SIST 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)
EN ISO 13485 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). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of this International Standard 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 this International Standard 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 this International Standard reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of this International Standard 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.
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SLOVENSKI STANDARD
SIST EN ISO 13485:2016
01-maj-2016
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SIST EN ISO 13485:2012
SIST EN ISO 13485:2012/AC:2012
SIST-TP CEN ISO/TR 14969:2010
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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.
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SIST EN ISO 13485:2016
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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.
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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 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.
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
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.
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
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.
EN ISO 13485:2016 provides requirements for a quality system applicable to medical devices. Because
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.
5
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
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.
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
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 paragraph (b), 2nd 4.1, 5.6, 7.1, 8.2.4, Covered provided that the methods and acceptance criteria
indent 8.3, 8.4, 8.5.2, 8.5.3 chosen by the manufacturer ensure that the requirements
of the Directive are fulfilled.
3.2 3rd paragraph (b) 3rd 1, 4.1, 4.2, 7.4, 8.5.1 Covered.
indent
3.2 3rd paragraph (c) 1st 4.2, 7.3.2, 7.3.3, Covered provided that the applicable quality management
indent 7.3.7, 7.3.9, 7.3.10 system documentation includes design specifications
identifying standards which will be applied and a
description of the solutions adopted to fulfil the essential
requirements which apply when harmonized standards
are not applied in full.
3.2, 3rd paragraph (c), 2nd 7.3.1, 7.3.6, 7.3.7, Covered.
indent 7.3.9
3.2, 3rd paragraph (c), 3rd Not covered.
indent
3.2, 3rd paragraph (c), 4th 7.3.6, 7.3.7 Covered provided that the quality management system
indent records include the pre-clinical evaluation.
3.2, 3rd paragraph (c), 5th Not covered. Clause 7.3.7 does not include the details of
indent Annex 7.
3.2, 3rd paragraph (d), 1st 4.2, 6.4, 7.1, 7.4 7.5 Covered provided that the quality management system
indent documentation includes relevant documents and records
in regards to sterilization and purchasing.
3.2, 3rd paragraph (d), 2nd 4.2, 7.5.8, 7.5.9 Covered.
indent
3.2, 3rd paragraph (e) 4.2, 7.1, 7.4.3, 7.5.1, Covered provided that the documented frequency at which
7.5.9.1, 7.6, 8.2.6 tests are carried out is detailed in the quality management
system documentation.
6.1 Not covered. The specific time periods in Directive are not
specified in 4.2.4 or 4.2.5.
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
ZA.2 Relationship with Annex 5 of Directive 90/385/EEC (as amended)
Compliance with this European Standard does not provide presumption of conformity with all the
aspects of Annex 5, as outlined in Table ZA.2. Therefore, a manufacturer or a Notified Body has to take
additional provisions to ensure conformity, and claim or certify conformance, with Annex 5 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.2 — Correspondence between this European Standard and Annex 5 of Directive
90/385/EEC (as amended)
Paragraph of Directive Clause(s) of this
Comments/Qualifying remarks
90/385/EEC, Annex 5 European
Standard
3.1, 1st paragraph Not covered.
3.1, 2nd paragraph, 1st indent Not covered.
3.1, 2nd paragraph, 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 5 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 paragraph, 3rd indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered.
3.1, 2nd paragraph, 4th indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered.
3.1, 2nd paragraph, 5th indent 4.1, 4.2 Covered in part provided that quality management system
includes the technical documentation relating to the
applicable approved type(s) of medical device(s).
Reference to the EC type-examination certificate is not
covered.
3.1, 2nd paragraph, 6th 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. Reference to the EC type-examination
certificate is not covered.
3.2, 2nd paragraph 4.1, 4.2 Covered.
3.2, 3rd paragraph (a) 4.2.1, 4.2.3, 5.1, 5.3, Covered.
5.4.1
3.2, 3rd paragraph (b), 1st 5.5.1, 5.5.2 Covered.
indent
3.2, 3rd paragraph (b), 2nd 4.1, 5.6, 7.1, 8.2.4, Covered provided that the methods and acceptance
indent 8.3, 8.4, 8.5.2, 8.5.3 criteria chosen by the manufacturer ensure that the
requirements of the Directive are fulfilled.
3.2, 3rd paragraph (b), 3rd 1, 4.1, 4.2, 7.4, 8.5.1 Covered.
indent
3.2, 3rd paragraph (c), 1st 4.2, 6.4, 7.1, 7.4, 7.5 Covered provided that the quality management system
indent documentation includes relevant documents and records
in regards to sterilization and purchasing.
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
Paragraph of Directive Clause(s) of this Comments/Qualifying remarks
90/385/EEC, Annex 5 European
Standard
3.2, 3rd paragraph (c), 2nd 4.2, 7.5.3 Covered.
indent
3.2, 3rd paragraph (d) 7.1, 7.4.3, 7.6, 8.2.6 Covered provided that the frequency at which tests are
carried out is documented in the quality management
system documentation.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC (as amended)
ZB.0 General
This European Standard has been prepared under a Commission's standardization request M/023 to
provide one voluntary means of conforming to requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this European Standard is cited in the Official Journal of the European Union under Directive
93/42/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 Tables ZB.1, ZB.2 and
ZB.3 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 II, V and VI of that Directive
and associated EFTA regulations. This Annex ZB explains to which requirements, under which
conditions and to what extent presumption of conformity can be claimed.
EN ISO 13485:2016 provides requirements for a quality system applicable to medical devices. Because
this standard describes a quality system that is connected in part or in whole to the conformity
assessment requirements of 93/42/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 ZB.1, ZB.2 and ZB.3.
The Conformity Assessment Annexes II, V and VI 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 ZB.1, ZB.2 and ZB.3 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 93/42/EEC, 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.
10
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. See EN ISO 14971, Annex ZA for the interpretation of this
expression in the light of the EU Directive.
NOTE 3 This Annex ZB 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 ZB.1, ZB.2 or ZB.3, 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.
ZB.1 Relationship with Annex II of Directive 93/42/EEC (as amended)
Compliance with this European Standard does not provide a presumption of conformity with all the
aspects of Annex II, as outlined in Table ZB.1. Therefore, a manufacturer or a Notified Body has to take
additional provisions to ensure conformity, and claim or certify conformance, with Annex II 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 ZB.1 — Correspondence between this European Standard and Annex II of Directive
93/42/EEC (as amended)
Paragraph of Directive Clause(s) of this Comments/Qualifying remarks
93/42/EEC, Annex II European Standard
3.1, 1st sentence Not covered.
3.1, 2nd sentence, 1st Not covered.
indent
3.1, 2nd sentence, 2nd Not covered.
indent
3.1, 2nd sentence, 3rd Not covered.
indent
3.1, 2nd sentence, 4th 4.1.1, 4.1.2, 4.1.3, 4.1.4, Covered. The documentation required in this European
indent 4.1.6, 4.2.1, 4.2.2, 4.2.3, Standard covers the quality system documentation meant
4.2.4, 4.2.5 in 3.2 of Annex II when the explicit legal requirements are
incorporated into the quality system documentation. See
also coverage of 3.2 below.
