SIST EN ISO 13485:2003

SLOVENSKI STANDARD
SIST EN ISO 13485:2003
01-november-2003
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SIST EN ISO 13485:2002
SIST EN ISO 13488:2002
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Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2003)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2003)
Dispositifs médicaux - Systemes de manegement de la qualité - Exigences a des fins
réglementaires (ISO 13485:2003)
Ta slovenski standard je istoveten z: EN ISO 13485:2003
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 13485:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 13485
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2003
ICS 03.120.10; 11.040.01 Supersedes EN ISO 13485:2000 and EN ISO 13488:2000
English version
Medical devices - Quality management systems - Requirements
for regulatory purposes (ISO 13485:2003)
Dispositifs médicaux - Systèmes de manegement de la Qualitätssicherungssysteme - Medizinprodukte -
qualité - Exigences à des fins réglementaires (ISO Systemanforderungen zur Erfüllung gesetzlicher
13485:2003) Anforderungen (ISO 13485:2003)
This European Standard was approved by CEN on 16 June 2003.
CEN 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 Management Centre or to any CEN 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 member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13485:2003 E
worldwide for CEN national Members.

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EN ISO 13485:2003 (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 Management Centre (CMC) with the assistance of the CEN/CENELEC Co-ordinating
Working Group on quality supplements for medical devices.
This European Standard supersedes EN ISO 13485:2000 and EN ISO 13488:2000.
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 January 2004, and conflicting national
standards shall be withdrawn at the latest by July 2006.
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
Directive(s).
For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this
document.
NOTE The following is specifically intended for organisations that need to comply with
one or more of the “New Approach” 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
to other parties involved in that process.
The publication of EN ISO 13485:2003 has implications for Council Decision 93/465/EEC of 22
July 1993 concerning the modules for the various phases of the conformity assessment
procedures and the rules for affixing and use of the CE conformity marking, which are intended
to be used in the technical harmonization directives. It is important to note that the modules used
in individual technical harmonization directives may vary in some respects compared to those
described in Council Decision 93/465/EEC. In all cases, it is the annex of the applicable
directive(s) which is legally binding. The principles set out in this foreword remain valid
regardless of these variations.
Two of the modules cited in Council Decision, i.e. modules D and H, require that “the
manufacturer must operate an approved quality system”. The scope of the quality systems
required by these modules addresses:
- Production, final inspection and testing (module D),
- Design manufacture and final product inspection and testing (module H).
Where organizations wish to implement quality management systems in conformance with
modules D or H, they may use EN ISO 13485:2003. In seeking compliance with modules D or H
organizations may exclude specific requirements.
Where organizations wish to implement quality management systems in conformance with
module E, they may use EN 46003:1999 (which is in the process of being revised into the format
of EN ISO 13485:2003)
2

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EN ISO 13485:2003 (E)
Module D Module H
Permissible exclusions Permissible exclusions
Sub-clause 7.3: design and development NO exclusions permitted
Module D is the basis for annex V of 93/42/EEC directive and the basis for annex VII of
98/79/EC directive.
Module H is the basis for annex 2 of 90/385/EEC directive, for annex II of 93/42/EEC directive
and for annex II of 98/79/EC directive.
It should be noted that EN ISO 13485:2003 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 13485:2003 has the same format as EN ISO 9001:2000 and most of
the same requirements, compliance with EN ISO 13485:2003 does not provide conformity with
EN ISO 9001:2000.
It should be noted that where the exclusions described in sub-clause 1.2 of EN ISO 13485:2003
are exceeded, conformity to EN ISO 13485:2003 shall not be claimed.
According to CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 13485:2003 has been approved by CEN as EN ISO 13485:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
3

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EN ISO 13485:2003 (E)
Annex ZA
(normative)
Normative references to international publications with their corresponding
European publications
This European Standard incorporates, by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text, and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by (mod.),
the relevant EN/HD applies.
Publication Year Title EN/HD Year
ISO 9000 2000 Quality management systems – EN ISO 9000 2000
Fundamentals and vocabulary
4

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EN ISO 13485:2003 (E)
Annex ZB
(informative)
Relationship of this document with EC Directives
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 EC
Directive(s) :
- EC Directive 93/42/E(E)C
Compliance with this document provides one means of conforming with the specific essential
requirements of the Directive concerned and associated EFTA regulations.
WARNING: Other requirements and other EC Directives may be applicable to the product(s)
falling within the scope of this document.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
5

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INTERNATIONAL ISO
STANDARD 13485
Second edition
2003-07-15


Medical devices — Quality management
systems — Requirements for regulatory
purposes
Dispositifs médicaux — Systèmes de management de la qualité —
Exigences à des fins réglementaires





Reference number
ISO 13485:2003(E)
©
ISO 2003

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ISO 13485:2003(E)
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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ii © ISO 2003 — All rights reserved

