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软件实验室申请cnas最常见不符合项及整改方法

软件检测实验室的管理或技术活动不满足CNAS发布的认可要求文件,包括认可规则、认可准则、认可说明和认可方案中规定的相关要求,以及实验室自身管理体系和相应检测或校准方法中规定的要求时,CNAS评审组会在文件评审、现场评审中提出不符合项,对一般不符合项的处理措施:实验室应在2个月内完成纠正与纠正措施。如果评审组判定不符合项构成严重不符合项时,要在1个月内完成纠正和纠正措施,并进行现场跟踪验证。

 

在cnas认可为官方公布的文件中,不符合项通常包括以下几种类型:

· 缺乏必要的资源,如设备、人力、设施等;

· 未实施有效的质量控制程序;

· 测量溯源性不满足相关要求;

· 人员能力不足以胜任所承担的工作;

· 操作程序,包括检测或校准的方法,缺乏技术有效性;

· 实验室管理体系文件不满足 CNAS 认可要求;

· 实验室运作不满足其自身文件要求;

· 实验室未定期接受监督评审、未缴纳费用等。

 

在实际操作过程中,最常遇到的不符合项会有以下几种情况:

1.质量管理体系文件未涉及准则中部分条款的内容;

2.质量管理体系文件的规定与准则要求偏离;

3.质量管理体系文件中对某项活动有明确的规定,但实验室或实验室某个工作人员违反规定;

4.质量管理体系文件中对某项活动有明确的规定,但实验室未执行;

5.质量管理体系文件中对某项活动有明确的规定,实验室有执行,但是执行不到位;

6.实验室的某个工作人员个人工作失误。

 

不符合项的整改流程:

 

在评审过程中,出现不符合项时,我们软件检测实验室应该积极快速应对,制定纠正措施,实施纠正措施并产生证明材料,制作和提交整改报告。

在制定纠正措施时,纠正措施必须与原因分析中阐述的原因一一对应。通常,纠正措施应包含以下内容:

1.修订或增加体系文件,增加新的程序文件、作业指导书、记录表格。

2.对不符合进行纠正,不符合可能涉及人、机、料、法、环各个方面

3.如有证据表明发现的不符合影响到以往检测结果的准确性,且检测报告已发出,则需要追回检测报告,重新送样检测;

4.举一反三,核查实验室检测活动的其他环节、其他部门、其他人员等是否存在相同的问题,如果有类似问题,一并进行纠正;

5.培训和宣贯,对准则、修订或增加的质量管理体系文件、标准进行培训或宣贯,避免类似问题的再次发生。

 

进行整改时,应有充分的证明材料,证明材料主要有以下几个方面:

1.凡涉及文件修订或新增的,必须有文件控制记录,比如文件的发放、回收、修订记录复印页。必须有修订页修订前后复印页、修订文件修订内容前后复印页,新增的文件应有新增文件的复印件;

2.凡涉及采购物品的,应用采购合同或发票复印件。涉及校准/检定的,应有校准/检定证书复印件。涉及人员考核上岗的,应有考核记录复印件。涉及耗材验收的,应有验收记录复印件。涉及环境条件监控的,应有监控记录复印件;

3.凡涉及重新检测的,应有整改前后客户委托单、检测原始记录、检测报告的复印件;

4.凡进行举一反三,核查相同问题的,应有核查记录;

5.凡涉及培训和宣贯的,必须有培训宣贯记录复印件,如有考核的,应有考核记录复印件。

注意,采取的纠正措施证明材料必须与纠正措施一一对应。在编制整改报告时,可将各不符合项的纠正措施表、证明资料装订在一起,便于查阅。

 

整改报告模版:

软件测试cnas

国家认可委:

于XXXX年XX月XX至XX日按CNAS-CL01:2018 《检测和校准实验室能力认可准则》、CNAS-CL01-A019:2018《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》对XX进行了实验室认可现场技术评审,评审组开出了XX个不符合项要求限期整改。

我单位于XXXX年XX月XX日召开了整改工作专项会议,成立了以XX为组长的整改小组(见附件一),对存在问题,认真查找分析原因,制定了整改计划,对不符合项进行了切实有效地整改,并于XXXX年XX月XX日完成整改工作,现将整改结果及有关材料呈交评审组,敬请予以审查。

一、第一个不符合项整改情况

(一)不符合项内容:实验室不能提供XX记录,与CNAS-CL01:2018中XX规定不符合。

(二)原因分析:对CNAS-CL01:2018中XX条款的要求学习理解不透,虽按XX,但未XX。

(三)整改措施:组织相关人员,加强对CNAS-CL01:2018中XX条款和《XX程序》的学习理解。修订XX,增加《XX记录》表格,按照相关程序要求做好XX工作。

(四)整改完成情况:按照《XX程序》的要求,分别在XX月和XX月对认可范围内的所有产品标准和检验方法进行了两次有效性查新(见《XX记录》);按照《XX程序》要求,对文件进行了XX。  

(五)整改证明材料:整改证明材料(一):附件1-1XX、附件1-2XX、附件1-3XX、附件1-4XX、附件1-5XX、附件1-6纠正措施跟踪验证表。  


二、第二个不符合项整改情况  ………  

本次监督评审共发现XX个不符合项,主要集中在XX等几个方面,说明在我们的日常工作中尚有许多不足之处需要完善。通过这次整改,我们举一反三,进一步加强人员培训学习,强化体系文件持续改进,使我站人员对质量管理体系有了更深的体会,使人员的质量意识、执行能力得到进一步提升,服务能力进一步加强,工作效率进一步提高,更好地为社会提供优质检验服务,为保障软件产品质量做出更大的贡献。  

 

xxxxxxxxxxxxxx(盖章)

xxxx 年xx月 xx日

 

 

 

以上就是我们为大家整理的软件测试实验室在申请CNAS认可时,会遇到的不符合项、处置方案、报告模版的相关内容,如需软件测试实验室CNAS认可相关的资料模版、软件CNAS认证费用清单、软件CNAS认证工具清单对比等资料,可关注我的主页,在专栏中查看相关内容。