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2012年10月中国合格评定国家认可委员会(CNAS)决定将血站实验室认可的推荐准则由ISO/IEC17025(CNAS-CL01)变更为ISO15189(CNAS-CL02)。本文针对血站实验室开展ISO15189实验室认可工作,探讨了《血站实验室质量管理规范》、ISO15189和ISO/IEC17025之间的异同点,ISO15189认可准则中的特定要求和条款;同时以本中心为例解读如何建立将ISO15189、“一法两规”、ISO/IEC17025和ISO9000融合在一起的质量管理体系和建立体系时需要注意的问题。
In October 2012, China National Accreditation Service for Conformity Assessment (CNAS) decided to change the recommended standard recommended by Blood Station Laboratory from ISO / IEC17025 (CNAS-CL01) to ISO15189 (CNAS-CL02). In this paper, we carry out ISO15189 laboratory accreditation work for bloodstain laboratory, discuss the similarities and differences between “Quality Control Laboratory of bloodstain laboratory”, ISO15189 and ISO / IEC17025, and the specific requirements and clauses in ISO15189 accreditation criteria. At the same time, As an example to explain how to establish a quality management system that integrates ISO15189, “a law two rules”, ISO / IEC17025 and ISO9000 together and the problems that need attention when establishing the system.