19011审核指南.docx
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19011审核指南
前言```````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````3
0引言```````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````4
1范围```````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
2引用标准```````````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3术语和定义```````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.1审核```````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.2审核准则````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.3审核证据````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.4审核发现````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.5审核结论````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.6审核委托方````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.7受审核方````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.8审核员````````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.9审核级````````````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.10技术专家``````````````````````````````````````````````````````````````````````````````````````````````````````````````5
3.11审核方案``````````````````````````````````````````````````````````````````````````````````````````````````````````````6
3.12审核员资格``````````````````````````````````````````````````````````````````````````````````````````````````````````6
3.13中等教育```````````````````````````````````````````````````````````````````````````````````````````````````````````````6
4审核基本原则```````````````````````````````````````````````````````````````````````````````````````````````````````````````6
5审核方案的管理```````````````````````````````````````````````````````````````````````````````````````````````````````````6
5.1总则````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````6
5.2审核方案的权限、目标、程度和范围````````````````````````````````````````````````````````````````6
5.3职责、资源和程序````````````````````````````````````````````````````````````````````````````````````````````````7
5.4审核方案的实施````````````````````````````````````````````````````````````````````````````````````````````````````7
5.5审核的监控和评审````````````````````````````````````````````````````````````````````````````````````````````````7
5.6记录````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````8
5.7联合审核````````````````````````````````````````````````````````````````````````````````````````````````````````````````8
6审核活动```````````````````````````````````````````````````````````````````````````````````````````````````````````````````````8
6.1审核的启动`````````````````````````````````````````````````````````````````````````````````````````````````````````````8
6.1.1目的、范围和审核准则`````````````````````````````````````````````````````````````````````````````````8
6.1.2审核的可行性`````````````````````````````````````````````````````````````````````````````````````````````````8
6.1.3审核组的组建`````````````````````````````````````````````````````````````````````````````````````````````````8
6.1.4与受审核方的初步接触`````````````````````````````````````````````````````````````````````````````````9
6.1.5文件评审`````````````````````````````````````````````````````````````````````````````````````````````````````````9
6.2现场审核的准备````````````````````````````````````````````````````````````````````````````````````````````````````9
6.2.1审核的策划`````````````````````````````````````````````````````````````````````````````````````````````````````9
6.2.2审核任务的下达`````````````````````````````````````````````````````````````````````````````````````````````9
6.2.3审核员的审核准备`````````````````````````````````````````````````````````````````````````````````````````10
6.2.4审核职责的引用文件`````````````````````````````````````````````````````````````````````````````````````10
6.2.5工作文件`````````````````````````````````````````````````````````````````````````````````````````````````````````10
6.3现场审核````````````````````````````````````````````````````````````````````````````````````````````````````````````````10
6.3.1首次会议`````````````````````````````````````````````````````````````````````````````````````````````````````````10
6.3.2陪同的作用和职责`````````````````````````````````````````````````````````````````````````````````````````10
6.3.3信息的收集和验证`````````````````````````````````````````````````````````````````````````````````````````10
6.3.4审核发现`````````````````````````````````````````````````````````````````````````````````````````````````````````11
