Health services - Quality management systems - Guide for the use of EN ISO 9001:2000

A quality management system is a management system to direct and control an organisation with regard to quality (ISO 9000:2000).
The guide is generally applicable to the health services sector and will complement national legislation. Furthermore other national requirements, sector specific requirements and standards may complement the guide or be used in parallel.
The main target groups for this guide are strategic decision-makers at all levels in the health services sector and all staff who are involved in the development, implementation and assessment of a quality management system in a health care organisation, including the stakeholders.  
This guide is generally applicable to all health care organisations regardless of structure, organisation, owner, size, type of service provided, locally used approaches or location.  When using and adapting this guide every organisation needs to consider the nature, culture, complexity, legislation, regulation, etc. of their organisation and further specify their own requirements and use complementary national and local information.  
The guide also applies to the requirements of patient organisations, owners, users, insurers, inspectorates and to relevant legislation.  In this manner the guide provides a basis for national requirements on health services, e.g. Provisions and Recommendations, for purchasers of health services, for contracts and agreements, and for supervision, audit, certification and accreditation in the health services sector.

Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme - Anleitung zur Anwendung von EN ISO 9001:2000

Die Einführung eines Qualitätsmanagementsystems sollte eine strategische Entscheidung einer Organisation sein. Gestaltung und Verwirklichung des Qualitätsmanagementsystems einer Organisation werden von sich verändernden Erfordernissen, besonderen Zielen, den bereitgestellten Produkten, den angewendeten Prozessen und der Größe und Struktur der Organisation beeinflusst. Es ist nicht die Absicht dieser Internationalen Norm zu unterstellen, dass Qualitätsmanagementsysteme einheitlich strukturiert oder einheitlich dokumentiert sein müssen.
Die in dieser Internationalen Norm festgelegten Anforderungen an ein Qualitätsmanagementsystem ergänzen die Anforderungen an Produkte. Als  ANMERKUNG" gekennzeichnete Informationen dienen als Anleitung zum Verständnis oder der Erläuterung der zugehörigen Anforderung.
Diese Internationale Norm kann von internen und externen Parteien einschließlich Zertifizierungsstellen verwendet werden, um die Fähigkeit der Organisation zur Erfüllung der Anforderungen der Kunden, der Behörden und der eigenen Organisation zu bewerten.
Die in ISO 9000 und ISO 9004 niedergelegten Grundsätze für das Qualitätsmanagement wurden bei der Erarbeitung dieser Internationalen Norm berücksichtigt.

Services en santé - Systèmes de management de la qualité - Guide d'utilisation de l'EN ISO 9001:2000

Un système de management de la qualité est un système de management permettant d'orienter et de contrôler un organisme en matière de qualité (ISO 9000:2000).
Le présent guide s'applique généralement au secteur des services de santé et complète la législation nationale en vigueur. Par ailleurs, d'autres exigences nationales et exigences et normes spécifiques à ce secteur (y compris des normes professionnelles) peuvent compléter le guide ou être utilisées en parallèle.
Les principaux groupes cibles du présent guide sont les décideurs stratégiques à tous les niveaux du secteur des services de santé, ainsi que toutes les personnes impliquées dans l'élaboration, la mise en oeuvre et l'évaluation d'un système de management de la qualité dans un organisme sanitaire, y compris les parties prenantes.
Le présent guide s'applique en règle générale à toutes les organisations de santé indépendamment de la structure, de l'organisme, du propriétaire, de la taille, du type de service fourni, des approches locales ou du site d'implantation. Lors de l'utilisation et de l'adaptation du présent guide, chaque organisme doit tenir compte de la nature, la culture, la complexité, la législation, la réglementation, etc. de son organisme et spécifier par ailleurs ses propres exigences, de même qu'utiliser les informations nationales et locales complémentaires.
Le présent guide s'applique également aux exigences des organismes de patients, aux propriétaires, utilisateurs, assureurs et bureaux d'inspection, ainsi qu'à la législation pertinente. De ce fait, le présent document fournit une base pour les exigences nationales relatives aux services de santé, par exemple les dispositions et recommandations, pour les acheteurs de services de santé, pour les contrats et les accords et pour les processus de contrôle, d'audit, de certification et d'agrément dans le secteur des services de santé.

