Ukuthola idivayisi yezokwelapha · Umhlahlandlela osebenzayo womthengi
Ukuhlola abakhiqizi bezinsimbi zokuhlinza kudinga okungaphezu kokuqhathanisa usayizi wekhathalogi kanye nenani leyunithi. Ukubuyekeza okuthembekile kuhlola ubunikazi bomkhiqizi obusemthethweni, isistimu yekhwalithi, isimo sokulawula esiqondene nomkhiqizo othile, izinto zokwakha, izilawuli zenqubo, ukulandeleka, amasampula, ukusebenza kokulethwa, nokusekelwa kwangemuva kwemakethe. Lolu hlu lokuhlola lwamaphuzu ayi-12 luguqula lezo zidingo zibe inqubo ephindaphindwayo yokukhetha umhlinzeki.
Umhlola Kanjani Umkhiqizi Wezinsimbi Zokuhlinza?
Qala ngokucaciswa kwemfuneko yomsebenzisi ebhaliwe, bese uhlola ikhandidethi ngayinye ngezigaba ezine: ukubuyekezwa kwedokhumenti, ingxoxo yobuchwepheshe, ukuhlolwa kwesampula, futhi—lapho ubungozi buthethelela khona—ukucwaninga okukude noma okusendaweni. Ungagunyazi umhlinzeki ngokusekelwe kuphela kusitifiketi se-PDF, isimangalo sewebhusayithi, noma isampula eyamukelekayo ngokubukeka.
Impendulo emfushane engcono kakhulu: khetha umkhiqizi ohlinzeka ngobufakazi obuqine kakhulu obungaqinisekiswa bedivayisi yakho ethile kanye nemakethe—hhayi ngempela inkampani enohlu olude kakhulu lwemikhiqizo noma ikhotheshini ephansi kakhulu.
Chaza Izidingo Zakho Ngaphambi Kokuxhumana Nabahlinzeki
Umphakeli akakwazi ukuhlinzeka ngekhotheshini enengqondo noma iphakheji yokuhambisana kuze kube yilapho umkhiqizo ohlosiwe uchazwa ngokucacile. Lungiselela idokhumenti yezidingo emfushane ngaphambi kokudala uhlu olufushane.
- Idivayisi nokusetshenziswa okuhlosiwe: igama lensimbi, inqubo, isimo esingasebenziseka kabusha noma sokusebenzisa kanye, kanye nokuthi ihlinzekwa yodwa noma njengengxenye yesistimu yokufakelwa.
- Imakethe eqondiwe: amazwe okuthengiswayo, ukuhlukaniswa kwedivayisi, umzila wokubhalisa osebenzayo, ulimi, ukulebula, kanye nezimfuneko zokungenisa ezweni noma ummeleli ogunyaziwe.
- Ukucaciswa kobuchwepheshe: ubukhulu, ukubekezelelana, ibanga lezinto ezibonakalayo, ubulukhuni, ukuphela kwendawo, ijometri yokusebenzelana, imidwebo, nezindlela zokuhlola.
- Ukucutshungulwa: isimo sokuhlanza, ukudlula, ukupakisha, isimo sokuvala inzalo, ukuhambisana nokuvala inzalo, nemiyalo eqinisekisiwe yokucubungula kabusha lapho kufanele khona.
- Ububanzi bezentengiselwano: ivolumu yesimo sezulu, ukuhleleka kokuqala, isikhathi sokuhola okuqondiwe, ukumiswa kokupakisha, ilebula yangasese, namadokhumenti adingekayo.
Ukubuyekeza okomkhiqizi izigaba zomkhiqizo wamathambo zingasiza ukuthola ukuthi ububanzi bayo obujwayelekile bokukhiqiza bufana nokuthenga okuhleliwe. Ububanzi bekhathalogi bubodwa, nokho, abubonisi ikhono lawo wonke amadivayisi asohlwini.
Uhlu Lokuhlola Olunamaphuzu Ayi-12 Lwabakhiqizi Bezinsimbi Zokuhlinza
- Qinisekisa umkhiqizi osemthethweni kanye nezibopho zesayithi Khomba ukuthi ubani umnikazi wedizayini yedivayisi, okhiqiza ingxenye ngayinye, owenza ukuqedela nokupakisha, nokuthi ubani okhipha umkhiqizo oqediwe. Rekhoda amakheli kanye nezinqubo ezibalulekile ezinikezwa ngaphandle.