3.1, 2nd sentence, 5th 4.1, 5.1, 5.4, 5.5, 5.6 Covered.
indent
3.1, 2nd sentence, 6th 4.1, 5.1, 5.4, 5.5, 5.6 Covered.
indent
3.1, 2nd sentence, 7th Not covered. This European Standard includes
indent requirements on post market surveillance, and reporting
adverse events and field safety corrective actions to
3.1, 7th indent (i)
authorities but does not cover all the details required by
3.1, 7th indent (ii)
the Directive including timescales for reporting.
11
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
Paragraph of Directive Clause(s) of this Comments/Qualifying remarks
93/42/EEC, Annex II European Standard
3.2, 1st paragraph, 1st Not covered. The application of this European Standard
sentence 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.
3.2, 1st paragraph, 2nd 4.1, 4.2, 7.1 Covered.
sentence
3.2, 2nd paragraph 4.1, 4.2, 7 Covered provided quality management system
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 II is incorporated into the quality system
documentation.
3.2, 3rd paragraph (a) 4.2.3, 5.1, 5.3, 5.4.1 Covered.
3.2, 3rd paragraph (b) 4.2.2, 5.1 Covered.
3.2, 3rd paragraph (b), 1st 1, 4.2.2, 5.1, 5.5.1, 5.5.2 Covered.
indent
3.2, 3rd paragraph (b), 2nd 4.1, 5.6, 7.1, 8.2.2, 8.3, Covered provided that the methods and acceptance
indent 8.4, 8.5.2, 8.5.3 criteria chosen by the manufacturer ensure that the
requirements of the Directive are fulfilled.
3.2, 3rd paragraph (b), 3rd 1, 4.1, 4.2, 7.4, 8.5.1 Covered.
indent
3.2, 3rd paragraph (c) 7.1, 7.2, 7.3 Covered.
3.2, 3rd paragraph (c), 1st 4.2.3, 7.2, 7.3.3, 7.3.4, Covered provided that the documentation containing a
indent 7.3.10 general description of the medical device includes any
variants.
3.2, 3rd paragraph (c), 2nd 4.2, 7.3.3, 7.3.4, 7.3.6, Covered provided that the applicable quality management
indent 7.3.8 system documentation includes design specifications
identifying standards which will be applied and a
description of the solutions adopted to fulfil the essential
requirements which apply when harmonized standards
are not applied in full.
3.2, 3rd paragraph (c), 3rd 7.3.1, 7.3.6, 7.3.7, 7.3.8, Covered.
indent 7.3.9, 7.3.10
3.2, 3rd paragraph (c), 4th 7.3.2, 7.3.3, 7.3.5, 7.3.6 Covered.
indent
3.2, 3rd paragraph (c), 5th 4.2.3 Covered provided that the quality management system
indent documentation includes a statement indicating whether
or not the medical device incorporates, as an integral part,
a substance or a human blood derivative and the data on
the tests conducted in this connection required to assess
the safety, quality and usefulness of that substance or
human blood derivative, taking account of the intended
purpose of the medical device.
12
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (E)
Paragraph of Directive Clause(s) of this Comments/Qualifying remarks
93/42/EEC, Annex II European Standard
3.2, 3rd paragraph (c), 6th 4.2.3 Covered provided that the quality management system
indent documentation includes a statement indicating whether
or not the device is manufactured utilizing tissues of
animal origin as referred to in Commission Directive
2003/32/EC.
3.2, 3rd paragraph (c), 7th Not covered.
indent
3.2, 3rd paragraph (c), 8th 7.3.5, 7.3.8 Covered provided that the quality management system
indent records include the pre
...
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.
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SIST EN ISO 13485:2016
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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.
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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 . 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
2
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (D)
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 . 34
8 Messung, Analyse und Verbesserung . 35
8.1 Allgemeines . 35
8.2 Überwachung und Messung . 35
8.2.1 Rückmeldungen . 35
8.2.2 Reklamationsbearbeitung . 35
8.2.3 Berichterstattung an Regulierungsbehörden . 36
8.2.4 Internes Audit . 36
8.2.5 Überwachung und Messung von Prozessen . 37
8.2.6 Überwachung und Messung des Produkts . 37
8.3 Lenkung nichtkonformer Produkte. 37
8.3.1 Allgemeines . 37
8.3.2 Maßnahmen als Reaktion auf vor der Auslieferung festgestellte nichtkonforme Produkte . 37
8.3.3 Maßnahmen als Reaktion auf nach der Auslieferung festgestellte nichtkonforme
Produkte . 38
8.3.4 Nacharbeit . 38
8.4 Datenanalyse . 38
8.5 Verbesserung . 39
8.5.1 Allgemeines . 39
8.5.2 Korrekturmaßnahmen . 39
8.5.3 Vorbeugungsmaßnahmen . 39
Anhang A (informativ) Vergleich des Inhalts zwischen ISO 13485:2003 und ISO 13485:2016 . 40
Anhang B (informativ) Zusammenhang zwischen ISO 13485:2016 und ISO 9001:2015 . 47
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EU-Richtlinie 90/385/EWG (geänderte Fassung) . 55
ZA.0 Allgemeines . 55
ZA.1 Zusammenhang mit Anhang 2 der Richtlinie 90/385/EWG (geänderte Fassung) . 56
ZA.2 Zusammenhang mit Anhang 5 der Richtlinie 90/385/EWG (geänderte Fassung) . 58
3
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (D)
Anhang ZB (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EU-Richtlinie 93/42/EWG (geänderte Fassung) . 61
ZB.0 Allgemeines . 61
ZB.1 Zusammenhang mit Anhang II der Richtlinie 93/42/EWG (geänderte Fassung) . 62
ZB.2 Zusammenhang mit Anhang V der Richtlinie 93/42/EWG (geänderte Fassung) . 65
ZB.3 Zusammenhang mit Anhang VI der Richtlinie 93/42/EWG (geänderte Fassung) . 66
Anhang ZC (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EU-Richtlinie 98/79/EG . 69
ZC.0 Allgemeines . 69
ZC.1 Zusammenhang mit Anhang III der Richtlinie 98/79/EG . 70
ZC.2 Zusammenhang mit Anhang IV der Richtlinie 98/79/EG . 72
ZC.3 Zusammenhang mit Anhang VII der Richtlinie 98/79/EG . 75
Literaturhinweise . 78
4
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (D)
Europäisches Vorwort
Dieses Dokument (EN ISO 13485:2016) wurde vom Technischen Komitee ISO/TC 210 „Quality management
and corresponding general aspects for medical devices“ in Zusammenarbeit mit dem Technischen Komitee
CEN/CLC/TC 3 „Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte“
erarbeitet, dessen Sekretariat vom NEN gehalten wird.
Diese Europäische Norm muss den Status einer nationalen Norm erhalten, entweder durch Veröffentlichung
eines identischen Textes oder durch Anerkennung bis September 2016, und etwaige entgegenstehende
nationale Normen müssen bis März 2019 zurückgezogen werden.
