EN ISO 13485:2016
(Main)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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 supersedes EN ISO 13485:2012.
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 Directives.
For relationship with EU Directives, see informative Annex ZA, ZB and ZC, which are integral parts of
this document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the United Kingdom.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard within the
meaning of Annex ZA, ZB and ZC, the user should always check that any referenced document has not
been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the extent
(in whole or in part) to which they apply.
Table 1 — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 9000:2015 EN ISO 9000:2015 ISO 9000:2015
Endorsement notice
The text of ISO 13485:2016 has been approved by CEN as EN ISO 13485:2016 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC (as amended)
ZA.0 General
This European standard has been prepared under a Commission’s standardisation request M/023 to
provide one voluntary means of conforming to requirements of Council Directive of 20 June 1990 on the
approximation of the laws of the Member States relating to active implantable medical devices [OJ L
189].
Once this European Standard is cited in the Official Journal of the European Union under Directive
90/385/EEC (as amended) and has been implemented as a national standard in at least one Member
State, compliance with the normative clauses of this European Standard given in Table ZA.1 or
Table ZA.2 confer, within the limits of the scope of this European Standard, a presumption of conformity
with the requirements on a manufacturer’s quality system as given in Annexes 2 and 5 of that Directive
and associated EFTA regulations. This Annex ZA explains to which requirements, under which
conditions and to what extent presumption of conformity can be claimed.
this standard describes a quality system that is connected in part or in whole to the conformity
assessment requirements of 90/385/EEC (as amended), it is not meaningful to link individual clauses of
the standard to specific Essential Requirements. Compliance with all the normative clauses in EN
ISO 13485 will ensure that a process is in place to address quality system aspects related to medical
devices, which are included in the conformity assessment annexes of the Directive. However, because
this is an adoption of an international standard, intended to be applicable in jurisdictions all over the
world, it is not the primary goal of the standard to cover exactly the European quality system
requirements. Therefore, for all of the quality system requirements, conformity is not entirely achieved
by complying only with the requirements specified in this standard. Manufacturers and conformity
assessment bodies will need to feed the quality system requirements in the applicable Annex of the
Directive into the processes provided by the standard. Explanation on the correspondence of the
standard and the requirements of the Directive is included in Tables ZA.1 and ZA.2.
The Conformity Assessment Annexes 2 and 5 of the Directive include description of the regulatory
process and activities undertaken by the Notified Body, which both are outside of the scope of this
European Standard and therefore not covered by this European Standard. Furthermore, the
requirements of the Directive refer to an application to a Notified Body, not to the requirement for a
quality system as such. Accordingly, coverage of legal requirements can only be presumed to the extent
listed in Tables ZA.1 and ZA.2 in an application to a Notified Body:
— contains the necessary quality system documentation;
— has been reviewed and approved by a Notified Body,
and the undertakings listed in the application are correctly executed by the manufacturer.
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 98/79/EC, as amended by 2007/47/EC.
This means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’,
‘minimized’ or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 4, 5, 8, 9 and 10 of the Directive. See EN ISO 14971, Annex ZB for the interpretation of this
expression in the light of the EU Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When a requirement does not appear in Table ZA.1 or ZA.2, it means that it is not addressed by this
European Standard.
NOTE 5 This annex uses the term “quality system” as used in the Directive whereas this European Standard
uses the term “quality management system” in accordance with ISO terminology.
ZA.1 Relationship with Annex 2 of Directive 90/385/EEC (as amended)
Compliance with this European Standard does not provide presumption of conformity with all the
aspects of Annex 2, as outlined in Table ZA.1. Therefore, a manufacturer or a Notified Body has to take
additional provisions to ensure conformity, and claim or certify conformance, with Annex 2 of this
Directive. The legal requirements must be examined, applied and verified one by one and the solutions
adopted must become part of the quality system in the meaning of the Directive.
Table ZA.1 — Correspondence between this European Standard and Annex 2 of Directive
90/385/EEC (as amended)
Paragraph of Directive Clause(s) of this Comments/Qualifying remarks
90/385/EEC, Annex 2 European
Standard
3.1, 1st sentence Not covered.
3.1, 2nd sentence, 1st indent Not covered.
3.1, 2nd sentence, 2nd indent 4.1.1, 4.1.2, 4.1.3, Covered. The documentation required in this European
4.1.4, 4.1.6, 4.2.1, Standard covers the quality system documentation meant
4.2.2, 4.2.3, 4.2.4, in 3.2 of Annex 2 when the explicit legal requirements are
4.2.5 incorporated into the quality system documentation. See
also coverage of 3.2 below.
