BS PD CEN/TR 15592-2007 医疗卫生服务.质量管理体系.性能改善用医疗卫生服务中EN ISO 9004-2000标准的使用指南

标准号：BS PD CEN/TR 15592-2007
中文标准名称：医疗卫生服务.质量管理体系.性能改善用医疗卫生服务中EN ISO 9004-2000标准的使用指南
英文标准名称：Health services — Quality management systems — Guide for the use of EN ISO 9004:2000 in health services for performance improvement
标准类型：C00
发布日期：2007/7/31 12:00:00
实施日期：2007/7/31 12:00:00
中国标准分类号：C00
国际标准分类号：03.120.10;11.020
引用标准：EN ISO 9000-2005;CEN/TS 15224-2005
适用范围：This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectivesof customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization.This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.This Technical Report provides assistance on how the EN ISO 9004:2000 guidelines may be applied to health services, without prescribing the activities that need to be done by the health service provider; the latter should use its own professional knowledge and/or follow guidelines and protocols established by relevant professional bodies.Even though EN ISO 9004:2000 promotes a better understanding of the EN ISO 9001:2000 requirements, its scope goes further than that. It is a technical document for managers and process owners to monitor and improve organisation performance, minimise risks, reduce costs, satisfy customers and improve competitiveness.To fulfil the requirements of processes that have impact on patient safety this Technical Report provides an approach for improvement of risk management in the organisation.An important value of EN ISO 9004:2000 is that it can be used for self-assessment (see Annex A) comparing the performance of the organisation with the 290 individual “should” performance improvement guideline statements of the standard. These statements can be used to create a check list for evaluators (see A.3).Using the EN ISO 9004:2000 criteria, organisations can assess the maturity of their quality management system (see A.2) and identify opportunities for improvement.This Technical Report ensures that those health system activities that are necessary for continuous improvement, risk management and reduction of variation and organisational waste are carried outconsistently and in a controlled manner.This Technical Report addresses any health system or health care organisation involved in the provision of health services to the population including prevention, care and rehabilitation, regardless of the type and size of the system/organisation and the product or service provided.