醫(yī)療器材優(yōu)良制造的規(guī)范

1、醫(yī)療器材優(yōu)優(yōu)良制造造規(guī)范目錄Conteent頁(yè)碼(Paage)壹、總則、Genneraal 1一、法源源依據(jù)1 BBylaaw 1二、本規(guī)規(guī)範(fàn)之專專用名詞詞2 DDefiinittionns 1貳、品質(zhì)系系統(tǒng)之要要求、Quaalitty SSysttem Reggulaatioon 2一、管理理階層之之責(zé)任1 MManaagemmentt Reespoonsiibillityy 2二、品質(zhì)質(zhì)系統(tǒng)2 QQuallityy Syysteem4三、合約約審查3 CConttracct RReviiew6四、設(shè)計(jì)計(jì)管制4 DDesiign Conntrool7五、文件件與資料料管制5 DDocuume

2、nnt aand Datta CConttroll 9六、採(cǎi)購(gòu)購(gòu)6 PPurcchassingg 10七、客戶戶供應(yīng)品品之管制制7 CConttroll off Cuustoomerr-suupplliedd Prroduuct 12八、產(chǎn)品品之識(shí)別別與追溯溯性8 PProdductt Iddenttifiicattionn annd Traaceaabillityy12九、製程程管制9 PProccesss Coontrrol 13十、檢驗(yàn)驗(yàn)與測(cè)試試10 IInsppecttionn annd TTesttingg16十一、檢檢驗(yàn)、量量測(cè)及測(cè)測(cè)試設(shè)備備之管制制11 Conntrool oof

3、 IInsppecttionn, MMeassureemennt aand Tesst EEquiipmeent18十二、檢檢驗(yàn)與測(cè)測(cè)試狀況況12 Insspecctioon aand Tesst SStattus 20十三、不不合格品品之管制制13 Conntrool oof NNoncconfformmingg Prroduuct20十四、矯矯正與預(yù)預(yù)防措施施14 Corrrecctivve aand Preevenntivve AActiion 22十五、搬搬運(yùn)、儲(chǔ)儲(chǔ)存、包包裝、防防護(hù)及 交貨15 Hanndliing, Sttoraage, Paackaaginng, Prreseer

4、vaatioon aand Delliveery24十六、品品質(zhì)紀(jì)錄錄之管制制16 Conntrool oof QQuallityy Reecorrds 25十七、內(nèi)內(nèi)部品質(zhì)質(zhì)稽核17 Intternnal Quaalitty AAudiits26十八、訓(xùn)訓(xùn)練18 Traainiing27十九、服服務(wù)19 Serrviccingg 27二十、統(tǒng)統(tǒng)計(jì)技術(shù)術(shù)20 Staatissticcal Tecchniiquees 27參、附則 、Suuppllemeent 27實(shí)施日期期規(guī)定 Impplemmenttatiion Datte27壹、總則則、Genneraal一、本規(guī)範(fàn)範(fàn)依藥事事法第五五十七條

5、條之規(guī)定定訂定之之。1 Thhis praactiice hass beeen esttabllishhed bassed on Artticlle 557 oof tthe Phaarmaaceuuticcal Afffairrs LLaw.醫(yī)療器材製製造工廠廠（以下下簡(jiǎn)稱製製造業(yè)者者）除應(yīng)應(yīng)符合藥藥事法規(guī)規(guī)定外，其其品質(zhì)制制度應(yīng)依依本規(guī)範(fàn)範(fàn)實(shí)施。Mediccal devvicee maanuffacttureers (shhalll bee deesiggnatted as mannufaactuurerrs hhereeinaafteer) shaall nott onnly connf

6、orrm tto tthe Phaarmaaceuuticcal Afffairrs LLaw, buut ttheiir qquallityy syysteems shaall alsso ffolllow thiis ppraccticce ffor thee immpleemenntattionn.二、本規(guī)範(fàn)範(fàn)之專用用名詞其其意義如如下：2 Deefinnitiionss(一)主動(dòng)動(dòng)式醫(yī)療療器材：指以電電能或其其他能源源，非直直接由人人員或重重力產(chǎn)生生以發(fā)揮揮其功能能者。2.1 acttivee meediccal devvicee: AAny meddicaal ddeviice re

7、llyinng ffor itss fuuncttionningg onn a souurcee off ellecttriccal eneergyy orr anny ssourrce of powwer othher thaan tthatt diirecctlyy geenerrateed bby tthe humman boddy oor ggravvityy.(二)主動(dòng)動(dòng)植入式式醫(yī)療器器材：指指以醫(yī)療療或外科科方式，將將主動(dòng)式式醫(yī)療器器材的全全部或部部分植入入人體或或人體之之自然腔腔道內(nèi)，並並持續(xù)留留置者。2.2 acttivee immplaantaablee meediccal

