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 (including professional
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.