av男人的天堂在线观看国产,亚洲国产精品久久久久久,99re66在线观看精品免费,成人性生交大全免,人妻精品国产一区二区

內容提要(yao)：產(chan)品檢(jian)(jian)驗是有源(yuan)醫療器(qi)械生產(chan)企業質量管理體系運行中重要(yao)的(de)質量保(bao)證(zheng)措施，直(zhi)接影響到產(chan)品上市(shi)后的(de)安(an)全(quan)性和有效性。文(wen)章基于法規要(yao)求，結合體系核查中發現(xian)的(de)問題(ti)，提出(chu)有源(yuan)醫療器(qi)械產(chan)品檢(jian)(jian)驗環節現(xian)場(chang)檢(jian)(jian)查關(guan)注點，旨在為(wei)現(xian)場(chang)檢(jian)(jian)查工(gong)作提供(gong)一定參考。

關(guan) 鍵 詞：有源醫療器械 質(zhi)量(liang)管(guan)理(li)體(ti)系核查 質(zhi)量(liang)控制 產(chan)品檢驗

根據產(chan)(chan)(chan)(chan)品(pin)(pin)作(zuo)用(yong)原理(li)(li)分類，醫(yi)(yi)療(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)可劃分為(wei)有(you)(you)源(yuan)醫(yi)(yi)療(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)和無(wu)源(yuan)醫(yi)(yi)療(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)。有(you)(you)源(yuan)醫(yi)(yi)療(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)是指需要(yao)使用(yong)電(dian)(dian)、氣等(deng)(deng)能源(yuan)驅(qu)動，而不(bu)是直接(jie)由(you)人(ren)體(ti)或(huo)者重力(li)產(chan)(chan)(chan)(chan)生(sheng)(sheng)的能量，發揮(hui)其(qi)功能的器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)[1]。常(chang)見的有(you)(you)各(ge)類醫(yi)(yi)用(yong)電(dian)(dian)氣類產(chan)(chan)(chan)(chan)品(pin)(pin)，如X射線機、超聲診斷儀(yi)(yi)、醫(yi)(yi)用(yong)監(jian)護儀(yi)(yi)、呼吸機、麻醉(zui)機、高(gao)頻手術設(she)備等(deng)(deng)，以及各(ge)類家用(yong)的醫(yi)(yi)療(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)產(chan)(chan)(chan)(chan)品(pin)(pin)，如血糖儀(yi)(yi)、電(dian)(dian)子血壓(ya)計、霧化器(qi)(qi)(qi)、磁(ci)電(dian)(dian)治(zhi)療(liao)儀(yi)(yi)等(deng)(deng)。為(wei)保障醫(yi)(yi)療(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)全(quan)生(sheng)(sheng)命周期質量安全(quan)可控(kong)(kong)，依據《醫(yi)(yi)療(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)監(jian)督管(guan)(guan)理(li)(li)條例》[2] 及相關(guan)法規(gui)(gui)要(yao)求(qiu)，醫(yi)(yi)療(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)企業(ye)應當建立健全(quan)覆蓋研發設(she)計、采購、生(sheng)(sheng)產(chan)(chan)(chan)(chan)、過程(cheng)控(kong)(kong)制(zhi)、產(chan)(chan)(chan)(chan)品(pin)(pin)檢驗、倉儲、銷售(shou)及售(shou)后(hou)服務(wu)等(deng)(deng)環(huan)節的質量管(guan)(guan)理(li)(li)體(ti)系，確保產(chan)(chan)(chan)(chan)品(pin)(pin)符合(he)國家強制(zhi)性標準、行業(ye)技術規(gui)(gui)范及注冊審(shen)評要(yao)求(qiu)，實現(xian)(xian)從(cong)產(chan)(chan)(chan)(chan)品(pin)(pin)立項(xiang)到退市的全(quan)鏈條閉環(huan)管(guan)(guan)理(li)(li)。其(qi)中(zhong)，產(chan)(chan)(chan)(chan)品(pin)(pin)檢驗在(zai)質量管(guan)(guan)理(li)(li)體(ti)系運行中(zhong)作(zuo)為(wei)重要(yao)的質量控(kong)(kong)制(zhi)活(huo)動，也是監(jian)管(guan)(guan)部門(men)在(zai)現(xian)(xian)場(chang)核查中(zhong)特別關(guan)注的內(nei)容(rong)。本文(wen)對江蘇省三百余家次有(you)(you)源(yuan)醫(yi)(yi)療(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)質量管(guan)(guan)理(li)(li)體(ti)系核查工作(zuo)中(zhong)發現(xian)(xian)的問題進(jin)行匯(hui)總分析，結合(he)法規(gui)(gui)及標準要(yao)求(qiu)，從(cong)產(chan)(chan)(chan)(chan)品(pin)(pin)檢驗環(huan)節給(gei)出相關(guan)現(xian)(xian)場(chang)檢查關(guan)注點，旨(zhi)在(zai)為(wei)現(xian)(xian)場(chang)檢查工作(zuo)提供實用(yong)性參(can)考。

