ISO 15189:2012技术要求变化要点解读  

Important changes in technical requirements of ISO 15189:2012

作　　者：胡冬梅[1] 周亚莉[1] 李军燕[1] 翟培军[1] 

机构地区：[1]北京中国合格评定国家认可中心,100062

出　　处：《中华临床实验室管理电子杂志》2014年第3期27-30,共4页Chinese Journal of Clinical Laboratory Management(Electronic Edition）

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ISO 15189:2007《医学实验室质量和能力的专用要求》。新版标准在条款编排及实质内容等方面均有显著改变,为实验室及各相关方理解和应用新标准带来了新的课题。本文重点分析新版标准中技术要求的重要变化,以帮助实验室等各相关方识别新要求,针对性地更新和加强实验室的技术工作,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 1, 2012, which replaced the second edition ISO 15189：2007 ＂Medical laboratories - Particular requirements for quality and competence＂. The new edition standard revised substantially both in the written style and the contents, which bring up new issues for medical laboratories and the related bodies to understand and implement the new standard. This article focused on the important changes in the technical requirements of this new edition to enable the medical laboratories and the related bodies to identify, renew, and strengthen the required technical work so as to comply with the new requirements in laboratory construction, management and accreditation.

关 键 词：医学实验室 质量 能力 认可 

分 类 号：R197.3[医药卫生—卫生事业管理]