我国医院引进ISO9000族国际标准必要性与有效性的思考

我国医院引进ISO9000族标准,进行质量管理体系认证,尚处于起步和探索阶段,有必要对其必要性和有效性加以思考与探讨.质量体系和/或质量管理体系认证,是质量管理发展的新阶段,也是21世纪医院质量管理的发展方向.为实现医院质量管理现代化,引进ISO9000族标准的必要性是毋庸置疑的;同时这也是医院改革、发展和适应社会主义市场经济体制、与国际接轨的需要.医院进行ISO9000认证,必须强调其有效性.本文探讨了医院质量管理体系有效性的基本标志、实现有效性的基本途径和影响有效性的主要障碍.克服各种主要障碍是确保医院质量管理体系认证健康发展的重要保障.笔者还认为,医院分级管理评审与引进ISO9000族标准建立和完善医院质量管理体系,两者有联系又有区别.医院评审是对医院功能定位的综合评估,进行这种综合评审不能完全替代建立和完善质量管理体系;就像不能完全替代建立医院经济管理体系、科技管理体系以及医院信息系统等各项管理体系一样.两者应该相辅相成,而不是相互替代和相互排斥的.在自愿原则下医院质量管理体系认证工作应积极推行.

A REFLECTION OF THE NECESSITY AND EFFECTIVENESS TO IMPLEMENT ISO 9000 SERIAL STANDARDS IN CHINESE HOSPITALS

It is still in a beginning and exploring stage for hospitals in our country to introduce ISO 9000 serial standards and carry out certification under a quality control system. It is therefore necessary to reflect and investigate its necessity and effectiveness. Quality system and/or quality control system certification is a new stage of quality control and also the developmental trend of hospital quality management in the 21st century. In order to modernize the hospital quality control system, it is indubitably necessary to introduce ISO 9000. Furthermore, it is also the demand in the course of hospital reform, development and adaptation to the socialist market economy system and the international practice. Special attention shall be paid to the effectiveness during implementation of ISO 9000 certification. This article discusses the basic standards of the effectiveness, basic ways to reach effectiveness and the major impediment to effectiveness. To overcome vario!us major impediments is the major premise to guarantee the healthy development of hospital quality control system . The authors also point out that there is both association and difference between the leveled hospital accreditation system and the ISO 9000 serial standatls to establish and improve hospital quality management system. Hospital accreditation is a comprehensive evaluation of the function and position of a hospital, which can not totally replace the establishment and improvement of quality control system, as it can not totally replace the establishment of hospital financial management system, research management system, hospital information system, and other administration systems. These two approaches shall supplement and complement each other rather than replace and discriminate against each other. Under the principle of voluntary participation, the hospital quality control system certification shall be introduced actively.