8、devvicee: AAny acttivee meediccal devvicee whhichh iss inntenndedd too bee tootallly or parrtiaallyy inntrooducced surrgiccallly oor mmediicallly, innto thee huumann boody or by meddicaal iinteerveentiion intto aa naaturral oriificce, andd whhichh iss inntenndedd too reemaiin aafteer tthe prooceddur

9、ee.(三)植入入式醫(yī)療療器材：指醫(yī)療療器材以以外科方方式，全全部或部部分植入入人體或或人體之之自然腔腔道內(nèi)、替替代上表表皮或眼眼表面，並並保留在在人體內(nèi)內(nèi)三十天天以上，且且只能藉藉由醫(yī)療療或外科科方式取取出者。2.3 impplanntabble meddicaal ddeviice: Anny mmediicall deevicce iinteendeedto bbe ttotaallyy orr paartiiallly iintrroduucedd innto thee huumann boody or natturaal oorifficee, oor to rrepllacee a

10、nn eppithheliial surrfacce oor tthe surrfacce oof tthe eyeeby suurgiicall innterrvenntioon, andd whhichh iss inntenndedd too reemaiin aafteer tthe proocedduree foor aat lleasst 330 ddayss annd wwhicch ccan onlly bbe rremoovedd byy meediccal or surrgiccal inttervventtionn.(四)無(wú)菌菌醫(yī)療器器材：指指醫(yī)療器器材經(jīng)過(guò)過(guò)滅菌處處理，

11、確確認(rèn)滅菌菌成效，並並標(biāo)示無(wú)菌字樣者者。2.4 steerille mmediicall deevicce: Anyy meediccal devvicee laabellledd ass stteriile.(五)客戶戶怨訴：指客戶戶以書面面、電訊訊或口頭頭的方式式，對(duì)上上市醫(yī)療療器材之之特性、品品質(zhì)、耐耐用性、可可靠性、安安全性及及功能等等表示不不滿。2.5 cusstommer commplaaintt: AAny wriitteen, eleectrroniic oor oorall coommuuniccatiion thaat aalleegess deeficciennciees

12、 rrelaatedd too thhe iidenntitty, quaalitty, durrabiilitty, relliabbiliity, saafetty oor pperfformmancce oof aa meediccal devvicee thhat hass beeen plaacedd onn thhe mmarkket.(六)說(shuō)明明事項(xiàng)：指製造造業(yè)者為為執(zhí)行矯矯正或預(yù)預(yù)防措施施及符合合中央衛(wèi)衛(wèi)生主管管機(jī)關(guān)管管理規(guī)定定，於交交貨時(shí)，對(duì)對(duì)醫(yī)療器器材之使使用、修修改、退退貨及銷銷毀，提提供補(bǔ)充充的資料料或建議議事項(xiàng)。2.6 advvisoory notticee: NNo

13、tiice isssuedd byy thhe mmanuufaccturrer, suubseequeent to delliveery of thee meediccal devvicee, tto pprovvidee suuppllemeentaary infformmatiion andd/orr too addvisse wwhatt acctioon sshouuld be takken inthe usee off a meddicaal ddeviice,the moddifiicattionn off a meddicaal ddeviice,the retturnn to

14、o thhe mmanuufaccturrer of a mmediicall deevicce,the desstruuctiion of a mmediicall deevicce,t rsocrterrei tn annd iin ccomppliaancee wiith nattionnal reggulaatorry rrequuireemennts.(七)風(fēng)險(xiǎn)險(xiǎn)分析：界定危危害及評(píng)評(píng)估風(fēng)險(xiǎn)險(xiǎn)之有效效的調(diào)查查資訊。2.7 rissk aanallysiis: Thee innvesstiggatiion of avaailaablee innforrmattionn too idde

15、nttifyy haazarrds andd too esstimmatee riiskss.貳、品質(zhì)系系統(tǒng)之要要求、Quaalitty SSysttem Reggulaatioon 一、管理階階層之責(zé)責(zé)任1 Maanaggemeent Ressponnsibbiliity(一)品質(zhì)質(zhì)政策1.1 Quaalitty PPoliicy製造業(yè)者管管理階層層擔(dān)負(fù)實(shí)實(shí)責(zé)者，應(yīng)應(yīng)明文訂訂定其品品質(zhì)政策策，包括括品質(zhì)目目標(biāo)與對(duì)對(duì)品質(zhì)的的承諾。品品質(zhì)政策策應(yīng)與製製造業(yè)者者組織目目標(biāo)和其其顧客之之期望及及需求相相關(guān)聯(lián)。製製造業(yè)者者應(yīng)確保保此品質(zhì)質(zhì)政策於於組織內(nèi)內(nèi)各階層層均瞭解解、實(shí)施施與維持持。The mma

