2017年最新醫(yī)療器械質(zhì)量手冊(cè)

1、控制狀態(tài)：受控□非受控□質(zhì)量手冊(cè)依據(jù)：據(jù)：YYT02872017文件編號(hào)：文件編號(hào)：編制：制：審核：核：批準(zhǔn)：準(zhǔn)：20170828發(fā)布20170828實(shí)施有限公司發(fā)布有限公司文件編號(hào)版本號(hào)01質(zhì)量手冊(cè)頁(yè)次第2頁(yè)共102頁(yè)5.4.2質(zhì)量管理體系策劃.................................................................................................

2、...285.5職責(zé)、職權(quán)與溝通...........................................................................................................295.5.1職責(zé)與權(quán)限.....................................................................................

3、...........................305.5.2管理者代表................................................................................................................375.5.3內(nèi)部溝通..........................................................

4、..........................................................385.6管理評(píng)審...........................................................................................................................395.6.1總則.....................

5、.......................................................................................................395.6.2評(píng)審輸入和輸出.......................................................................................................

6、.396.資源管理................................................426.1資源提供...........................................................................................................................436.2人力資源......................

7、.....................................................................................................436.3基礎(chǔ)設(shè)施..............................................................................................................

8、.............456.4工作環(huán)境和污染的控制...................................................................................................456.4.1工作環(huán)境..................................................................................

9、..................................456.4.2污染控制....................................................................................................................467.產(chǎn)品實(shí)現(xiàn).................................................46

10、7.1產(chǎn)品實(shí)現(xiàn)的策劃...............................................................................................................477.2與顧客有關(guān)的過程......................................................................................

11、.....................487.2.1產(chǎn)品要求的確定、評(píng)審、溝通................................................................................487.3設(shè)計(jì)和開發(fā).........................................................................................

12、..............................507.3.1總則............................................................................................................................507.3.2設(shè)計(jì)和開發(fā)策劃...........................................

13、.............................................................517.3.3設(shè)計(jì)和開發(fā)輸入........................................................................................................517.3.4設(shè)計(jì)和開發(fā)輸出...........................

14、.............................................................................527.3.5設(shè)計(jì)和開發(fā)評(píng)審........................................................................................................527.3.6設(shè)計(jì)和開發(fā)驗(yàn)證...........