IRIS内审员主要培训教材.ppt

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * 8.3.2 客户让步放行Customer Concession The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires. 当顾客让步放行的授权到期后，组织必须确保与初始的或代替的规范相符合。 ? Material shipped, which is subject to such a concession, shall be clearly and appropriately identified. This applies equally to purchased products. 所装运的材料涉及让步放行时，必须适当清楚地标识。这同样适用于采购的产品。 The organization should define and implement a customer Concession Process. 组织应该确定并实施顾客让步放行过程。 The organization shall reach agreement with such a request from suppliers before submission to the customer. 在向顾客交付前，组织必须确保供方让步放行请求已得到批准。 8.4 数据分析Analysis of Data In addition to ISO 9001:2008, the organization should ensure that a Process for the analysis of data is in place (see clause 8.2.2) and the performance of this Process should be measured by a KPI (see annex 3). 除ISO 9001:2008的要求外 ，组织应确保制定数据分析的过程（见8.2.2），且此过程的绩效应通过关键绩效指标来测量（见附件3 ）。 In addition to the ISO 9001:2008, the analysis of data shall provide information relating to: 除ISO9001:2008的要求外，数据分析应提供以下有关方面的信息： e) external incident reports associated with the organization’s Products and 外部事件报告，涉及组织产品和 f) Product Safety. 产品安全 8.5.1 持续改进 Continual Improvement The organization should define and implement improvement Processes, based on corrective and preventive actions (see clause 8.5.2 and 8.5.3). 组织应确定并实施基于纠正和预防措施的改进过程，（见第8.5.2和8.5.3 ） 。 8.5.2 纠正措施 Corrective Action In addition to the ISO9001: 2000 requirements, the documented procedure shall define requirements to: 除ISO9001:2008 的要求外，文件化程序必须明确要求： ? g) document the effectiveness and close out of corrective action. 纠正措施的有效性和关闭情况形成文件。 The organization should define and implement a corrective action Process, which is regularly reviewed in a multidisciplinary assessment (se