ISO15189：2012《医学实验室质量和能力的要求》解读-对制造商的要求  

Interpretation of ISO 15189：2012 ＂Medical laboratories - Requirements for quality and competence＂ - Requirements for IVD manufacturers

作　　者：胡冬梅[1] 周亚莉[1] 翟培军[1] 

机构地区：[1]中国合格评定国家认可中心,北京100062

出　　处：《中华检验医学杂志》2015年第7期502-504,共3页Chinese Journal of Laboratory Medicine

摘　　要：体外诊断医疗器械的制造商是医学实验室外部服务的重要供方，制造商提供的设备、试剂及耗材的质量和良好售后维护服务是保证医学实验室检验结果的质量起着至关重要作用。也是建立并维护制造商声誉和信誉的重要保障。ISO15189：2012《医学实验室质量和能力的要求》（第三版）于2012年11月1日发布，替代ISO15189：2007。新版标准中有很多涉及体外诊断医疗器械制造商的要求。通过对标准中对体外诊断医疗器械制造商要求的分析，帮助制造商更好理解标准从而满足医学实验室的需求，以及医学实验室准确理解标准要求，更科学合理选择外部服务，促进制造商与医学实验室的有机合作。In vitro diagnostic （IVD） manufacturers were important suppliers of external servicesto medical laboratories. There equipment, reagents, calibration and maintenauce services played an important role in ensuring the quality of medical laboratory tests. It is also helpful for IVD manufacturers to establish and maintain a good reputation and credibility. ISO 15189：2012＂ Medical laboratories - Requirements for quality and competence＂ was issued onNovember 1, 2012, which replaced the second edition （I50 15189： 2007）. Requirements related to IVD manufacturers are involved in the new edition standard. The article aimed to help medical laboratories and IVD manufacturers understand the requirements; therefore, laboratories would know how to select suppliers based on their ability to supply external services, IVD manufacturers would know how to meet the needs of laboratories, and the cooperation between IVD manufacturers and laboratories would be facilitated.

关 键 词：实验室  医院 质量控制 诊断设备 

分 类 号：F426.4[经济管理—产业经济]