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cnas最新公布认可常见问题汇总,赶紧查漏补缺

在近期举办的全国合格评定机构认可工作专题会议上,公布了在受理过程、评审过程和不符合项整改过程中最容易出现问题的一些地方。让我们一起来看一下,重点规避这些问题。

 

一、在受理过程中存在的主要问题:

 

1、对CNAS认可规范不熟悉。

 

软件测试实验室在申请CNAS资质时,庞大的文件体系和内容让我们很难在短时间内全面把握CNAS对软件测试实验室的各类要求。针对这个问题我们为大家进行了分类梳理,为大家标出了需要重点参考的文件,帮助大家清晰掌握认可要求。

软件测试CNAS认可文件

cnas官方也发布了CNAS-实验室认可规范文件清单,大家可以根据这个清单去梳理和学习。

 

2、未依据认可规范要求建立和有效运行质量管理体系。

3、体系文件中要素覆盖不全。

针对以上两点可以参照《检测和校准实验室能力认可准则》核查表和《检测和校准实验室能力认可准则在软件检测领域的应用说明》核查表对自己的质量管理体系进行核查。

 

4、资源不足:检验/检测员数量不足、从业资格缺失。

 

软件测试实验室的人员应满足以下要求:

 

a、 从事软件测试人员,应具有计算机及相关专业的大专(含)以上学历、并获得国家或行业承认的软件测试技术专业培训合格资质或计算机软件相关专业的高级工程师,具备与软件测试任务相适应的被测试软件背景知识和软件测试技术。

 

b、 各类人员其他应满足的要求包括:

 

(1)从事软件测试项目管理、测试需求分析、测试策划和测试设计活动的人员,一般应有2年(含)以上软件开发工作经历或3年以上软件测试技术工作经历;(2)软件测试执行人员,一般应有3个月(含)以上软件测试技术岗位实习工作经历,并至少实习完成1个软件测试项目;(3)负责软件测试结果评价(评估)、方法确认、质量核查的人员,以及软件测试报告审核人和批准人,一般应有3年(含)以上软件测试技术工作经历。

 

c、实验室对软件检测人员进行的培训,应包括安全保密、知识产权保护以及软件测试有关的法规、标准。

 

d、实验室应:

 

(1)至少具有5名软件检测人员;(2)由熟悉软件项目管理、开发、测试及标准、规程、规范的技术人员负责组织实施软件检测任务;(3)由熟悉软件检测过程以及软件测试标准、规范、规程,软件质量评价和软件测试质量评价的人员,负责对软件检测人员实施质量核查,审核软件测试过程和形成的软件测试工作产品是否符合相应的标准、规范;(4)由熟悉软件测试需求、测试结果评价和判定准则的人员负责对软件测试输入和测试结果进行核查。

 

5、认可申请书填写不规范。

 

提交的申请资料应齐全完整、表述准确、文字清晰,认可申请书的重点核查内容有:

 

a)申请书正文,主要审查以下内容:

 “实验室声明”页公章、签字齐全并符合要求;

申请书内容填写完整;

申请认可的实验室名称符合规定。

b)申请书附表,主要审查以下内容:

申请的授权签字人资质与认可准则及其在相应领域应用说明和CNAS-CL01-G001的符合性,是否有足够的技术工作背景支撑。

实验室人员的学历、专业等与认可要求的符合性。

申请认可的检测/校准能力的填写符合CNAS-EL03《检测和校准实验室认可能力范围表述说明》及相应领域能力表述说明的要求,有相应检测/校准经历支撑。

实验室的设施和设备属性满足认可要求。

实验室仪器设备计量溯源的信息。

从事的内部校准与认可要求的符合性。

实验室参加能力验证的符合性。

认可准则及其在特殊领域的应用说明核查表(适用时)填写的完整性和符合性。

 

6、申请认可前有错误使用认可标识的行为。

标识的使用可以参照CNAS-R01:2023《认可标识使用和认可状态声明规则》。该文件最新版本于近期刚开始实施,大家可以下载最新版本进行学习。

 

7、能力范围超出CNAS现有认可领域。

8、分支机构法律地位不明确。

 

二、在评审过程中存在的主要问题:

 

1、持续识别公正性的风险。

软件测试实验室应该从组织结构和管理制度保障、管理层公正性承诺、员工行为规范、以及风险管理四个层间进行公正性风险的规避。

 

2、记录管理不符合程序文件规定要求。

软件测试实验室应建立记录控制程序,对记录的管理做好相关规定,如需记录控制程序模版,可私信我。

 

3、PT能力验证覆盖领域和频次。

4、软件版本控制及更新。

软件测试实验室应该建立《仪器设备管理程序》,对设备的购置/调拨、验收、使用、维护、检定/校准/检查和管理工作进行管理。指定专人负责设备的管理,包括校准、维护和期间核查等。每年制定检定校准、期间计划以提示对到期设备进行校准、核查和维护。对于软件测试设备,应对测试工具软件进行版本升级和配置控制,防止误用。

 

5、技术人员队伍不稳定,个别人员甚至交叉任职。

 

三、不符合项整改中存在的主要问题:

 

1、不能做到举一返三

 

2、只实施纠正,不实施纠正措施

 

3、不符合项整改超期

 

针对该部分,跟大家分享之前写过的不符合项整改的步骤:

对于不符合项,经过实验室确认后,应立即纠正,分析原因,采取纠正措施,以及纠正措施的有效性进行验证等步骤整改,一般包括下面5个步骤:

1.立即将发现的不符合加以控制或者消除;

2.举一反三,排查其他地方是否存在类似的问题,一并纠正;

3.调查分析产生问题的原因;

4.针对原因采取对应的纠正措施;

5.实施纠正措施,控制纠正措施的执行情况;

6.验证纠正措施的有效性;

 

不符合项的整改需要注意8个方面:

1.一般只针对所提出的不符合项进行,若有其他问题也应该指出;

2.原因分析要彻底,要抓住要害;

3.实施过程有无困难,是否需要其他部门的人配合和支持;

4.涉及文件修改,体系调整的是否已经有效执行;

5.是否在要求内的时限完成;

6.判断最终的整改效果,可以重新抽样确认;

7.整改要有记录,记录需要得到控制;

8.没有完成或者无法完成的需要提交实验室管理者进行决策。

 

不符合项的整改流程:

1.制定整改计划

通过和评审组的交流,实验室明确需整改的项目和具体要求,制定出有针对性的纠正措施,现场评审结束后,实验室质量主管在征得最高管理者同意后,应发布整改计划,明确整改内容、要求、完成期限以及整改责任部门和责任人。

2.按计划实施整改

在这一过程中,质量主管和质量管理部门要跟踪整改工作进展情况,检查执行效果;对实施效果不满意的,应和整改责任人或整改部门负责人沟通、努力达到评审组提出的要求。在整改实施过程中,实验室应做好记录,一方面可以提供评审组跟踪审核,另一方面也是质量改进的见证。

3.编制整改报告

经验证,确认纠正措施到位后,实验室应收集汇总整改见证材料并将其编目,编制整改工作报告,具体说明每一不符合项的整改情况及效果,如果有观察项,还应说明预防措施。

4.提交整改报告

实验室向评审组长提交整改报告。评审组长验收并填写验收及最终推荐意见后,提交CNAS秘书处评定委员会评定。

 

不符合项整改报告模版:

首先提供一个封面,写清楚整改单位、编制、审核和签发人员以及日期。