SIST-TP CEN ISO/TR 14969:2010

SLOVENSKI STANDARD
SIST-TP CEN ISO/TR 14969:2010
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
SIST-TP CEN ISO/TR 14969:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN ISO/TR 14969:2010

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SIST-TP CEN ISO/TR 14969:2010



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.

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SIST-TP CEN ISO/TR 14969:2010
CEN ISO/TR 14969:2005 (E)
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.
2

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SIST-TP CEN ISO/TR 14969:2010

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

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SIST-TP CEN ISO/TR 14969:2010
ISO/TR 14969:2004(E)
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ii © ISO 2004 – All rights reserved

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SIST-TP CEN ISO/TR 14969:2010
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

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SIST-TP CEN ISO/TR 14969:2010
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:
hwoehrle@aami.org. 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 text of ISO 13485 is directly quoted, it appears enclosed in boxes
prefaced by: “ISO 13485:2003, Medical devices — Quality management systems — Requirements for
regulatory purposes”.
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SIST-TP CEN ISO/TR 14969:2010
ISO/TR 14969:2004(E)
Introduction
0.1 General
0.1.1 This Technical Report provides guidance to assist in the development, implementation and
maintenance of quality management systems that aim to meet the requirements of ISO 13485 for
organizations that design and develop, produce, install and service medical devices, or that design, develop
and provide related services. It provides guidance related to quality management systems for a wide variety of
medical devices and related services. Such medical devices include active, non-active, implantable and non-
implantable medical devices and in vitro diagnostic medical devices.
ISO 13485 specifies the quality management system requirements for medical devices for regulatory
purposes (see Annex A). ISO 13485 accommodates the previous ISO 13488 by permissible exclusion as
specified in ISO 13485:2003, 1.2.
When judging the applicability of the guidance in this Technical Report, one should consider the nature of the
medical device(s) to which it will apply, the risk associated with the use of these medical devices, and the
applicable regulatory requirements.
As used in this Technical Report, the term “regulatory requirement” includes any part of a law, ordinance,
decree or national and/or regional regulation applicable to quality management systems for medical devices
and related services.
This Technical Report provides some approaches that an organization can use to implement and maintain a
quality management system which conforms with ISO 13485. Alternative approaches can be used if they also
satisfy the requirements of ISO 13485.
0.1.2 The guidance given in this Technical Report is applicable to the design, development, production,
installation and servicing of medical devices of all kinds. It describes concepts and methods that can be
considered by organizations which are establishing and maintaining quality management systems.
An organization can voluntarily incorporate guidance from this Technical Report, wholly or in part, into its
quality management system.
0.1.3 Guidance contained in this Technical Report can be useful as background information for those
representing quality management system assessors, Conformity Assessment Bodies and regulatory
enforcement bodies.
The guidance contained in this Technical Report is not to be used for identifying specific deficiencies of quality
management systems, unless such guidance is voluntarily incorporated by the organization into the
documentation describing and supporting the organization’s quality management system, or unless such
guidance is specifically made part of the regulatory requirements relevant to the organization’s operation.
0.2 Process approach
ISO 13485 promotes the adoption of a process approach when developing, implementing and improving the
effectiveness of a quality management system, with the objective of meeting customer and regulatory
requirements, and providing medical devices that meet customer and regulatory requirements.
For an organization to function effectively, it has to identify and manage numerous linked activities. An activity
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.
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SIST-TP CEN ISO/TR 14969:2010
ISO/TR 14969:2004(E)
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.”
An advantage of the process approach is the ongoing control which it provides over the linkage between the
individual processes within the system of processes, as well as over their combination and interaction.
If used within a quality management system, such an approach emphasizes the importance of
 understanding and meeting requirements,
 considering processes in terms of added value,
 obtaining results of process performance and effectiveness, and
 improving processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages
presented in ISO 13485:2003, Clauses 4 to 8. This illustration shows that customers and regulatory authorities
play a significant role in defining requirements as inputs. Monitoring of customer feedback requires the
evaluation of information relating to whether the organization has met the customer requirements. The model
shown in Figure 1 covers all the requirements of ISO 13485, but does not show processes at a detailed level.


