht in drei offiziellen Fassungen (Deutsch, Englisch, Französisch). Eine Fassung in einer anderen
Sprache, die von einem CEN und CENELEC-Mitglied in eigener Verantwortung durch Übersetzung in seine Landessprache
gemacht und dem Management-Zentrum mitgeteilt worden ist, hat den gleichen Status wie die offiziellen Fassungen.

CEN- und CENELEC-Mitglieder sind die nationalen Normungsinstitute und elektrotechnischen Komitees von Belgien, Bulgarien,
Dänemark, Deutschland, der ehemaligen jugoslawischen Republik Mazedonien, Estland, Finnland, Frankreich, Griechenland,
Irland, Island, Italien, Kroatien, Lettland, Litauen, Luxemburg, Malta, den Niederlanden, Norwegen, Österreich, Polen, Portugal,
Rumänien, Schweden, der Schweiz, der Slowakei, Slowenien, Spanien, der Tschechischen Republik, der Türkei, Ungarn, dem
Vereinigten Königreich und Zypern.





CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2016 CEN/CENELEC Alle Rechte der Verwertung, gleich in welcher Form und in Ref. Nr. EN ISO 13485:2016 D
welchem Verfahren, sind weltweit den nationalen Mitgliedern
von CEN und den Mitgliedern von CENELEC vorbehalten.

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

SIST EN ISO 13485:2016
EN ISO 13485:2016 (D)
Inhalt
Seite
Europäisches Vorwort . 5
Vorwort . 7
Einleitung . 8
1 Anwendungsbereich . 11
2 Normative Verweisungen . 11
3 Begriffe . 11
4 Qualitätsmanagementsystem . 17
4.1 Allgemeine Anforderungen . 17
4.2 Dokumentationsanforderungen . 18
4.2.1 Allgemeines .
...

SLOVENSKI SIST EN ISO 13485
STANDARD maj 2016
Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za
zakonodajne namene (ISO 13485:2016)
Medical devices – Quality management systems – Requirements for regulatory
purposes (ISO 13485:2016)
Medizinprodukte – Qualitätsmanagementsysteme – Anforderungen für
regulatorische Zwecke (ISO 13485:2016)
Dispositifs médicaux – Systèmes de management de la qualité – Exigences à
des fins réglementaires (ISO 13485:2016)
Referenčna oznaka
ICS 03.100.70; 11.020.01 SIST EN ISO 13485:2016 (sl, en)
Nadaljevanje na straneh II in III ter od 1 do 129
© 2018-02: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 13485 : 2016
NACIONALNI UVOD
Standard SIST EN ISO 13485 (sl, en), Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za
zakonodajne namene (ISO 13485:2016), 2016, ima status slovenskega standarda in je istoveten
evropskemu standardu EN ISO 13485 (en, de, fr), Medical devices – Quality management systems –
Requirements for regulatory purposes (ISO 13485:2016), 2016.
Ta standard nadomešča SIST EN ISO 13485:2012, SIST EN ISO 13485:2012/AC:2012 in SIST-TP
CEN ISO/TR 14969:2010.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 13485:2016 je pripravil tehnični odbor Evropskega komiteja za
standardizacijo CEN/CLC/TC 3 Vodenje kakovosti in ustrezni splošni vidiki za medicinske pripomočke
(Quality management and corresponding general aspects for medical devices). Slovenski standard
SIST EN ISO 13485:2016 je prevod evropskega standarda EN ISO 13485:2016. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v enem izmed treh
uradnih jezikov CEN. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC VAZ Varovanje
zdravja.
Odločitev za izdajo tega standarda je dne 3. februarja 2016 sprejel SIST/TC VAZ Varovanje zdravja.
ZVEZE S STANDARDI
S privzemom tega evropskega standarda veljajo za omenjeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO 9000:2015 Sistemi vodenja kakovosti – Osnove in slovar
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 13485:2016
PREDHODNA IZDAJA
– standard SIST EN ISO 13485:2012, SIST EN ISO 13485:2012/AC:2012 in SIST-TP CEN ISO/TR
14969:2010
II

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

SIST EN ISO 13485 : 2016

OPOMBE

– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN ISO
13485:2016 to pomeni “slovenski standard”.

– Uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO 13485:2016 in je objavljen z dovoljenjem

CEN-CENELEC
Upravni center
Avenue Marnix 17
B-1000 Bruselj

This national document is identical with EN ISO 13485:2016 and is published with the permission of

CEN-CENELEC
Management Centre
Avenue Marnix 17
B-1000 Brussels
III

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

EVROPSKI STANDARD EN ISO 13485
EUROPEAN STANDARD

EUROPÄISCHE NORM
marec 2016
NORME EUROPÉENNE

ICS 03.120.10; 11.040.01 Nadomešča EN ISO 13485:2012





Slovenska izdaja

Medicinski pripomočki – Sistemi vodenja kakovosti –
Zahteve za zakonodajne namene (ISO 13485:2016)


Medical devices – Quality Dispositifs médicaux – Systèmes Medizinprodukte –
management systems – de management de la qualité – Qualitätsmanagementsysteme –
Requirements for regulatory Exigences à des fins Anforderungen für regulatorische
purposes (ISO 13485:2016) réglementaires (ISO 13485:2016) Zwecke (ISO 13485:2016)






Ta evropski standard je CEN sprejel 30. januarja 2016.

Člani CEN in CENELEC morajo izpolnjevati notranje predpise CEN/CENELEC, s katerimi je
predpisano, da mora biti ta evropski standard brez kakršnih koli sprememb sprejet kot nacionalni
standard. Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na
voljo pri Upravnem centru CEN-CENELEC ali članih CEN in CENELEC.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Upravnem centru CEN-CENELEC, veljajo kot uradne izdaje.

Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški odbori Avstrije,
Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske,
Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nekdanje jugoslovanske republike
Makedonije, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije,
Španije, Švedske, Švice, Turčije in Združenega kraljestva.








CEN CENELEC
Evropski komite za standardizacijo Evrops
...

SLOVENSKI STANDARD
oSIST prEN ISO 13485:2015
01-maj-2015
0HGLFLQVNLSULSRPRþNL6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]D]DNRQRGDMQH
QDPHQH ,62',6
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO/DIS 13485:2015)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO/DIS 13485:2015)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO/DIS 13485:2015)
Ta slovenski standard je istoveten z: prEN ISO 13485
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
oSIST prEN ISO 13485:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 13485:2015

---------------------- Page: 2 ----------------------
oSIST prEN ISO 13485:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 13485.2
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-02-05 2015-04-05
Medical devices — Quality management systems —
Requirements for regulatory purposes
Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins réglementaires
ICS: 11.040.01; 03.120.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 13485.2:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

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oSIST prEN ISO 13485:2015
ISO/DIS 13485.2:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2015 – All rights reserved

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oSIST prEN ISO 13485:2015
ISO DIS 2 13485:2015
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or
utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or
posting on the internet or an intranet, without prior written permission. Permission can be requested
from either ISO at the address below or ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
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Published in Switzerland.
Contents
Foreword . 5
0 Introduction . 5
0.1 General …………………………………………………………………………………………………………………………………5
0.2 Process approach ………………………………………………………………………………………………………………….6
0.3 Relationship with ISO 9001 ……………………………………………………………………………………………………6
0.4 Compatibility with other management systems ………………………………………………………………………6
1 Scope .
...

SLOVENSKI STANDARD
oSIST prEN ISO 13485:2014
01-maj-2014
0HGLFLQVNLSULSRPRþNL6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]D]DNRQRGDMQH
QDPHQH ,62',6
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO/DIS 13485:2014)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO/DIS 13485:2014)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO/DIS 13485:2014)
Ta slovenski standard je istoveten z: prEN ISO 13485
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
oSIST prEN ISO 13485:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 13485:2014

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oSIST prEN ISO 13485:2014
DRAFT INTERNATIONAL STANDARD
ISO/DIS 13485
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2014-02-20 2014-07-20
Medical devices — Quality management systems —
Requirements for regulatory purposes
Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins réglementaires
[Revision of second edition (ISO 13485:2003)and ISO 13485:2003/Cor 1:2009]
ICS: 11.040.01;03.120.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND composition will be undertaken at publication stage.
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 13485:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014

---------------------- Page: 3 ----------------------
oSIST prEN ISO 13485:2014
ISO/DIS 13485:2014(E)

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved

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oSIST prEN ISO 13485:2014
ISO/DIS 13485:2014(E)
ISO/DIS 13485:201X
Contents     Page

Foreword

0 Introduction
0.1 General
0.2 Process approach
0.3 Relationship with other standards
0.4 Compatibility with other management systems

1 Scope
1.1 General
1.2 Application

2 Normative references

3 Terms and definitions

4 Quality management system
4.1 General requirements
4.2 Documentation requirements

5 Management
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review

6 Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment

7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4
...

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