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CNAS软件检测实验室监督评审与复评审重点解析

一、监督评审

监督评审指的是CNAS 为验证获准认可实验室是否持续地符合认可条件而在认可有效期内安排的定期或不定期的评审。监督评审分为定期监督评审、不定期监督评审及日常监督。

1、定期监督评审

获准认可实验室应在认可批准后的 12 个月内,接受 CNAS 安排的第一次定期监督评审,以后每隔最长 18 个月、12 个月应接受第二、第三次定期监督评审。

1)定期监督评审的范围可以是认可领域以及认可要求的全部或部分内容。

2)在认可有效期内的定期监督评审应覆盖获准认可实验室被认可的全部领域和 CNAS的全部认可要求。

3)对多地点的获准认可实验室,每次监督应覆盖所有地点。

4)定期监督评审不需要获准认可实验室提出申请,有关评审要求和现场评审程序与初次认可相同。

5)监督中发现不符合时,被评审方在明确整改要求后应拟订并实施纠正措施计划,纠正措施完成期限一般为二个月,对影响检测、校准和检查结果的严重不符合,应在一个月内完成。

6)实验室的扩项评审应尽可能与定期监督评审结合进行。

7)在实施定期监督评审时,应考虑前一次监督的结果、参加能力验证的情况,尤其是能力验证结果不满意时的纠正措施实施情况。

2、不定期监督评审

以下情况时,CNAS 可随时安排不定期监督评审或不定期的访问:

1)获准认可实验室如发生下列变化(应在变更后一个月内以书面形式通知 CNAS )。

a)获准认可实验室的名称、地址、法律地位发生变化。

b) 获准认可实验室的组织机构、高级管理和技术人员、授权签字人发生变更。

c)认可范围内的重要试验设备、环境、检测、校准、检查工作范围及检测项目发生重大改变。

d)其它可能影响其认可范围内业务活动和体系运行的变更。

2)CNAS 的认可要求变化。

3)CNAS 认为需要对投诉、其他情况反映进行调查时。

3、日常监督

日常监督包括现场监督评审和其他监督活动。

1)就与认可有关的事宜询问获准认可实验室。

2)审查获准认可实验室就认可覆盖的范围所做的声明。

3)要求获准认可实验室提供文件和记录(如审核报告、用于验证获准认可实验室服务有效性的内部质量控制结果、投诉记录、管理评审记录)。

4)监视获准认可实验室的表现(如参加能力验证的结果 )。

监督评审的重点:

定期监督主要评价被评审实验室与认可规则、认可准则、已认可技术能力的持续符合性,执行能力验证政策的情况,实验室变更情况,上次评审发现的不符合是否采取有效的纠正措施、上次评审的观察项等。

 

二、复评审

复评审指的是获得认可的认证机构要求延长认可资格时,在认可证书有效期终止前 6 个月向 CNAS重新提出书面认可申请。

复评审重点

复评审相当于重新进行一次“初审”。所以,初审重点也即复评审重点。

1、质量保证体系运行,包括体系文件的宣贯覆盖率、原始记录填写是否完整、能力验证、作业指导书、《质量手册》和《程序文件》的操作性和针对性、标准物质的标示信息等。

2、标准、规范、规程的更新、宜贯、培训,包括标准的查新、标准的受控情况、非标方法的确认等。

3、仪器设备及档案管理 ,包括设备档案信息是否完整、检定和校准体系文件是否完整设备的唯一性标示、设备的维护保养记录等。

4、试验检测硬件环境,包括防止仪器交叉影响措施、安全措施等。

5、样品管理、试验检测记录与报告、人员等。