Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003)

Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation ihre Fähigkeit zur Bereitstellung von Medizinprodukten und zugehörigen Dienstleistungen darzulegen hat, die ständig die Anforderungen der Kunden und die für Medizinprodukte und zugehörige Dienstleistungen zutreffenden gesetzlichen Anforderungen erfüllen.
Das primäre Ziel dieser Internationalen Norm ist die Ermöglichung der Harmonisierung der für Medizinprodukte zutreffenden gesetzlichen Anforderungen an Qualitätsmanagementsysteme. Im Ergebnis dessen enthält sie einige besondere Anforderungen an Medizinprodukte und schließt einige Anforderungen von ISO 9001 aus, die nicht als Anforderungen für gesetzliche Zwecke geeignet sind. Wegen dieser Ausschlüsse können Organisationen, deren Qualitätsmanagementsysteme dieser Internationalen Norm entsprechen, keine Konformität mit ISO 9001 beanspruchen, außer wenn ihr Qualitätsmanagementsystem mit allen Anforderungen von ISO 9001 konform ist (siehe Anhang B).

Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003)

L'ISO 13485:2003 énonce les exigences relatives au système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir régulièrement des dispositifs médicaux et des services associés conformes aux exigences des clients et aux exigences réglementaires applicables aux dispositifs médicaux et aux services associés.
Le principal objectif de l'ISO 13485:2003 est de faciliter la mise en oeuvre d'exigences réglementaires harmonisées en matière de dispositifs médicaux, dans le cadre des systèmes de management de la qualité. Par conséquent, elle comprend certaines exigences particulières concernant les dispositifs médicaux, mais certaines exigences de l'ISO 9001, non appropriées en tant qu'exigences réglementaires, en sont exclues. Du fait de ces exclusions, les organismes dont les systèmes de management de la qualité sont conformes à l'ISO 13485:2003 ne peuvent revendiquer la conformité à l'ISO 9001 que si leurs systèmes de management de la qualité sont conformes à l'ensemble des exigences de l'ISO 9001.
Toutes les exigences de l'ISO 13485:2003 sont spécifiques aux organismes fournissant des dispositifs médicaux, indépendamment du type ou de la taille de l'organisme.
Le fait que des exigences réglementaires autorisent l'exclusion des systèmes de contrôle de conception et de développement peut servir à justifier leur exclusion du système de management de la qualité. Ces réglementations peuvent prévoir d'autres dispositions qui doivent être appliquées dans le système de management de la qualité. Il incombe à l'organisme de s'assurer que ses demandes de conformité à l'ISO 13485:2003 correspondent à l'exclusion des systèmes de contrôle de conception et de développement.
Lorsqu'une ou plusieurs exigences définies à l'Article 7 de l'ISO 13485:2003 ne peuvent être appliquées en raison de la nature du ou des dispositifs médicaux auxquels s'applique le système de management de la qualité, l'organisme n'est pas tenu d'inclure cette (ces) exigence(s) dans son système de management de la qualité.
Les processus requis par l'ISO 13485:2003, qui sont applicables au(x) dispositif(s) médical (médicaux) mais non adoptés par l'organisme, relèvent de la responsabilité de ce dernier qui en tient compte dans son système de management de la qualité.

Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2003)

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

General Information

Status
Withdrawn
Publication Date
12-Mar-2012
Withdrawal Date
19-Apr-2016
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
20-Apr-2016
Due Date
13-May-2016
Completion Date
20-Apr-2016

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SLOVENSKI STANDARD
SIST EN ISO 13485:2012
01-april-2012
1DGRPHãþD
SIST EN ISO 13485:2003
SIST EN ISO 13485:2003/AC:2009
0HGLFLQVNLSULSRPRþNL6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]D]DNRQRGDMQH
QDPHQH ,62

Medical devices - Quality management systems - Requirements for regulatory purposes

(ISO 13485:2003)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2003)

Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins

réglementaires (ISO 13485:2003)
Ta slovenski standard je istoveten z: EN ISO 13485:2012
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 13485:2012 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 13485:2012
---------------------- Page: 2 ----------------------
SIST EN ISO 13485:2012
EUROPEAN STANDARD
EN ISO 13485
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2012
ICS 03.120.10; 11.040.01 Supersedes EN ISO 13485:2003
English version
Medical devices - Quality management systems - Requirements
for regulatory purposes (ISO 13485:2003)