- Qinisekisa uhlelo lokuphatha ikhwalithi Cela isitifiketi samanje se-ISO 13485 futhi uqinisekise igama lenhlangano, ikheli lokukhiqiza, ububanzi besitifiketi, inhlangano ekhipha izitifiketi, ukugunyazwa, isimo sesitifiketi, nosuku lokuphelelwa yisikhathi.
- Qinisekisa ukugunyazwa kwemakethe okuqondene nomkhiqizo Qondanisa umkhiqizo ngqo, imodeli, ukusetshenziswa okuhlosiwe, ukuhlukaniswa, nomkhiqizi osemthethweni nemibhalo edingekayo kumakethe ngayinye okuyiwa kuyo. Ukubhaliswa kwenkampani akufani nokugunyazwa komkhiqizo noma ukugunyazwa.
- Buyekeza izinto ezisetshenziswayo nezilawuli zabahlinzeki Idinga ukucaciswa kwezinto ezibonakalayo nezitifiketi, izilawuli ezigunyaziwe zabahlinzeki, ukuhlolwa okungenayo, ukuhlukaniswa kwezindawo, kanye nenqubo yokusingatha ukushintshwa noma izinguquko zezinto.
- Hlola amandla okukhiqiza Qinisekisa ukuthi ukwenza imishini, ukufoja, ukwelashwa kokushisa, ukushisela, ukupholisha, ukudlula, ukuhlanganisa, ukuhlanganisa, kanye namandla okuhlola afana nomkhiqizo. Nquma ukuthi yiziphi izinyathelo ezinikezwa ngaphandle nokuthi zilawulwa kanjani.
- Hlola ukuqinisekiswa kwenqubo nokulinganiswa Buza ukuthi izinqubo ezikhethekile ziqinisekiswa kanjani nokuthi ukuhlolwa, ithoshi, ubukhulu, ugesi, nezinye izisetshenziswa zokulinganisa zilinganiswa futhi zigcinwa kanjani.
- Ukulandelelwa kokuhlola nokulawula amadokhumenti Khetha isampula yenqwaba bese ucela umkhiqizi ukuthi ayilandele abuyele ezintweni ezingavuthiwe, amarekhodi omhambi noma omzila, ukuhlolwa, ukungahambisani, ukulebula, ukupakisha, nokuvunyelwa kokukhishwa.
- Hlola ukusebenza kobuchwepheshe nokusebenziseka Vuma amasampuli ngokumelene nemidwebo kanye nemibandela yekesi yokusebenzisa efana nokufaneleka, ukuqondanisa, ukubamba, ukusebenza kokusika, ukudluliswa kwetorque, ukusebenzisana kwesixhumi esibonakalayo, i-ergonomics, nokucubungula okuphindaphindiwe.
- Buyekeza izibopho zokuhlanza, ukupakisha, nokuvala inzalo Cacisa ukuthi amadivaysi ahlinzekwa ngokungewona oyinyumba noma oyinyumba, iyiphi inhlangano eqinisekisa ukuhlanzwa nokuvalwa, nokuthi ibuphi ubuqotho bokupakishwa, impilo yeshelufu, i-bioburden, nobufakazi bokulebula obusebenzayo.
- Hlola izilawuli zokuklama nokwenza ngendlela oyifisayo Kumsebenzi we-OEM/ODM, buyekeza okokufaka kwedizayini, ukuphathwa kwengozi, imidwebo, ukuqinisekiswa, ukuqinisekiswa, impahla esunguliwe, ukugunyazwa kwesampula, ukudluliswa kwedizayini, kanye nezibopho zokulawula ushintsho.
- Linganisa umthamo nokuthembeka kokulethwa Hlola isikhathi esingokoqobo sokuhola, izithiyo zomthamo, ubuncane be-oda, isitokwe sokuphepha, ukuphatha isibikezelo, ukuqinisekiswa kwe-oda, ukunemba kokupakisha, imibhalo yokuthekelisa, nezinhlelo zokuthola kabusha ukubambezeleka.
