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实验室评审前期该准备哪些内容?有了这个清单质量负责人再也不用头疼了!

2017-09-06 00:004380
 portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">实验评审内容准备

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">1、实验室该有的人员到位情况;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">2、实验室经理/主管、技术主管、质量主管、监督员、取样人员的任命;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">3、实验室组织结构图;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">4、指定关键管理人员(实验室经理/主管、技术主管、质量主管、监督员、取样人员)的代理人;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">5、有关三级文件的建立,如实验室内部文件管理、记录管理、样品管理、环境管理、外出抽样;SOP、标准物质管理/标准溶液SOP、实验室废弃物管理SOP、食品检测应急预案等;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">6、实验室现场使用的所有文件和标准是否受控;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">7、如有分包,分包方名册及资质档案建立情况;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">8、关键试剂的技术性验收记录;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">9、供应商评估、资质档案与合格供应商名册的建立;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">10、年度员工培训计划;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">11、检测人员的技术档案(含学历证明、各类资质证明、技术能力评估表等);

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">12、实验室员工是否接受ISO17025和质量管理体系的培训;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">13、目前环境满足检测方法/标准的情况;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">14、各不相容区域是否有隔离以防止交叉污染;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">15、实验室关键区域是否有出入授权标识;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">16、所有检测标准/方法是否进行了方法确认/证实,并保存记录;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">17、如果不同的检测人员对同一份标准的理解和操作存在不同,是否制定检测SOP;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">18、定量检测项目是否有进行不确定度评估,提供评估报告;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">19、需要的仪器设备是否已经到位;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">20、××年度的设备校准/维护保养计划是否制定;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">21、需要校准的设备是否已经送外校准/检定;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">22、关键设备的档案是否建立;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">23、设备在使用前是否进行了确认,并有记录;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">24、设备校准/有效状态的标识状况;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">25、××年度设备期间核查计划;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">26、抽样计划和程序在抽样地点是否能够获得;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">27、申请书附表准备,包括以下附表:

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">附表1-1:实验室授权签字人一览表(中、英文)

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表1-2:授权签字人申请表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表2-1:申请的检测能力范围(中、英文)

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表3:实验室人员一览表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表4-1:检测实验室仪器设备/标准物质配置表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表5-1:实验室参加能力验证/测量审核一览表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表5-2:实验室参加实验室间比对一览表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表8:参加能力验证活动的计划表
portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">28、实验室平面图;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">29、实验室所从事活动的说明,以及当实验室是法人实体的一部分时,两者关系的说明。(NJTC-QM质量手册有描述);

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">30、对申请认可的标准/方法现行有效性进行的核查情况(提交核查报告,自行核查时核查报告需要包含核查人、时间、方式、结果);

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">31、对于初次申请认可和申请扩大认可范围的实验室,在申请范围内,至少参加一次CNAS或其承认的机构所组织的能力验证活动,或CNAS承认的实验室间比对,或CNAS安排的测量审核活动,且获得满意结果的证据,或对于不满意结果能证明已开展了有效纠正措施的证据;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">32、参加实验室间比对的情况(提交实验室间比对的结果和评价);

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">33、典型项目的检测报告及不确定度评估报告。



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