Dispositifs médicaux - Systèmes de manegement de la Medizinprodukte - Qualitätsmanagementsysteme -

qualité - Exigences à des fins réglementaires (ISO Anforderungen für regulatorische Zwecke (ISO

13485:2003) 13485:2003)
This European Standard was approved by CEN on 24 January 2012.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving

this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning

such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre

has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United

Kingdom.
CEN-CENELEC Management Centre,
Avenue Marnix 17, B-1000 Brussels

© 2012 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13485:2012 E

worldwide for CEN national Members and for CENELEC
Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Conformity

Assessment Requirements of EU Directive 90/385/EEC ...................................................................5

Annex ZB (informative) Relationship between this European Standard and the Conformity

Assessment Requirements of EU Directive 93/42/EEC .................................................................. 10

Annex ZC (informative) Relationship between this European Standard and the Conformity

Assessment Requirements of EU Directive 98/79/EC ..................................................................... 17

---------------------- Page: 4 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
Foreword

The text of the International Standard ISO 13485:2003 has been prepared by Technical Committee ISO/TC

210 "Quality management and corresponding general aspects for medical devices, Working Group 1". The

transposition into a European Standard has been managed by the CEN-CENELEC Management Centre

(CCMC) with the assistance of the CEN-CENELEC Technical Committee 3 "Quality Management and

corresponding general aspects for medical devices".

This European Standard shall be given the status of a national standard, either by publication of an identical

text or by endorsement, at the latest by August 2012, and conflicting national standards shall be withdrawn at

the latest by August 2012.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports quality system requirements of EU Medical Devices

Directives. Compliance with EN ISO 13485 does not provide a presumption of conformity with all the aspects

of the quality systems of the Medical Devices Directives. It is important that the organization and the Notified

Body identify the regulatory requirements that are not covered by the standard. The Annexes Z of this

standard shall be used for this purpose, describing the relationship between this European Standard and the

conformity assessment requirements of the Medical Devices Directives.
This document supersedes EN ISO 13485:2003.

NOTE The following is specifically intended for organizations that need to comply with one or more of the European

Directives for medical devices (90/385/EEC, 93/42/EEC and 98/79/EC) in order to affix CE marking on their products and

for other parties involved in that process whilst other Directives might also require a CE marking.

Where organizations wish to implement quality systems in conformance with Directives 90/385/EEC,

93/42/EEC and 98/79/EC, they may use EN ISO 13485:2012. EN ISO 13485:2012 provides a framework to

enable a manufacturer to meet some of the quality system requirements for an EC Declaration of Conformity

(Annex 2 and Annex 5 of Directive 90/385/EEC; Annex II, V and VI of Directive 93/42/EEC; or Annex III, IV

and VII of Directive 98/79/EC).

In seeking compliance with the quality systems requirements of the Medical Devices Directives, organizations

may exclude specific requirements from EN ISO 13485. The table below shows the exclusions that are

permitted.

The European Directives use the term "quality system" whereas EN ISO 13485 uses the term "quality management

system" in accordance with ISO terminology.
---------------------- Page: 5 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
Directive 90/385/EEC Directive 93/42/EEC Directive 98/79/EC

For Annex 2, no exclusions are For Annex II, no exclusions are For Annex III and IV, no

permitted permitted exclusions are permitted

For Annex 5, exclusion of 7.3 of For Annex V, exclusion of 7.3 For Annex VII, exclusion of 7.3

EN ISO 13485 is permitted from EN ISO 13485 is permitted from EN ISO 13485 is permitted

For Annex VI, exclusion of 7.3,
7.5.1 and 7.5.2 from EN ISO
13485 are permitted

It should be noted that where the exclusions described in 1.2 of EN ISO 13485:2012 are exceeded, conformity

to EN ISO 13485:2012 shall not be claimed.

The requirements in ISO 13485:2003 describe a systematic approach, within which manufacturers can

identify, review and decide on the appropriate manner to incorporate regulatory requirements, other

standards, and regulatory guidance documents into their quality management system. In this context, EN ISO

13485 requires the manufacturer to provide quality management system elements including: necessary

resources, infrastructure and competent personnel; documentation and records for the operation of the quality

management system; systems of internal audit and management review; systems to address nonconformity,

corrective action and preventive action.

