醫(yī)療器械質(zhì)量記錄(全套表格)

1、1醫(yī)療器械質(zhì)量管理記錄醫(yī)療器械質(zhì)量管理記錄1、文件修訂申請表....................................................................................................................................................32、文件發(fā)放記錄表................................

2、....................................................................................................................43、文件回收記錄表..............................................................................................

3、......................................................54、文件銷毀申請表....................................................................................................................................................65、文件銷毀記

4、錄表....................................................................................................................................................76、質(zhì)量管理體系問題改進(jìn)和措施跟蹤記錄..................................................

5、..........................................................87、醫(yī)療器械群體不良事件基本信息表....................................................................................................................98、醫(yī)療器械不良反應(yīng)事件報告表............

6、.............................................................................................................109、質(zhì)量查詢、投訴、服務(wù)記錄...............................................................................................

7、...............................1110、質(zhì)量事故調(diào)查、處理表....................................................................................................................................1211、醫(yī)療器械質(zhì)量投訴處理記錄.........................

8、...................................................................................................1312、質(zhì)量事故處理跟蹤記錄..........................................................................................................

9、..........................1413、員工健康檔案表................................................................................................................................................1514、員工健康檢查匯總表........................

10、................................................................................................................1615、年度質(zhì)量培訓(xùn)計劃表..............................................................................................

11、..........................................1716、培訓(xùn)簽到表........................................................................................................................................................1817、培訓(xùn)實施記錄表....

12、............................................................................................................................................1918、員工個人培訓(xùn)教育檔案.................................................................

13、...................................................................2019、設(shè)施設(shè)備臺帳..............................................................................................................................................

14、......2120、設(shè)施設(shè)備運行維護(hù)使用記錄............................................................................................................................2221、計量器具檢定記錄............................................................

15、................................................................................2322、醫(yī)療器械養(yǎng)護(hù)質(zhì)量情況分析季度報表............................................................................................................2423、醫(yī)療器械質(zhì)量

16、信息反饋表................................................................................................................................2524、醫(yī)療器械質(zhì)量信息傳遞處理單.....................................................................

17、...................................................2625、醫(yī)療器械召回記錄............................................................................................................................................2726、醫(yī)療器械追回記錄...

18、.........................................................................................................................................2827、不合格醫(yī)療器械臺帳.....................................................................