内部质量体系审核程序(程序文件)

xx试验室程序文件标题：内部质量体系审核程序文件编号：xx-xx-03版号：第一版第一次修订发布日期：xx年03月01日编制：审核：批准：修订记录章号条号修订内容批准人批准日期备注03-1xx试验室文件编号：xx-xx-03第2页共5页标题：内部质量体系审核程序第1版目录1、目的·································································03-32、范围·································································03-33、职责·································································03-33.1最高管理者··························································03-33.2主任································································03-33.3质量负责人··························································03-33.4内审员······························································03-33.5资料员······························································03-34、工作程序·····························································03-34.1编制审核计划························································03-34.2审核的准备··························································03-34.3审核的实施··························································03-44.4审核报告····························································03-44.5对审核所发现问题的反应··············································03-44.6纠正措施的跟踪验证··················································03-44.7记录的保存··························································03-45、相关文件·····························································03-46、质量记录·····························································03-503-2xx试验室文件编号：xx-xx-03第3页共5页标题：内部质量体系审核程序第1版1、目的通过质量体系审核、检查、评价和验证质量体系运行的符合性、有效性，发现质量管理中存在的问题，采取纠正和预防措施，本试验室质量体系满足标准的要求，确保有效和持续改进。2、范围本程序适用于城市xx工程试验室内部质量体系审核。3、职责3.1最高管理者负责审批，仲裁经采取纠正措施不能有效处置的情况。3.2主任负责审批年度内部审核计划和追加审核计划，调配所需的资源。审核内部审核结果，向最高管理者和管理评审会议报告内部审核中发现的主要问题和采取的改进措施。3.3质量负责人负责编制年度内部审核计划和追加审核计划，组织实施内部审核。向主任报告内部审核情况。3.4内审员负责按照本程序和审核计划，准备和实施内部审核，编制检查表、客观公正地收集证据，记录分析评价结果，写出书面材料，向质量负责人报告；认可受审核方的纠正措施计划、验证纠正措施完成情况。3.5资料员负责保存内部审核记录。4、工作程序4.1编制审核计划4.1.1常规审核质量负责人负责编制年度内部审核计划，经主任审核后报最高管理者审批。4.1.2追加审核当遇到下列情况时，可酌情增加审核：①、发生了严重的质量问题或委托方有严重的抱怨；②、试验室领导层、隶属关系、内部机构、质量方针和目标、检验项目的扩充、检测设施和仪器设备以及市场条件等发生重大变化；③、认证机构复查评审或监督评审前；4.1.3审核计划的内容应包括：受审核部门、审核的目的、审核的范围、审核方法、审核的日期、审核的依据、审核组组成等。4.2审核的准备4.2.1审核组一般由2-3人组成，审核员由经培训具有内审员资格且与被审核部门无直接责任的人员担任，内审组长由质量负责人担任。03-3xx试验室文件编号：xx-xx-03第4页共5页标题：内部质量体系审核程序第1版4.2.2内审组长组织内审员学习有关文件，拟定审核日程，编制审核检查表。4.2.3审核组提前5天将审核日程及审核的目的、范围和要求通知受审核方。4.2.4受审核方如对审核日期和审核项目有异议，可在拟审核日期前2天通知审核组，有关事宜经协商另行确定。4.2.5受审核方应做好接受审核的准备工作，并确定陪同审核的人员。4.3审核的实施4.3.1审核组长主持召开首次会议，说明审核的目的、范围、依据、方法和日程安排。4.3.2内审员按检查表实施审核，做出记录，有不符合项(或基本符合项)时，填写不符合报告，并请受审核方负责人签字认可。4.3.3审核组长主持召开末次会议，报告审核结果，宣读不符合报告，并请受审核方负责人填写纠正措施计划。4.4审核报告4.4.1审核组长应按规定的格式，根据审核结果组织编制审核报告，5日内将审核报告副本发至被审核方。4.4.2审核报告应包括以下内容：审核目的、审核范围、审核依据、审核实施情况、基本评价、不符合项分布、主要问题分析及纠正措施建议。4.5对审核所发现问题的反应4.5.1受审核方对每一份不符合报告必须在5日内向质量负责人做出书面反应，详细说明所采取的纠正措施、必要的预防措施和完成的期限。4.5.2受审核方如果不能接受审核组提出的纠正措施建议，则应向质量负责人解释不能接受的原因。必要时评审组应对纠正措施建议进行修订。4.5.3受审核方如果对不符合报告没有做出反应，质量负责人应加以追查，如仍无反应，应向主任报告。4.6纠正措施的跟踪、验证4.6.1当到达预定的纠正措施完成日期，或质量负责人已接到纠正措施完成的报告，质量负责人应委派一名内审员验证其完成情况。4.6.2当内审员确认纠正措施已经完成并有效后，应在不符合报告表中的“验证”栏中签署验证意见，关闭该不符合报告。4.6.3如受审核方无正当理由在规定的期限内未能完成纠正措施，且不能提出内审员可以接受的完成期限，质量负责人应向主任报告此情况。4.7记录的保存内部审核应做好记录，并全部归档，执行《记录和档案管理程序》。5、相关文件03-4xx试验室文件编号：xx-xx-03第5页共5页标题：内部质量体系审核程序第1