CNAS-CL07-A001-2021 医学参考测量实验室能力认可准则的应用要求
简介
CNAS-CL07-A001
医学参考测量实验室能力认可准则的应用要求
Application Requirements of Accreditation Criteria for the Competence of Reference Measurement Laboratories in Laboratory Medicine
中国合格评定国家认可委员会
2021年 11月 25日实施
2021年05月 25日发布 目次 前 言 ................................................................................................................................................2 1范围...........................................................................................................................................3 2引用文件...................................................................................................................................3 3术语和定义...............................................................................................................................4 4一般要求...................................................................................................................................4 5结构要求...................................................................................................................................4 6资源要求...................................................................................................................................4 6.1 总则....................................................................................................................................4 6.2 人员....................................................................................................................................4 6.3 设施和环境条件................................................................................................................5 6.4 设备....................................................................................................................................6 6.5 计量溯源性........................................................................................................................7 6.6 参考物质............................................................................................................................8 6.7 外部提供的产品和服务....................................................................................................8 7过程要求...................................................................................................................................9 7.1 要求、标书和合同评审.....................................................................................................9 7.2 方法的选择、验证和确认（参考测量程序）.................................................................9 7.3 检测或校准物品的处置/样品处理.................................................................................10 7.4 测量记录..........................................................................................................................11 7.5 测量不确定度评定..........................................................................................................11 7.6 确保测量结果的有效性..................................................................................................11 7.7 报告测量结果..................................................................................................................12 7.8 投诉..................................................................................................................................12 7.9 不符合工作......................................................................................................................12 7.10 数据控制和信息管理....................................................................................................12 8管理要求.................................................................................................................................13 8.1 总则..................................................................................................................................13 8.2 内部审核...........................................................................................................................13 8.3 管理体系文件的控制（方式 A）...................................................................................13 8.4 记录控制（方式 A）.......................................................................................................13 8.5 应对风险和机遇的措施（方式 A）...............................................................................13 8.6 改进（方式 A）...............................................................................................................13 8.7 纠正措施（方式 A）.......................................................................................................13 8.8 内部审核（方式 A）.......................................................................................................13 8.9 管理评审（方式 A）.......................................................................................................13 附录 A（规范性附录）.................................................................................................................14 附录 B（规范性附录）.................................................................................................................15
CNAS-CL07-A001
医学参考测量实验室能力认可准则的应用要求
Application Requirements of Accreditation Criteria for the Competence of Reference Measurement Laboratories in Laboratory Medicine
中国合格评定国家认可委员会
2021年 11月 25日实施
2021年05月 25日发布 目次 前 言 ................................................................................................................................................2 1范围...........................................................................................................................................3 2引用文件...................................................................................................................................3 3术语和定义...............................................................................................................................4 4一般要求...................................................................................................................................4 5结构要求...................................................................................................................................4 6资源要求...................................................................................................................................4 6.1 总则....................................................................................................................................4 6.2 人员....................................................................................................................................4 6.3 设施和环境条件................................................................................................................5 6.4 设备....................................................................................................................................6 6.5 计量溯源性........................................................................................................................7 6.6 参考物质............................................................................................................................8 6.7 外部提供的产品和服务....................................................................................................8 7过程要求...................................................................................................................................9 7.1 要求、标书和合同评审.....................................................................................................9 7.2 方法的选择、验证和确认（参考测量程序）.................................................................9 7.3 检测或校准物品的处置/样品处理.................................................................................10 7.4 测量记录..........................................................................................................................11 7.5 测量不确定度评定..........................................................................................................11 7.6 确保测量结果的有效性..................................................................................................11 7.7 报告测量结果..................................................................................................................12 7.8 投诉..................................................................................................................................12 7.9 不符合工作......................................................................................................................12 7.10 数据控制和信息管理....................................................................................................12 8管理要求.................................................................................................................................13 8.1 总则..................................................................................................................................13 8.2 内部审核...........................................................................................................................13 8.3 管理体系文件的控制（方式 A）...................................................................................13 8.4 记录控制（方式 A）.......................................................................................................13 8.5 应对风险和机遇的措施（方式 A）...............................................................................13 8.6 改进（方式 A）...............................................................................................................13 8.7 纠正措施（方式 A）.......................................................................................................13 8.8 内部审核（方式 A）.......................................................................................................13 8.9 管理评审（方式 A）.......................................................................................................13 附录 A（规范性附录）.................................................................................................................14 附录 B（规范性附录）.................................................................................................................15
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