1.醫(yi)療器械質量(liang)控制的相關要(yao)求

質(zhi)量(liang)(liang)(liang)控(kong)(kong)制(zhi)是指在(zai)醫療器械的(de)(de)設計、生(sheng)產(chan)(chan)、檢驗(yan)和銷售過程中采(cai)取的(de)(de)一系(xi)(xi)列措施(shi)和技術(shu)活動，目標在(zai)于確保產(chan)(chan)品符合預定的(de)(de)質(zhi)量(liang)(liang)(liang)標準(zhun)和要(yao)求，以(yi)保障(zhang)用戶及患者(zhe)的(de)(de)安全與健(jian)康(kang)。質(zhi)量(liang)(liang)(liang)控(kong)(kong)制(zhi)覆(fu)蓋了從原材料采(cai)購、生(sheng)產(chan)(chan)過程、到出廠檢驗(yan)和市(shi)場后監管的(de)(de)全過程，是質(zhi)量(liang)(liang)(liang)管理(li)體系(xi)(xi)的(de)(de)關(guan)鍵組成部分。

根據2021 年6 月(yue)1 日起實施的(de)《醫(yi)療(liao)器(qi)(qi)械監(jian)督管(guan)理條(tiao)例(li)》[2]（國務院令(ling)第(di)(di)739 號(hao)），醫(yi)療(liao)器(qi)(qi)械全生(sheng)(sheng)(sheng)命周期質量管(guan)理要(yao)(yao)(yao)求(qiu)被系(xi)統(tong)化提(ti)升至新(xin)的(de)監(jian)管(guan)高(gao)度。其(qi)中，第(di)(di)三(san)(san)十(shi)條(tiao)規定了從事醫(yi)療(liao)器(qi)(qi)械生(sheng)(sheng)(sheng)產(chan)(chan)(chan)活動，應當(dang)具備(bei)(bei)(bei)(bei)的(de)條(tiao)件：“有能(neng)對(dui)生(sheng)(sheng)(sheng)產(chan)(chan)(chan)的(de)醫(yi)療(liao)器(qi)(qi)械進行(xing)質量檢驗(yan)的(de)機構(gou)或(huo)者(zhe)專職(zhi)(zhi)檢驗(yan)人員以及(ji)檢驗(yan)設備(bei)(bei)(bei)(bei)；有保(bao)證醫(yi)療(liao)器(qi)(qi)械質量的(de)管(guan)理制(zhi)(zhi)度”；第(di)(di)三(san)(san)十(shi)三(san)(san)條(tiao)從制(zhi)(zhi)度設計(ji)維度提(ti)出(chu)(chu)系(xi)統(tong)性(xing)要(yao)(yao)(yao)求(qiu)：“醫(yi)療(liao)器(qi)(qi)械生(sheng)(sheng)(sheng)產(chan)(chan)(chan)質量管(guan)理規范應當(dang)對(dui)醫(yi)療(liao)器(qi)(qi)械的(de)設計(ji)開發、生(sheng)(sheng)(sheng)產(chan)(chan)(chan)設備(bei)(bei)(bei)(bei)條(tiao)件、原材料采購(gou)、生(sheng)(sheng)(sheng)產(chan)(chan)(chan)過程控制(zhi)(zhi)、產(chan)(chan)(chan)品(pin)放行(xing)、企業(ye)的(de)機構(gou)設置和人員配備(bei)(bei)(bei)(bei)等影響(xiang)醫(yi)療(liao)器(qi)(qi)械安全、有效(xiao)的(de)事項(xiang)作(zuo)出(chu)(chu)明確(que)規定。”；第(di)(di)三(san)(san)十(shi)五條(tiao)確(que)立(li)了以注冊(ce)人/備(bei)(bei)(bei)(bei)案人為質量責(ze)任主(zhu)體(ti)的(de)制(zhi)(zhi)度：“醫(yi)療(liao)器(qi)(qi)械注冊(ce)人、備(bei)(bei)(bei)(bei)案人、受托生(sheng)(sheng)(sheng)產(chan)(chan)(chan)企業(ye)應當(dang)按照醫(yi)療(liao)器(qi)(qi)械生(sheng)(sheng)(sheng)產(chan)(chan)(chan)質量管(guan)理規范，建立(li)健(jian)全與所生(sheng)(sheng)(sheng)產(chan)(chan)(chan)醫(yi)療(liao)器(qi)(qi)械相適應的(de)質量管(guan)理體(ti)系(xi)并保(bao)證其(qi)有效(xiao)運行(xing)；嚴格按照經注冊(ce)或(huo)者(zhe)備(bei)(bei)(bei)(bei)案的(de)產(chan)(chan)(chan)品(pin)技(ji)術要(yao)(yao)(yao)求(qiu)組織(zhi)生(sheng)(sheng)(sheng)產(chan)(chan)(chan)，保(bao)證出(chu)(chu)廠的(de)醫(yi)療(liao)器(qi)(qi)械符合強制(zhi)(zhi)性(xing)標(biao)準以及(ji)經注冊(ce)或(huo)者(zhe)備(bei)(bei)(bei)(bei)案的(de)產(chan)(chan)(chan)品(pin)技(ji)術要(yao)(yao)(yao)求(qiu)。”。《醫(yi)療(liao)器(qi)(qi)械生(sheng)(sheng)(sheng)產(chan)(chan)(chan)監(jian)督管(guan)理辦法(fa)》（國家市場監(jian)督管(guan)理總局令(ling)第(di)(di)53 號(hao)）[3] 第(di)(di)九條(tiao)也(ye)對(dui)從事醫(yi)療(liao)器(qi)(qi)械生(sheng)(sheng)(sheng)產(chan)(chan)(chan)需具備(bei)(bei)(bei)(bei)的(de)條(tiao)件從檢驗(yan)機構(gou)、專職(zhi)(zhi)檢驗(yan)人員、檢驗(yan)設備(bei)(bei)(bei)(bei)等方(fang)面提(ti)出(chu)(chu)了同樣的(de)要(yao)(yao)(yao)求(qiu)。

