CNAS—CL02 医学实验室质量和能力认可准则 (ISO 15189:2007) Accreditation Criteria for the Quality and Competence of Medical Laboratories 中国合格评定国家认可委员会 2 目 录 前 言 ............................................................................................................................................. 3 1.范围 .............................................................................................................................................. 4 2.规范性引用文件 .......................................................................................................................... 4 3.术语和定义 .................................................................................................................................. 4 4.管理要求 ...................................................................................................................................... 6 4.1 组织和管理 .............................................................................................................................. 6 4.2 质量管理体系 .......................................................................................................................... 7 4.3 文件控制 .................................................................................................................................. 9 4.4 合同的评审 .............................................................................................................................. 9 4.5 委托实验室的检验 ................................................................................................................ 1 0 4.6 外部服务和供应 .................................................................................................................... 1 1 4.7 咨询服务 ................................................................................................................................ 1 1 4.8 投诉的解决 .......