16、nuufaccturrers mmanaagemmentt wiith exeecuttivee reespoonsiibillityy shhalll deefinne aand doccumeent itss pooliccy ffor quaalitty, inccluddingg obbjecctivves forr ui dtcmmtoui.hqly pooliccy sshalll bbe rreleevannt tto tthe mannufaactuurerrs orgganiisattionnal goaals andd thhe eexpeectaatioons andd

17、neeedss off itts ccusttomeers. Thhe mmanuufaccturrer shaall seh ipi dso pmt datn lelot gitn(二)組織織1.2 Orgganiisattionn1.權(quán)責(zé)1.2.11 RRespponssibiilitty aand Autthorrityy對(duì)能影響品品質(zhì)之管管理、執(zhí)執(zhí)行及查查證工作作人員，其其職責(zé)、權(quán)權(quán)限與相相互關(guān)係係均應(yīng)加加以明文文規(guī)定。特特別是對(duì)對(duì)於那些些需要組組織賦予予其自由由與授權(quán)權(quán)，以進(jìn)進(jìn)行下列列工作的的人員：The rrespponssibiilitty, autthorrityy annd

18、iinteerreelattionn off peersoonneel wwho mannagee, pperfformm annd vveriify worrk aaffeectiing quaalitty sshalll bbe ddefiinedd annd ddocuumenntedd, ppartticuularrly forr peersoonneel wwho neeed tthe orgganiisattionnal freeedoom tto:(1) 發(fā)發(fā)起措施施以防止止有關(guān)於於產(chǎn)品、製製程及品品質(zhì)系統(tǒng)統(tǒng)有任何何不符合合情事之之發(fā)生；(1) iinittiatte aacti

19、ion to preevennt tthe occcurrrencce oof aany nonnconnforrmittiess reelattingg too thhe pprodductt, pproccesss annd qquallityy syysteem;(2) 鑑鑑別並記記錄任何何有關(guān)於於產(chǎn)品、製製程及品品質(zhì)系統(tǒng)統(tǒng)的問(wèn)題題；(2) iidenntiffy aand reccordd anny pprobblemms rrelaatinng tto tthe prooducct, proocesss aand quaalitty ssysttem;(3) 經(jīng)經(jīng)由規(guī)定定管道發(fā)發(fā)起、

20、建建議或提提出解決決辦法；(3) iinittiatte, reccommmendd orr prroviide sollutiionss thhrouugh dessignnateed cchannnells;(4) 查查證解決決措施之之執(zhí)行情情況；(4) vveriify thee immpleemenntattionn off sooluttionns;(5) 在在缺陷或或不滿意意狀況被被矯正前前，管制制不合格格產(chǎn)品被被進(jìn)一步步加工、交交貨或安安裝。(5) cconttroll fuurthher proocesssinng, delliveery or insstalllattionn

21、 off nooncoonfoormiing prooducct uuntiil tthe defficiienccy oor uunsaatissfacctorry ccondditiion hass beeen corrrecctedd.2.資源1.2.22 Reesouurcees製造業(yè)者應(yīng)應(yīng)鑑定資資源需求求，並提提供適當(dāng)當(dāng)?shù)馁Y源源，包括括指派訓(xùn)訓(xùn)練有素素人員以以從事管管理、執(zhí)執(zhí)行及查查證活動(dòng)動(dòng)，包括括內(nèi)部品品質(zhì)稽核核。The mmanuufaccturrer shaall ideentiify ressourrce reqquirremeentss annd pprovvidee ad

22、dequuatee reesouurcees, inccluddingg thhe aassiignmmentt off trrainned perrsonnnell ffor mannageemennt, perrforrmannce of worrk aand verrifiicattionn acctivvitiies inccluddingg innterrnall quualiity audditss.3.品質(zhì)負(fù)負(fù)責(zé)人1.2.33 Quualiity Reppressenttatiive製造業(yè)者管管理階層層擔(dān)負(fù)實(shí)實(shí)責(zé)者，應(yīng)應(yīng)指派管管理階層層中之一一員為品品質(zhì)負(fù)責(zé)責(zé)人，於於原有職職責(zé)外

23、，應(yīng)應(yīng)授權(quán)從從事下列列工作：The mmanuufaccturrers mmanaagemmentt wiith exeecuttivee reespoonsiibillityy shhalll apppoiint a mmembber of thee afteswmamth rpte off ottherr reespoonsiibillitiies, shhalll deefinne aauthhoriity forr:(1) 確確保品質(zhì)質(zhì)系統(tǒng)係係按照本本規(guī)範(fàn)予予以建立立、實(shí)施施及維持持。(1) euntt atst tlh, immpleemenntedd annd mmainntaii