Figure 1 — Model of a process-based quality management system
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SIST-TP CEN ISO/TR 14969:2010
ISO/TR 14969:2004(E)
In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA
can be briefly described as follows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer
requirements and the organization’s policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for
the product and report the results.
Act: take actions to improve process performance.
0.3 Relationship with other standards, guidance documents and regulatory requirements
The relationship between ISO 13485, this Technical Report and the general standards for quality
management systems (ISO 9001 and ISO 9004) is summarized as follows.
a) This Technical Report provides guidance on the application of ISO 13485.
b) ISO 13485 specifies requirements for quality management systems in order to achieve regulatory
compliance in the medical devices industries. It follows the format, structure and process approach of
ISO 9001. It differs from ISO 9001 in that it specifies additional requirements but does not include the
explicit requirements for continual improvement and customer satisfaction.
c) ISO 9001 is an International Standard for quality management systems in general.
d) ISO 9004 gives guidance on a wider range of objectives of quality management systems than does this
Technical Report, particularly for the continual improvement of an organization’s overall performance and
efficiency, as well as its effectiveness. ISO 9004 is suitable as a guide for organizations whose top
management wishes to move beyond the requirements of ISO 13485, in pursuit of continual performance
improvement and customer satisfaction. However, it is not intended for certification or for contractual
purposes.
ISO 13485 includes those generic quality management system requirements contained in ISO 9001 that are
relevant to a regulated organization that designs and develops, produces, installs and/or services medical
devices, or which designs and develops and provides related services. This Technical Report, however, does
not set out to provide specific guidance with respect to these generic quality management system
requirements which are common to both ISO 13485 and ISO 9001. Guidance on ISO 9001 can be found, for
example, in the ISO brochure, ISO 9001 for Small Businesses – What to do, and in ISO 9000 Introduction and
Package module.
Guidance provided in this Technical Report has taken into consideration requirements and guidance
contained in documents from the following organizations:
 Global Harmonization Task Force (GHTF);
 International Organization for Standardization (ISO);
 European Committees for Standardization (CEN and CENELEC);
 national regulatory bodies.
Many of these documents are listed in the Bibliography.
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SIST-TP CEN ISO/TR 14969:2010
ISO/TR 14969:2004(E)
0.4 Compatibility with other management systems
Conformance to ISO 13485 quality management system requirements does not automatically constitute
conformity with national or regional regulatory requirements. It is the organization’s responsibility to identify
and establish compliance with relevant regulatory requirements.


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SIST-TP CEN ISO/TR 14969:2010
TECHNICAL REPORT ISO/TR 14969:2004(E)

Medical devices — Quality management systems — Guidance
on the application of ISO 13485:2003
1 Scope
1.1 General
This Technical Report 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.
This Technical Report does not include requirements to be used as the basis of regulatory inspection or
certification assessment activities.
NOTE The terms “should”, “can” and “might” within this Technical Report are used as follows. “Should” is used to
indicate that, amongst several possibilities to meet a requirement in ISO 13485, one is recommended as being particularly
suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required.
“Can” and “might” are used to indicate possibilities or options. These terms do not indicate requirements.
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.
1.2 Application
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory
purposes

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SIST-TP CEN ISO/TR 14969:2010
ISO/TR 14969:2004(E)
1.2.1 General
Certain product realization requirements of ISO 13485 can legitimately be omitted in one of two ways: they
can be “excluded”, or they might be “not applicable”. It is important to note, however, that any exclusion or
non-applicability should be detailed and justified in the organization’s quality manual.
1.2.2 Exclusions
Some regulatory requirements permit organizations to place some medical devices on the market without
having to demonstrate conformance with design and development controls (see ISO 13485:2003, 7.3).
Organizations should determine the exclusion of 7.3 on a product-by-product, market-by-market basis.
Even if the organization is permitted by regulations to exclude the requirements of 7.3, it still has obligations to
meet product realization requirements of ISO 13485:2003, 7.2, 7.4 and 7.5 and 7.6.
1.2.3 Non-applicability
ISO 13485 provides for the organization to omit from its quality management system those product realization
requirements that are not applicable due to the nature of the medical device.
For example, an organization providing single-use, sterile medical devices does not need to include within its
quality management system elements related to installation and servicing. Similarly, an organization providing
non-sterile medical devices does not need to include the elements related to sterilization.
It is important for the organization to review carefully all the requirements of ISO 13485:2003, Clause 7, in
order to identify those requirements that do apply to functions performed by the organization. Once those
requirements are identified, the organization is obliged to comply with ISO 13485:2003, 7.1, and to perform
the planning associated with identified product realization requirements.
EXAMPLE An organization intends
 to place its own label on a medical device designed and developed, produced, and serviced by suppliers outside its
quality management system, and to market this medical device,
 to communicate with customers who have purchased the medical device, and
 to have systems in place for receiving customer complaints.
Even though the organization does not perform design and development activities itself, it cannot consider 7.3 to be
non-applicable. It still has obligations to meet the requirements of 7.3, unless relevant regulations permit an exclusion.
Once the organization identifies those requirements, it is obliged under 7.1 to plan for the quality management system
processes needed to meet those requirements.
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
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 and ISO 13485 apply.
NOTE The terms provided in Annex A should be regarded as generic, as definitions provided in national regulatory
requirements can differ.
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SIST-TP CEN ISO/TR 14969:2010
ISO/TR 14969:2004(E)
4 Quality management system
4.1 General requirements
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory
purposes


4.1.1 An element of managing an organization is the implementation and maintenance of an effective
quality management system that is designed to enable an organization to provide medical devices that meet
customer and regulatory requirements.
The organization can maintain the effectiveness of its established quality management system through a
range of activities, such as
 internal audits,
 management review,
 corrective and preventive actions, and
 independent external assessments.


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SIST-TP CEN ISO/TR 14969:2010
ISO/TR 14969:2004(E)
4.1.2 Maintaining the effectiveness of the quality management system in its ability to meet customer and
regulatory requirements will typically involve the organization responding effectively to external factors, such
as
 changes in regulatory requirements, including adverse event reporting, and
 customer feedback,
and internal changes, such as changes to
 key personnel,
 facilities,
 manufacturing processes and equipment, including related software,
 software related to the quality management syste
...