CEN/TS 15224:2005
(Main)Health services - Quality management systems - Guide for the use of EN ISO 9001:2000
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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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
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
...
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