24、nedd inn acccorrdannce witth tthiss GMMP aand(2) 將將品質(zhì)系系統(tǒng)之運(yùn)運(yùn)作情況況向管理理階層提提出報(bào)告告，以供供檢討，並並作為改改進(jìn)品質(zhì)質(zhì)系統(tǒng)的的依據(jù)。(2) rrepoortiing on thee peerfoormaancee off thhe qquallityy syysteem tto tthe mannageemennt ffor revvieww annd aas aa baasiss foor iimprroveemennt oof tthe quaalitty ssysttem.(3) 確確保其所所產(chǎn)製醫(yī)醫(yī)療器材材之安全全及功效

25、效。(3) eunt fyneeinsetgohmucrgec ve)(三)管理理審查1.3 Mannageemennt RReviiew製造業(yè)者管管理階層層擔(dān)負(fù)實(shí)實(shí)責(zé)者，應(yīng)應(yīng)於規(guī)定定期間內(nèi)內(nèi)對(duì)品質(zhì)質(zhì)系統(tǒng)加加以審查查，以充充分確保保滿足本本規(guī)範(fàn)之之要求以以及供應(yīng)應(yīng)者所宣宣示的品品質(zhì)政策策與目標(biāo)標(biāo)，能繼繼續(xù)地適適合且具具有效果果。審查查之紀(jì)錄錄應(yīng)予維維持。The mmanuufaccturrers mmanaagemmentt wiith exeecuttivee reespoonsiibillityy shhalll reevieew tthe quaalitty ssysttem at de

26、ffineed iinteervaals suffficciennt tto eensuure itss coontiinuiing suiitabbiliity andd efffecctivveneess in sattisffyinng tthe reqquirremeentss off thhis Praactiice andd thhe mmanuufaccturrers sstatted quaalitty ppoliicy andd obbjecctivves. Reecorrds of succh rreviiewss shhalll bee maainttainned.二、品

27、質(zhì)系系統(tǒng)2 Quualiity Sysstemm(一)概述述2.1 Genneraal製造業(yè)者應(yīng)應(yīng)建立、書書面訂定定及維持持其品質(zhì)質(zhì)系統(tǒng)，藉藉以確保保產(chǎn)品符符合規(guī)定定的要求求，製造造業(yè)者應(yīng)應(yīng)準(zhǔn)備品品質(zhì)手冊(cè)冊(cè)涵蓋本本規(guī)範(fàn)之之各項(xiàng)要要求。此此項(xiàng)品質(zhì)質(zhì)手冊(cè)應(yīng)應(yīng)包括或或提及品品質(zhì)系統(tǒng)統(tǒng)的各項(xiàng)項(xiàng)書面程程序，以以及略述述本品質(zhì)質(zhì)系統(tǒng)所所使用之之文件架架構(gòu)。The mmanuufaccturrer shaall esttabllishh, ddocuumennt aand maiintaain a qquallityy syysteem aas aa meeanss off ennsurringg thha

28、t prooducct cconfformms tto sspeccifiied reqquirremeentss. Thee maanuffacttureer sshalll pprepparee a quaalitty mmanuual covveriing thee reequiiremmentts oof tthiss Prractticee. TThe quaalitty mmanuual shaall inccludde oor mmakee reeferrencce tto tthe quaalitty ssysttem prooceddurees aand outtlinne

29、tthe strructturee off thhe ddocuumenntattionn ussed in thee quualiity sysstemm. TThe mannufaactuurerr shhalll esstabblissh aand doccumeent thee sppeciifieed rrequuireemennts.(二)品質(zhì)質(zhì)系統(tǒng)程程序2.2 Quaalitty SSysttem Prooceddurees製造業(yè)者應(yīng)應(yīng)：The ssuppplieer sshalll1.遵照本本規(guī)範(fàn)要要求及既既定之品品質(zhì)政策策，明定定各項(xiàng)書書面程序序；及(1) ppreppare

30、e doocummentted prooceddurees cconssisttentt i eeimtotsPcca eaftesteqlyoc d2.有效執(zhí)執(zhí)行品質(zhì)質(zhì)系統(tǒng)與與其書面面程序。(2) eeffeectiivelly iimpllemeent thee quualiity sysstemm annd iits doccumeenteed pprocceduuress.為達(dá)到本規(guī)規(guī)範(fàn)之目目的，構(gòu)構(gòu)成品質(zhì)質(zhì)系統(tǒng)之之各項(xiàng)程程序，其其範(fàn)圍與與細(xì)節(jié)應(yīng)應(yīng)視工作作之複雜雜性、所所使用之之方法與與技巧、以以及執(zhí)行行業(yè)務(wù)人人員所需需之訓(xùn)練練而定。For tthe purrposses of thi