除(chu)上述(shu)法規(gui)(gui)文件外，國家藥(yao)品(pin)監(jian)督管理(li)局陸續(xu)出(chu)臺了系列規(gui)(gui)范(fan)(fan)性文件。《醫(yi)(yi)療(liao)(liao)器械生(sheng)(sheng)產質(zhi)量(liang)管理(li)規(gui)(gui)范(fan)(fan)》[4]（以下簡(jian)稱《規(gui)(gui)范(fan)(fan)》）對產品(pin)質(zhi)量(liang)控制提出(chu)了明確的標準和要(yao)(yao)(yao)求；《醫(yi)(yi)療(liao)(liao)器械生(sheng)(sheng)產質(zhi)量(liang)管理(li)規(gui)(gui)范(fan)(fan)現(xian)場(chang)檢(jian)查(cha)指導(dao)原則(ze)》[5]（以下簡(jian)稱《指導(dao)原則(ze)》）又對現(xian)場(chang)檢(jian)查(cha)要(yao)(yao)(yao)點進行了細化(hua)；同時，為嚴格醫(yi)(yi)療(liao)(liao)器械成(cheng)品(pin)放行，提升產品(pin)質(zhi)量(liang)保證水平，總(zong)局制定了《醫(yi)(yi)療(liao)(liao)器械生(sheng)(sheng)產企業質(zhi)量(liang)控制與成(cheng)品(pin)放行指南》[6]，指導(dao)醫(yi)(yi)療(liao)(liao)器械生(sheng)(sheng)產企業按產品(pin)技(ji)術(shu)要(yao)(yao)(yao)求做好(hao)質(zhi)量(liang)管理(li)，強化(hua)采(cai)購、生(sheng)(sheng)產、檢(jian)驗過程(cheng)中(zhong)的質(zhi)量(liang)控制。

2.體系核查發(fa)現問題(ti)

2.1 基本情況

依(yi)據《規范》及(ji)其現(xian)(xian)場檢查指導(dao)原則的(de)章(zhang)節設(she)置(zhi)，對江蘇省三百余家次有源醫(yi)療器械(xie)質(zhi)量(liang)管理(li)體系(xi)核查工(gong)作(zuo)中(zhong)發現(xian)(xian)的(de)問(wen)題進行了(le)匯(hui)總分(fen)析。《指導(dao)原則》共十一章(zhang)節，核查中(zhong)共發現(xian)(xian)6078 個缺陷，其中(zhong)設(she)計與開發、文件(jian)管理(li)、質(zhi)量(liang)控制(zhi)章(zhang)節出(chu)現(xian)(xian)不(bu)符合(he)項目的(de)比例較(jiao)高，見表(biao)1。

表1. 有源(yuan)醫療器械生(sheng)產企業現(xian)場檢查發現(xian)問題的分布情(qing)況

不符合項目類別 不符合項目數量（個） 占比 (%)
機構與人員 434 7.14
廠房與設施 495 8.14
設備 537 8.84
文件管理 852 14.02
設計與開發 1119 18.41
采購 793 13.05
生產管理 818 13.46
質量控制 822 13.52
銷售和售后服務 56 0.92
不合格品控制 62 1.02
不良事件監測(ce)、分析和改進 90 1.48

質(zhi)量控制(zhi)章節的不(bu)符合項目主要(yao)出(chu)現在《指導(dao)原(yuan)則》的8.1.1、8.1.2、8.2.1、8.4.2、8.6.1 條(tiao)款(kuan)(kuan)上，見圖1。這5 個條(tiao)款(kuan)(kuan)的內(nei)容分別指向程序(xu)文件(jian)、文件(jian)規定(ding)內(nei)容、儀(yi)器(qi)校準、檢驗記錄及留樣(yang)管(guan)理。