3.1, 2nd sentence, 3rd indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered in part. This European Standard requires top
management commitment to implementation of the quality
system and that documented procedures are implemented
but does not require a signed undertaking.
3.1, 2nd sentence, 4th indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered in part. This European Standard requires
maintenance of the approved quality system but does not
require a signed undertaking.
3.1, 2nd sentence, 5th indent Not covered. This European Standard includes
requirements on post-market surveillance, and reporting
adverse events and field safety corrective actions to
authorities but does not cover all the details required by
the Directive including timescales for reporting.
3.2, 1st paragraph Not covered. The application of this European Standard
does not by itself ensure the fulfilment of all regulatory
requirements of the Directive. The legal requirements
must be examined, applied and verified one by one and the
solutions adopted become part of the quality system in the
meaning of the Directive.
Paragraph of Directive Clause(s) of this Comments/Qualifying remarks
90/385/EEC, Annex 2 European
Standard
3.2, 2nd paragraph, 1st 4.1, 4.2 Covered.
sentence
3.2, 2nd paragraph, 2nd 4.1, 4.2 Covered.
sentence
3.2, 2nd paragraph, 3rd 4.1, 4.2, 7 Covered provided quality management system
sentence documentation makes possible a uniform interpretation of
the quality policies and procedures, such as quality
programs, quality plans, quality manuals and quality
records, and that the applicable documentation listed in
3.2 of Annex 2 is incorporated into the quality system
documentation.
3.2, 3rd paragraph (a) 4.2.1, 4.2.3, 5.1, 5.3, Covered.
5.4.1
3.2, 3rd paragraph (b) 4.2.2, 5.1.1 Covered.
3.2, 3rd paragraph (b), 1st 4.2.2, 5.1, 5.5.1, Covered.
indent 5.5.2
3.2, 3rd parag
...
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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 . 18
