ISO質量管理體係培訓講義(ppt 141頁)

ISO質量管理體係培訓講義目錄:
一、質量管理體係認證標準
二、ISO 9000:2000中的重要術語
三、ISO 13485:2003
四、醫療器械專用術語
五、Management System / 管理體係
六、質量管理體係方法
七、質量管理體係評價

ISO質量管理體係培訓講義內容摘要：
質量管理體係方法：
— determining the needs and expectations of customer and other interested parties.
/ 確定顧客和其他相關方的需求和期望。
— establishing the quality policy and quality objectives.
/建立質量方針和質量目標。
— determining the processes and responsibilities necessary to attain the quality objectives.
/ 確定為實現質量目標所需的過程和職責。
— determining and providing the resources necessary to attain the quality objectives.
/ 確定和提供為實現質量目標所需的資源。
— establishing methods to measure the effectiveness and efficiency of each process.
/ 確定測量每一過程的有效性和效率的方法。
— applying these measures to determine the effectiveness and efficiency of each process.
/ 應用這些方法測量每一過程的有效性和效率。
— determining means of preventing nonconformities and eliminating their causes.
/ 確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.
/ 建立和應用質量管理體係持續改進的過程。

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