iso13485-2016《醫(yī)療器械質(zhì)量管理體系-用于法規(guī)的要求》

1、13535INTERNATIONALISOISOSTARD1348513485第三版201631醫(yī)療器械質(zhì)量管理體系用于法規(guī)的要求335354.2.2質(zhì)量手冊....................................................................124.2.3醫(yī)療器械文件............................................................

2、....124.2.4文件控制....................................................................134.2.5記錄控制....................................................................135管理職責(zé)...................................................

3、.........................135.1管理承諾........................................................................135.2以顧客為關(guān)注焦點................................................................145.3質(zhì)量方針............................

4、............................................145.4策劃............................................................................145.5職責(zé)、權(quán)限與溝通................................................................145.5.1職責(zé)和權(quán)限....

5、..............................................................145.5.2管理者代表..................................................................155.5.3內(nèi)部溝通....................................................................1

6、55.6管理評審........................................................................155.6.1總則........................................................................155.6.2評審輸入................................................

7、....................155.6.3評審輸出....................................................................166資源管理............................................................................166.1資源提供.............................

8、...........................................166.2人力資源........................................................................166.3基礎(chǔ)設(shè)施........................................................................166.4工作環(huán)境和污染控制.

9、.............................................................176.4.1工作環(huán)境....................................................................176.4.2污染控制....................................................................1

10、77產(chǎn)品實現(xiàn)............................................................................177.1產(chǎn)品實現(xiàn)的策劃..................................................................177.2與顧客有關(guān)的過程...............................................

11、.................187.2.1與產(chǎn)品有關(guān)的要求的確定......................................................187.2.2與產(chǎn)品有關(guān)的要求的評審......................................................187.2.3溝通..................................................