2-ISO9001：2015质量管理体系基础培训(5.31).ppt

* 四、 审核过程 5、纠正、预防措施及其跟踪 不符合原因的分析； 纠正、预防措施的提出； 纠正、预防措施的确认和批准； 纠正、预防措施计划的实施。 纠正、预防措施的跟踪和验证。 * 四、 审核过程 6、汇总分析 步骤及内容： 编制不符合项的矩阵式表格。 动态比较（与上次比）： 从发展的历史和趋势来分析； 从不符合的总数量对比来分析； 从不符合的性质对比来分析； 从各部门自身的比较来分析； 从各要素自身的比较来分析； 纠正措施计划完成的情况的比较来分析； 以判断体系是否符合ISO 持续改进的精神。 并将结果上报给最高领导层，做为管理评审的输入。 * 四、审核过程 6、汇总分析 不符合项矩阵表（例） 要素 4.2 5 6 7.2 7.4 7.5 7.6 8 部门 总经理 管代 总务 1 2 4 2 5 3 生产 工程 3 0 1 0 0 3 2 1 A B * 问题解答 * * * * 4.1 General requirements (Slide 1) In addition to the requirements to establish, document and maintain a quality management system (1994: 4.2), the requirement to continually improve is added. Also, it is the process which now has to be identified and managed to ensure specified requirements are met. * 4.1 General requirements (Slide 2) Emphasis here is on the process which now has to be identified and managed to ensure specified requirements are met. To implement the systems, the organisation must: a) identify the processes needed for the quality management system; b) determine the sequence and interaction of these processes; c) determine criteria and methods required to ensure the effective operation and control of these processed; d) ensure the availability of information necessary to support the operation and monitoring of these processes; e) measure, monitor and analyse these processes, and implement action necessary to achieve planned results and continual improvement. These processes are to be managed in accordance with the requirements of the Standard. * 4.2 General documentation requirements This Clause sets out the requirements for quality management systems documentation. The Clause points out that the documentation should be structured to fit: - the size and type of organisation; - complexity and interaction of the processes; - competence of personnel. Note that ISO/DIS 9000:2001 calls for documented proce