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2005-2006年,卫生部相继发布了《血站管理办法》、《血站质量管理规范》、《血站实验室质量管理规范》(以下简称“一法两规”),这是我国输血事业发展史上具有里程碑意义的大事,标志着我国血液管理的法规体系日趋完善〔1〕。之后,各地血站纷纷建立甚至多次换版提升了质量管理体系以满足其要求。血站无论是以ISO9000标准为框架,以2个规范为具体要求构建质量管理体系,还是仅根据2个规范的要求构建质量管理体系,都离不开对术
From 2005 to 2006, the Ministry of Health successively released the “Measures for the Administration of Blood Stations,” “Standards for Quality Control of Blood Stations,” and “Standards for Quality Control of Blood Station Laboratories” (hereinafter referred to as “One Law and Two Rules”), Blood transfusion has a milestone in the history of the development of major events, marking China’s blood management laws and regulations of the system is perfect [1]. After that, blood stations all over the country have set up even many times to upgrade the quality management system to meet their requirements. Blood stations both in the framework of ISO9000 standards, with two specifications for the specific requirements of the construction of quality management system, or just based on the requirements of the two norms to build quality management system, can not do without surgery