- Buyekeza izikhalazo, i-CAPA, iwaranti, nokuqhubeka Qinisekisa ukukhuphuka kwesikhalazo, ukuhlaziya imbangela yezimpande, isenzo sokulungisa nesokuvimbela, isenzo sasendle noma ukwesekwa kokukhumbula, izingxenye eziyisipele, ukulungiswa, imigomo yesiqinisekiso, nokuqhubeka kwebhizinisi.
Uziqinisekisa Kanjani Izimangalo Zekhwalithi Nezokulawula
I-ISO 13485 iyindinganiso yesistimu yekhwalithi
I-ISO 13485 icacisa izidingo zesistimu yokuphatha ikhwalithi yezinhlangano ezibandakanyeka kumjikelezo wempilo wedivayisi yezokwelapha. Kuwubufakazi obuzwakalayo lapho isitifiketi sivumelekile futhi ububanzi baso buhlanganisa inhlangano efanele, isayithi, kanye nemisebenzi. Lokhu ngokwako akufakazisi ukuthi yonke imikhiqizo ekukhathalogi ibhalisiwe, ifanelekile ngokomtholampilo, noma igunyaziwe emakethe yakho.
Cela isitifiketi esiphelele kunelogo enqanyuliwe. Iqinisekise nenhlangano ekhipha izitifiketi noma isizindalwazi sayo somphakathi lapho kungenzeka khona, futhi uqhathanise igama lenkampani nekheli ngokumelene nezingcaphuno, ama-invoyisi, izimemezelo, amalebula, namarekhodi emikhiqizo.
Ukumakwa kwe-CE kufanele kufaniswe nedivayisi kanye nomzila we-EU MDR
Nge-European Union, nquma ukuhlukaniswa kwedivayisi kanye nomzila wokuhlola ukuhambisana osebenzayo ngaphansi Kwe-Medical Device Regulation. Buyekeza i-EU Declaration of Conformity futhi, lapho ikilasi lidinga ukubandakanyeka kwemizimba eyazisiwe, isitifiketi esisebenzayo kanye nemininingwane yomzimba owaziswayo. Qinisekisa ukuthi umndeni womkhiqizo, umkhiqizi osemthethweni, i-Basic UDI-DI lapho kufanele khona, inhloso ehlosiwe, nokuqondanisa kobubanzi besitifiketi.
Ukubhaliswa kokusungulwa kwe-FDA akuyona imvume ye-FDA
I-FDA ikubeka ngokusobala ukuthi ukubhaliswa kwesikhungo nokufakwa kuhlu kwedivayisi akubonisi ukugunyazwa, ukugunyazwa, noma ukugunyazwa. E-United States, hlola ukuhlukaniswa kwedivayisi nokuthi idivayisi ngqo idinga imvume engu-510(k), imvume ye-PMA, ukugunyazwa kwe-De Novo, noma ikhululiwe. Qinisekisa irekhodi lesizindalwazi elifanelekile kunokuthembela ebhejini 'ebhaliswe nge-FDA'.
| Idokhumenti noma funa | Okufanele uqinisekise | Lokho okungakufakazeli kukodwa |
|---|---|---|
| Isitifiketi se-ISO 13485 | Igama elisemthethweni, isayithi, ububanzi, umkhiphi, ukugunyazwa, isimo, nokuphelelwa yisikhathi. | Ukugunyazwa kwemakethe okuqondene nomkhiqizo noma ukufaneleka komtholampilo. |
| Ukumakwa kwe-CE / imibhalo ye-EU | Ubunikazi bedivayisi, ukuhlukaniswa, isimemezelo, umzimba owaziswa lapho kufanele, kanye nokufakwa kwe-MDR. | Ukugunyazwa ngaphandle kohlaka olusebenzayo lwase-Europe. |
| Ukubhaliswa/ukufakwa kuhlu kwe-FDA | Idatha yokusungulwa kwamanje neyokufakwa kuhlu kanye nomzila wokulawula osebenzayo wedivayisi. | Ukugunyazwa kwe-FDA, imvume, ukugunyazwa, noma ukuvumela okuzimele. |
| Umbiko wokuhlola | Ilebhu egunyaziwe lapho kufanele khona, ubunikazi besampula, indlela, indlela yokwamukela, idethi, kanye nomphumela. | Ukuthi yonke indawo yokukhiqiza iyafana nesampula ehloliwe. |
| Isitifiketi sokuhlaziya/sokuhambisana | Idatha eqondene nenqwaba, ukucaciswa, imiphumela, igunya lokukhipha, nezihlonzi ezilandelekayo. | Ukusebenza kwalo lonke uhlelo lwekhwalithi ngaphandle kwamarekhodi asekelayo. |
Yini Okufanele Uyihlole Ngesikhathi Sefekthri noma Ukuhlolwa Kwekhwalithi?