2.2 發現問題
檢驗設備管理不到位。①檢驗工裝無編號標識，未納入檢驗工裝管理。②儀器校準范圍未涵蓋實際使用范圍。③缺少檢驗儀器和設備在搬運、維護、貯存期間的防護要求。④分辨率、空間頻率檢測軟件無確認記錄。
批檢驗過程記錄不規范。①過程檢驗記錄內容不全，缺少調試檢驗記錄。②成品檢驗報告書中應填寫數值的檢驗結果項實際填寫“符合”。③成品檢驗未記錄主要檢驗設備的名稱及編號，未記錄原始數據。④過程檢驗和成品檢查記錄缺少復核人簽名。
檢驗規范制定不合理。①光學性能項目直接采用外協商的檢驗結果，未進行進貨檢驗和出廠檢驗。②成品檢驗項目設置不合理，將產品技術要求中所有性能條款作為出廠檢驗項目。③產品技術要求中部分參數在原材料進貨檢驗和成品出廠檢驗中均未進行檢測。④企業不具備負壓儀電路板和鋰電池進貨檢驗能力，且未委托有資質的第三方進行檢驗。
檢驗方法不明確。①檢驗操作規程未細化，不能指導檢驗操作，如成品檢驗作業指導書中未明確耐壓測試和漏電流測試的具體接線方法。②檢驗規程中未制定噪聲檢驗的環境要求。③檢驗方法與標準規定的方法不一致。
留(liu)樣(yang)(yang)管(guan)理(li)不到位(wei)。①未根據(ju)產(chan)(chan)品(pin)特點制(zhi)定(ding)(ding)相應的(de)留(liu)樣(yang)(yang)管(guan)理(li)規定(ding)(ding)。②留(liu)樣(yang)(yang)檢驗(yan)(yan)規定(ding)(ding)未明確一般留(liu)樣(yang)(yang)、重點留(liu)樣(yang)(yang)的(de)具體要(yao)求(qiu)，如樣(yang)(yang)品(pin)數(shu)量、檢驗(yan)(yan)周(zhou)期及檢驗(yan)(yan)內容等。③留(liu)樣(yang)(yang)管(guan)理(li)規定(ding)(ding)未明確對影響產(chan)(chan)品(pin)質量的(de)關鍵元器(qi)件(jian)（如過濾器(qi)、電極等）進行留(liu)樣(yang)(yang)。④未按照留(liu)樣(yang)(yang)程序文件(jian)規定(ding)(ding)對試生產(chan)(chan)產(chan)(chan)品(pin)的(de)主要(yao)原材料A類(lei)物資(zi)進行留(liu)樣(yang)(yang)。

3.體系(xi)核查中產品檢驗關注點

3.1 檢驗人員

檢驗(yan)(yan)人(ren)員的(de)專業(ye)(ye)技術能力和管理人(ren)員管理能力是影響檢驗(yan)(yan)質量(liang)的(de)檢驗(yan)(yan)質量(liang)的(de)兩大(da)核心(xin)要素。《規(gui)范》中明確，生產(chan)企(qi)業(ye)(ye)應當(dang)配備滿足生產(chan)規(gui)模(mo)和質量(liang)控制(zhi)需求的(de)專職質量(liang)檢驗(yan)(yan)人(ren)員，并依(yi)據企(qi)業(ye)(ye)制(zhi)定的(de)檢驗(yan)(yan)作業(ye)(ye)指導書對檢驗(yan)(yan)人(ren)員進(jin)行培(pei)訓。

檢(jian)查員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)需關(guan)注(zhu)：①通過(guo)查看(kan)檢(jian)驗人(ren)員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)個人(ren)檔案，核實檢(jian)驗人(ren)員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)的(de)任職(zhi)(zhi)條件是(shi)否(fou)(fou)符合崗(gang)位任職(zhi)(zhi)條件（如學歷、專業(ye)(ye)(ye)、工作(zuo)技能(neng)、工作(zuo)經驗）規定(ding)。人(ren)員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)專業(ye)(ye)(ye)背景的(de)一(yi)般(ban)要求(qiu)為電(dian)(dian)子電(dian)(dian)氣專業(ye)(ye)(ye)、軟件專業(ye)(ye)(ye)、機(ji)械專業(ye)(ye)(ye)。②參照質(zhi)檢(jian)部門人(ren)員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)清(qing)單，抽查檢(jian)驗、復核及批準(zhun)人(ren)員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)培訓(xun)(xun)(xun)記錄，與相(xiang)應人(ren)員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)進行(xing)面(mian)對面(mian)交流，核查人(ren)員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)專業(ye)(ye)(ye)技能(neng)及培訓(xun)(xun)(xun)效果。核實是(shi)否(fou)(fou)開(kai)展相(xiang)關(guan)培訓(xun)(xun)(xun)并進行(xing)考核，有(you)無實際的(de)培訓(xun)(xun)(xun)內容(rong)，是(shi)否(fou)(fou)開(kai)展對相(xiang)關(guan)人(ren)員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)能(neng)力的(de)評價。③通過(guo)指(zhi)定(ding)檢(jian)驗人(ren)員(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)(yuan)根據作(zuo)業(ye)(ye)(ye)指(zhi)導書對樣品進行(xing)檢(jian)驗實操(cao)，觀(guan)察檢(jian)驗操(cao)作(zuo)方法(fa)，是(shi)否(fou)(fou)能(neng)做到重復檢(jian)驗全過(guo)程，檢(jian)驗方法(fa)符合要求(qiu)，且(qie)檢(jian)驗結(jie)果準(zhun)確。

3.2 環境和設施

《規范(fan)》中(zhong)明確企業應當配備與產品(pin)檢(jian)驗要(yao)求相適應的(de)(de)檢(jian)驗場所和設(she)施。生產企業應根(gen)據有源(yuan)產品(pin)的(de)(de)特(te)點(dian)，確保環境設(she)施能夠滿足(zu)檢(jian)驗方(fang)法的(de)(de)要(yao)求。