Es wird auf die Möglichkeit hingewiesen, dass einige Elemente dieses Dokuments Patentrechte berühren
können. CEN [und/oder CENELEC] sind nicht dafür verantwortlich, einige oder alle diesbezüglichen
Patentrechte zu identifizieren.
Dieses Dokument ersetzt EN ISO 13485:2012.
Dieses Dokument wurde unter einem Mandat erarbeitet, das die Europäische Kommission und die
Europäische Freihandelszone dem CEN erteilt haben, und unterstützt grundlegende Anforderungen der EU-
Richtlinien.
Zum Zusammenhang mit EU-Richtlinien siehe informativen Anhang ZA, ZB, und ZC, die Bestandteil dieses
Dokuments sind.
Entsprechend der CEN-CENELEC-Geschäftsordnung sind die nationalen Normungsinstitute der folgenden
Länder gehalten, diese Europäische Norm zu übernehmen: Belgien, Bulgarien, Dänemark, Deutschland, die
ehemalige jugoslawische Republik Mazedonien, Estland, Finnland, Frankreich, Griechenland, Irland, Island,
Italien, Kroatien, Lettland, Litauen, Luxemburg, Malta, Niederlande, Norwegen, Österreich, Polen, Portugal,
Rumänien, Schweden, Schweiz, Slowakei, Slowenien, Spanien, Tschechische Republik, Türkei, Ungarn,
Vereinigtes Königreich und Zypern.
Die folgenden zitierten Dokumente sind für die Anwendung dieses Dokuments erforderlich. Bei undatierten
Verweisungen gilt die letzte Ausgabe des in Bezug genommenen Dokuments (einschließlich aller
Änderungen). Bei datierten Verweisungen gilt nur die in Bezug genommene Ausgabe. Jedoch sollte der
Anwender für die weitere Verwendung dieser Norm im Sinne von Anhang ZA, Anhang ZB und Anhang ZC
stets überprüfen, dass jedes zitierte Dokument nicht ersetzt worden ist, und dass dessen relevanter Inhalt
immer noch als der allgemein anerkannte Stand der Technik erachtet werden kann.
Wenn im Text der ISO-Norm auf eine IEC- oder ISO-Norm verwiesen wird, muss dies als normative
Verweisung auf die entsprechende EN-Norm verstanden werden, sofern vorhanden, und andernfalls auf die
datierte Ausgabe der ISO- oder IEC-Norm, wie unten aufgeführt.
ANMERKUNG Die Art und Weise, in der diese in Bezug genommenen Dokumente in den verbindlichen
Anforderungen zitiert sind, bestimmt das Ausmaß (als Ganzes oder teilweise), in dem sie gelten.
Tabelle — Beziehung zwischen normativen Verweisungen und datierten EN- und ISO-Normen
Normative Verweisungen wie in Entsprechende datierte Norm
Abschnitt 2 der ISO-Norm
aufgeführt
EN ISO
ISO 9000:2015 EN ISO 9000:2015 ISO 9000:2015
5
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (D)
Anerkennungsnotiz
Der Text von ISO 13485:2016 wurde vom CEN als EN ISO 13485:2016 ohne irgendeine Abänderung
genehmigt.
6
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (D)
Vorwort
ISO (die Internationale Organisation für Normung) ist eine weltweite Vereinigung von Nationalen
Normungsorganisationen (ISO-Mitgliedsorganisationen). Die Erstellung von Internationalen Normen wird
normalerweise von ISO Technischen Komitees durchgeführt. Jede Mitgliedsorganisation, die Interesse an
einem Thema hat, für welches ein Technisches Komitee gegründet wurde, hat das Recht, in diesem Komitee
vertreten zu sein. Internationale Organisationen, staatlich und nicht-staatlich, in Liaison mit ISO, nehmen
ebenfalls an der Arbeit teil. ISO arbeitet eng mit der Internationalen Elektrotechnischen Kommission (IEC)
bei allen elektrotechnischen Themen zusammen.
Die Verfahren, die bei der Entwicklung dieses Dokuments angewendet wurden und die für die weitere Pflege
vorgesehen sind, werden in den ISO/IEC-Direktiven, Teil 1 beschrieben. Im Besonderen sollten die für die
verschiedenen ISO-Dokumentenarten notwendigen Annahmekriterien beachtet werden. Dieses Dokument
wurde in Übereinstimmung mit den Gestaltungsregeln der ISO/IEC-Direktiven, Teil 2 erarbeitet (siehe
www.iso.org/directives).
Es wird auf die Möglichkeit hingewiesen, dass einige Elemente dieses Dokuments Patentrechte berühren
können. ISO ist nicht dafür verantwortlich, einige oder alle diesbezüglichen Patentrechte zu identifizieren.
Details zu allen während der Entwicklung des Dokuments identifizierten Patentrechten finden sich in der
Einleitung und/oder in der ISO-Liste der empfangenen Patenterklärungen (siehe www.iso.org/patents).
Jeder in diesem Dokument verwendete Handelsname wird als Information zum Nutzen der Anwender
angegeben und stellt keine Anerkennung dar.
Eine Erläuterung der Bedeutung ISO-spezifischer Benennungen und Ausdrücke, die sich auf
Konformitätsbewertung beziehen, sowie Informationen über die Beachtung der WTO-Grundsätze zu
technischen Handelshemmnissen (TBT, en: Technical Barriers to Trade) durch ISO enthält der folgende Link:
www.iso.org/iso/foreword.html.
Das für dieses Dokument verantwortliche Komitee ist ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
Diese dritte Ausgabe von ISO 13485 ersetzt die zweite Ausgabe (ISO 13485:2003) und ISO/TR 14969:2004,
die technisch überarbeitet wurden. Sie beinhaltet das Technische Corrigendum ISO 13485:2003/Cor.1:2009.
Eine Zusammenfassung der Änderungen in dieser dritten Ausgabe gegenüber der Vorgängerausgabe gibt
Anhang A.
7
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SIST EN ISO 13485:2016
EN ISO 13485:2016 (D)
Einleitung
0.1 Allgemeines
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.
Die Begriffsbestimmungen in den anwendbaren regulatorischen Anforderungen unterscheiden sich von
Land zu Land und von Region zu Region. Die Organisation muss verstehen, wie die Begriffsbestimmungen in
dieser Internationalen Norm angesichts regulatorischer Begriffsbestimmungen in den
Zuständigkeitsbereichen, in denen die Medizinprodukte verfügbar gemacht werden, zu interpretieren sind.
Diese Internationale Norm kann auch von internen und externen Parteien einschließlich
Zertifizierungsstellen verwendet werden, um die Fähigkeit der Organisation zur Erfüllung von
Kundenanforderungen und regulatorischen Anforderungen, die auf das Qualitätsmanagementsystem
anwendbar sind, sowie die Fähigkeit der Organisation zur Erfüllung der eigenen Anforderungen zu
bewerten. Es wird betont, dass die in dieser Internationalen Norm festgelegten Anforderungen an das
Qualitätsmanagementsystem zusätzlich zu den technischen Anforderungen an Produkte gelten, die
notwendig sind, um die Anforderungen des Kunden und die anwendbaren regulatorischen Anforderungen
an die Sicherheit und Leistung zu erfüllen.