Ingozi inquma ukujula kocwaningo. Ithuluzi elijwayelekile elinobungozi obuncane lingahlolwa ngamadokhumenti, ukuhlolwa kwevidiyo ebukhoma, nokuhlolwa kwesampula. Isethi yethuluzi elisha elihambisana nokufakelwa, idivayisi eyinyumba, inqubo ebalulekile evela ngaphandle, noma uhlelo lwelebula yangasese yesikhathi eside ingase ithethelele ukuhlola okusendaweni kanye nokuqinisekisa okubanzi.
Ukucwaninga okuwusizo kulandela i-oda langempela noma inkatho ngokusebenzisa indawo. I-XC Medico ukulawulwa kwekhwalithi kanye nokuhlola konke kunikeza isibonelo sezindawo zenqubo abathengi abangacela ukuzibona.
| Indawo yokucwaninga | Ubufakazi bokucela | Isibonelo sombuzo |
|---|---|---|
| Izinto ezingenayo | Uhlu olugunyaziwe lwabahlinzeki, isitifiketi sempahla, ukuhlolwa okungenayo, namarekhodi okuvalelwa. | Ingxenye yezinto ezibonakalayo ihlotshaniswa kanjani nensimbi eqediwe? |
| Izilawuli zokukhiqiza | Iziyalezo zomsebenzi, amarekhodi omzila, izinqubo eziqinisekisiwe, ukufaneleka komsebenzisi, kanye nokuhlolwa okusacutshungulwa. | Ukuchezuka kutholwa futhi kuqukethwe kanjani? |
| Isilinganiso | Isimo sokulinganisa, indlela yokulinganisa, amandla egeji, namarekhodi okuhlola. | Ingabe ukubekezelelwa kwensimbi kungalinganiswa ngokwethembeka? |
| Umkhiqizo ongahambisani | Ukwehlukaniswa, igunya lokumisa, ukugunyazwa kokusebenza kabusha, namarekhodi ethrendi. | Ubani ongagunyaza ukuchezuka, futhi ingabe ikhasimende liyaziswa? |
| Shintsha ukulawula | Umlando wokubuyekeza, ukuhlolwa komthelela, ukuqinisekiswa, ukuqinisekiswa, kanye nesaziso sekhasimende. | Yiziphi izinguquko ezidinga imvume yomthengi ebhaliwe? |
| Ukulandeleka | Amarekhodi ezinombolo ze-serial, isihambi, ukulebula, ukupakishwa, nobufakazi bokukhululwa. | Ingabe inkatho eyodwa eqediwe ingalandelelwa kuzo zombili izinkomba? |
| Izikhalazo kanye CAPA | Amafayela ezikhalo, izindlela zembangela, ukuhlola ukusebenza kwe-CAPA, nemithetho yokwenyuka. | Kuhlonzwa futhi kuvinjwe kanjani ukwehluleka okuphindelelayo? |
Indlela Yokuqinisekisa Amasampula Ensimbi Yokuhlinza
Isampula epholishiwe ayanele. Dala isampula ebhaliwe yokugunyaza uhlelo olubonisa ukusetshenziswa okuhlosiwe kwethuluzi kanye nobungozi. Umkhiqizi nomthengi kufanele bavumelane ngemidwebo, ileveli yokubuyekeza, izindlela zokuhlola, indlela yokwamukela, ubuningi besampula, nokuthi amasampula agunyaziwe aba kanjani ochwepheshe bokukhiqiza.
- Ubunikazi: imodeli, ukubuyekezwa komdwebo, uhlangothi, usayizi, izimpawu, inkatho, nokucushwa kokupakisha.
- Ubukhulu nezixhumi ezibonakalayo: izilinganiso ezibucayi, izingxenye zokukhwelana, ukuhambelana kokufakelwa noma isikulufu, ukuphuma, ukuqondanisa, nokubekezelelana.