31、is GGMP, thhe rrangge aand dettaill off thhe pprocceduuress thhat forrm ppartt off thhe qquallityy syysteem sshalll bbe ddepeendeent upoon tthe commpleexitty oof tthe worrk, thee meethoods useed, andd thhe sskillls andd trrainningg neeedeed bby pperssonnnel invvolvved in carrryiing outt thhe aactiiv

32、itty.(三)品質(zhì)質(zhì)規(guī)劃2.3 Quaalitty PPlannninng製造業(yè)者應(yīng)應(yīng)明文訂訂定如何何達(dá)成品品質(zhì)要求求。品質(zhì)質(zhì)規(guī)劃應(yīng)應(yīng)與製造造業(yè)者品品質(zhì)系統(tǒng)統(tǒng)中之其其他要求求相一致致，且應(yīng)應(yīng)以適合合製造業(yè)業(yè)者作業(yè)業(yè)方式之之格式予予以書面面化。為為達(dá)成產(chǎn)產(chǎn)品、專專案計(jì)畫畫，或合合約所規(guī)規(guī)定之要要求，製製造業(yè)者者應(yīng)適時(shí)時(shí)考慮下下列適合合之項(xiàng)目目The ssuppplieer sshalll ddefiine andd doocummentt hoow tthe reqquirremeentss foor qquallityy shhalll bee meet. Quaalitty pplannn

33、inng sshalll bbe cconssisttentt wiith alll ottherr reequiiremmentts oof aa suuppllierrs quaalitty ssysttem andd shhalll bee doocummentted in a fformmat to suiit tthe supppliiers ooperratiion. Thhe ssuppplieer sshalll ggivee coonsiiderratiion to thee foolloowinng aactiivittiess, aarrt ensci qres foor

34、 pprodductts, proojecct oor cconttraccts:1.擬訂品品質(zhì)計(jì)畫畫；(1) tthe preeparratiion of quaalitty pplanns;2.為達(dá)到到要求的的品質(zhì)，可可能需要要之任何何管制、製製程、設(shè)設(shè)備（包包括檢驗(yàn)驗(yàn)與測(cè)試試設(shè)備）、夾夾具、所所有生產(chǎn)產(chǎn)資源與與技術(shù)之之鑑別及及獲得；(2) tthe ideentiificcatiion andd accquiisittionn off anny cconttrolls, proocesssess, eequiipmeent, (iinclludiing insspecctioon aan

35、d tesst eequiipmeent), ffixtturees, ressourrcess annd sskillls thaat mmay be neeededd too acchieeve thee reequiiredd quualiity;3.確保設(shè)設(shè)計(jì)、製製程、安安裝、服服務(wù)、檢檢驗(yàn)及測(cè)測(cè)試程序序，以及及適用文文件之間間具有相相容性；(3) eensuurinng tthe commpattibiilitty oof tthe dessignn, tthe ocopcs,naao rcg iinsppecttionn annd ttestt prroceedurres andd

36、 thhe aappllicaablee doocummenttatiion;4.需要時(shí)時(shí)，得更更新品質(zhì)質(zhì)管制、檢檢驗(yàn)及測(cè)測(cè)試技術(shù)術(shù)，包括括發(fā)展新新儀器等等；(4) t di,sesr atctliptnnttgenu,nunt voe wnreao5.鑑別任任何超出出已知現(xiàn)現(xiàn)有技術(shù)術(shù)狀況能能力之量量測(cè)要求求，而開(kāi)開(kāi)發(fā)此項(xiàng)項(xiàng)所需能能力，須須有充裕裕的時(shí)間間；(5) tthe ideentiificcatiion of anyy meeasuuremmentt reequiiremmentt innvollvinng ccapaabillityy thhat excceedds tthe kno

37、own staate of thee arrt, in suffficciennt ttimee foor tthe neeededd caapabbiliity to be devveloopedd;6.在產(chǎn)品品獲得實(shí)實(shí)現(xiàn)的適適當(dāng)階段段，適切切的查證證工作之之鑑別；(6) tthe ideentiificcatiion of suiitabble verrifiicattionn att appproopriiatee sttagees iin tthe reaalissatiion of prooducct;7.釐清所所有特性性項(xiàng)目與與需求的的允收準(zhǔn)準(zhǔn)則，包包含主觀觀因素在在內(nèi)；(7) t

38、 afaoosnr ctitf leusnruen,nuntswcctn bcvemt8.品質(zhì)紀(jì)紀(jì)錄之鑑鑑別與準(zhǔn)準(zhǔn)備。(8) tthe ideentiificcatiion an preeparratiion of quaalitty rrecoordss.製造業(yè)應(yīng)建建立並維維持完整整的製造造程序、安安裝與維維修之檔檔案，且且以書面面文字規(guī)規(guī)範(fàn)醫(yī)療療器材之之每一類類型或型型號(hào)的產(chǎn)產(chǎn)品規(guī)格格與品質(zhì)質(zhì)制度要要求（製製程與品品質(zhì)保證證），或或此類資資訊之參參照處所所。mucr a tlhnmniai nindun fi eru efao dui smeimt(osa ataun)ocompplett