Die Einführung eines Qualitätsmanagementsystems ist eine strategische Entscheidung einer Organisation.
Design und Implementierung des Qualitätsmanagementsystems einer Organisation werden beeinflusst
durch:
a) das Organisationsumfeld, Änderungen in diesem Umfeld und den Einfluss, den das Organisationsumfeld
auf die Konformität der Medizinprodukte hat;
b) die sich verändernd
...
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
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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 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
---------------------- Page: 4 ----------------------
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.
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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
2
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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. 55
2 Normative references . 55
3 Terms and definitions . 55
4 Quality management system . 65
4.1 General requirements . 65
4.2 Documentation requirements. . 67
4.2.1 General . 67
4.2.2 Quality manual . 67
4.2.3 Medical device file . 67
4.2.4 Control of documents . 69
4.2.5 Control of records . 69
5 Management responsibility . 71
5.1 Management commitment . 71
5.2 Customer focus . 71
5.3 Quality policy . 71
5.4 Planning . 71
5.4.1 Quality objectives . 71
5.4.2 Quality management system planning . 71
5.5 Responsibility, authority and communication . 71
5.5.1 Responsibility and authority . 71
5.5.2 Management representative . 73
5.5.3 Internal communication . 73
5.6 Management review . 73
5.6.1 General . 73
5.6.2 Review input . 73
5.6.3 Review output . 73
6 Resource management . 75
6.1 Provision of resources . 75
6.2 Human resources . 75
6.3 Infrastructure . 75
6.4 Work environment and contamination control . 77
3
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SIST EN ISO 13485 : 2016
6.4.1 Delovno okolje . 76
6.4.2 Obvladovanje kontaminacije . 76
7 Realizacija proizvoda . 76
7.1 Planiranje realizacije proizvodov . 76
7.2 Procesi, povezani z odjemalci . 78
7.2.1 Določitev zahtev v zvezi s proizvodom . 78
7.2.2 Pregled zahtev v zvezi s proizvodom . 78
7.2.3 Komunikacija . 78
7.3 Snovanje in razvoj . 80
7.3.1 Splošno . 80
7.3.2 Planiranje snovanja in razvoja . 80
7.3.3 Vhodni podatki za snovanje in razvoj . 80
7.3.4 Rezultati snovanja in razvoja . 80
7.3.5 Pregled snovanja in razvoja . 82
7.3.6 Verifikacija snovanja in razvoja . 82
7.3.7 Validacija snovanja in razvoja . 82
7.3.8 Prenos snovanja in razvoja . 84
7.3.9 Obvladovanje sprememb snovanja in razvoja . 84
7.3.10 Dokumentacija snovanja in razvoja . 84
7.4 Nabava . 84
7.4.1 Proces nabave . 84
7.4.2 Informacije za nabavo . 86
7.4.3 Verifikacija nabavljenih proizvodov . 86
7.5 Proizvodnja in izvedba storitev . 86
7.5.1 Obvladovanje proizvodnje in izvedbe storitev . 86
7.5.2 Čistost proizvoda . 88
7.5.3 Nameščanje . 88
7.5.4 Servisiranje . 88
7.5.5 Posebne zahteve za sterilne medicinske pripomočke . 88
7.5.6 Validacija procesov za proizvodnjo in izvedbo storitev . 90
7.5.7 Posebne zahteve za validacijo procesov za sterilizacijo in sterilne barierne sisteme . 90
7.5.8 Identifikacija . 90
7.5.9 Sledljivost . 92
7.5.10 Lastnina odjemalcev . 92
7.5.11 Ohranitev proizvoda . 92
7.6 Obvladovanje nadzorne in merilne opreme . 92
8 Merjenja, analiza in izboljševanje . 94
8.1 Splošno . 94
8.2 Nadzorovanje in merjenje . 94
8.2.1 Povratne informacije . 94
8.2.2 Ravnanje s pritožbami . 96
4
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SIST EN ISO 13485 : 2016
6.4.1 Work environment . 77
6.4.2 Contamination control . 77
7 Product realization . 77
7.1 Planning of product realization . 77
7.2 Customer-related processes . 79
7.2.1 Determination of requirements related to product . 79
7.2.2 Review of requirements related to product . 79
7.2.3 Communication . 79
7.3 Design and development . 81
7.3.1 General . 81
7.3.2 Design and development planning . 81
7.3.3 Design and development inputs . 81
7.3.4 Design and development outputs . 81
7.3.5 Design and development review . 83
7.3.6 Design and development verification . 83
7.3.7 Design and development validation . 83
7.3.8 Design and development transfer . 85
7.3.9 Control of design and development changes . 85
7.3.10 Design and development files . 85
7.4 Purchasing . 85
7.4.1 Purchasing process . 85
7.4.2 Purchasing information . 87
7.4.3 Verification of purchased product . 87
7.5 Production and service provision . 87
7.5.1 Control of production and service provision . 87
7.5.2 Cleanliness of product . 89
7.5.3 Installation activities . 89
7.5.4 Servicing activities . 89
7.5.5 Particular requirements for sterile medical devices . 89
7.5.6 Validation of processes for production and service provision . 91
7.5.7 Particular requirements for v
...
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
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015
---------------------- Page: 3 ----------------------
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
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
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved
---------------------- Page: 4 ----------------------
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
Web www.iso.org
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 . 8
1.1 General …………………………………………………………………………………………………………………………………8
1.2 Application ……………………………………………………………………………………………………………………………8
2 Normative references . 9
3 Terms and definitions . 9
4 Quality management system . 13
4.1 General requirements ………………………………………………………………………………………………………….13
4.2 Documentation requirements ……………………………………………………………………………………………….14
5 Management . 16
5.1 Management commitment ……………………………………………………………………………………………………16
2 © ISO DIS2 13485:2015 – All rights reserved
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oSIST prEN ISO 13485:2015
ISO DIS2 13485:2015
5.2 Customer focus ……………………………………………………………………………………………………………………16
5.3 Quality policy ………………………………………………………………………………………………………………………16
5.4 Planning ………………………………………………………………………………………………………………………………17
5.5 Responsibility, authority and communication ……………………………………………………………………….17
5.6 Management review …………………………………………………………………………………………………………….18
6 Resource management . 18
6.1 Provision of resources ………………………………………………………………………………………………………….18
6.2 Human resources …………………………………………………………………………………………………………………19
6.3 Infrastructure ………………………………………………………………………………………………………………………19
6.4 Work environment ……………………………………………………………………………………………………………….20
7 Product realization …………………………………………………………………………………………………………….….20
7.1 Planning of product realization …………………………………………………………………………………………….20
7.2 Customer-related processes …………………………………………………………………………………………………21
7.3 Design and development …………………………………………………………………………………………………….22
7.4 Purchasing ………………………………………………………………………………………………………………………….25
7.5 Production and service provision ……………………………………………………………………………………….27
7.6 Control of monitoring and measuring devices …………………………………………………………………….30
Measurement, analysis and improvement ……………………………………………………………………………….31
8.1 General …………………………………………………………………………………………………………………………….31
8.2 Monitoring and measurement ……………………………………………………………………………………………31
8.3 Control of nonconforming product …………………………………………………………………………………… 34
8.4 Analysis of data …………………………………………………………………………………………………………………35
8.5 Improvement …………………………………………………………………………………………………………………….35
Annex A (informative) Comparison of content of ISO 13485:2003 and ISO DIS2 13485:2015 ……. 37
Annex ZA (informative) Relationship between this European Standard and the
Conformity Assessment Requirements of EU Directive 90/385/EEC (as amended).………………………91
Annex ZB (informative) Relationship between this European Standard and the
Conformity Assessment Requirements of EU Directive 93/42/EEC. (as amended) .………………………96
© ISO DIS2 13485:2015– All rights reserved 3
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oSIST prEN ISO 13485:2015
ISO DIS 2 13485:2015
Annex ZC (informative) Relationship between this European Standard and the
Conformity Assessment Requirements of EU Directive 98/79/EC (as amended) ……………………………104
Bibliography . 112
4 © ISO DIS2 13485:2015 – All rights reserved
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oSIST prEN ISO 13485:2015
ISO DIS2 13485:2015
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
The committee responsible for this document is ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
This third edition cancels and replaces the second edition (ISO 13485:2003), which has been technically
revised. Details of the changes between the second and this third edition of this Standard are described
in Annex A.