檢(jian)(jian)(jian)查員(yuan)(yuan)需關(guan)注：主要(yao)包括兩方面的環(huan)(huan)境(jing)控制措施，一是(shi)對(dui)產品(pin)的防(fang)(fang)(fang)護(hu)(hu)(hu)（如(ru)防(fang)(fang)(fang)靜(jing)(jing)(jing)(jing)(jing)電、清(qing)潔保證）措施，二是(shi)對(dui)檢(jian)(jian)(jian)驗人(ren)(ren)員(yuan)(yuan)的安全防(fang)(fang)(fang)護(hu)(hu)(hu)措施。具體如(ru)下：①環(huan)(huan)境(jing)溫濕度是(shi)否(fou)(fou)適宜。溫度一般在(zai)18~28?C，相對(dui)濕度在(zai)80%以下，避免(mian)(mian)影響電路板質量。②防(fang)(fang)(fang)靜(jing)(jing)(jing)(jing)(jing)電保護(hu)(hu)(hu)措施是(shi)否(fou)(fou)到(dao)(dao)位。企業是(shi)否(fou)(fou)建立靜(jing)(jing)(jing)(jing)(jing)電防(fang)(fang)(fang)護(hu)(hu)(hu)程序，對(dui)防(fang)(fang)(fang)靜(jing)(jing)(jing)(jing)(jing)電區域內工作臺架(jia)的防(fang)(fang)(fang)靜(jing)(jing)(jing)(jing)(jing)電要(yao)求，以及(ji)對(dui)檢(jian)(jian)(jian)驗人(ren)(ren)員(yuan)(yuan)穿(chuan)戴防(fang)(fang)(fang)靜(jing)(jing)(jing)(jing)(jing)電服、鞋及(ji)手環(huan)(huan)進行了規(gui)范，避免(mian)(mian)電子元器件、電路板等(deng)被(bei)靜(jing)(jing)(jing)(jing)(jing)電擊穿(chuan)。現場察看檢(jian)(jian)(jian)驗人(ren)(ren)員(yuan)(yuan)是(shi)否(fou)(fou)有防(fang)(fang)(fang)靜(jing)(jing)(jing)(jing)(jing)電保護(hu)(hu)(hu)措施[7]。③人(ren)(ren)員(yuan)(yuan)安全防(fang)(fang)(fang)護(hu)(hu)(hu)是(shi)否(fou)(fou)到(dao)(dao)位。如(ru)電氣(qi)安全測試時，是(shi)否(fou)(fou)配備了絕(jue)緣(yuan)手套、絕(jue)緣(yuan)地墊、隔離(li)裝置、警示(shi)標識等(deng)，確(que)保檢(jian)(jian)(jian)驗區域人(ren)(ren)員(yuan)(yuan)的安全。

3.3 檢驗設備

檢驗(yan)(yan)(yan)設(she)(she)備(bei)(bei)作為產品檢驗(yan)(yan)(yan)質量(liang)保證的(de)(de)前提，企業應(ying)對其進行(xing)全面的(de)(de)管理。應(ying)至少(shao)做到：①根據產品質量(liang)管理的(de)(de)實(shi)際需要(yao)(yao)配備(bei)(bei)滿足檢驗(yan)(yan)(yan)要(yao)(yao)求的(de)(de)檢驗(yan)(yan)(yan)設(she)(she)備(bei)(bei)、計(ji)量(liang)器具(ju)及相關(guan)檢驗(yan)(yan)(yan)工具(ju)。②建立(li)檢驗(yan)(yan)(yan)設(she)(she)備(bei)(bei)的(de)(de)檔案，制定設(she)(she)備(bei)(bei)操作規(gui)程和維(wei)護保養規(gui)程，保存計(ji)量(liang)/ 校準證明、使(shi)用和維(wei)修記錄。③對在檢驗(yan)(yan)(yan)中(zhong)使(shi)用的(de)(de)對檢測結果(guo)有(you)影響的(de)(de)計(ji)算機軟(ruan)件(jian)進行(xing)確認。