39、e mmanuufaccturringg, aandinsttalllatiion andd seerviicinng, if appproppriaate,for eeachh tyype/moddel of meddicaal ddeviice, orr reeferrrinng tto tthe loccatiion(s) of thiis iinfoormaatioon.三、合約審審查3 Coontrractt Reevieew(一)概述述3.1 Genneraal製造業(yè)者應(yīng)應(yīng)建立並並維持合合約審查查及協(xié)調(diào)調(diào)各項(xiàng)審審查活動(dòng)動(dòng)之書面面程序。The mmanuufaccturrer sha

40、all esttabllishh annd mmainntaiin ddocuumenntedd prroceedurres forr coontrractt reevieew aand forr thhe cco-oordiinattionn off thhesee acctivvitiies.(二)審查查3.2 Revvieww在提出每一一份標(biāo)單單，或接接受每一一份合約約或訂單單（記載載要求條條件）之之前，製製造業(yè)者者應(yīng)對(duì)該該標(biāo)單、合合約或訂訂單加以以審查，以以確保：Beforre ssubmmisssionn off a tennderr, oor tthe acccepttancce

41、oof aa coontrractt orr orrderr (sstattemeent of reqquirremeent), tthe tennderr, cconttracct oor oordeer sshalll bbe rreviieweed bby tthe mannufaactuurerr too ennsurre tthatt:1.要求事事項(xiàng)已適適切地明明文規(guī)定定。如係係口頭訂訂貨，沒(méi)沒(méi)有書面面的要求求依據(jù)時(shí)時(shí)，製造造業(yè)者應(yīng)應(yīng)確保在在接受之之前，訂訂單之要要求事項(xiàng)項(xiàng)均已獲獲同意；(1) tthe reqquirremeentss arre aadeqquattelyy dee

42、finned andd doocummentted; wwherre nno wwritttenn sttateemennt oof rrequuireemennt iis aavaiilabble forr ann orrderr reeceiivedd byy veerbaal mmeanns, thee maanuffacttureer sshalll eensuure thaat tthe ordder reqquirremeentss arre aagreeed befforee thheirr acccepptannce;2.在合約約或訂單單中，任任何事項(xiàng)項(xiàng)與標(biāo)單單所載不不同之處處

43、，皆已已解決；(2) aany diffferrencces bettweeen tthe conntraact or ordder reqquirremeentss annd tthosse iin tthe tennderr arre rresoolveed;3.製造業(yè)業(yè)者有能能力滿足足合約或或所接訂訂單之要要求事項(xiàng)項(xiàng)。(3) tthe mannufaactuurerr haas tthe cappabiilitty tto mmeett thhe cconttracct oor oordeer rrequuireemennts.(三)合約約修訂3.3 Ameendmmentt too a

44、 Conntraact製造業(yè)者應(yīng)應(yīng)鑑別合合約如何何修訂，並並正確地地傳送至至製造業(yè)業(yè)者組織織內(nèi)之有有關(guān)部門門。The mmanuufaccturrer shaall ideentiify howw ann ammenddmennt tto aa coontrractt iss maade andd coorreectlly ttrannsfeerreed tto tthe funnctiionss coonceerneed wwithhin thee maanuffacttureer oorgaanissatiion.(四)紀(jì)錄錄3.4 Reccordds合約審查紀(jì)紀(jì)錄應(yīng)予予以維持持。r na

45、 vwslbmnid四、設(shè)計(jì)管管制4 Deesiggn CConttroll(一)概述述4.1 Genneraal製造業(yè)者應(yīng)應(yīng)建立並並維持各各項(xiàng)書面面程序，藉藉以管制制與查證證產(chǎn)品之之設(shè)計(jì)，以以確保規(guī)規(guī)定要求求得以達(dá)達(dá)成。The mmanuufaccturrer shaall esttabllishh annd mmainntaiin ddocuumenntedd prroceedurres to conntrool aand verrifyy thhe ddesiign of thee prroduuct in ordder to enssuree thhat thee sppeciifie