Zdravstvene storitve – Sistemi vodenja kakovosti – Vodilo za uporabo EN ISO 9001:2000

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SIST-TS CEN/TS 15224:2006
Zdravstvene storitve – Sistemi vodenja kakovosti – Vodilo za uporabo EN ISO
Health services - Quality management systems - Guide for the use of EN ISO 9001:2000
Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme -
Anleitung zur Anwendung von EN ISO 9001:2000
Services en santé - Systemes de management de la qualité - Guide d'utilisation de l'EN
ISO 9001:2000
Ta slovenski standard je istoveten z: CEN/TS 15224:2005
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
SIST-TS CEN/TS 15224:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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CEN/TS 15224
November 2005
ICS 03.120.10; 11.020

English Version
Health services - Quality management systems - Guide for the
use of EN ISO 9001:2000
Services en santé - Systèmes de management de la Dienstleistungen in der Gesundheitsversorgung -
qualité - Guide d'utilisation de l'EN ISO 9001:2000 Qualitätsmanagementsysteme - Anleitung zur Anwendung
von ISO 9001:2000
This Technical Specification (CEN/TS) was approved by CEN on 1 October 2005 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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.
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/TS 15224:2005: E
worldwide for CEN national Members.

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CEN/TS 15224:2005 (E)
Contents Page
Foreword .3
0 Introduction.4
0.1 General .4
0.2 Process approach.8
0.3 Relationship with ISO 9004 .9
0.4 Compatibility with other management systems .10
1 Scope .10
1.1 General .11
1.2 Application .11
2 Normative reference .11
3 Terms and definitions.11
4 Quality management system.22
4.1 General requirements .22
4.2 Documentation requirements .23
5 Management responsibility.26
5.1 Management commitment.26
5.2 Customer focus.26
5.3 Quality policy .27
5.4 Planning.27
5.5 Responsibility, authority and communication.28
5.6 Management review .29
6 Resource management.30
6.1 Provision of resources .30
6.2 Human resources.30
6.3 Infrastructure.31
6.4 Work environment.31
7 Product realisation.32

7.1 Planning of product realisation .32
7.2 Customer-related processes.33
7.3 Design and development.35
7.4 Purchasing .38
7.5 Production and service provision.39
7.6 Control of monitoring and measuring devices .42
8 Measurement, analysis and improvement .43
8.1 General .43
8.2 Monitoring and measurement .43
8.3 Control of non-conforming product .45
8.4 Analysis of data .45
8.5 Improvement .46
Annex A (informative) Practical guide for the implementation of EN ISO 9001:2000 in health care
organisations .48


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CEN/TS 15224:2005 (E)
This Technical Specification (CEN/TS 15224:2005) has been prepared by Working Group CEN/BT/TF 142,
the secretariat of which is held by SIS.
This guide for the health services sector is intended to aid the user with the interpretation of the standard
EN ISO 9001:2000 Quality management systems - Requirements when implementing a quality management
system. The guide is not intended for certification purposes on its own.
In Annex A, practical and informative recommendations are provided for all who are involved in the
development, implementation and assessment of a quality management system in a health care organisation.
This Guide for the use of EN ISO 9001:2000 in health services has been developed by CEN/BT/TF 142, a
task force of health experts including experienced physicians, nurses and health administrators, representing
different sectors and levels in the European health services sector.
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 Electro technical Commission (IEC) on all matters of electro technical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
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 International Standard may be the
subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 2, Quality systems.
This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with
ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. Those
organizations which have used ISO 9002:1994 and ISO 9003:1994 in the past may use this International
Standard by excluding certain requirements in accordance with 1.2.
The title of ISO 9001 has been revised in this edition and no longer includes the term “Quality assurance”.
This reflects the fact that the quality management system requirements specified in this edition of ISO 9001,
in addition to quality assurance of product, also aim to enhance customer satisfaction.
Annexes A and B of this International Standard are for information only.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this CEN Technical Specification: 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.

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CEN/TS 15224:2005 (E)
0 Introduction
0.1 General

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.
The quality management system requirements specified in this International Standard are complementary to
requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the
associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to
assess the organization's ability to meet customer regulatory and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration
during the development of this International Standard.