檢(jian)(jian)(jian)(jian)查(cha)員需關注：①檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)設(she)(she)(she)備(bei)(bei)(bei)配(pei)備(bei)(bei)(bei)是(shi)(shi)(shi)否(fou)足夠。是(shi)(shi)(shi)否(fou)按(an)照進貨檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)、過程檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)、出廠(chang)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)項(xiang)目的(de)(de)(de)(de)(de)需要(yao)(yao)配(pei)備(bei)(bei)(bei)相應的(de)(de)(de)(de)(de)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)設(she)(she)(she)備(bei)(bei)(bei)。以出廠(chang)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)中(zhong)電氣安全性能檢(jian)(jian)(jian)(jian)測(ce)為例，至少應配(pei)備(bei)(bei)(bei)接地電阻測(ce)試儀（如適用(yong)）、漏電流測(ce)試儀、耐壓測(ce)試儀。②檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)設(she)(she)(she)備(bei)(bei)(bei)的(de)(de)(de)(de)(de)管(guan)理(li)。關注檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)設(she)(she)(she)備(bei)(bei)(bei)在(zai)(zai)維(wei)護計劃下的(de)(de)(de)(de)(de)維(wei)護保養記錄(lu)、故障(zhang)處(chu)置記錄(lu)、校準驗(yan)(yan)(yan)(yan)證報告等(deng)文件(jian)的(de)(de)(de)(de)(de)完整(zheng)性，設(she)(she)(she)備(bei)(bei)(bei)是(shi)(shi)(shi)否(fou)能夠持續滿足檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)需求(qiu)。是(shi)(shi)(shi)否(fou)建立程序規定(ding)檢(jian)(jian)(jian)(jian)測(ce)設(she)(she)(she)備(bei)(bei)(bei)在(zai)(zai)使用(yong)、搬運(yun)、維(wei)護、貯存(cun)的(de)(de)(de)(de)(de)要(yao)(yao)求(qiu)，以防(fang)止對設(she)(she)(she)備(bei)(bei)(bei)造(zao)成損壞(huai)或失準；檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)設(she)(she)(she)備(bei)(bei)(bei)是(shi)(shi)(shi)否(fou)具(ju)備(bei)(bei)(bei)有效(xiao)期(qi)內(nei)的(de)(de)(de)(de)(de)符合要(yao)(yao)求(qiu)的(de)(de)(de)(de)(de)第三方檢(jian)(jian)(jian)(jian)定(ding)或校準證書；設(she)(she)(she)備(bei)(bei)(bei)狀態標識(shi)是(shi)(shi)(shi)否(fou)清晰。③檢(jian)(jian)(jian)(jian)測(ce)用(yong)軟件(jian)的(de)(de)(de)(de)(de)管(guan)理(li)。檢(jian)(jian)(jian)(jian)測(ce)過程中(zhong)用(yong)到(dao)的(de)(de)(de)(de)(de)對檢(jian)(jian)(jian)(jian)測(ce)結(jie)果有影(ying)響的(de)(de)(de)(de)(de)軟件(jian)是(shi)(shi)(shi)否(fou)在(zai)(zai)確認范圍內(nei)，如設(she)(she)(she)備(bei)(bei)(bei)/ 檢(jian)(jian)(jian)(jian)測(ce)工裝的(de)(de)(de)(de)(de)配(pei)套軟件(jian)、電腦(nao)用(yong)軟件(jian)；是(shi)(shi)(shi)否(fou)滿足專人管(guan)理(li)使用(yong)、具(ju)有訪(fang)問使用(yong)權限、檢(jian)(jian)(jian)(jian)測(ce)數據防(fang)篡改的(de)(de)(de)(de)(de)要(yao)(yao)求(qiu)。