This edition of ISO 13485 addresses quality assurance of product, customer requirements, and other
elements of quality management systems for regulatory purposes.
0 Introduction
0.1 General
This International Standard specifies requirements for a quality management system that can be used
by an organization involved in one or more stage(s) of the life-cycle of a medical device including the
design and development, production, storage and distribution, installation or servicing of medical
devices, and the design, development, or provision of associated activities (e.g. technical support). The
requirements in this standard may also be used by suppliers or other external parties providing
product (e.g., sterilization services, calibration services, distribution services) to such organizations.
Such a supplier or external party may voluntarily choose to conform to the requirements of this
standard or may be required by contract to conform.
Several jurisdictions have regulatory requirements for the application of quality management systems
by organizations with a variety of roles in the supply chain for medical devices. Consequently, this
standard expects that the organization:
identifies its role(s) under applicable regulatory requirements,
identifies the regulatory requirements that are applicable for its activities under these roles, and
incorporates these applicable regulatory requirements within its quality management system.
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oSIST prEN ISO 13485:2015
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This International Standard can also be used by internal and external parties, including certification
bodies, to assess the organization’s ability to meet customer and regulatory requirements applicable to
the quality management system and the organization’s own requirements. It is emphasized that the
quality management system requirements specified in this International Standard are complementary
to the technical requirements for products that are necessary to meet customer and applicable
regulatory requirements for safety and performance.
The adoption of a quality management system is a strategic decision of an organization. The design and
implementation of an organization's quality management system is influenced by:
a) its organizational environment, changes in that environment, and the risks associated with that
environment;
b) its varying needs;
c) its particular objectives;
d) the products it provides;
e) the processes it employs;
f) its size and organizational structure; and
g) applicable regulatory requirements.
It is not the intent of this International Standard to imply uniformity in the structure of quality
management systems or uniformity of documentation.
There is a wide variety of medical devices and some of the particular requirements of this International
Standard only apply to named groups of medical devices. These groups are defined in Clause 3.
0.2 Process approach
This International Standard is based on a process approach to quality management.
Any activity that receives input(s) and converts them to output(s) can be considered as a process. Often
the output from one process directly forms the input to the next process.
For an organization to function effectively, it has to identify and manage numerous linked processes.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred
to as the “process approach.”
When used within a quality management system, such an approach emphasizes the importance of:
a) understanding and meeting requirements,
b) considering processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) improving processes based on objective measurement.
0.3 Relationship with ISO 9001
While this is a stand-alone standard, it is based on, and follows the format of, ISO 9001:2008 for the
convenience of users in the medical device sector.
0.4 Compatibility with other management systems
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oSIST prEN ISO 13485:2015
ISO DIS2 13485:2015
This International Standard does not include requirements specific to other management systems, such
as those particular to environmental management, occupational health and safety management, or
financial management. However, this International Standard enables an organization to align or
integrate its own quality management system with related management system requirements. It is
possible for an organization to adapt its existing management system(s) in order to establish a quality
management system that complies with the requirements of this International Standard.
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oSIST prEN ISO 13485:2015
ISO DIS 2 13485:2015
Medical devices – Quality management systems – Requirements
for regulatory purposes
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system that can be used
by an organization involved in one or more stages of the life-cycle including the design and
development, production, storage and distribution, installation, or servicing of a medical device and the
design, development or provision of associated activities (e.g. technical support). The quality
management system of the organization demonstrates the ability to consistently meet customer and
applicable regulatory requirements. It may also be used by suppliers or external parties that provide
goods and quality management system related services to such organizations.
The main objective of this International Standard is to facilitate global alignment of appropriate
regulatory requirements for quality management systems applicable to organizations providing
medical devices. As a result, it includes some particular requirements for medical devices and excludes
some of the requirements of ISO 9001:2008 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 9001:2008 unless their quality management
system conforms to all the requirements of ISO 9001:2008.
1.2 Application
All requirements of this International Standard are specific to organizations regardless of their type or
size.
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 this International Standard, 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 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 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 this
International Standard reflect exclusion of design and development controls.
If any requirement(s) in Clauses 6, 7 or 8 of this International Standard is (are) not applicable due to the
activities undertaken by the organization or 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. For the clauses that are determined to be not applicable, the organization
documents justification as described section 4.2.2.
In this International standard the following terms or phases are used in the context described below:
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ISO DIS2 13485:2015
When a requirement is qualified by the phrase ‘as appropriate’, it is deemed to be ‘appropriate’
unless the organization can justify otherwise. A requirement is considered ‘appropriate’ if it is
necessary for:
o the product to meet requirements;
o the organization to carry out corrective action; or
o the organization to manage risks.
When a requirement is required to be ‘documented’, it is also required to be established,
implemented and maintained.
When the term ‘risk’ is used, the application of the term is within the scope of this International
standard and pertains to:
o the safety or performance requirements or
o meeting applicable regulatory requirements.
When the term ‘product’ is used, it can also mean ‘service’. Product applies to outputs that are
intended for, or required by, a customer, or any intended output resulting from a product
realization process.
When the term ‘regulatory requirements’ is used, it encompasses statutory, regulatory and legal
requirements. The application of the term ‘regulatory requirements’ is limited to requirements
for the quality management system and the safety or performance of the medical device.
Information marked “NOTE” is for guidance in understanding or clarifying the associated
requirement.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 together with the
following apply. The following definitions should be regarded as generic, as definitions provided in
applicable regulatory requirements can differ slightly and take precedence.