4.2.2 Qualitätsmanagement-Handbuch . 18
4.2.3 Medizinproduktakte . 19
4.2.4 Lenkung von Dokumenten . 19
4.2.5 Lenkung von Aufzeichnungen . 20
5 Verantwortung der Leitung . 20
5.1 Verpflichtung der Leitung . 20
5.2 Kundenorientierung . 20
5.3 Qualitätspolitik. 20
5.4 Planung . 21
5.4.1 Qualitätsziele . 21
5.4.2 Planung des Qualitätsmanagementsystems . 21
5.5 Verantwortung, Befugnis und Kommunikation . 21
5.5.1 Verantwortung und Befugnis . 21
5.5.2 Beauftragter der Leitung . 21
5.5.3 Interne Kommunikation . 22
5.6 Managementbewertung . 22
5.6.1 Allgemeines . 22
5.6.2 Eingaben für die Bewertung . 22
5.6.3 Ergebnisse der Bewertung . 22
6 Management von Ressourcen . 23
6.1 Bereitstellung von Ressourcen . 23
6.2 Personelle Ressourcen . 23
6.3 Infrastruktur . 23
6.4 Arbeitsumgebung und Lenkung der Kontamination . 24
6.4.1 Arbeitsumgebung . 24
6.4.2 Lenkung der Kontamination . 24
7 Produktrealisierung . 24
7.1 Planung der Produktrealisierung . 24
7.2 Kundenbezogene Prozesse . 25
7.2.1 Ermittlung der Anforderungen bezüglich des Produkts . 25
7.2.2 Bewertung der Anforderungen bezüglich des Produkts . 25
7.2.3 Kommunikation . 26
7.3 Entwicklung . 26
7.3.1 Allgemeines . 26
7.3.2 Entwicklungsplanung . 26
7.3.3 Entwicklungseingaben . 26
7.3.4 Entwicklungsergebnisse . 27
7.3.5 Entwicklungsbewertung . 27
7.3.6 Entwicklungsverifizierung . 28
7.3.7 Entwicklungsvalidierung . 28
7.3.8 Übertragung der Entwicklung . 28
7.3.9 Lenkung von Entwicklungsänderungen . 29
7.3.10 Entwicklungsakten . 29
7.4 Beschaffung . 29
7.4.1 Beschaffungsprozess . 29
7.4.2 Beschaffungsangaben . 30
7.4.3 Verifizierung von beschafften Produkten . 30
7.5 Produktion und Dienstleistungserbringung . 30
7.5.1 Lenkung der Produktion und der Dienstleistungserbringung . 30
7.5.2 Sauberkeit von Produkten . 31
7.5.3 Tätigkeiten bei der Installation . 31
7.5.4 Tätigkeiten zur Instandhaltung . 31
7.5.5 Besondere Anforderungen für sterile Medizinprodukte . 32
7.5.6 Validierung der Prozesse zur Produktion und zur Dienstleistungserbringung . 32
7.5.7 Besondere Anforderungen für die Validierung von Sterilisationsprozessen und
Sterilbarrieresystemen . 33
7.5.8 Identifizierung . 33
7.5.9 Rückverfolgbarkeit . 33
7.5.10 Eigentum des Kunden . 34
7.5.11 Produkterhaltung . 34
7.6 Lenkung von Überwachungs- und Messmitteln .
...
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.
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
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
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
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 Evropski komite za standardizacijo v elektrotehniki
European Committee for Standardization European Committee for Electrotechnical Standardization
Europäisches Komitee für Normung Europäisches Komitee für Elektrotechnische Normung
Comité Européen de Normalisation Comité Européen de Normalisation Electrotechnique
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj
© 2016 CEN/CENELEC Lastnice avtorskih pravic so vse države članice CEN/CENELEC Ref. št. EN ISO 13485:2016 E
EUROPEAN STANDARD EN ISO 13485
EUROPÄISCHE NORM
NORME EUROPÉENNE
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 Medizinprodukte - Qualitätsmanagementsysteme -
la qualité - Exigences à des fins réglementaires Anforderungen für regulatorische Zwecke
(ISO 13485:2016) (ISO 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
European Committee for Standardization European Committee for Electrotechnical Standardization
Europäisches Komitee für Normung Europäisches Komitee für Elektrotechnische Normung
Comité Européen de Normalisation Comité Européen de Normalisation Electrotechnique
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.
SIST EN ISO 13485 : 2016
VSEBINA Stran
Predgovor k evropskemu standardu . 8
Dodatek ZA (informativni): Povezava med tem evropskim standardom in bistvenimi zahtevami Direktive
EU 90/385/EGS (z vsemi dopolnili) . 12
Dodatek ZB (informativni): Povezava med tem evropskim standardom in bistvenimi zahtevami Direktive
EU 93/42/EGS (z vsemi dopolnili) . 20
Dodatek ZC (informativni): Povezava med tem evropskim standardom in bistvenimi zahtevami Direktive
EU 98/79/ES . 32
Predgovor k mednarodnemu standardu . 46
Uvod . 48
1 Področje uporabe . 54
2 Zveze s standardi . 54
3 Izrazi in definicije . 54
4 Sistem vodenja kakovosti . 64
4.1 Splošne zahteve . 64
4.2 Zahteve glede dokumentacije . 66
4.2.1 Splošno . 66
4.2.2 Poslovnik kakovosti . 66
4.2.3 Dokumentacija medicinskega pripomočka . 66
4.2.4 Obvladovanje dokumentov . 68
4.2.5 Obvladovanje zapisov . 68
5 Odgovornost vodstva . 70
5.1 Zavezanost vodstva . 70
5.2 Osredotočenost na odjemalce . 70
5.3 Politika kakovosti . 70
5.4 Planiranje . 70
5.4.1 Cilji kakovosti . 70
5.4.2 Planiranje sistema vodenja kakovosti . 70
5.5 Odgovornosti, pooblastila in komuniciranje . 70
5.5.1 Odgovornosti in pooblastila . 70
5.5.2 Predstavnik vodstva . 72
5.5.3 Notranje komuniciranje . 72
5.6 Vodstveni pregled . 72
5.6.1 Splošno . 72
5.6.2 Vhodni podatki za pregled . 72
5.6.3 Rezultati pregleda . 72
6 Vodenje virov . 74
6.1 Preskrba virov . 74
6.2 Človeški viri . 74
6.3 Infrastruktura . 74
6.4 Delovno okolje in obvladovanje kontaminacije . 76
SIST EN ISO 13485 : 2016
Contents Page
European foreword . 9
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC (as amended) . 13
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC (as amended) . 21
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC . 33
Foreword. 47
Introduction . 49
1 Scope.
...
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