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

General Information

Status
Withdrawn
Publication Date
15-Nov-2005
Withdrawal Date
23-Oct-2012
Current Stage
9960 - Withdrawal effective - Withdrawal
Due Date
24-Oct-2012
Completion Date
24-Oct-2012

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SLOVENSKI STANDARD
SIST-TS CEN/TS 15224:2006
01-marec-2006
Zdravstvene storitve – Sistemi vodenja kakovosti – Vodilo za uporabo EN ISO
9001:2000

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
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
SULSRPRþNLQDVSORãQR
SIST-TS CEN/TS 15224:2006 en

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

---------------------- Page: 1 ----------------------
TECHNICAL SPECIFICATION
CEN/TS 15224
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
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.
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/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

Bibliography...................................................................................................................................................62

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CEN/TS 15224:2005 (E)
Foreword

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.

Leadership

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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