3.1
advisory notice
notice issued by the organization, subsequent to delivery of the medical device, to provide
supplementary information or to advise what action should be taken in the:
• use of a medical device,
• modification of a medical device,
• return of the medical device to the organization that supplied it, or
• destruction of a medical device
NOTE to entry: Issuance of an advisory notice might be required to comply with applicable regulatory
requirements.
3.2
authorized representative
any natural or legal person who has received a documented mandate from a manufacturer to act on his
behalf with respect to applicable regulatory requirements in (a) specified jurisdiction(s)
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3.3
clinical evaluation
assessment and analysis of clinical evidence pertaining to a medical device to verify the clinical safety
and performance of the device when used as intended by the manufacturer
3.4
complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality,
durability, reliability, usability, safety or performance of a medical device that has been released
from the organization’s control or a service that affects the use of such medical devices
3.5
distributor
any natural or legal person in the supply chain who, on their own behalf, furthers the availability of a
medical device to the end user. [SOURCE: GHTF/SG1/N055, definition 5.3]
Note 1 to entry: More than one distributor may be involved in the supply chain.
Note 2 to entry: Persons in the supply chain involved in activities such as storage and transport on behalf of the
manufacturer, importer or distributor, are not distributors under this definition.
3.6
implantable medical device
medical device intended to:
• be totally or partially introduced into the human body or a natural orifice, or
• replace an epithelial surface or the surface of the eye, and
is intended to remain after the procedure for at least 30 days, and which can only be removed by
medical or surgical intervention
3.7
importer
any natural or legal person with responsibility to first make a medical device manufactured in one
jurisdiction available in another specified jurisdiction
Note to entry: A distributor might also act as an importer where it is the first recipient of product from the
manufacturer in a particular country.
3.8
labelling
written, printed, graphic or electronic information:
• affixed to a medical device or any of its containers or wrappers,
• accompanying a medical device, or
• provided for a medical device by other means
related to the identification, technical description, intended purpose and proper use of the medical
device, but excluding shipping documents
NOTE to entry: Applicable regulatory requirements refer to “labelling” as “information supplied by the
manufacturer.” This could include advertising, or marketing information.
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3.9
life-cycle
all phases in the life of a medical device, from the initial conception to final decommissioning and
disposal. [SOURCE: ISO 14971:2007, definition 2.7]
3.10
manufacturer
any natural or legal person with responsibility for design or manufacture of a medical device with the
intention of making the medical device available for use, under their name; whether or not such a
medical device is designed or manufactured by that person or on their behalf by another person(s)
Note 1 to entry: The definition of the “medical device manufacturer” differs from nation to nation and region
to region. The organization needs to understand how the definition in the Standard will be interpreted in light
of regulatory definitions for “medical device manufacturer” or equivalent term in the various nations and
regions in which its medical devices are sold.
Note 2 to entry: This ‘natural or legal person’ has ultimate legal responsibility for ensuring compliance with
applicable regulatory requirements for the medical device in the countries or jurisdictions where it is
intended to be made available or sold, unless this responsibility is specifically imposed on another person by
the Regulatory Authority (RA) within that jurisdiction.
Note 3 to entry: The manufacturer’s responsibilities are described in applicable regulatory requirements.
These responsibilities might include meeting both pre-market requirements and post-market requirements,
such as adverse event reporting and notification of corrective actions.
Note 4 to entry: ‘Design or manufacture’, as referred to in the above definition, may include specification
development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling,
sterilization, installation, or remanufacturing of a medical device; or putting a collection of medical devices,
and possibly other products, together for a medical purpose.
Note 5 to entry: Any person who assembles or adapts a medical device that has already been supplied by
another person for an individual patient, in accordance with the instructions for use, is not the manufacturer,
provided the assembly or adaptation does not change the intended use of the medical device.
Note 6 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on
behalf of the original manufacturer and who makes it available for use under his own name, should be
considered the manufacturer of the modified medical device.
Note 7 to entry: An authorized representative, distributor or importer who only adds its own address and
contact details to the medical device or the packaging, without covering or changing the existing labelling, is
not considered a manufacturer.
Note 8 to entry: To the extent that an accessory is subject to the applicable regulatory requirements of a
medical device, the person responsible for the design or manufacture of that accessory is considered to be a
manufacturer.
[Based on GHTF/SG1/N055:2009, definition 5.1].
3.11
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article, intended by the manufacturer to be used, alone or
in combination, for human beings for one or more of the specific purpose(s) of:
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ISO DIS 2 13485:2015
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices, or
• providing information for medical purposes by means of in vitro examination of specimens
derived from the human body
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
NOTE to entry: Products which might be considered to be medical devices in some jurisdictions but not in others
include:
• disinfection substances,
• aids for persons with disabilities,
• devices incorporating animal or human tissues,
• devices for in-vitro fertilization or assisted reproduction technologies.
[SOURCE: Based on GHTF/SG1/N071 2012, definition 5.1]
3.12
performance evaluation
assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device
to achieve its intended use
3.13
post market surveillance
systematic process to collect and analyse experience gained from medical devices which have been
placed on the market
3.14
risk
combination of the probability of occurrence of harm and the severity of that harm [SOURCE: ISO
14971:2007, definition 2.16]
3.15
risk management
systematic application of management policies, procedures, and practices to the tasks of analyzing,
evaluating, controlling, and monitoring risk [SOURCE: ISO 14971:2007, definition 2.22]
3.16
sterile medical device
medical device intended to meet the requirements for sterility
NOTE to entry: The requirements for sterility of a medical device might be subject to applicable regulatory
requirements or standards.
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oSIST prEN ISO 13485:2015
ISO DIS2 13485:2015
4 Quality management system
4.1 General requirements
4.1.1 The organization shall document
...
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
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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
E-mail copyright@iso.org
Web www.iso.org
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 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
ISO/DIS 13485:201X 1
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oSIST prEN ISO 13485:2014
ISO/DIS 13485:2014(E)
Contents Page
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
Annex A (informative) Explanation of differences between
ISO 13485:201x and ISO 9001:2008
Annex B (informative) Explanation of differences between
ISO 13485:201x and ISO 13485:2003
ISO/DIS 13485:201X 2
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oSIST prEN ISO 13485:2014
ISO/DIS 13485:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting
a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
This third edition cancels and replaces the second edition (ISO 13485:2003), which has been technically
revised. Details of the changes between the second and this third edition of this Standard are described
in Annex B.
This edition of ISO 13485 addresses quality assurance of product, customer requirements, and other
elements of quality management systems for regulatory purposes.
ISO/DIS 13485:201X 3
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oSIST prEN ISO 13485:2014
ISO/DIS 13485:2014(E)
0 Introduction
0.1 General
This International Standard specifies requirements for a quality management system that can be used by
an organization involved in stages of the life-cycle of a medical device including the design and
development, production, storage and distribution, installation or servicing of medical devices, and the
design, development, and provision of associated activities (e.g., technical support). The requirements in
this standard may also be used by suppliers or other external parties providing goods and services (e.g.,
sterilization services, calibration services, distribution services) to medical device organizations. Such a
supplier or external party may voluntarily choose to conform to the requirements of this standard or may
be required by contract to conform.