46、ed rrequuireemennts aree meet.設(shè)計(jì)過(guò)程中中，製造造業(yè)者應(yīng)應(yīng)評(píng)估風(fēng)風(fēng)險(xiǎn)分析析之必要要性，並並維持任任何風(fēng)險(xiǎn)險(xiǎn)分析的的執(zhí)行紀(jì)紀(jì)錄。uo eegpcst naurhlvuehndorknysnmnirosfnrknyseoe(二)設(shè)計(jì)計(jì)與開(kāi)發(fā)發(fā)規(guī)劃4.2 Dessignn annd DDeveeloppmennt PPlannninng製造業(yè)者應(yīng)應(yīng)為每一一設(shè)計(jì)與與開(kāi)發(fā)活活動(dòng)擬訂訂各項(xiàng)計(jì)計(jì)畫，這這些計(jì)畫畫應(yīng)描述述或言及及這些活活動(dòng)，並並界定彼彼等執(zhí)行行之責(zé)任任。指派派合格人人員並配配備充分分資源擔(dān)擔(dān)任設(shè)計(jì)計(jì)與開(kāi)發(fā)發(fā)工作。這這些計(jì)畫畫應(yīng)隨設(shè)設(shè)計(jì)的進(jìn)進(jìn)展而予予以更新新。The

47、 mmanuufaccturrer shaall preeparre pplanns ffor eacch ddesiign andd deevellopmmentt acctivvityy. TThe plaans shaall desscriibe or reffereencee thhesee acctivvitiies andd deefinne rrespponssibiilitty ffor theeir impplemmenttatiion. Thhe ddesiign andd deevellopmmentt acctivvitiies shaall be asssignned

48、 to quaaliffiedd peersoonneel eequiippeed wwithh addequuatee reesouurcees. Thee pllanss shhalll bee uppdatted as thee deesiggn eevollvess.(三)組織織與技術(shù)術(shù)之介面面4.3 gitn denaIeas參與設(shè)計(jì)過(guò)過(guò)程的各各群組間間，其組組織與技技術(shù)之介介面，應(yīng)應(yīng)予以界界定，必必要的資資料須予予文件化化、傳遞遞並定期期檢討。Organnisaatioonall annd ttechhniccal intterffacees bbetwweenn diiffeer

49、ennt ggrouups whiich inpput intto tthe dessignn prroceess shaall be deffineed aand thee neecesssarry iinfoormaatioon ddocuumenntedd, ttrannsmiitteed aand reggulaarlyy reevieewedd.(四)設(shè)計(jì)計(jì)輸入4.4 Dessignn Innputt與產(chǎn)品相關(guān)關(guān)之設(shè)計(jì)計(jì)輸入要要求，包包括適用用的法令令、規(guī)章章要求，製製造業(yè)者者應(yīng)予鑑鑑別並文文件化，且且應(yīng)審查查輸入要要求之選選擇是否否適當(dāng)。不不完整、混混淆不清清或互相相抵觸的的要求，

50、應(yīng)應(yīng)與提出出這些要要求者會(huì)會(huì)同加以以解決。Desiggn iinpuut rrequuireemennts rellatiing to thee prroduuct, inncluudinng aappllicaablee sttatuutorry andd reegullatoory reqquirremeentss shhalll bee iddenttifiied, doocummentted andd thheirr seelecctioon rreviieweed bby tthe mannufaactuurerr foor aadeqquaccy. Inncommpleete, a

51、mmbigguouus oor cconfflicctinng rrequuireemennts shaall be ressolvved witth tthosse rrespponssiblle ffor impposiing theese reqquirremeentss.設(shè)計(jì)輸入應(yīng)應(yīng)將任何何合約檢檢討的結(jié)結(jié)果均納納入考慮慮。Desiggn iinpuut sshalll ttakee innto connsidderaatioon tthe ressultts oof aany conntraact revvieww acctivvitiies.(五)設(shè)計(jì)計(jì)輸出4.5 Dessignn

52、 Ouutpuut設(shè)計(jì)輸出應(yīng)應(yīng)予文件件化，並並以對(duì)設(shè)設(shè)計(jì)輸入入要求能能被查證證及作有有效性確確認(rèn)方式式予以表表達(dá)。Desiggn ooutpput shaall be doccumeenteed aand exppresssedd inn teermss thhat cann bee veeriffiedd annd vvaliidatted agaainsst ddesiign inpput reqquirremeentss.設(shè)計(jì)輸出應(yīng)應(yīng)：Desiggn ooutpput shaall:1.符合設(shè)設(shè)計(jì)輸入入要求；(1) mmeett thhe ddesiign inpput reqquirr

53、emeentss;2.包含或或列出參參考之允允收準(zhǔn)則則；(2) cconttainn orr maake reffereencee too acccepptannce criiterria;3.鑑別對(duì)對(duì)產(chǎn)品安安全與正正常作用用極為重重要的設(shè)設(shè)計(jì)特性性（如操操作、儲(chǔ)儲(chǔ)存、搬搬運(yùn)、維維護(hù)及處處理之要要求）；(3) iidenntiffy tthosse ccharractteriistiics of thee deesiggn tthatt arre ccrucciall too thhe ssafee annd ppropper funnctiioniing of thee prroduuct