3.4 檢驗規范

《規范》中明確企業應當根據強制性標準以及經注冊或者備案的產品技術要求制定產品的檢驗規程，并出具相應的檢驗報告或者證書。因此，企業應當基于科學和風險管理原則，制定進貨檢驗、過程檢驗、出廠檢驗規程等并明確制定依據。
檢(jian)(jian)(jian)(jian)查(cha)員需(xu)關注(zhu)(zhu)：①檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)規(gui)(gui)范制(zhi)(zhi)定的(de)(de)(de)(de)依據。通過查(cha)閱(yue)進(jin)(jin)貨(huo)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)、過程(cheng)(cheng)(cheng)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)、出(chu)廠檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)規(gui)(gui)程(cheng)(cheng)(cheng)，評判檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)規(gui)(gui)程(cheng)(cheng)(cheng)是(shi)否(fou)(fou)(fou)涵蓋強制(zhi)(zhi)性標(biao)準(zhun)以(yi)及注(zhu)(zhu)冊(ce)產(chan)(chan)(chan)品(pin)(pin)技(ji)(ji)(ji)術(shu)要(yao)(yao)(yao)求(qiu)(qiu)的(de)(de)(de)(de)性能指標(biao)。關注(zhu)(zhu)企(qi)業(ye)質量管理(li)體系文件(jian)(jian)中的(de)(de)(de)(de)進(jin)(jin)貨(huo)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)規(gui)(gui)程(cheng)(cheng)(cheng)、過程(cheng)(cheng)(cheng)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)規(gui)(gui)程(cheng)(cheng)(cheng)、出(chu)廠檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)規(gui)(gui)程(cheng)(cheng)(cheng)，評判其是(shi)否(fou)(fou)(fou)完整(zheng)涵蓋強制(zhi)(zhi)性國家(jia)標(biao)準(zhun)/ 行(xing)(xing)(xing)業(ye)標(biao)準(zhun)的(de)(de)(de)(de)技(ji)(ji)(ji)術(shu)要(yao)(yao)(yao)求(qiu)(qiu)，以(yi)及產(chan)(chan)(chan)品(pin)(pin)技(ji)(ji)(ji)術(shu)要(yao)(yao)(yao)求(qiu)(qiu)的(de)(de)(de)(de)性能指標(biao)，并通過設計驗(yan)(yan)(yan)(yan)(yan)證(zheng)、工藝驗(yan)(yan)(yan)(yan)(yan)證(zheng)等手段確認(ren)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)項(xiang)目的(de)(de)(de)(de)充分(fen)性和檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)方(fang)法(fa)(fa)(fa)的(de)(de)(de)(de)適用(yong)性。對未列入(ru)批檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)項(xiang)目的(de)(de)(de)(de)內容，是(shi)否(fou)(fou)(fou)進(jin)(jin)行(xing)(xing)(xing)了(le)評估(gu)及控(kong)(kong)制(zhi)(zhi)。②進(jin)(jin)貨(huo)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)控(kong)(kong)制(zhi)(zhi)。參照進(jin)(jin)貨(huo)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)規(gui)(gui)程(cheng)(cheng)(cheng)、圖樣、質量協議等文件(jian)(jian)，核查(cha)進(jin)(jin)貨(huo)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)記錄(lu)。檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)項(xiang)目一(yi)般包(bao)括來料的(de)(de)(de)(de)尺寸、外觀、規(gui)(gui)格、包(bao)裝、電(dian)氣性能（如導通性能、整(zheng)體功能參數）、軟(ruan)件(jian)(jian)版本信(xin)息等。③過程(cheng)(cheng)(cheng)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)控(kong)(kong)制(zhi)(zhi)。是(shi)否(fou)(fou)(fou)識別關鍵過程(cheng)(cheng)(cheng)并通過過程(cheng)(cheng)(cheng)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)進(jin)(jin)行(xing)(xing)(xing)質量控(kong)(kong)制(zhi)(zhi)，如是(shi)否(fou)(fou)(fou)包(bao)含老化、調試、軟(ruan)件(jian)(jian)燒錄(lu)等工序的(de)(de)(de)(de)控(kong)(kong)制(zhi)(zhi)項(xiang)目。④出(chu)廠檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)控(kong)(kong)制(zhi)(zhi)。關注(zhu)(zhu)企(qi)業(ye)出(chu)廠檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)項(xiang)目和注(zhu)(zhu)冊(ce)產(chan)(chan)(chan)品(pin)(pin)技(ji)(ji)(ji)術(shu)要(yao)(yao)(yao)求(qiu)(qiu)之間的(de)(de)(de)(de)差(cha)異，存在(zai)差(cha)異的(de)(de)(de)(de)項(xiang)目是(shi)否(fou)(fou)(fou)通過批檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)或周期性檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)進(jin)(jin)行(xing)(xing)(xing)控(kong)(kong)制(zhi)(zhi)。⑤檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)方(fang)法(fa)(fa)(fa)是(shi)否(fou)(fou)(fou)科學(xue)。檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)方(fang)法(fa)(fa)(fa)是(shi)否(fou)(fou)(fou)采用(yong)相關標(biao)準(zhun)規(gui)(gui)定的(de)(de)(de)(de)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)方(fang)法(fa)(fa)(fa)，并與產(chan)(chan)(chan)品(pin)(pin)技(ji)(ji)(ji)術(shu)要(yao)(yao)(yao)求(qiu)(qiu)中的(de)(de)(de)(de)方(fang)法(fa)(fa)(fa)一(yi)致。若企(qi)業(ye)采用(yong)非標(biao)準(zhun)檢(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)方(fang)法(fa)(fa)(fa)，是(shi)否(fou)(fou)(fou)建立相應(ying)控(kong)(kong)制(zhi)(zhi)程(cheng)(cheng)(cheng)序，并進(jin)(jin)行(xing)(xing)(xing)了(le)方(fang)法(fa)(fa)(fa)學(xue)驗(yan)(yan)(yan)(yan)(yan)證(zheng)與確認(ren)，證(zheng)明(ming)其與標(biao)準(zhun)方(fang)法(fa)(fa)(fa)的(de)(de)(de)(de)等效性。

3.5 檢驗記錄

原始(shi)檢(jian)驗(yan)記(ji)錄和檢(jian)測數(shu)據(ju)(ju)應(ying)作為出廠檢(jian)驗(yan)報告的(de)(de)質(zhi)量證(zheng)據(ju)(ju)鏈基礎，構成產(chan)品質(zhi)量追(zhui)(zhui)溯體系(xi)的(de)(de)重(zhong)要數(shu)據(ju)(ju)節點，同(tong)時為后續的(de)(de)質(zhi)量改進和風險評估提供了重(zhong)要信息(xi)。生產(chan)企(qi)業應(ying)確保原始(shi)檢(jian)驗(yan)記(ji)錄全(quan)面、真實(shi)、科學、準(zhun)確和規范(fan)，以保證(zheng)檢(jian)驗(yan)數(shu)據(ju)(ju)和過程(cheng)的(de)(de)追(zhui)(zhui)溯性(xing)要求。

