我国医学参考测量实验室认可现状和展望

    Current Status and Development of Accreditation of Medical Reference Measurement Laboratories in China

    • 摘要: 中国合格评定国家认可委员会(CNAS)依据ISO/IEC 17025《检测和校准实验室能力的通用要求》和ISO 15195《检验医学 参考测量实验室的要求》于2012年建立起医学参考测量实验室认可制度。目前CNAS认可医学参考测量实验室30余家,其中15家加入国际检验医学联合溯源委员会(JCTLM)参考测量实验室列表,为体外诊断医疗器械制造商校准品赋值、室间质评机构组织正确度评价、常规医学实验室检测项目的正确度验证和一致化工作等多方面发挥了重要作用。就我国医学参考测量实验室国内认可现状及在国际JCTLM中参考测量服务、参考方法和参考物质进行分析,以期为广大医学参考测量领域相关机构及人员提供信息,共同推进我国医学校准、检测领域的工作质量。

       

      Abstract: The medical reference measurement laboratory accreditation scheme against ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories and ISO 15195 Medical laboratories — Requirements for quality and competence was set up by China National Accreditation for Conformity Assessment (CNAS) in 2012. Seventeen laboratories have been accredited by CNAS since then, and 8 of them have been approved to be listed in The Joint Committee on Traceability in Laboratory Medicine (JCTLM) database. These accredited laboratories have played a very important role in the value assignment for In Vitro Diagnostic (IVD) product calibrators, trueness PT, and trueness verification for the routine measurement procedures in medical laboratories. The current status of the accreditation for medical reference measurement laboratories will be addressed in this article, with aim to share information with the laboratory specialists, and to facilitate the quality in medical calibration and testing field.

       

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