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CNAS软件检测机构实验室间比对怎么做

实验室间比对是按照预先规定的条件,由两个或多个实验室对相同或类似的物品进行测量或检测的组织、实施和评价。软件测试实验室在申请CNAS或CMA资质时,需要根据CNAS-CL01文件中7.6条款的内容进行实验室间比对,实验室间比对是判断和监控实验室能力的有效手段。

 

与实验室间比对经常一同出现的还有“能力验证”和“测量审核”,能力验证是特殊的实验室间比对,是由CNAS承认的机构组织的实验室间比对,而“测量审核”指的是一对一的能力验证。软件测试实验室在选择实验室间比对时需要注意,选择的实验室需要3家或3家以上,需要在相同范围内已经取得CNAS/CMA资质。

 

 

实验室比对的管理要求

 

1.实验室应根据年度质量控制计划的需要制定用于内部质量控制的比对试验计划。

 

2.实验室用于内部质量控制的比对试验计划中,应明确各项比对试验的检测项目、比对形式、参加人员、预计日期、结果评价准则、不满意结果的处置要求等内容。

 

3.进行比对试验时,实验室应采取必要的措施杜绝弄虚作假、结果串通或结果修正。

 

4.比对试验完成后,实验室应对比对试验的结果进行汇总、分析和评价,并形成比对试验报告。

 

5.实验室应针对比对试验中出现的问题进行原因分析,根据其对实验室出具检测结果的影响采取纠正措施、预防措施或相应的改进措施。

 

比对实验实施方案设计的方法

 

1、实验室比对实验方案设计

 

参与比对实验方案设计的人员包括熟悉实验室质量管理、检测方法和统计学等方面工作的技术人员。必要时,可以成立比对实验技术小组,负责方案的设计,实施的监督以及比对过程的指导,比对方案的内容一般包括:

 

1)目的;

2)开始时间和结束时间;

3)比对形式、检测项目、仪器设备、检测方法、参加人员等;

4)所用样品的描述,例如均匀性、稳定性、发放形式和处置要求;

5)检测技术的要求,例如重复测试次数的要求;

6)记录要求;

7)评价方法和判断的准则;

8)出现不符合处置的要求;

9)其他需要特殊注意的事项。 

 

2、比对试验的开展:

1)实验室开展比对试验进行内部质量控制时,应确认其环境条件不会对所要求的检测质量产生不良影响。

2)实验室开展比对试验进行内部质量控制时,应确认用于检测的对结果准确性或有效性有显著影响的所有设备,包括辅助测量设备,经过校准并通过有效的期间核查保持其校准状态的置信度。

3)参与比对试验的人员,应按检测方法的要求进行测试,如实记录试验结果及相关信息,提交检测报告和原始记录。

4)当试验过程中出现可能影响比对试验结果统计分析的意外情况时,比对试验负责人应及时分析各种因素,与检测人员进行充分协调,并做出继续按原试验方案进行或修改原试验方案、执行新方案的决定。

 

比对实验室的设计很重要,后面对比对结果的应用和比对结果的评价,都有赖于于比对实验室的设计,另外实验的设计一定要冲着比对的目的而去。

 

实验室间比对结果利用

 

比对试验的评价结果分为满意和不满意。根据工作需要,实验室可增加用于比对试验结果评价的临界可疑判据的规定。

比对试验结果满意时,认为实验室对检测结果的监控有效,符合内部质量控制的要求。

比对试验结果为可疑时,实验室应尽快分析出现疑问的原因,并开展有效的改进活动,必要时修改作业性文件。