- Impahla nokuqedwa: ibanga, ubulukhuni, isimo esingaphezulu, ukumelana nokugqwala lapho kufanele khona, ukudlula, ukunamathela, nokuhlanzeka.
- Umsebenzi: ukubamba, ukubandakanyeka kwe-ratchet, ukuziphatha kokusika noma ukubhoboza, ukudluliswa kwetorque, ukukhiya, ukukhulula, nokuguga.
- Ukucutshungulwa kabusha: ukumelana nemijikelezo ehlosiwe yokuhlanza nokuvala inzalo, okuhlanganisa amalunga, ama-lumens, izimpawu, okokumboza, nezibambo.
- Ukupakishwa nokulebula: ukubala, ukuvikelwa, ukuhlonza, imiyalelo, ulimi, i-UDI noma idatha yenkatho lapho kufanele khona, nokuqina kwezokuthutha.
Ukuhlola ukuphinda: ngemva kokuvunywa kwesampula yegolide, hlola amasampuli asuka endaweni yokuqala yokukhiqiza usebenzisa indlela efanayo. Lokhu kusiza ukunquma ukuthi ingabe umenzi angakwazi yini ukukhiqiza kabusha umklamo ogunyaziwe esikalini.
Ukuhlola i-OEM kanye nekhono lensimbi yangokwezifiso
Ukwenza ngendlela oyifisayo kungasho ilogo kuthreyi ekhona, isibambo esilungisiwe, ithuluzi elizinikele lokufakelwa, noma idivayisi entsha ngokuphelele. Lawa maphrojekthi awanayo ingcuphe yokulawula noma yobunjiniyela. Ngaphambi kokwabelana ngemidwebo noma amasampula, chaza ubumfihlo, ubunikazi bokuklama, ukusetshenziswa okuvunyelwe kwempahla eqanjiwe engemuva, ubunikazi bamathuluzi, kanye nokufinyelela kumarekhodi okuqinisekisa.
Ukuze uthole ilebula yangasese noma uhlelo lwangokwezifiso, buyekeza olomkhiqizi amakhono we-OEM/ODM we-orthopedic bese ubuza ukuthi ubani umnikazi womsebenzi ngamunye wokulawula ukwakheka. Umhlinzeki onekhono kufanele ahumushe izidingo zomsebenzisi zibe izicaciso ezilawulwayo nezinguquko zedokhumenti—anganciki emilayezweni engakahleleki noma isampula elingagunyaziwe.
| Izinga lokwenza ngendlela oyifisayo | Ububanzi obujwayelekile | Kudingeka ukulawulwa okuncane |
|---|---|---|
| Ukubhrenda | Ilogo, amalebula, ikhathoni, izithombe zethreyi, nemiyalo. | Ukugunyazwa komsebenzi wobuciko, ukubuyekezwa kokulebula, ukulawulwa kokubuyekeza, nokuhlolwa kolimi lwemakethe. |
| Ukucushwa | Setha ukwakheka, isakhiwo sethreyi, osayizi, nobuningi. | Ibhili egunyaziwe yezinto zokwakha, ukubuyekezwa kokuhambisana, ukuqinisekiswa kokubala, nohlu lokupakisha. |
| Ukuguqulwa komkhiqizo | Ubukhulu, isibambo, isixhumi esibonakalayo, impahla, isiphetho, noma umsebenzi. | Ukuhlolwa kobungozi, ukugunyazwa komdwebo, ukuqinisekiswa, ukuqinisekiswa lapho kudingeka khona, nokulawula ushintsho. |
| Ukuthuthukiswa komkhiqizo omusha | Umqondo omusha noma isistimu yezinsimbi. | Izilawuli zedizayini ezisemthethweni, ukusebenziseka nokulawulwa kobungozi, isu lokulawula, ukuqinisekiswa, ukuqinisekiswa, nokudluliselwa kwedizayini. |
Ukupakisha, Setha Ukuphelela, kanye Nokuhambisana Nokuvalwa Kwenzalo
Amasethi wezinsimbi awaphumeleli ekusebenzeni lapho amathuluzi angawodwana engekho, ebhalwe ngokungeyikho, elimele ekuhambeni, engahambisani nokufakwayo, noma kunzima ukukhonjwa. Idinga uhlu lokupakisha olulawulwayo kanye nenani lokugcina elifaniswa nendawo yethreyi nesihlonzi sensimbi. Kuzinhlelo ezisebenziseka kabusha, hlola ukugeleza kwamanzi, ukomiswa, ukuqaqa, ukufinyelela kokuhlanza, isisindo, ukuvikelwa kwezingxenye ezibukhali, nokuhambisana nenqubo yokuvala inzalo ehlosiwe.