Several jurisdictions have regulatory requirements for the application of quality management systems by
organizations with a variety of roles in the supply chain for medical devices. Consequently, this standard
expects that the organization
identifies its role(s) under appropriate regulatory requirements,
identifies the regulatory requirements that are appropriate for its activities under these roles, and
incorporates these appropriate regulatory requirements within its quality management system.
This International Standard can also be used by internal and external parties, including certification
bodies, to assess the organization’s ability to meet customer and appropriate regulatory requirements
applicable to the quality management system, and the organization’s own requirements. It is emphasized
that the quality management system requirements specified in this International Standard are
complementary to the technical requirements for products that are necessary to meet customer and
appropriate regulatory requirements for safety and performance.
The adoption of a quality management system should be a strategic decision of an organization. The
design and implementation of an organization's quality management system is influenced by
a) its organizational environment, changes in that environment, and the risks associated with that
environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure, and
g) appropriate regulatory requirements
It is not the intent of this International Standard to imply uniformity in the structure of quality management
systems or uniformity of documentation.
There is a wide variety of medical devices and some of the particular requirements of this International
Standard only apply to named groups of medical devices. These groups are defined in Clause 3.
Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
ISO/DIS 13485:201X 4
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oSIST prEN ISO 13485:2014
ISO/DIS 13485:2014(E)
NOTE Throughout the text of this International Standard, wherever the term ‘product’ occurs, it can also mean
“service.”
0.2 Process approach
This International Standard is based on a process approach to quality management.
An activity or set of activities using resources, and managed in order to enable the transformation of
inputs into outputs, can be considered as a process. Often the output from one process directly forms the
input to the next.
For an organization to function effectively, it has to identify and manage numerous linked processes. The
application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred
to as the “process approach.”
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) improvement of processes based on objective measurement.
0.3 Relationship with other standards
0.3.1 Relationship with ISO 9001
While this is a stand-alone standard, it is based on, and follows the format of, ISO 9001:2008 for the
convenience of users in the medical device sector. Annex A shows the correspondence between
ISO 13485:201X and ISO 9001:2008.
Those clauses or subclauses that are quoted directly and unchanged from ISO 9001:2008 are in normal
font. The fact that these subclauses are presented unchanged is noted in Annex A.
Where the text of this International Standard is not identical to the text of ISO 9001:2008, the sentence or
indent containing that text as a whole is shown in italics (in blue italics for electronic versions). The nature
and reasons for the text changes are noted in Annex A.
It is intended to revise ISO/TR 14969 to provide guidance for the application for this version of ISO
13485.
0.4 Compatibility with other management systems
This International Standard does not include requirements specific to other management systems, such
as those particular to environmental management, occupational health and safety management, or
financial management. However, this International Standard enables an organization to align or integrate
its own quality management system with related management system requirements. It is possible for an
organization to adapt its existing management system(s) in order to establish a quality management
system that complies with the requirements of this International Standard.
ISO/DIS 13485:201X 5
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oSIST prEN ISO 13485:2014
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oSIST prEN ISO 13485:2014
ISO/DIS 13485:2014(E)
Medical devices — Quality management systems —
Requirements for regulatory purposes
1 Scope
1.1 General
This Internrnational Stanndard specifies requiremennts for an orgaanization thatt needs to demmonstrate thaat its
quality maanagement syystem has thee ability to maanage the life--cycle of meddical devices and associateed
activities cconsistently too meet custommer and apprropriate regullatory requiremments. It mayy also be usedd by
suppliers or external paarties that proovide goods aand quality syystem related services to mmedical devicee
organizatiions.
The main objective of tthis Internatioonal Standardd is to facilitatee global alignnment of apprropriate regulaatory
requiremeents for qualityty managemeent systems appplicable to oorganizations providing meedical devicess. As
a result, itt includes somme particular requirementss for medical ddevices and eexcludes somme of the
requiremeents of ISO 90001:2008 that are not apprropriate as reegulatory requuirements. Beecause of thesse
exclusionss, organizatioons whose quuality management systemss conform to this Internatioonal Standardd
cannot claaim conformitty to ISO 9001:2008 unlesss their qualityy managemennt systems coonform to all thhe
requiremeents of ISO 90001:2008 (seee Annex A).
NOTES
1) Thhroughout thiss standard, sttatutory, regulaatory and legaal requirementts are encommpassed in thee term
“rregulatory requirements”.
2) Thhroughout the text of this Innternational Staandard, wherever the term ““product” occurrs, it can also mean
“sservice.” The teerm “product” oonly applies to
a)) product intennded for, or reequired by, a customer, or any intended output resultinng from the pproduct
realization pprocesses.
1.2 Application
All requireements of thiss Internationaal Standard arre specific to oorganizationss regardless oof their type oor
size.
Whereverr requirementts are specifieed as applyingg to medical ddevices, the rrequirements apply equallyy to
associated services ass supplied by the organizattion.
The proceesses required by this Interrnational Stanndard, which are applicablle to the mediical device(s), but
which aree not performeed by the orgaanization, aree the responsiibility of the oorganization aand are accouunted
for in the oorganization’ss quality mannagement system by monittoring, maintaaining, and coontrolling the
processess. These proccesses, and thhe responsibiilities of externrnal parties that undertake such processses
on behalff of the organiization, need to be identifieed in the orgaanization’s quaality managemment system. If
the responnsibilities diffefer due to apppropriate natioonal or regionnal regulatory requirementss, the role of eeach
party needs to be clearrly defined in the quality mmanagement ssystem.
If approprriate regulatorry requiremennts permit excclusions of deesign and devvelopment conntrols, this can be
used as aa justification ffor their excluusion from thee quality manaagement systtem. These reegulatory
requiremeents can provvide alternativee arrangemennts that are too be addresseed in the quallity managemment
system. Itt is the responnsibility of thee organizationn to ensure thaat claims of cconformity witth this Internaational
Standard reflect exclussion of designn and developpment controllss.
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ISO/DIS 13485:2014(E)
If any requirement(s) in Clauses 6, 7 or 8 of this International Standard is (are) not applicable due to the
activities undertaken by the organization or 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.
In this International Standard the term “where appropriate” is used several times. When a requirement is
qualified by this phrase, it is deemed to be “appropriate” unless the organization can justify otherwise. A
requirement is considered “appropriate” if it is necessary for any of the following:
the product to meet specified requirements,
the organization to carry out corrective action
the organization to manage risks.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 together with the following
apply. The following definitions should be regarded as generic, as definitions provided in appropriate
national regulatory requirements can differ slightly and take precedence.
3.1
active implantable medical device
active medical device which is intended to be an implantable medical device
3.2
active medical device
medical device, operation of which depends on a source of electrical energy or any source of power other
than that directly generated by the human body or gravity and which acts by converting this energy.
NOTE Medical devices intended to transmit energy, substances or other elements between an active medical
device and the patient, without any significant change of the energy, substance, or other element, are not considered
to be active medical devices.