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ISO 13485:2003(E)
Contents Page
Foreword. iv
0 Introduction . v
0.1 General. v
0.2 Process approach . v
0.3 Relationship with other standards . vi
0.4 Compatibility with other management systems . vi
1 Scope. 1
1.1 General. 1
1.2 Application. 1
2 Normative references . 2
3 Terms and definitions. 2
4 Quality management system . 4
4.1 General requirements . 4
4.2 Documentation requirements . 4
5 Management responsibility. 6
5.1 Management commitment. 6
5.2 Customer focus. 6
5.3 Quality policy. 6
5.4 Planning . 7
5.5 Responsibility, authority and communication. 7
5.6 Management review. 8
6 Resource management. 8
6.1 Provision of resources . 8
6.2 Human resources. 9
6.3 Infrastructure. 9
6.4 Work environment. 9
7 Product realization. 10
7.1 Planning of product realization . 10
7.2 Customer-related processes. 10
7.3 Design and development. 11
7.4 Purchasing. 13
7.5 Production and service provision . 14
7.6 Control of monitoring and measuring devices . 17
8 Measurement, analysis and improvement. 17
8.1 General. 17
8.2 Monitoring and measurement. 18
8.3 Control of nonconforming product . 19
8.4 Analysis of data. 19
8.5 Improvement. 20
Annex A (informative) Correspondence between ISO 13485:2003 and ISO 13485:1996. 21
Annex B (informative) Explanation of differences between ISO 13485:2003 and ISO 9001:2000 . 25
Bibliography . 57

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ISO 13485:2003(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 second edition cancels and replaces the first edition (ISO 13485:1996), which has been technically
revised. It also cancels and replaces ISO 13488:1996. Those organizations which have used ISO 13488 in the
past may use this International Standard by excluding certain requirements in accordance with 1.2.
This edition of ISO 13485 has a revised title and addresses quality assurance of product, customer
requirements, and other elements of quality system management.
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ISO 13485:2003(E)
0 Introduction
0.1 General
This International Standard specifies requirements for a quality management system that can be used by an
organization for the design and development, production, installation and servicing of medical devices, and
the design, development, and provision of related services.
It can also be used by internal and external parties, including certification bodies, to assess the organization’s
ability to meet customer and regulatory requirements.
Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
It is emphasized that the quality management system requirements specified in this International Standard
are complementary to technical requirements for products.
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 varying needs,
particular objectives, the products provided, the processes employed and the size and structure of the
organization. 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 inputs and converts them to outputs can be considered as a process.
For an organization to function effectively, it has to identify and manage numerous linked processes.
Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management, can be referred to as the “process approach”.
0.3 Relationship with other standards
0.3.1 Relationship with ISO 9001
While this is a stand-alone standard, it is based on ISO 9001.
Those clauses or subclauses that are quoted directly and unchanged from ISO 9001 are in normal font. The
fact that these subclauses are presented unchanged is noted in Annex B.
Where the text of this International Standard is not identical to the text of ISO 9001, 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 B.
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ISO 13485:2003(E)
0.3.2 Relationship with ISO/TR 14969
ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO 13485.
0.4 Compatibility with other management systems
This International Standard follows the format of ISO 9001 for the convenience of users in the medical device
community.
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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INTERNATIONAL STANDARD ISO 13485:2003(E)

Medical devices — Quality management systems —
Requirements for regulatory purposes
1 Scope
1.1 General
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).
1.2 Application
All requirements of this International Standard are specific to organizations providing medical devices,
regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used
as a justification for their exclusion from the quality management system. These regulations 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 [see 4.2.2 a) and 7.3].
If any requirement(s) in Clause 7 of this International Standard is(are) not applicable due to 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 [see 4.2.2 a)].
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 [see 4.1 a)].
In this International Standard the terms “if appropriate” and “where appropriate” are used several times. When
a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization
can document a justification otherwise. A requirement is considered “appropriate” if it is necessary in order for
 the product to meet specified requirements, and/or
 the organization to carry out corrective action.
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ISO 13485:2003(E)
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 9000:2000, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply, together with the
following.
The following terms, used in this edition of ISO 13485 to describe the supply chain, have been changed to
reflect the vocabulary currently used:
supplier -------------> organization ----------> customer
The term “organization” replaces the term “supplier” used in ISO 13485:1996, and refers to the unit to which
this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean
“service”.
Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to
related services as supplied by the organization.
The following definitions should be regarded as generic, as definitions provided in national regulations can
differ slightly and take precedence.
3.1
active implantable medical device
active medical device which is intended to be totally or partially introduced, surgically or medically, into the
human body or by medical intervention into a natural orifice, and which is intended to remain after the
procedure
3.2
active medical device
medical device relying for its functioning on a source of electrical energy or any source of power other than
that directly generated by the human body or gravity
3.3
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.
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ISO 13485:2003(E)
3.4
customer 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 placed on the market
3.5
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
NOTE This definition applies to implantable medical devices other than active implantable medical devices.
3.6
labelling
written, printed or graphic matter
 affixed to a medical device or any of its containers or wrappers, or
 accompanying a medical device,
related to identification, technical description, and use of the medical device, but excluding shipping
documents
NOTE Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer.”
3.7
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,
 co
...