檢(jian)(jian)(jian)(jian)(jian)查員需關(guan)(guan)注：①檢(jian)(jian)(jian)(jian)(jian)驗(yan)記(ji)(ji)(ji)(ji)錄(lu)(lu)是否(fou)完整(zheng)。關(guan)(guan)注進(jin)貨檢(jian)(jian)(jian)(jian)(jian)驗(yan)、過(guo)程檢(jian)(jian)(jian)(jian)(jian)驗(yan)、成品檢(jian)(jian)(jian)(jian)(jian)驗(yan)等(deng)(deng)(deng)環節的原(yuan)始(shi)(shi)記(ji)(ji)(ji)(ji)錄(lu)(lu)、檢(jian)(jian)(jian)(jian)(jian)測報告/證(zheng)書，以及檢(jian)(jian)(jian)(jian)(jian)驗(yan)方(fang)法(fa)驗(yan)證(zheng)和(he)確認記(ji)(ji)(ji)(ji)錄(lu)(lu)的完整(zheng)性。存(cun)在部分項目委托(tuo)檢(jian)(jian)(jian)(jian)(jian)驗(yan)的，是否(fou)有(you)相(xiang)關(guan)(guan)項目檢(jian)(jian)(jian)(jian)(jian)驗(yan)報告及委托(tuo)檢(jian)(jian)(jian)(jian)(jian)驗(yan)協議等(deng)(deng)(deng)[8]。②原(yuan)始(shi)(shi)記(ji)(ji)(ji)(ji)錄(lu)(lu)內容(rong)是否(fou)全面。原(yuan)始(shi)(shi)記(ji)(ji)(ji)(ji)錄(lu)(lu)模板是否(fou)能夠詳細記(ji)(ji)(ji)(ji)錄(lu)(lu)檢(jian)(jian)(jian)(jian)(jian)驗(yan)基本信息，檢(jian)(jian)(jian)(jian)(jian)驗(yan)記(ji)(ji)(ji)(ji)錄(lu)(lu)應完整(zheng)涵蓋：檢(jian)(jian)(jian)(jian)(jian)驗(yan)樣本的唯一(yi)性標識（如批號/ 序列號）、檢(jian)(jian)(jian)(jian)(jian)驗(yan)設(she)備編號、溫濕度等(deng)(deng)(deng)環境參數(shu)監測記(ji)(ji)(ji)(ji)錄(lu)(lu)、檢(jian)(jian)(jian)(jian)(jian)驗(yan)方(fang)法(fa)、儀器參數(shu)的設(she)定(ding)值(zhi)與實際運行范圍等(deng)(deng)(deng)。同時需建立檢(jian)(jian)(jian)(jian)(jian)驗(yan)結果計算模型，明確數(shu)值(zhi)修(xiu)約規則，并(bing)在記(ji)(ji)(ji)(ji)錄(lu)(lu)中體現。③記(ji)(ji)(ji)(ji)錄(lu)(lu)的填(tian)(tian)寫和(he)保存(cun)。是否(fou)制(zhi)定(ding)檢(jian)(jian)(jian)(jian)(jian)驗(yan)記(ji)(ji)(ji)(ji)錄(lu)(lu)相(xiang)關(guan)(guan)的管理制(zhi)度，明確記(ji)(ji)(ji)(ji)錄(lu)(lu)填(tian)(tian)寫和(he)保存(cun)的要求。是否(fou)采取(qu)措施防止(zhi)電子記(ji)(ji)(ji)(ji)錄(lu)(lu)原(yuan)始(shi)(shi)數(shu)據(ju)丟失和(he)改動。

4.小結

在有源(yuan)器(qi)械(xie)企業的(de)生(sheng)產(chan)(chan)(chan)質量(liang)(liang)管理(li)體系現場(chang)檢(jian)(jian)(jian)(jian)查(cha)(cha)(cha)中，產(chan)(chan)(chan)品檢(jian)(jian)(jian)(jian)驗作(zuo)為(wei)重(zhong)要的(de)質量(liang)(liang)控制(zhi)活動(dong)，需要檢(jian)(jian)(jian)(jian)查(cha)(cha)(cha)員(yuan)特別關(guan)注。醫療(liao)器(qi)械(xie)生(sheng)產(chan)(chan)(chan)企業對人(ren)、機、料、法、環的(de)規范化管理(li)要求(qiu)，構成了覆蓋產(chan)(chan)(chan)品全(quan)生(sheng)命周期質量(liang)(liang)控制(zhi)的(de)五大核心模(mo)塊，也形成了現場(chang)檢(jian)(jian)(jian)(jian)查(cha)(cha)(cha)的(de)關(guan)鍵切入點。本文基于醫療(liao)器(qi)械(xie)法規及(ji)指(zhi)南性(xing)文件要求(qiu)，結合有源(yuan)醫療(liao)器(qi)械(xie)質量(liang)(liang)管理(li)體系核查(cha)(cha)(cha)過程(cheng)中發現的(de)問題(ti)，提出了有源(yuan)醫療(liao)器(qi)械(xie)產(chan)(chan)(chan)品檢(jian)(jian)(jian)(jian)驗環節(jie)現場(chang)檢(jian)(jian)(jian)(jian)查(cha)(cha)(cha)關(guan)注點，供醫療(liao)器(qi)械(xie)檢(jian)(jian)(jian)(jian)查(cha)(cha)(cha)員(yuan)參考。檢(jian)(jian)(jian)(jian)查(cha)(cha)(cha)員(yuan)需結合產(chan)(chan)(chan)品特性(xing)及(ji)生(sheng)產(chan)(chan)(chan)企業質量(liang)(liang)管理(li)實際，全(quan)面關(guan)注生(sheng)產(chan)(chan)(chan)企業對人(ren)、機、料、法、環等(deng)因素的(de)控制(zhi)方法，做好現場(chang)核查(cha)(cha)(cha)工作(zuo)。

本文由廣州(zhou)佳譽(yu)醫療器械有(you)限公司/佛(fo)山(shan)浩揚醫療器械有(you)限公司聯合編輯