ISO15189实验室质量管理体系建立与实施  

作　　者：张汉奎[1] 陈桂山[1] 杨有业[1] 梁锦胜[1] 张秀明[1] 

机构地区：[1]广东省中山市中山大学附属中山医院,528403

出　　处：《中国现代药物应用》2010年第13期231-233,共3页Chinese Journal of Modern Drug Application

摘　　要：质量是实验室生存的保证,一个有效临床实验室质量管理体系,能满足患者和临床医护部门的要求,能充分实现实验室本身利益,使实验室持续发展,长期蓬勃生存。ISO15189(E)《医学实验室-质量和能力的专用要求》,是专门针对医学实验室的管理标准,本文介绍建立和实施ISO15189实验室质量管理体系的方法与应用意义。Quality is the guarantee of a laboratory＇ s survival. A valid clinical laboratory quality management system not only can satisfy requirements of patients, clinical doctors and nurses, but also can fully implement the profit of the laboratory itself, which will bring it persistent development and rising existence. ISO15189（E）, that is medical laboratories-particular requirements for quality and competence, is a manage- ment standard specially for medical laboratories. Here we introduced the method and application value of estab- lishing and performing ISO15189 medical laboratory quality management system.

关 键 词：ISO15189 医学实验室 质量管理体系 

分 类 号：F203[经济管理—国民经济]