Uma isiqukathi esingasebenziseka kabusha esiqinile siyingxenye yesistimu, buyekeza okomkhiqizi izinketho zesitsha sokuvala inzalo kanye nendlela yokucubungula kabusha eqinisekisiwe yesikhungo sokunakekelwa kwempilo. Isiqukathi noma ithreyi akufanele kuthathwe ngokuthi iyahambisana ngoba nje amathuluzi alingana ngokomzimba ngaphakathi kwaso.
Linganisa Amandla, Ukulethwa, Isevisi, kanye Nezindleko Ziphelele
Ngemva kokuba izidingo zobuchwepheshe nezekhwalithi sezihlangatshezwane, qhathanisa nohlelo lwezohwebo. Cela umthamo ojwayelekile nophakeme, izithiyo zezinto ezingavuthiwe, inani elincane le-oda, isikhathi sokuhola sesampula, isikhathi sokuhola sokukhiqiza, imithetho yokubikezela, ama-Incoterms, imibhalo yokuthekelisa, indlela yokupakisha, kanye nenqubo yesaziso sokulibaziseka. Buyekeza okomphakeli imodeli ye-supply-chain ne-warehousing , bese uyihlola ngobufakazi njengedatha yakamuva yokulethwa ngesikhathi.
Izindleko eziphelele zobunikazi zihlanganisa okungaphezulu kakhulu kwentengo yeyunithi:
- ziqu, ukubhaliswa, ukucwaningwa kwamabhuku, ukuhlolwa, kanye nezindleko zokuqinisekisa;
- amathuluzi, umsebenzi wobuciko, ukupakisha, ukuvala inzalo, ukuthwala impahla, imisebenzi, kanye nempahla;
- amathuluzi alahlekile noma alimele, ukuthunyelwa okuphuthumayo okushintshwayo, kanye nokuphazamiseka kwenqubo;
- ukulungiseka, izingxenye ezisele, ukuseviswa, ukungafakwa kwewaranti, nokusingatha izikhalazo;
- izindleko kanye nengozi yokushintsha abahlinzeki uma ukusebenza kungamukeleki.
Ngaphambi kokugunyazwa, izikhathi zokuphendula idokhumenti, ubunikazi bezikhalazo, ukugunyazwa kokubuyisela, imibiko yophenyo, ukukhanda noma ukushintshwa kwemizila, kanye nokuxhumana okukhuphukayo. I-XC Medico ishicilela yamanje yayo emva kokuthengisa kanye nenqubo yewaranti yokubuyekezwa komthengi.
Isibonelo Ikhadi Lamaphuzu Lomkhiqizi Wensimbi Yokuhlinza
Faka amaphuzu umbandela ngamunye ukusuka ku-0 kuye ku-5, phindaphinda ngesisindo esiphakanyisiwe, bese urekhoda ubufakazi obubuyekeziwe. Misa amasango okuphasiswa okuphoqelekile/okufeyila ezimfuneko zomthetho nezokulawula ukuze amaphuzu aphezulu okuhweba angakwazi ukunxephezela ngokuphuthelwa ukuthobela imithetho.