6.3.5与受审核方的沟通``````````````````````````````````````````````````````````````````````````````````````````11
6.3.6末次会议的准备`````````````````````````````````````````````````````````````````````````````````````````````12
6.3.7与受审核方的末次会议`````````````````````````````````````````````````````````````````````````````````12
6.4审核的报告```````````````````````````````````````````````````````````````````````````````````````````````````````````12
6.4.1审核报告的编制`````````````````````````````````````````````````````````````````````````````````````````````12
6.4.2报告的内容`````````````````````````````````````````````````````````````````````````````````````````````````````12
6.4.3报告的批准和分发`````````````````````````````````````````````````````````````````````````````````````````13
6.4.4文件的保存``````````````````````````````````````````````````````````````````````````````````````````````````````13
6.5审核的完成````````````````````````````````````````````````````````````````````````````````````````````````````````````13
6.6审核的后续活动````````````````````````````````````````````````````````````````````````````````````````````````````13
7家质量和环境管理体系审核员的资格````````````````````````````````````````````````````````````````````````13
7.1引言````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````13
7.2所需的最低教育水平、培训、工作和审核经历````````````````````````````````````````````````13
7.2.1引言````````````````````````````````````````````````````````````````````````````````````````````````````````````````13
7.2.2教育水平````````````````````````````````````````````````````````````````````````````````````````````````````````13
7.2.3培训````````````````````````````````````````````````````````````````````````````````````````````````````````````````14
7.2.4工作经历````````````````````````````````````````````````````````````````````````````````````````````````````````14
7.2.5审核经历`````````````````````````````````````````````````````````````````````````````````````````````````````````14
7.3个人素质````````````````````````````````````````````````````````````````````````````````````````````````````````````14
7.4能力```````````````````````````````````````````````````````````````````````````````````````````````````````````````````````15
7.4.1基本能力````````````````````````````````````````````````````````````````````````````````````````````````````````15
7.4.1.1审核程序、方法和技巧````````````````````````````````````````````````````````````````````````15
7.4.1.2管理体系和引用文件`````````````````````````````````````````````````````````````````````````````15
7.4.1.3组织情况`````````````````````````````````````````````````````````````````````````````````````````````````15
7.4.1.4适用的法律、法规和其他要求`````````````````````````````````````````````````````````````15
7.4.2专门能力````````````````````````````````````````````````````````````````````````````````````````````````````````16
7.4.2.1质量管理原则和技术`````````````````````````````````````````````````````````````````````````````16
7.4.2.2作业过程、产品和服务`````````````````````````````````````````````````````````````````````````16
7.4.2.3环境科学和技术`````````````````````````````````````````````````````````````````````````````````````16
7.4.2.4作业的技术和环境因素``````````````````````````````````````````````````````````````````````````16
7.5审核组长资格````````````````````````````````````````````````````````````````````````````````````````````````````````17
7.6双重资格````````````````````````````````````````````````````````````````````````````````````````````````````````````````17
7.7审核员的评价过程````````````````````````````````````````````````````````````````````````````````````````````````17
7.8持续专业发展````````````````````````````````````````````````````````````````````````````````````````````````````````18
7.9审核组的组建````````````````````````````````````````````````````````````````````````````````````````````````````````18
7.10语言``````````````````````````````````````````````````````````````````````````````````````````````````````````````````````18
附录A(提示的附录)组建内审审核组的评价方法示例``````````````````````````````````````18
前言
国际标准化组织(ISO)是由各国标准化团体(ISO成员团体)组成的世界性的联合性的联合会。
制定国际标准的工作通常由ISO的技术委员会完成。
各成员团体若对某技术委员会确立的项感兴趣,均有权参加该委员会的工作。
与ISO保持联系的各国际组织(官方的或非官方的)也可参加有关工作。
在电工技术标准化方面,ISO与国际电工委员会(IEC)保持密切合作关系。
由技术委员会通过的国际标准草案提案提交各成员团体表决,需取得至少75%参加表决的成员团体的同意,才能作为国际标准正式发布。
国际标准ISO19011是由国际标准化组织质量管理和质量保证技术委员会支持技术分委员会(ISO/TC176/S3)与环境管理体系审核与有关的环境调查分委员会(ISO/TC207/SC2)联合制定的。
本国际标准代替ISO10011-1、ISO10011-2、ISO10011-3、ISO14010、ISO14011和ISO14012。
本标准的附录A仅供参考。
0引言
ISO9000和ISO14000系列国际标准强调了审核作为一个基本的管理手段,在实现组织的质量或环境管理方针中所阐述的目标的重要性。
本标准化给出了与审核有关的定义并为审核员开展内部与