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ISO13485簡介

ISO13485---醫療器械質量管理體系認證

一、什么是ISO13485?

        ISO13485標準的全稱是《醫療器械 質量管理體系 用于法規的要求》(Medical device-Quality management system-requirements for regulatory)。該標準由ISO/TC210技術委員會制定,是以ISO9001為基礎的獨立標準。標準規定了對相關組織的質量管理體系要求,但并不是ISO9001標準在醫療器械行業中的實施指南。

二、應用

        ISO13485標準自1996年發布以來,得到全世界廣泛的實施和應用,從名稱上即明確是用于法規的質量管理體系要求。醫療器械在國際上不僅只是一般的上市商品在商業環境中運行,它還要受到國家和地區法律、法規的監督管理,如美國的FDA、歐盟的MDD(歐盟醫療器械指令)、中國的《醫療器械監督管理條例》。因此,該標準必須受法律約束,在法規環境下運行,同時必須充分考慮醫療器械產品的風險,要求在醫療器械產品實現全過程中進行風險管理。所以除了專用要求外,可以說ISO13485實際上是醫療器械法規環境下的ISO9001。

        歐洲和加拿大普遍以ISO 13485作為質量保證體系的要求,建立醫療器械質量保證體系均以這些標準為基礎。醫療器械要進入美國,則要滿足QSR820的要求。中國等同轉換的標準為YY/T 0287。

三、ISO13485的效益

   1.可作為遵守法律、法規和合同要求的證據

   2.管理風險并使風險最小化

   3.強調能力

   4.預防缺陷優先于糾正缺陷

   5.改進績效質量

   6.顧客和員工滿意

   7.內部過程透明而清晰

   8.節省時間和成本

   9.質量方針和企業目標的實現

       10.提升經營效益

四、總結

        ISO13485標準針對不同的醫療器械產品提供了不同的要求,如有源的、無源的、植入的和非植入的、體外診斷、醫療器械軟件、醫療器械貿易服務、儲運服務等。總之,醫療企業企業和一切直接延伸的產品和服務,都可以按照自己的產品的不同類型、有針對性地、有選擇性地來建立醫療器械質量管理體系。

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