标准号:BS DD CEN/TS 15224-2006
中文标准名称:保健.质量管理体系. EN ISO 9001-2000的使用指南
英文标准名称:Health services - Quality management systems - Guide for the use of EN ISO 9001:2000
标准类型:C05
发布日期:2006/4/28 12:00:00
实施日期:2006/4/28 12:00:00
中国标准分类号:C05
国际标准分类号:03.120.10;11.020
适用范围: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.