54、(e.g. opeerattingg, sstorragee, hhanddlinng, maiinteenannce andd diispoosall reequiiremmentts).設(shè)計(jì)輸出文文件在發(fā)發(fā)佈前，應(yīng)應(yīng)加以審審查。Desiggn ooutpput doccumeentss shhalll bee reevieewedd beeforre rreleeasee.(六)設(shè)計(jì)計(jì)審查4.6 Dessignn Reevieew在設(shè)計(jì)過(guò)程程中之適適當(dāng)階段段，應(yīng)規(guī)規(guī)劃並執(zhí)執(zhí)行對(duì)設(shè)設(shè)計(jì)結(jié)果果作正式式書面審審查。每每次設(shè)計(jì)計(jì)審查參參與者應(yīng)應(yīng)包括所所有有關(guān)關(guān)所審查查之設(shè)計(jì)計(jì)階段部部門之代代表，需

55、需要時(shí)，並並請(qǐng)其他他專業(yè)人人員參加加。各項(xiàng)項(xiàng)審查紀(jì)紀(jì)錄應(yīng)予予維持。At appproopriiatee sttagees oof ddesiign, foormaal ddocuumenntedd reevieews of thee deesiggn sshalll bbe pplannnedd annd ccondductted. PPartticiipannts at eacch ddesiign revvieww shhalll inncluude reppressenttatiivess off alll ffuncctioons conncerrnedd wiith thee dee

56、siggn sstagge bbeinng rreviieweed, as welll aas ootheer sspecciallistt peersoonneel, as reqquirred. RRecoordss off suuch revviewws sshalll bbe mmainntaiinedd.(七)設(shè)計(jì)計(jì)查證4.7 Dessignn Veerifficaatioon在設(shè)計(jì)過(guò)程程中之適適當(dāng)階段段，應(yīng)實(shí)實(shí)施設(shè)計(jì)計(jì)查證，以以確保設(shè)設(shè)計(jì)階段段之輸出出能符合合其設(shè)計(jì)計(jì)輸入要要求。設(shè)設(shè)計(jì)查證證措施應(yīng)應(yīng)予記錄錄。At appproopriiatee sttagees oof ddesi

57、ign, deesiggn vveriificcatiion shaall be perrforrmedd too ennsurre tthatt thhe ddesiign staage outtputt meeetss thhe ddesiign staage inpput reqquirremeentss. Thee deesiggn vveriificcatiion meaasurres shaall be reccordded.(八)設(shè)計(jì)計(jì)確認(rèn)4.8 Dessignn Vaaliddatiion為確保產(chǎn)品品符合既既定之使使用者需需求或要要求項(xiàng)目目，應(yīng)實(shí)實(shí)施設(shè)計(jì)計(jì)確認(rèn)。Desiggn

58、vvaliidattionn shhalll bee peerfoormeed tto eensuure thaat pprodductt coonfiirmss too deefinned useer nneedds aand/or reqquirremeentss.製造業(yè)者應(yīng)應(yīng)執(zhí)行臨臨床評(píng)估估，並維維持紀(jì)錄錄，以作作為設(shè)計(jì)計(jì)確認(rèn)的的一部份份。As paart of dessignn vaaliddatiion, thhe ssuppplieer sshalll pperfformm annd mmainntaiin rrecoordss off clliniicall evvaluuati

59、ionss.(九)設(shè)計(jì)計(jì)變更4.9 Dessignn Chhangges所有設(shè)計(jì)變變更與修修改事宜宜，在實(shí)實(shí)施前應(yīng)應(yīng)予以鑑鑑別、記記載、審審查並經(jīng)經(jīng)被授權(quán)權(quán)人員核核準(zhǔn)。All ddesiign chaangees aand moddifiicattionns sshalll bbe iidenntiffiedd, ddocuumenntedd, rreviieweed aand appprovved trepsn fehrmentn五、文件與與資料管管制5 Doocummentt annd DDataa Coontrrol(一)概述述5.1 Genneraal製造業(yè)者應(yīng)應(yīng)建立並並維持書書面程序

60、序，以管管制所有有與本規(guī)規(guī)範(fàn)要求求有關(guān)之之文件與與資料，在在可行之之範(fàn)圍內(nèi)內(nèi)尚包括括外來(lái)之之原始文文件，如如標(biāo)準(zhǔn)與與顧客之之圖樣等等。mucr a tlhnmnidundrer noa cesndah leohruen iPcciinclludiing, too thhe eexteent apppliccablle, doccumeentss off exxterrnall orrigiin ssuchh ass sttanddardds aand cusstommer draawinngs.(二)文件件與資料料之核發(fā)發(fā)5.2 ce da pv dse文件與資料料在發(fā)行行前，應(yīng)應(yīng)由被授授權(quán)人