CNAS— CL02 (第三版) 医学实验室质量和能力认可准则 Accreditation Criteria for the Quality and Competence of Medical Laboratories (ISO 15189:2012,IDT) 中国合格评定国家认可委员会 二〇一三年十一月CNAS-CL02:2012 第 1 页 共 54 页 2013 年11 月22 日发布 2014年11 月01 日实施 目次 前言 ...................................................................................................................................................... 2 1 范围 .................................................................................................................................................. 3 2 规范性引用文件 .............................................................................................................................. 3 3 术语和定义 ...................................................................................................................................... 3 4 管理要求 .......................................................................................................................................... 7 4.1 组织和管理责任 ........................................................................................................................... 7 4.2 质量管理体系 ..............................................................................................................................11 4.3 文件控制 ..................................................................................................................................... 12 4.4 服务协议 ..................................................................................................................................... 13 4.5 受委托实验室的检验 ................................................................................................................. 14 4.6 外部服务和供应 ......................................................................................................................... 14 4.7 咨...