CEN ISO/TR 14969:2005

Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)

ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.

Medizinprodukte - Qualitätssicherungssysteme - Anleitungen zur Anwendung von ISO 13485:2003 (ISO/TR 14969:2004)

Dispositifs médicaux - Systèmes de gestion de qualité - Lignes directrices pour l'application de l'ISO 13485:2003 (ISO/TR 14969:2004)

Medicinski pripomočki - Sistemi vodenja kakovosti - Navodila za uporabo ISO 13485:2003 (ISO/TR 14969:2004)

To tehnično poročilo zagotavlja navodila za uporabo zahtev za sisteme vodenja kakovosti, ki jih zajema ISO 13485. Ne dodaja ali kako drugače spreminja zahtev, ki se uporabljajo kot osnova za predpisano pregledovanje in dejavnosti certifikacijskega ocenjevanja. To vodilo se lahko uporablja za boljše razumevanje zahtev ISO 13485 in predstavitev nekaterih metod in pristopov, ki so na voljo za izpolnjevanje zahtev ISO 13485.

General Information

• Status: Withdrawn
• Publication Date: 07-Jun-2005
• Withdrawal Date: 01-Mar-2016
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 02-Mar-2016
• Completion Date: 02-Mar-2016
• Ref Project: SIST-TP CEN ISO/TR 14969:2010 - Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)

Relations

• Replaced By: EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Effective Date: 20-Apr-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2010
0HGLFLQVNLSULSRPRþNL6LVWHPLYRGHQMDNDNRYRVWL1DYRGLOD]DXSRUDER,62
,6275
Medical devices - Quality management systems - Guidance on the application of ISO
13485:2003 (ISO/TR 14969:2004)
Medizinprodukte - Qualitätssicherungssysteme - Anleitungen zur Anwendung von ISO
13485:2003 (ISO/TR 14969:2004)
Dispositifs médicaux - Systèmes de gestion de qualité - Lignes directrices pour
l'application de l'ISO 13485:2003 (ISO/TR 14969:2004)
Ta slovenski standard je istoveten z: CEN ISO/TR 14969:2005
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL REPORT
CEN ISO/TR 14969
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
June 2005
ICS 11.040.01; 03.120.10
English version
Medical devices - Quality management systems - Guidance on
the application of ISO 13485:2003
Dispositifs médicaux - Systèmes de gestion de qualité -
Lignes directrices pour l'application de l'ISO 13485:2003

This Technical Report was approved by CEN on 3 March 2005. It has been drawn up by the Technical Committee CEN/CLC/WG QS.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TR 14969:2005 E
worldwide for CEN national Members.

Foreword
The text of ISO/TR 14969:2004 has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices”. The transposition into a CEN
ISO/TR 14969 has been managed by the CEN/CENELEC Co-ordinating Working Group on quality
supplements for medical devices (CEN/CLC/CWG QS) the Secretariat of which is held by DIN in
collaboration with the CEN Management Centre (CMC).
With the publication of CEN ISO/TR 14969:2005 the following standards became obsolete and shall
be withdrawn:
* EN 724:1994 .Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and
EN 46002 for non-active medical devices.,

* EN 928:1995 .In vitro diagnostic systems - Guidance on the application of EN 29001 and EN
46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices.

* EN 50103:1995 .Guidance on the application of EN 29001 and EN 46001 and of EN 29002
and EN 46002 for the active (including active implantable) medical device industry."

It should be noted that the above-mentioned European standards which are not replaced by CEN
ISO/TR 14969:2005, were harmonized under the European Medical Devices Directives (90/385/EEE,
93/42/EEC and (98/79/EC). CEN ISO/TR 14969:2005 is not proposed for harmonization and so does
not provide a presumption of conformity with regard to these European Directives.
TECHNICAL ISO/TR
REPORT 14969
First edition
2004-10-15
Medical devices — Quality management
systems — Guidance on the application
of ISO 13485:2003
Dispositifs médicaux — Systèmes de gestion de qualité — Lignes
directrices pour l'application de l'ISO 13485:2003

Reference number
ISO/TR 14969:2004(E)
©
ISO 2004
ISO/TR 14969:2004(E)
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ISO/TR 14969:2004(E)
Contents Page
Foreword. iv
Introduction . v
0.1 General. v
0.2 Process approach. v
0.3 Relationship with other standards, guidance documents and regulatory requirements. vii
0.4 Compatibility with other management systems . viii
1 Scope. 1
1.1 General. 1
1.2 Application. 1
2 Normative references . 2
3 Terms and definitions. 2
4 Quality management system . 3
4.1 General requirements. 3
4.2 Documentation requirements . 4
5 Management responsibility. 9
5.1 Management commitment. 9
5.2 Customer focus. 10
5.3 Quality policy. 10
5.4 Planning . 11
5.5 Responsibility, authority and communication. 13
5.6 Management review. 14
6 Resource management. 17
6.1 Provision of resources . 17
6.2 Human resources. 17
6.3 Infrastructure. 19
6.4 Work environment. 19
7 Product realization. 22
7.1 Planning of product realization . 22
7.2 Customer-related processes . 25
7.3 Design and development. 27
7.4 Purchasing. 36
7.5 Production and service provision. 39
7.6 Control of monitoring and measuring devices . 49
8 Measurement, analysis and improvement. 51
8.1 General. 51
8.2 Monitoring and measurement. 52
8.3 Control of nonconforming product . 56
8.4 Analysis of data. 58
8.5 Improvement. 58
Annex A (informative) Terms used in certain regulatory administrations to describe documents
referenced in this Technical Report. 64
Annex B (informative) Analysis of significant changes from ISO 13485:1996 to ISO 13485:2003. 65
Bibliography . 73

ISO/TR 14969:2004(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.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard ("state of the art", for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
Attention is drawn to the possibility that some of the elements of this Technical Report may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TR 14969 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
NOTE ISO/TC 210/WG1 is prepared to accept questions and comments related to the content of ISO 13485:2003
and/or ISO/TR 14969:2004. Please address all such questions and comments to the ISO/TC 210 secretariat at:
[e-mail]. These questions and comments will be considered for development of additional guidance in the
application of ISO 13485:2003 either by revision of ISO/TR 14969 or the development of a “Frequently Asked Questions”
document. You will not receive a response to your questions or comments, however, they will be considered for future use
as noted above.
This first edition of ISO/TR 14969 cancels and replaces ISO 14969:1999, which has been technically revised.
Throughout this Technical Report, when the tex
...