Health services and quality management systems
In the health services sector, services provided by health care professionals to individuals are central. The
professional responsibility of the staff in the care/service provision is critical. Health care professionals are
increasingly becoming self regulated: professional groups in this sector implement, guard and promote their
professional practice and they guard the quality of their work with codes and standards developed by their
professional associations.
In the health services sector requirements for quality management have to be interpreted differently than in
industry and other types of business for the following reasons:
- The health services are characterised by the physical and mental involvement of the patient in the
process of care provision. Thus, the provision of care is based on the continuous interaction between health
care professionals (provider) and customers.
- The customer may have little knowledge of the professional aspects of the service delivered. The
relationship between the patient and the professional is an unequal one considering the professional input;
choices will be highly influenced by the professional.
- Commonly, the purchase and the receipt of health services are separated (so called “Third party
payment”). Thus, the provider may have to satisfy different quality demands from its two main customers: the
patient and the purchaser.
- Health services are characterized by complexities such as relations and interactions between patients,
health care professionals, health suppliers, insurers, industry and governmental bodies. In addition health
services are subject to constant change introduced by evolving technologies.
By the use of a quality management system the processes that are directly or indirectly related to the health
services provided, can be controlled to meet these requirements.
In interpreting the EN ISO 9001:2000 standard, the national approaches to improving quality in the health
service sector have been found to share a number of common principles. These principles have formed the
basis for creating the uniform requirements of this guidance document. These principles are:
Customer focus
A customer centred approach is an important objective in the development of public and private services and
it constitutes one of the main drivers for health services reforms. Close co-operation between the customer

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CEN/TS 15224:2005 (E)
and the professional results in genuine and mutual influence and dialogue between equal partners. The
heterogeneity of customers means that the understanding of different backgrounds and the development of
versatile service capabilities are necessary. Health services need to be tailored to the customer’s
requirements taking into account their environment and immediate community. Thus, services delivered have
to meet both general and individual requirements.
Stakeholder involvement
The definition of care and quality of care requires inputs from all parties involved, which in addition to the
provider and purchaser, also include the patient/customer and the professionals. Such input is also
instrumental for bringing the stakeholder’s perspective of care into the planning process and the periodical
and independent assessment of customer satisfaction into the quality improvement process.
In health care organisations, leadership is crucial for organisational and quality management with a sharp
customer focus that inspires, promotes and supports a quality culture. Quality improvement concerns, equally,
professionals and the management. Health care professionals are responsible for their professional practice;
the management is however accountable for the safety and quality of all services offered by the organisation.
People and care vision
Health services are ‘people working with people’. Quality development in the health service sector therefore
requires a shift from authoritative management paradigms to a people-oriented culture that can effect team
and group skills for continuous process improvement and intelligent, learning organisations. Guidance and
motivation of staff is essential and requires constant and structured communication, not only in between staff
members but also between staff and customers.
Process orientation
Modern health services constitute integrated processes that span functions and clinical specialisations and
also across different health services providers. Care is delivered through core processes that follow the
patient from the time of referral/ request until after the discharge, including follow-up. Core processes,
however, depend on a number of vital inputs in the form of supporting processes. Risk management is critical
to any health service and is best achieved through an integrated process approach.
Guidance through information
Professional practice is increasingly evidence-based, i.e. scientifically oriented, and best practices are
captured in protocols, guidelines and other resources which must keep pace with scientific developments. It is
essential that the care provided can be continually evaluated and adjusted according to scientific progress.
This requires systematic monitoring of activities and their outcomes.
It is also important to recognise the strong synergies between quality and information technology in an
organisation. Information systems are geared to effectively support, control and monitor standardised,
integrated processes. On the other hand, quality improvement in the knowledge based, complex and fast
evolving health services environment can effectively be carried out only with fully integrated information
technology support that links into the organisation’s longitudinal work-flows.
Partnerships for quality across health services
Health services are provided over a continuum that spans prevention and health promotion, diagnosis and
treatment to rehabilitation and health maintenance. The co-ordination of services between different providers
determines the extent of continuity of care that citizens receive within any health services system, over time
and across care providers. Eventually, in the regional context, it will be necessary to consider the
development of quality management systems encompassing care provider networks.


