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管理體系培訓

培訓背景

       ISO 13485標準規定了質量管理體系要求,組織可依此要求進行醫療器械的設計和開發、生產、安裝和服務,以及相關服務的設計、開發和提供。本標準也可用于內部和外部(包括認證機構)評定組織滿足顧客和法規要求的能力。ISO 13485自1996年發布以來,得到全世界廣泛的實施和應用,隨著歷史的發展,ISO組織在此基礎上又將此標準進行了兩次修訂,分別為ISO13485:2003和ISO 13485:2012。實施ISO13485可提高和改善企業的管理水平,規避法律風險,提高和保證產品的質量水平、有利于消除貿易壁壘、有利于增強產品的競爭力。

培訓收益

1. 了解質量管理的方法

2. 提升企業競爭力

3. 改進企業績效

4. 精簡運營,減少浪費

5. 鼓勵企業內部溝通

6. 提高客戶滿意度

7. 了解ISO13485認證流程和方法

培訓內容

1. ISO13485標準歷史背景和發展概況

2. 質量管理體系培訓

3. 管理職責培訓

4. 資源管理培訓

5. 產品實現培訓

6. 監視和測量培訓

7. ISO13485 認證程序

8. ISO13485審核常見問題

培訓對象

1. 企業高層管理人員

2. 企業管理者代表

3. 企業負責產品質量和安全的相關人員

4. 所有對ISO13485感興趣的人員

培訓時間

1天

培訓方式

廠內培訓或公開培訓。

培訓證書和資質

參加本課程培訓的學員可獲得久順企管集團(中國 英國 愛爾蘭)頒發的培訓證書。

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