从ISO 15189∶2012与ISO 15189∶2007的比较看国际对医学实验室要求的新变化  

Introduction of new international requirements for medical laboratory through comparison of ISO 15189∶2012 and ISO 15189 ∶2007

作　　者：翟培军[1] 胡冬梅[1] 贺学英 周亚莉[1] 

机构地区：[1]中国合格评定国家认可中心,北京100062 [2]全国医用临床检验实验室和体外诊断系统标准化技术委员会

出　　处：《中华检验医学杂志》2013年第10期865-868,共4页Chinese Journal of Laboratory Medicine

摘　　要：ISO 15189：2012《医学实验室质量和能力的要求》于2012年11月1日发布,替代ISO15189：2007《医学实验室质量和能力的专用要求》.研究新旧标准的变化,有利于医学实验室、监管机构、认可机构各方了解和理解新的国际要求,不断改进实验室的管理,以持续符合国际标准要求.本文深入分析新标准内容的重要变化,以帮助各方正确理解并更加有效地应用新标准,从而满足实验室建设、管理、认可等的新要求.ISO 15189：2012 ＂ Medical laboratories - Requirements for quality and competence＂ was issued on November l, 2012, which replaced the second edition （ISO 15189：2007 ＂Medical laboratories- Particular requirements for quality and competence＂）. A study on changes in new edition standard will facilitate medical laboratories, regulatory authorities, accreditation bodies to have a good understanding of requirements of this new edition. An implementation of new edition will assist medical laboratory to improve their management to continually meet requirements of international standards. To enable stakeholders mentioned above have a good understanding and application of this new edition, changes in new edition were discussed in depth in this article.

关 键 词：实验室 医院 质量控制 

分 类 号：R446[医药卫生—诊断学]