CEN/TS 15224:2005

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

Publication date:   Nov 14, 2006

Scope

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.