《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》植入性醫(yī)療器械檢查自查報(bào)告

1、TXJLGF007TXJLGF0071《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》植入性醫(yī)療器械醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》植入性醫(yī)療器械檢查自查報(bào)告檢查自查報(bào)告自查企業(yè)名稱(chēng)蓋章：自查產(chǎn)品名稱(chēng)(頁(yè)面不夠可附頁(yè))自查人員自查日期：2011115企業(yè)負(fù)責(zé)人（簽名）職務(wù)：（本表由檢查人員填寫(xiě)）《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》植入性醫(yī)療器械現(xiàn)場(chǎng)檢查記錄表《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》植入性醫(yī)療器械現(xiàn)場(chǎng)檢查記錄表TXJLGF007TXJLGF0073說(shuō)明：說(shuō)明：按照《醫(yī)

2、療器械生產(chǎn)質(zhì)量管理規(guī)范》和《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范植入性醫(yī)療器械實(shí)施細(xì)則》的要求，為了提高企業(yè)對(duì)質(zhì)量管理體系自我檢查的能力，統(tǒng)一檢查標(biāo)準(zhǔn)，制定本自查報(bào)告。企業(yè)在申請(qǐng)質(zhì)量管理體系考核之前，應(yīng)按照本報(bào)告要求進(jìn)行全面自查，并按要求逐項(xiàng)填寫(xiě)。1植入性醫(yī)療器械檢查項(xiàng)目共305項(xiàng)，其中重點(diǎn)檢查項(xiàng)目（條款前加“”）35項(xiàng)，一般檢查項(xiàng)目270項(xiàng)。2企業(yè)可以根據(jù)申請(qǐng)考核無(wú)菌醫(yī)療器械的特點(diǎn)、范圍、要求，確定相應(yīng)的檢查條款和內(nèi)容。對(duì)“不適用條款”應(yīng)當(dāng)說(shuō)明“

3、不適用的理由”。檢查組予以確認(rèn)。3對(duì)自查結(jié)果的填寫(xiě)，要求描寫(xiě)可核查的事實(shí)。對(duì)于只填寫(xiě)“是”“符合”的，可以作為資料不全退回補(bǔ)充。4企業(yè)承諾對(duì)自查情況的真實(shí)性負(fù)責(zé)，并愿意承擔(dān)任何由于失實(shí)而引起的法律后果。自查結(jié)果匯總：自查結(jié)果匯總：一、凡是“不適用條款”請(qǐng)用“”劃除：管理職責(zé)04010402040304040501050205030504050506010701070207030801080208030804080508060807080

4、8090109020903090409050906100110021003110111021103120112021204130113021303140114021403150115021601160216031701170217031704180118021803180418051901190219031904190520012002200320042005210121022103資源管理22012202230123022401240

5、225012502250325042601260227012702270327042705270628012802290129022903290430013002文件和管理30033004300531013102320133013302330333043401340234033501350235033601360237013702370338013802設(shè)計(jì)和開(kāi)發(fā)3803380438053901390239033904390540014

6、002400341014102410341044201420242034204420542064301430243034401440244034404440544064501采購(gòu)45024503460146024603470147024703480149014902500150025003500450055101510251035104520152025301540154025501550255035601560257015702580

7、158025803590159025903600160026101610262016202630163026303630464016402640364046405650165026503660166026603670167026703680168026803680468056901690269037001生產(chǎn)管理700271017102720172027203720472057301730273037304740174027501760

8、17701監(jiān)視和測(cè)量780178027803780478057806780779017902790380019002800380048005810181028201820283018302840184028403850185028601860286038701870288018802890190019002900391019102910392019202930193029401940294039501950295039601960297