標準號：BS DD CEN/TS 15224-2006
中文標準名稱：保健.質量管理體系. EN ISO 9001-2000的使用指南
英文標準名稱：Health services - Quality management systems - Guide for the use of EN ISO 9001:2000
標準類型：C05
發布日期：2006/4/28 12:00:00
實施日期：2006/4/28 12:00:00
中國標準分類號：C05
國際標準分類號：03.120.10;11.020
適用范圍：A quality management system is a management system to direct and control an organisation with regard toquality (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 professionalstandards) 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 sectorand all staff who are involved in the development, implementation and assessment of a quality managementsystem 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 everyorganisation needs to consider the nature, culture, complexity, legislation, regulation, etc. of their organisationand 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, inspectoratesand to relevant legislation. In this manner the guide provides a basis for national requirements on healthservices, e.g. Provisions and Recommendations, for purchasers of health services, for contracts andagreements, and for supervision, audit, certification and accreditation in the health services sector.