It should be noted that EN ISO 13485:2012 is a quality management system for medical devices specifically

for regulatory purposes. It is based on EN ISO 9001:2000 but in particular the requirements for “customer

satisfaction” and “continual improvement” have been modified. Therefore, while EN ISO 13485:2012 has the

same format as EN ISO 9001:2000 and most of the same requirements, compliance with EN ISO 13485:2012

does not provide conformity with EN ISO 9001:2000.

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, 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.
Endorsement notice

The text of ISO 13485:2003 has been approved by CEN as a EN ISO 13485:2012 without any modification.

---------------------- Page: 6 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Conformity Assessment
Requirements of EU Directive 90/385/EEC
ZA.1 General

This European Standard has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association to provide a means by which a manufacturer may demonstrate

conformity, and by which the Notified Body may assess the manufacturer's conformity, with the requirements

of Directive 90/385/EEC on active implantable medical devices.

Within the limits of the scope of this standard (Clause 1 of EN ISO 13485:2012), compliance with the

normative clauses of this standard according to the qualifying remarks presented in Tables ZA.1 and ZA.2

confers 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, once this standard is cited in the Official

Journal of the European Union under that Directive and has been implemented as a national standard in at

least one Member State. This Annex ZA explains to which requirements, under which conditions and to what

extent presumption of conformity can be claimed.

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 EN ISO 13485 and

therefore not covered by this 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 if 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.

ZA.2 Relationship with Annex 2 of Directive 90/385/EEC

Compliance with EN ISO 13485 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.

This annex uses the term "quality system" as used in the Directive whereas EN ISO 13485 uses the term "quality

management system" in accordance with ISO terminology.
---------------------- Page: 7 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)

Table ZA.1 ― Relationship between Annex 2 of Directive 90/385/EEC and the clauses of EN ISO 13485

Paragraph of Directive Clause(s) of EN Comments/Qualifying remarks
90/385/EEC, Annex 2 ISO 13485
3.1 first sentence Not covered
3.1 second sentence Not covered
1 indent
3.1 second sentence 4.1, 4.2 Partial coverage: The documentation required in
4.2 of the standard does not cover entirely the
2 indent
quality system documentation meant in 3.2 of
Annex 2 unless the explicit legal requirements
are incorporated into the quality system
documentation. See also coverage of 3.2 below.
3.1 second sentence Not covered
3 indent
3.1 second sentence Not covered
4 indent
3.1 second sentence 5 Not covered
indent
3.2 first paragraph Not covered. The application of EN ISO 13485
does not by itself assure the fulfilment of all
regulatory requirements of Directive 90/385/EEC.
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.
3.2 second paragraph, first 4.1, 4.2 Covered
sentence
3.2 second paragraph, 4.1, 4.2 Covered
second sentence
3.2 second paragraph, third Not covered
sentence
3.2 third paragraph (a) 4.2.1, 5.1, 5.3, Covered
5.4.1
3.2 third paragraph (b) 4.2.2, 5.1.1 Covered
3.2 third paragraph (b) 4.2.2, 5.1, 5.5.1, Covered
5.5.2
1 indent

3.2 third paragraph (b) 2 4.1, 5.6, 7.1, Covered provided that the methods and criteria

indent 8.2.2, 8.3, 8.4, chosen by the manufacturer ensure that the
8.5.2, 8.5.3 requirements of the Directive are fulfilled.

3.2 third paragraph (b) 3 4.1, 7.4, 8.5.1 Covered provided that the processes are

indent documented in accordance with 4.2.1.

3.2 third paragraph (c) 1 4.1, 5.6, 7.1, Covered provided that the methods and criteria

indent 8.2.2, 8.3, 8.4, chosen by the manufacturer ensure that the
8.5.2, 8.5.3 requirements of the Directive are fulfilled and
there is a description of the standards that will be
---------------------- Page: 8 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
applied.
3.2 third paragraph (c) 7.3.1, 7.3.5, 7.3.6, Covered
7.3.7
2 indent
3.2 third paragraph (c) Not covered
3 indent
3.2 third paragraph (c) Not covered
4 indent
3.2 third paragraph (c) Not covered
5 indent
3.2 third paragraph (d) 6.4, 7.5.1, 7.5.2 Covered
1 indent, sterilization
3.2 third paragraph (d) 7.4 Covered
1 indent, purchasing
3.2 third paragraph (d) 4.2, 7.1 Covered
1 indent, relevant
documents
3.2 third paragraph (d) 4.2, 7.5.3, Covered
2 indent

