EN ISO 13485:2016/AC:2016

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)

General Information

• Status: Withdrawn
• Publication Date: 20-Dec-2016
• Withdrawal Date: 27-Mar-2018
• ICS: 03.100.70 - Management systems
• 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: 28-Mar-2018
• 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/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 13485:2016/AC:2017 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Relations

• Replaced By: EN ISO 13485:2016/AC:2018 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Effective Date: 11-Apr-2018
• Corrects: EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.NRQRGDMQHMedizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)11.020.01Vodenje kakovosti in ravnanje z okoljem v zdravstvuQuality and environmental management in health care03.100.70Sistemi vodenjaManagement systemsICS:Ta slovenski standard je istoveten z:EN ISO 13485:2016/AC:2016SIST EN ISO 13485:2016/AC:2017en01-april-2017SIST EN ISO 13485:2016/AC:2017SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13485:2016/AC
December 2016
Décembre 2016
Dezember 2016 ICS 03.100.70; 11.040.01 English version Version Française Deutsche Fassung
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016) This corrigendum becomes effective on 21 December 2016 for incorporation in the official English version of the EN.
Ce corrigendum prendra effet le 21 décembre 2016 pour incorporation dans la version anglaise officielle de la EN.
Die Berichtigung tritt am 21. Dezember 2016 zur Einarbeitung in die offizielle Englische Fassung der EN in Kraft. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux membres nationaux du CEN et aux membres du CENELEC. Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern von CEN und den Mitgliedern von CENELEC vorbehalten. Ref. No. EN ISO 13485:2016:EN ISO 13485:2016/AC:2016 E
EN ISO 13485:2016 (E) 2 1 Modification to the European foreword The fourth sentence now reads: "This document supersedes EN ISO 13485:2012 and CEN ISO/TR 14969:2005." 2 Modification to Annex ZA The title of the Annex ZA now reads: "Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 90/385/EEC (as amended)" The first paragraph now reads: "This European Standard has been prepared under a mandate given to CEN/CENELEC by the European Union and the European Free Trade Association to provide a means by which a manufacturer may demonstrate conformity, and by which the Notified Body may assess the manufacturer’s conformity, with the requirements of Directive 90/385/EEC (as amended) on active implantable medical devices." The third paragraph has been deleted. The first sentence of Note 1, now reads: "NOTE 1 Where a reference from a clause of this European Standard to the risk management process is made, the risk management process needs to be in compliance with Directive 90/385/EEC, as amended by 2007/47/EC." The last sentence of Note 2 has been deleted. In Table ZA.1, several cross references have been corrected, e.g. the ones corresponding to: — 3.2, 3rd paragraph (b) — 3.2 3rd paragraph (b) 3rd indent — 3.2, 3rd paragraph (e) In Table ZA.2, several cross references have been corrected, e.g. the ones corresponding to: — 3.2, 3rd paragraph (b), 3rd indent — 3.2, 3rd paragraph (c), 2nd indent In the last paragraph, the warnings 1 and 2 have been grouped under the following warning: WARNING: The preceding text and tables are specifically intended for organizations that
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SLOVENSKI SIST EN ISO 13485:2016/AC

STANDARD april 2017
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/AC:2017 (sl)

Nadaljevanje na straneh II in od 1 do 4

© 2018-02: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 13485:2016/AC : 2017

NACIONALNI UVOD
Popravek SIST EN ISO 13485:2016/AC (sl), Medicinski pripomočki – Sistemi vodenja kakovosti –
Zahteve za zakonodajne namene (ISO 13485:2016), 2017, ima status slovenskega popravka in je
enakovreden evropskemu popravku EN ISO 13485:2016/AC (en, de, fr), Medical devices – Quality
management systems – Requirements for regulatory purposes (ISO 13485:2016), 2016.

NACIONALNI PREDGOVOR
Evropski popravek EN ISO 13485:2016/AC: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 popravek
primeru spora glede besedila slovenskega prevoda v tem popravku je odločilen izvirni evropski popravek
v enem izmed treh uradnih jezikov CEN. Slovensko izdajo popravka je pripravil tehnični odbor SIST/TC
VAZ Varovanje zdravja.
Odločitev za izdajo tega popravka je dne 15. februarja 2017 sprejel SIST/TC VAZ Varovanje zdravja.

OSNOVA ZA IZDAJO POPRAVKA
– privzem popravka EN ISO 13485:2016/AC:2016

OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski popravek”, v SIST EN ISO
13485:2016/AC:2017 to pomeni “slovenski popravek”.

– Uvod in nacionalni predgovor nista sestavni del popravka.

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

CEN-CENELEC
Upravni Cener
Avenue Marnix 17
B-1000 Bruselj
This national document is identical with EN ISO 13485:2016/AC:2016 and is published with the
permission of
CEN-CENELEC
Management Centre
Avenue Marnix 17
B-1000 Brussels
II
EVROPSKI STANDARD EN ISO 13485:2016/AC
EUROPEAN STANDARD
NORME EUROPÉENNE
december 2016
EUROPÄISCHE NORM
ICS 03.100.70; 11.040.01
Slovenska izdaja
Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za
zakonodajne namene (ISO 13485:2016)

Medical devices – Dispositifs médicaux – Systèmes Medizinprodukte –
Quality 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 popravek je začel veljati 21. decembra 2016 z vključitvijo v uradno angleško verzijo EN.

CEN
Evropski komite za standardizacijo
European Committee for Standardization
Europäisches Komitee für Normung
Comité Européen de Normalisation

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

© 2016 CEN/CENELEC Lastnice avtorskih pravic so vse države Ref. št. EN ISO 13485:2016/AC:2016 E
članice CEN in CENELEC.
SIST EN ISO 13485:2016/AC : 2017

Popravek
1 Sprememba evropskega predgovora

Četrti stavek se sedaj glasi:
“Ta dokument nadomešča EN ISO 13485:2012 in CEN ISO/TR 14969:2005.”

2 Sprememba dodatka ZA
Naslov dodatka ZA se sedaj glasi:

“Povezava med tem evropskim standardom in zahtevami glede ugotavljanja skladnosti Direktive EU
90/385/EGS (z vsemi dopolnili)”

Prvi odstavek se sedaj glasi:
“Ta evropski standard je bil pripravljen v okviru mandata, ki sta ga Evropska unija in Evropsko združenje
za prosto trgovino dala CEN/CENELEC, da bi zagotovila sredstva, s katerimi lahko proizvajalec dokaže
skladnost z zahtevami Direktive 90/385/EGS (z vsemi dopolnili) o aktivnih medicinskih pripomočkih za
vsaditev in s katerimi lahko priglašeni organ ugotovi, ali proizvajalec to skladnost
...