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CEN/TS 15224:2005 (E)
Demand oriented care
In the health services sector a fundamental change is taking place from supply-oriented care, i.e., care
determined by the service provider, to demand-oriented care, in which the expectations and needs of the
customer are central. However, the supply of care is not unlimited, one should thus strive for an optimum
balance of taking into account needs and wishes of the customer, modified by the professional judgements,
and availability of resources. This balance can ideally be determined during a process of open
communication and negotiation and must meet both the quality criteria of the purchaser/customer as well as
those of the patient and the professional.
Mutually beneficial supplier relationship
Third party services such as technical support, information and communication services, business consulting,
recruitment services, sanitation, catering, and training have a critical effect on a health care organisation’s
quality and its outcomes. Likewise, services provided by clinical laboratories and imaging departments,
critically affect treatment decisions made by other departments. Safe and high quality services may be
developed only on the grounds of mutual understanding and respect of customer requirements in the
numerous internal and external customer-provider relationships.
Continual improvement
Health services organisations are challenged to become continuously evolving learning environments that
systematically accept, process and interpret results, and improve performance by learning from past
experience. This is one key competence that can allow an organisation to perform successfully in an ever
changing environment with escalating pressures for higher quality and better cost containment.
European harmonisation and ISO compatibility
Health services are increasingly becoming international markets. Over the past years, there has been a
growing awareness that quality management systems may be applied to the health services sector to improve
quality and safety, and ultimately promote public accountability for health care providers and policymakers.
National approaches vary and different organisations may choose different methods and approaches to
quality management. The ISO standards provide an international standardisation framework for quality
management systems and their evaluation. Recognition of quality on the basis of commonly held standards
facilitates mutual recognition between organisations. Consequently, there is a strong case for ISO
compatibility with national quality management systems in the health services sector, especially in cross-
border contracting situations.
Guide to the use of EN ISO 9001:2000 in the health services
This is a guidance document for organisations in the health services sector to aid the user in the interpretation
and application of the standard EN ISO 9001:2000, Quality Management Systems - Requirements, when
developing and implementing a quality management system. A quality management system is a management
system to direct and control an organisation with regard to quality.
Annex A provides practical guidance on the implementation of a quality management system and is meant to
be informative and motivating.
The main target groups for this guide are strategic decision-makers at all levels in the health services sector
and all staff who are involved in the development, implementation and assessment of a quality management
system in a health organisation, including the stakeholders.
In this guide, the term health services means health services provided. The term health services is in other
connections used to nominate the health services sector. In this document health services sector will be used
to differentiate between the health services and the health services sector. The services that are included in
the term may vary from country to country; this has to be considered in the national translations. In this guide,
health services is considered to include hospital care, primary health care and preventive care, psychiatry and
dental services.

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CEN/TS 15224:2005 (E)
The original text of EN ISO 9001:2000 is framed and other referenced source text is marked.
The ISO introduction text to this guide generally explains the requirements in the ISO 9001 standard, clarifying
the process approach, the relationship with the ISO 9004 standard and the compatibility with other
management systems.
The Scope explains when and where the standard's requirements are applicable.
The terms and definitions described in Clause 3 of this guide are from the ISO 9000:2000 standard. In
addition, terms of special interest, importance and understanding for the health services sector are included.
In Clause 4, the general ISO requirements on quality management systems are specified complemented with
specifications of these requirements for the health services sector, when necessary.
In Clause 5 the management's responsibility is made explicit through the requirements in the standard and
complemented with specifications of these for the health services sector.
Clause 6 specifies requirements on the resource management in the organisation and these requirements are
also specified for the health services sector when needed.
Clause 7 specifies requirements for the realisation of the product that include the planning, the customer-
related processes, design and development, purchasing, service provision and the control of monitoring and
measuring devices. When needed, these requirements are also specified for the health services sector.
In Clause 8 the requirements on measurement, analysis and improvement processes are made explicit and
complemented with specifications when needed.
Annex A, "Practical guide for the implementation of EN ISO 9001:2000 in health care organisations", provides
practical and informative recommendations for all who are involved in the development, implementation and
assessment of a quality management system in a health care organisation.
The Bibliography has two parts. The first part consists of reference literature related to the EN ISO 9001:2000
standard. The second part contains reference documents supplied by the European CEN BT Task Force, that
has been used as background documents for the development of this guide for the health services. The list of
references to the guide does not claim to be comprehensive or covering all possible European or International
documents in the field. This part of the Bibliography should be considered as giving examples of documents
provided by the members of the task force.


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CEN/TS 15224:2005 (E)
0.2 Process approach

This International Standard promotes the adoption of a process approach when developing, implementing
and improving the effectiveness of a quality management system, to enhance customer satisfaction by
meeting customer 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.
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 that it provides over the linkage between the
individual processes within the system of processes, as well as over their combination and interaction.
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) continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process
linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining
requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to
customer perception as to whether the organization has met the customer requirements. The model shown
in Figure 1 covers all the requirements of this International Standard, but does not show processes at a
detailed level.
NOTE  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 continually improve process performance.


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CEN/TS 15224:2005 (E)

Figure 1 – Model of a process-based management system
The process approach in the health service sector is discussed and explained in
Clause 3.8 and in Annex A.

0.3 Relationship with ISO 9004

The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality
management system standards which have been designed to complement each other, but can also be us

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