最新IRIS内审员培训教材.ppt

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * 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). 组织应当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 (see clause 8.5.1). 组织应当确定并执行纠正措施过程，利用多方论证的评估进行定期评审（见8.5.1）。 8.5.3 预防措施 Preventive action The organization should define and implement a preventive action Process, which is regularly reviewed in a multidisciplinary assessment (see clause 8.5.1). 组织应确定并执行预防措施过程，利用多方论证的评估进行定期评审（见8.5.1）。 * * * * * * * * * * * * * * * * TUTOR NOTE: During the presentation of the K.O. questions the trainer should ask the delegates for typical relevant evidences (documents (procedures, plans), records …) which shall be investigated in the readiness review. He should write down these issues on the flip chart. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * 7.8 技术状态管理 Configuration management b) address change management process within the configuration management (see 7.13), 在技术状态管理中指出变更管理流程（见7.13)， c) maintain traceability during production and operations, 在生产和运行期间，保持可追溯性， For software development and Production a configuration management for applied tools has to be available. 对于软件开发和生产，SHOULD对所使用的工具进行技术状态管理。 NOTE 1 Guidance on configuration management is given in ISO10007. 注1：技术状态管理的指南见ISO10007。 NOTE 2 In cases where a change impacts a Product which is subject to configuratio