3.2 third paragraph (e) 4.2, 7.1, 7.5.3.2.1, Covered provided that the frequency at which

7.6, 8.2.4 tests are carried out is documented and that test
results can be traced to the test equipment used.
---------------------- Page: 9 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
ZA.3 Relationship with Annex 5 of Directive 90/385/EEC

Compliance with EN ISO 13485 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 ― Relationship between Annex 5 of Directive 90/385/EEC and the clauses of EN ISO 13485

Paragraph of Directive Clause(s) of EN Comments/Qualifying remarks
90/385/EEC, Annex 5 ISO 13485
3.1first paragraph Not covered
3.1 second paragraph Not covered
1 indent
3.1 second paragraph 4.1, 4.2 Partial coverage: The documentation required in
4.2 of the standard does not cover entirely the
2 indent
quality system documentation meant in 3.2 of
Annex 5 unless the explicit legal requirements
are incorporated into the quality system
documentation. See also coverage of 3.2 below.
3.1 second paragraph Not covered
3 indent
3.1 second paragraph Not covered
4 indent
3.1 second paragraph Not covered
5 indent
3.1 second paragraph Not covered
6 indent
3.2 first paragraph Not covered. The application of EN ISO 13485
does not by itself assure the fulfilment of all
regulatory requirements of Directive 90/385/EEC.
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.
3.2 second paragraph 4.1, 4.2 Covered
3.2 third paragraph (a) 4.2.1, 5.1, 5.3, Covered
5.4.1
3.2 third paragraph (b) 5.5.1, 5.5.2 Covered
1 indent

3.2 third paragraph (b) 4.1, 5.6, 7.1, Covered provided that the methods and criteria

8.2.2, 8.3, 8.4, chosen by the manufacturer ensure that the
2 indent
8.5.2, 8.5.3 requirements of the Directive are fulfilled.
3.2 third paragraph (b) 4.1, 7.4, 8.5.1 Covered provided that the processes are
documented in accordance with 4.2.1.
3 indent
3.2 third paragraph (c) 6.4, 7.5.1, 7.5.2 Covered
---------------------- Page: 10 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
1 indent, sterilization
3.2 third paragraph (c) 7.4 Covered
1 indent, purchasing
3.2 third paragraph (c) 4.2, 7.1 Covered
1 indent, relevant
documents
3.2 third paragraph (c) 4.2, 7.5.3 Covered
2 indent

3.2 third paragraph (d) 4.2, 7.1, 7.5.3.2.1, Covered provided that the frequency at which

7.6, 8.2.4 tests are carried out is documented and that test
results can be traced to the test equipment used.

WARNING ― The preceding text and tables are specifically intended for organizations that need to

comply with the European Directive 90/385/EEC in order to affix CE marking on their products and for

other parties involved in that process. Other Directives might also be applicable and require a CE

marking.
---------------------- Page: 11 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
Annex ZB
(informative)
Relationship between this European Standard and the Conformity Assessment
Requirements of EU Directive 93/42/EEC
ZB.1 General

This European Standard has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association to provide a means by which a manufacturer may demonstrate

conformity, and by which the Notified Body may assess the manufacturer's conformity, with the requirements

of Directive 93/42/EEC on medical devices.

Within the limits of the scope of this standard (Clause 1 of EN ISO 13485:2012), compliance with the

normative clauses of this standard according to the qualifying remarks presented in Tables ZB.1, ZB.2 and

ZB.3 confers 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, once this standard is cited in the

Official Journal of the European Union under that Directive and has been implemented as a national standard

in at least one Member State. This Annex ZB explains to which requirements, under which conditions and to

what extent presumption of conformity can be claimed.

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 EN ISO 13485 and

therefore not covered by this 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 if the 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.

ZB.2 Relationship with Annex II of Directive 93/42/EEC

Compliance with EN ISO 13485 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.

