ISO15189《医学实验室 质量和能力的要求》将发生重大变化  

Major changes will take place on ISO15189"Medical laboratories:requirements for quality and competence"

作　　者：翟培军[1] 胡冬梅[1] 付岳 邹迎曙 Zhai Peijun;Hu Dongmei;Fu Yue;Zou Yingshu(China National Accreditation Service for Conformity Assessment,Beijing 100062,China;Beijing Institute of Medical Device Testing,Beijing 101111,China)

机构地区：[1]中国合格评定国家认可中心,北京100062 [2]北京市医疗器械检验研究院,北京101111

出　　处：《中华检验医学杂志》2022年第7期677-680,共4页Chinese Journal of Laboratory Medicine

摘　　要：ISO15189《医学实验室质量和能力的要求》自2003年第1版发布后,在国际实验室认可合作组织(ILAC)的推动下,在全球得到广泛应用,成为医学实验室质量管理和能力建设、能力证实的基础性标准。ILAC的ISO15189认可互认制度是医学检验结果最权威的国际通行证,得到众多国际组织的采信。我国于2004年在国际上建立起ISO15189医学实验室认可制度,为提升我国医学实验室质量管理和技术能力,提高我国医学检验国际影响力等发挥了重要作用。ISO15189∶2012当前正由ISO/TC212进行修订。本次修订将带来重大变化,值得医学检验各方关注。为帮助医学实验室等各方及时了解国际标准新思路及国际标准化和认可新动态,该文对ISO15189修订情况和变化内容进行梳理和分析。Since the first edition of ISO15189"Medical laboratories:requirements for quality and competence"was published in 2003,it has been rapidly and widely used in the world under the promotion of the International Laboratory Accreditation Cooperation Organization(ILAC),and has become the basic standard for the quality management,capacity-building and capacity attestation of medical laboratories.The Mutual Recognition Arrangement(MRA)of ILAC for ISO15189 is the most authoritative international permit for examination results,which is accepted by international organizations.Since the establishment of ISO15189 medical laboratory accreditation system in 2004 in China,more than 530 medical laboratories have been accredited,which plays an important role in improving the quality and competence of medical laboratories in China,and improves the influence of Chinese medical laboratories in the world.ISO 15189:2012 is currently being revised by the International Organization for Standardization/Technical Committee on Clinical Laboratory Testing and in vitro diagnostic test systems(ISO/TC212).This revision will bring significant changes and the medical laboratory shall pay attention to these changes.In order to help medical laboratories understand the new ideas in advance,this paper summarizes and analyses the draft of the new international standards,and provides references for users.

关 键 词：实验室 医院 ISO15189 修订 

分 类 号：R197.323[医药卫生—卫生事业管理]