ISO质量管理体系培训讲义(ppt 141页)

ISO质量管理体系培训讲义目录:
一、质量管理体系认证标准
二、ISO 9000:2000中的重要术语
三、ISO 13485:2003
四、医疗器械专用术语
五、Management System / 管理体系
六、质量管理体系方法
七、质量管理体系评价

 

ISO质量管理体系培训讲义内容摘要：
质量管理体系方法：
— determining the needs and expectations of customer and other interested parties. 
/ 确定顾客和其他相关方的需求和期望。
— establishing the quality policy and quality objectives.
 /建立质量方针和质量目标。
— determining the processes and responsibilities necessary to attain the quality objectives.
 / 确定为实现质量目标所需的过程和职责。
— determining and providing the resources necessary to attain the quality objectives.
 / 确定和提供为实现质量目标所需的资源。
— establishing methods to measure the effectiveness and efficiency of each process.
 / 确定测量每一过程的有效性和效率的方法。
— applying these measures to determine the effectiveness and efficiency of each process.
 / 应用这些方法测量每一过程的有效性和效率。
— determining means of preventing nonconformities and eliminating their causes.
 / 确定防止不合格和消除其原因的措施。
— establishing and applying a process for continual improvement of the QMS.
 / 建立和应用质量管理体系持续改进的过程。

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