This annex uses the term "quality system" as used in the Directive whereas EN ISO 13485 uses the term "quality

management system" in accordance with ISO terminology.
---------------------- Page: 12 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)

Table ZB.1 ― Relationship between Annex II of Directive 93/42/EEC and the clauses of EN ISO 13485

Paragraph of Directive Clause(s) of EN ISO Comments/Qualifying remarks
93/42/EEC, Annex II 13485
3.1 first sentence Not covered
3.1 second sentence Not covered
1 indent
3.1 second sentence 2 Not covered
indent
3.1 second sentence 3 Not covered
indent
3.1 second sentence 4 4.1, 4.2 Partial coverage: The documentation required in
indent 4.2 of the standard does not cover entirely the
quality system documentation detailed in 3.2 of
Annex II unless the explicit legal requirements
are incorporated into the quality system
documentation. See also coverage of 3.2 below.
3.1 second sentence 5 4.1, 5.1, 5.4, 5.5, 5.6 Covered
indent
3.1 second sentence 6 4.1, 5.1, 5.4, 5.5, 5.6 Covered
indent
3.1 second sentence 7 Not covered
indent
3.2 first paragraph Not covered. The application of EN ISO 13485
does not by itself assure the fulfilment of all
first sentence
regulatory requirements of Directive 93/42/EEC.
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.
3.2 first paragraph 4.1, 4.2 Covered
second sentence
3.2 second paragraph Not covered
3.2 third paragraph (a) 4.2.1, 5.1, 5.3, 5.4.1 Covered
3.2 third paragraph (b) 4.2.2, 5.1.1 Covered
3.2 third paragraph (b) 1 4.2.2, 5.1, 5.5.1, Covered
indent 5.5.2

3.2 third paragraph (b) 2 4.1, 5.6, 7.1, 8.2.2, Covered provided that the methods and 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 third paragraph (b) 3 4.1, 4.2, 7.4, 8.5.1 Covered provided that control processes are

indent documented in accordance with 4.2.1.
3.2 third paragraph (c) 7.1, 7.2, 7.3 Covered
3.2 third paragraph (c) 1 Not covered
indent

3.2 third paragraph (c) 2 7.1, 7.2, 7.3.2, 7.3.3, Covered provided that there is a description of

---------------------- Page: 13 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
indent 7.3.6 the standards that will be applied.
3.2 third paragraph (c) 3 7.3.1, 7.3.5, 7.3.6, Covered
indent 7.3.7
3.2 third paragraph (c) 4 7.3.2, 7.3.3, 7.3.5, Covered
indent 7.3.6
3.2 third paragraph (c) 5 Not covered
indent
3.2 third paragraph (c) 6 Not covered
indent
3.2 third paragraph (c) 7 Not covered
indent
3.2 third paragraph (c) 8 Not covered
indent
3.2 third paragraph (c) 9 Not covered
indent
3.2 third paragraph (c) Not covered
10 indent
3.2 third paragraph (d) 6.4, 7.5.1, 7.5.2 Covered
1 indent, sterilization
3.2 third paragraph (d) 7.4 Covered
1 indent, purchasing
3.2 third paragraph (d) 4.2, 7.1 Covered
1 indent, relevant
documents
3.2 third paragraph (d) 4.2, 7.5.3 Covered
2 indent

3.2 third paragraph (e) 4.2, 7.1, 7.5.3.2.1, Covered provided that the frequency at which

7.6, 8.2.4 tests are carried out is documented and that test
results can be traced to the test equipment used.
---------------------- Page: 14 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
ZB.3 Relationship with Annex V of Directive 93/42/EEC

Compliance with EN ISO 13485 does not provide presumption of conformity with all the aspects of Annex V,

as outlined in Table ZB.2. Therefore, a manufacturer or a Notified Body has to take additional provisions to

ensure conformity, and claim or certify conformance, with Annex V 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.2 ― Relationship between Annex V of Directive 93/42/EEC and the clauses of EN ISO 13485

