实验室认可评审工作作业指导书

实验室认可评审工作作业指导书 目 录 1 目的.........................................................................................................4 2 范围 .......................................................................................................4 3 职责.........................................................................................................4 4 评审过程..................................................................................................5 4.1 任务接收...............................................................................................5 4.2 文件资料审查........................................................................................5 4.3 预评审...................................................................................................6 4.4 现场评审策划........................................................................................6 4.5 现场评审工作预备会..............................................................................8 4.6 现场评审活动........................................................................................8 4.6.1 首次会议............................................................................................8 4.6.2 现场观察、完善评审日程表................................................................9 4.6.3 现场评审..........................................................................................10 4.6.4 召开座谈会...............................................………………………………10 4.6.5 评审组内部会.................................................………………………….10 4.6.6 与实验室沟通................................................…………………………..10 4.6.7 末次会议..........................................................................................10 4.6.8 后续工作.............................................…………………………………..11 4.7 跟踪验证.............................................................................................11 5 现场评审时常遇问题的处理.....................................................................12 5.1 现场试验/测量审核/盲样试验结果处理..................................................12 5.2 对申请认可项目/参数的检测/校准经历要求...........................................12 5.3 对除标准方法以外的其它方法的认可要求... .........................................12 5.4 涉及能力验证的要求............................................................................12 5.5 对实验室评估测量不确定度的要求........................................................13 5.6 对量值溯源有效性的要求.....................................................................13 5.7 授权签字人的确认................................................................................14 5.8 不符合项和观察项要求.........................................................................14 5.9 对有移动设施的实验室的要求..............................................................15 5.10 对于租用设备的要求..........................................................................15 5.11 关于自校准实验室..............................................................................16 5.12 关于实验室符合相关法律法规的要求..................................................16 5.13 对内审员的要求.................................................................................16 5.14 对于多场所的现场评审问题................................................................16 5.15 现场评审发生危及人身健康安全情况的处理......................................….17 5.16 初次评审对实验室质量管理体系运行记录审查的起始时间.......…..…..17 5.17 现场评审时,实验室提出更改认可范围................................................17 5.18 现场评审时，评审人日数需要调整....................................................17 5.19 评审员不能按计划参加评审..............................................................17 5.20 现场评审时发现实验室故意损害CNAS声誉的行为...........................17 5.21 中途停止现场评审..............................................................................18 6 监督评审................................................................................................18 7 复评审....................................................................................................19 8 扩大认可范围的评审...............................................................................19 9 填写评审报告的要求...............................................................................20 10 对评审员的评价....................................................................................22 11 工作记录...............................................................................................22 12 相关表格......................................................................................22