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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. 掌握如何編制質量管理手冊

2. 了解如何編制程序文件

3. 學習如何設計記錄表格

4. 提高應審能力

5. 提升企業競爭力

6. 改進企業績效

7. 精簡運營,減少浪費

培訓內容

1. ISO13485標準歷史背景和發展概況

2. 質量方針的確定

3. 質量手冊的編制

4. 建立質量控制程序

5. 設計質量記錄表格

6. 現場審核案例分析

7. ISO13485審核常見問題和注意事項

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。

公開課報名表.doc

快速報名

聚福彩票

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