3.3
authorised representative
any natural or legal person who has received a documented mandate from a manufacturer to act on his
behalf in respect to appropriate regulatory requirements in (a) specified jurisdiction(s).
3.4
clinical evaluation
assessment and analysis of clinical evidence pertaining to a medical device to verify the clinical safety
and performance of the device when used as intended by the manufacturer.
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3.5
complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability,
reliability, safety or performance of a medical device that has been released from the organization’s
control
3.6
distributor
any natural or legal person in the supply chain who, on his own behalf, furthers the availability of a
medical device to the end user.
NOTES
1) More than one distributor may be involved in the supply chain.
2) Persons in the supply chain involved in activities such as storage and transport on behalf of the
manufacturer, importer or distributor, are not distributors under this definition. [GHTF-SG1-N055]
3.7
advisory notice
notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary
information and/or to advise what action should be taken in
• the use of a medical device,
• the modification of a medical device,
• the return of the medical device to the organization that supplied it, or
• the destruction of a medical device
NOTE Issue of an advisory notice might be required to comply with national or regional regulations.
3.8
implantable medical device
medical device intended
• to be totally or partially introduced into the human body or a natural orifice, or
• to replace an epithelial surface or the surface of the eye,
by surgical intervention, and which is intended to remain after the procedure for at least 30 days, and
which can only be removed by medical or surgical intervention
3.9
importer
any natural or legal person with responsibility to first make a medical device manufactured in one
jurisdiction available in another specified jurisdiction.
3.10
labelling
written, printed ,graphic or electronic information
• affixed to a medical device or any of its containers or wrappers, or
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• accompanying a medical device,
• provided for a medical device by other means
related to identification, technical description, intended purpose and proper use of the medical device, but
excluding shipping documents
NOTE Some appropriate regional and national regulatory requirements refer to “labelling” as “information
supplied by the manufacturer.” This could include advertising or marketing information.
3.11
life-cycle
all phases in the life of a medical device, from the initial conception to final decommissioning and disposal
3.12
manufacturer
any natural or legal person with responsibility for design and/or manufacture of a medical device with the
intention of making the medical device available for use, under their name; whether or not such a medical
device is designed and/or manufactured by that person or on their behalf by another person(s).
NOTES
1) The definition of the “medical device manufacturer” differs from nation to nation and region to region. The
organization needs to understand how the definition in the Standard will be interpreted in light of regulatory
definitions for “medical device manufacturer” or equivalent term in the various nations and regions in which
its medical devices are sold.
2) This ‘natural or legal person’ has ultimate legal responsibility for ensuring compliance with all appropriate
regulatory requirements for the medical device in the countries or jurisdictions where it is intended to be
made available or sold, unless this responsibility is specifically imposed on another person by the
Regulatory Authority (RA) within that jurisdiction.
3) The manufacturer’s responsibilities are described in GHTF guidance documents. These responsibilities
include meeting both pre-market requirements and post-market requirements, such as adverse event
reporting and notification of corrective actions.
4) ‘Design and/or manufacture’, as referred to in the above definition, may include specification development,
production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization,
installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other
products, together for a medical purpose.
5) Any person who assembles or adapts a medical device that has already been supplied by another person
for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the
assembly or adaptation does not change the intended use of the medical device.
6) Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the
original manufacturer and who makes it available for use under his own name, should be considered the
manufacturer of the modified medical device.
7) An authorised representative, distributor or importer who only adds its own address and contact details to
the medical device or the packaging, without covering or changing the existing labelling, is not considered a
manufacturer.
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8) To the extent that an accessory is subject to the appropriate regulatory requirements of a medical device,
the person responsible for the design and/or manufacture of that accessory is considered to be a
manufacturer.
3.13
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific purpose(s) of
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices,
• providing information for medical purposes by means of in vitro examination of specimens derived
from the human body,
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means.
NOTE Products which might be considered to be medical devices in some jurisdictions but not in others include:
• disinfection substances,
• aids for persons with disabilities,
• devices incorporating animal and/or human tissues,
• devices for.in-vitro fertilization or assisted reproduction technologies. [GHTF SG1 N071 2012]
3.14
post market surveillance
systematic process to collect and analyze experience gained from medical devices in the post-production
phase.
3.15
performance evaluation
assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to
achieve its intended use
3.16
risk
combination of the probability of occurrence of harm and the severity of that harm [ISO 14971:2007]
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3.17
risk managa ement
systematiic application of managemeent policies, pprocedures, aand practices to the tasks oof analyzing,
evaluatingg, controlling, and monitoriing risk [ISO 114971:2007]
3.18
sterile meedical devicee
medical ddevice intendeed to meet thee requirements for sterility
NOTE The requiremments for sterillity of a mediccal device mighht be subject tto appropriate national or reegional
regulatory requirements oor standards.
4 Quaality managgement sysstem
4.1 General requirrements
4.1.1 Thhe organizatioon shall documment a qualityy managemennt system andd maintain itss effectiveness in
accordancce with the reequirements oof this Internattional Standaard and approopriate regulattory requiremments.
The organnization shall establish, impplement and maintain any y requirement,, procedure, aactivity or speecial
arrangemment required tto be documeented by this International Standard.
The organnization shall document thee role(s) undeertaken by thee organizationn under the aappropriate
regulatoryy requirementts.
NOTE Example of tthe roles undeertaken by the organization iinclude manuffacturer, authorized represenntative,
importer, ddistributor.
4.1.2 Thhe organizatioon shall
a) determine the prrocesses needed for the quuality manageement systemm and their appplication
thrroughout the oorganization ttaking into account the rolees and responnsibilities of thhe organizatioon,
b) connsider a risk bbased approach when deveeloping the prrocesses neeeded for the qquality
mannagement sysstem
c) deteermine the seequence and interaction off these processses.
NOTE Processes nneeded for the quality mannagement sysstem referred to above incclude processes for
managemeent activities, pprovision of reesources, produuct realization,, and measureement, analysiis, and improvvement
including ppost market surveillance.
4.1.3 Foor each qualityy management system proocess, the orgganization shaall
a) determine ccriteria and meethods needeed to ensure tthat both the operation andd control of thhese
processes aare effective,
b) ensure the aavailability of resources annd informationn necessary tto support thee operation annd
monitoring oof these proceesses,
c) monitor, meeasure where applicable, aand analyze thhese processses,
d) implement aactions necesssary to achieeve planned rreesults and maaintain the effffectiveness oof
these proceesses, and
e) establish annd maintain reecords needeed to demonsttrate conformmance to this International
Standard annd compliancee with approppriate regulatoory requiremeents (see 4.2.4).
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4.1.4 Thhese processees shall be mmanaged by thhe organizatioon in accordannce with the rrequirements of
this Internnational Standdard and apprropriate regullatory requiremments. Channges to be maade to these
processess shall be evaaluated for theeir impact on the quality mmanagement ssystem and thhe medical deevices
produced by this system and controolled in accorddance with thee requiremennts of this Inteernational
...
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