iaf审核指南中英文对照版(doc73)-质量审查(编辑修改稿)

iaf审核指南中英文对照版(doc73)-质量审查(编辑修改稿)内容摘要：

职责以达成组织的质量目标。 determining and providing the resources and information necessary 确定并提供必要的资源和信 息。 establishing and applying methods to monitor and/or measure and analyse each process 确定并应用监视和测量和分析每个过程的方法。 establishing and applying a process for continual improvement of the effectiveness of the QMS 确定并应用持续改进质量管理体系的有效性的过程 . The process approach concept must be so well understood by auditors that they are not limited by the terminology in the standard。 however, auditees may use their own ―inhouse‖ terminology. Auditors must be aware that the application of the process approach will be different from anisation to anisation, depending on the size and plexity of the anisation and its activities. Special consideration should be given to the situation in small and medium enterprises (SME‘s), so that auditors should not expect so many processes in their QMSs. 审核员应清楚地理解过程方法的概念，不仅限于标准的术语；可是，受审核方可能用他们自己的术语。 审核员应认识到不同组织的过程方法应用，基于组织及其活动的规模和复杂程度。 尤其要考虑到中小型企业的情况，审核员不应期望在他们的质量管理体系有太多过程。 Helping an auditee to interpret the process approach 帮助受审核方说明过程方法 If an auditor is faced with a plete misunderstanding by an auditee, this situation should normally be identified at the 1st stage audit 审核员面对完全误解的受审核方的情况通常在第一阶段审核中发现 . The auditor should refer the auditee to recognized information sources, such as those indicated in the section above. (In particular, the referenced ISO/TC 176/SC 2/N544 document sets out different steps in the process approach and provides useful guidance with examples)审核员应参考受审核方的信息资源，如以上章节显示的信息 (通常参见 ISO/TC 176/SC 2/N544文件设定的过程方法的步骤和提供的指南 . The auditee should also pay sufficient consideration to 受审核方应 充分考虑 ISO 9001 Auditing Practices Group 169。 ISO amp。 IAF 2020 – All rights reserved。 the establishment of process objectives 过程目标的建立 , process planning 过程策划 , the availability of suitable records 可获得适当的记录 . Auditees frequently identify too many processes。 some or all of them are activities, which do not fulfil the requirements of a process, in the sense that ISO 9001:2020 uses the concept. In this situation, an auditor should (in the 1st stage audit) propose that the auditee performs a redefinition of its processes, based on . the criticality of the activities. This might be particularly relevant for SME‘s. 受审核方通常会识别许多的过程，其中一部分或全部是活动，不符合 ISO 9001:2020中使用的过程要求。 这种情况下，审核员应 (在第 1 阶段审核中 )建议受审核方基于活动的危险程度重新定义过程。 通常在中小型企业可能遇到。 ISO 9001 Auditing Practices Group 169。 ISO amp。 IAF 2020 – All rights reserved。 Determination of the “where appropriate” processes 确定适当的过程 Terminology 术语 Where the terminology used by the auditee is different to that used by the auditor, the auditor should understand the concepts in ISO 9001:2020 using ISO 9000:2020 and make a mental or written cross reference between the terminology of the auditee and his/her own for the same concepts, avoiding the use of QM jargon 当受审核方用的术语和审核 员不同时，审核员应运用ISO 9000:2020 理解 ISO 9001:2020 的概念，并在心里或写出书面的对照表，确定受审核方和他自己对同一个概念所用的术语，避免使用质量管理行话 . The definition of process 过程的定义 If the definition of process is not interpreted in the same way by the auditor and the auditee, the auditor should seek to understand the auditee‘s point of view and not impose his own view unless it is clear (supported with enough objective evidence) that the requirements of the standard are not met. The same is true if the auditor believes that certain processes have not been correctly identified or are missing 如果审核员和受审核方对过程的定义不能一致时，审核员应理解受审核方的观点，而不能强加他自己的观点，除非确定不能满足标准要求 (足够的客观证据 .支持 )。 审核员确定过程识别不正确或遗漏时也同样处理 . Exclusions 删减 The auditor should refer to clause of ISO 9001:2020, to the ISO/TC 176/SC 2/N524 document ISO 9000 Introduction and Support Package: Guidance on ISO 9001:2020, Clause 39。 Application39。 for further guidance, and the APG39。 s guidance on ISO 9001:2020 的 条款， ISO/TC 176/SC 2/N524 文件 ISO9000 介绍和支持文件： ISO 9001:2020 的 条款“应用”指南和 APG 的范围指南 . The auditor should obtain objective evidence that the auditee cannot exclude a specific requirement, before reaching a conclusion. 审核员应在做出审核结论之前获取受审核方不能删减要求的客观证据。 It is good practice for an auditor to utilize the standard ISO 9000:2020 Quality management systems Fundamentals and vocabulary and ISO/TC 176/SC 2/N524 as support documents, to explain the arguments to the auditee. 审核员利用标准 ISO 9000:2020 质量管理体系 基础和术语和 ISO/TC 176/SC 2/N524 作为支持文件，解释和受审核方的争议是一个很好的办法。 ISO 9001 Auditing Practices Group 169。 ISO amp。 IAF 2020 – All rights reserved。 Auditing “where appropriate” requirements 审核适当的要求 The auditee should determine the application of the ISO 9001 ―where appropriate requirements, as this will affect its ability to satisfy its customers39。 requirements. (It may be useful to refer the auditee to ISO 9001:2020 clause … where an anization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements‖.) 受审核方应确定 ISO9001”适当的”要求的应用，因为这些会影响到满足顾客要求的能 力。 (请受审核方参考 ISO 9001:2020条款 “ … 当组织 A需要证明其持续提供满足顾客和适用法规要求产品的能力时” )。 An auditor should ensure that the where appropriate requirements are really ‗appropriate‘ in relation to the proposed/actual scope of the auditee39。 s quality management system. Therefore the basis of audit should be against this criterion, which should form the benchmark when deciding what is appropriate or not. 审核员应确保”适当的”要求对于提议或实际的受审核方的质量管理体系范围确实是”适当的”。 因些确定是否适当时，审核基准应基于标准。 Issues that should be considered include应考虑的问题包括 : Does this requirement add value to this element of confidence, without the ‗where appropriate‘ being addressed? 没有确定“适当”时，此条款的要求是否可增值。 Does it increase the risk that the anisation cannot meet its customer requirements? (This may be more than a specific set of customer requirements, as it can include the demands and expectations of end users, consumers, or the supply chain). 是否增加组织不能满足顾。