Paragraph of Directive Clause(s) of EN ISO Comments/Qualifying remarks
93/42/EEC, Annex V 13485
3.1 Not covered
3.1 second paragraph 1 Not covered
indent
3.1 second paragraph 2 Not covered
indent
3.1 second paragraph 3 Not covered
indent
3.1 second paragraph 4 4.1, 4.2 Partial coverage: The documentation required in
indent 4.2 of the standard does not cover entirely the
quality system documentation meant in 3.2 of
Annex V unless the explicit legal requirements
are incorporated into the quality system
documentation. See also coverage of 3.2 below.
3.1 second paragraph 5 4.1, 5.1, 5.4, 5.5, 5.6 Covered
indent
3.1 second paragraph 6 4.1, 5.1, 5.4, 5.5, 5.6 Covered
indent
3.1 second paragraph 7 Not covered
indent
3.1 second paragraph 8 Not covered
indent
3.1 second paragraph 8
indent (i)
3.1 second paragraph 8
indent (ii)
3.2 first paragraph Not covered. The application of EN ISO 13485
does not by itself assure the fulfilment of all
regulatory requirements of Directive 93/42/EEC.
---------------------- Page: 15 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
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.
3.2 second paragraph 4.1, 4.2 Covered
3.2 third paragraph (a) 4.2.1, 5.1, 5.3, 5.4.1 Covered
3.2 third paragraph (b) 4.2.2 Covered
3.2 third paragraph (b) 1 5.1, 5.5.1, 5.5.2 Covered
indent

3.2 third paragraph (b) 2 4.1, 5.6, 7.1, 8.2.2, Covered provided that the methods and criteria

indent 8.3, 8.5.2 chosen by the manufacturer ensure that the
requirements of the directive are fulfilled.

3.2 third paragraph (b) 3 4.1, 4.2.1, 7.4, 8.5.1 Covered provided that control processes are

indent documented in accordance with 4.2.1.

3.2 third paragraph (c) 1 6.4, 7.5.1, 7.5.2 Covered provided that the explicit requirements

indent, sterilization of the Directive are incorporated into the quality
system documentation.
3.2 third paragraph (c) 1 7.4 Covered
indent, purchasing
3.2 third paragraph (c) 1 4.2, 7.1 Covered
indent, relevant
documents
3.2 third paragraph (c) 2 4.2, 7.5.3 Covered
indent

3.2 third paragraph (d) 4.2, 7.1, 7.5.3.2.1, Covered provided that the frequency at which

7.6, 8.2.4 tests are carried out is documented and that test
results can be traced to the test equipment used.
---------------------- Page: 16 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
ZB.4 Relationship with Annex VI of Directive 93/42/EEC

Compliance with EN ISO 13485 does not provide presumption of conformity with all the aspects of Annex VI,

as outlined in Table ZB.3. Therefore, a manufacturer or a Notified Body has to take additional provisions to

ensure conformity, and claim or certify conformance, with Annex VI 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.3 ― Relationship between Annex VI of Directive 93/42/EEC and the clauses of EN ISO 13485

Paragraph of Directive Clause(s) of EN ISO Comments/Qualifying remarks
93/42/EEC, Annex VI 13485
3.1first paragraph Not covered
3.1 second paragraph Not covered
1 indent
3.1 second paragraph Not covered
2 indent
3.1 second paragraph Not covered
3 indent
3.1 second paragraph 4.1, 4.2 Partial coverage: The documentation required in
4 indent 4.2 of the standard does not cover entirely the
quality system documentation detailed in 3.2 of
Annex VI unless the explicit legal requirements
are incorporated into the quality system
documentation. See also coverage of 3.2 below.
3.1 second paragraph 4.1, 5.4, 5.5, 5.6 Covered
5 indent
3.1 second paragraph 4.1, 5.4, 5.5, 5.6 Covered
6 indent
3.1 second paragraph Not covered
7 indent
3.1 second paragraph Not covered
8 indent
3.1 second paragraph
8 indent (i)
3.1 second paragraph
8 indent (ii)
---------------------- Page: 17 ----------------------
SIST EN ISO 13485:2012
EN ISO 13485:2012 (E)
3.2 first sentence Not covered
3.2 second and third 4.1, 4.2 Covered
sentences
3.2 second paragraph 4.2.1, 5.1, 5.3, 5.4.1 Covered
1 indent

3.2 second paragraph 4.2, 7.1, 7.6, 8.2.4 Covered provided that the frequency at which

tests are carried out is documented and that test
results can be traced to the test equipment used.
2 indent
3.2 second paragraph 4.1, 5.6, 7.1, 8.2.2, Covered provided that the methods and
8.3, 8.4, 8.5.2, 8
...

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