| Indawo yokuhlola | obuphakanyisiweyo | lobufakazi | Isango lephasi |
|---|---|---|---|
| Ubunikazi obusemthethweni kanye nesimo sokulawula | 15% | Imininingwane yebhizinisi, ukugunyazwa kwemakethe, ukufakwa kuhlu kwedivayisi noma imvume njengoba kusebenza. | Impoqo |
| Uhlelo lokuphatha ikhwalithi | 15% | I-ISO 13485 ububanzi/isimo, imiphumela yocwaningo, izinqubo, amarekhodi. | Impoqo |
| Amandla obuchwepheshe nawokukhiqiza | 20% | Izisetshenziswa, izinqubo, ukuqinisekiswa, opharetha, izilawuli zenqubo ephuma ngaphandle. | Kuyisibopho sobubanzi |
| Ikhwalithi yesampula nokusebenza | 20% | Umbiko wokuhlola, ukuhlolwa kokusebenza, ukuhambisana, ukuhlola ukucutshungulwa kabusha. | Impoqo |
| Ukulandeleka nokulawula ushintsho | 10% | Umsebenzi wokulandela umkhondo omningi, ukubuyekezwa kwamadokhumenti, isivumelwano sesaziso sekhasimende. | Impoqo |
| Ukudiliva nokuqhubeka nokuhlinzeka | 10% | Amandla, isikhathi sokuhola, umlando wokulethwa, isitokwe sokuphepha, uhlelo lwezimo eziphuthumayo. | Umkhawulo |
| Isevisi nokusekelwa komjikelezo wempilo | 5% | Inqubo yesikhalazo/CAPA, iwaranti, ukulungisa, izingxenye ezisele, ukukhuphuka. | Umkhawulo |
| Izindleko eziphelele nemibandela yezohwebo | 5% | Izindleko zokufika, i-MOQ, inkokhelo, ubunikazi bamathuluzi, ukukhishwa kwewaranti. | Umkhawulo |
Gcina ikhadi lamaphuzu eligcwalisiwe efayeleni lomhlinzeki, khomba izenzo ezivulekile nabanikazi, futhi usethe isikhawu sokuhlola kabusha ngokusekelwe engcupheni nokusebenza. Gada amaphutha angenayo, izikhalazo, izenzo zokulungisa, ukulethwa, ukuphendula, nezinguquko ezingagunyaziwe ngemva kokugunyazwa.
Common Supplier Red Flags
Hlola I-XC Medico's Manufacturing Scope
Lezi zinsiza zangaphakathi zingasekela ukubuyekezwa kwekhono elihlelekile. Abathengi kusafanele baqinisekise amadokhumenti nokufaneleka komkhiqizo ezimakethe zabo kanye nokusetshenziswa okuhlosiwe.
imibuzo ejwayelekile ukubuzwa
Isiphi isitifiketi esibaluleke kakhulu somkhiqizi wezinsimbi zokuhlinza?
Asikho isitifiketi esisodwa samazwe ngamazwe esigunyaza wonke umkhiqizi nomkhiqizo. I-ISO 13485 iyindinganiso yekhwalithi yedivayisi yezokwelapha ebalulekile, kodwa abathengi kufanele futhi baqinisekise izimfuneko zokulawula eziqondene nomkhiqizo wemakethe yendawo kanye nobubanzi besitifiketi nobuqiniso.
Ingabe ukubhaliswa kwe-FDA kusho ukuthi ithuluzi lokuhlinza ligunyazwe yi-FDA?
Cha. Ukubhaliswa kwesikhungo se-FDA nokufakwa kuhlu kwedivayisi akusho ukuthi indawo noma idivayisi igunyaziwe, isuliwe, noma igunyaziwe. Qinisekisa ukuhlukaniswa kwedivayisi okunembile kanye nomzila osebenzayo wokulawula we-FDA.
Ingabe umthengi kufanele ngaso sonke isikhathi enze ucwaningo lwefekthri esizeni?
Hhayi njalo. Ukujula kocwaningo kufanele kusekelwe engozini. Ukubuyekezwa kwedokhumenti, ukuhlolwa kwevidiyo ebukhoma, amasampula, nobufakazi benkampani yangaphandle kungase kwanele ekuthengeni okuthile okunengcuphe ephansi. Ubungozi obuphezulu, obunyumba, owenziwe ngokwezifiso, obubucayi, noma izinhlelo zesikhathi eside zokunikeza zingase zisekele ukuhlolwa kwamabhuku esizeni.
Mangaki amasampuli okufanele ahlolwe?
Ubuningi buncike engcupheni yedivayisi, ukwahluka, indlela yokuhlola, nosayizi we-oda. Linganisa amayunithi anele ukuze uhlole ubukhulu obubalulekile nomsebenzi, bese uqinisekisa ukuphindaphinda futhi usebenzisa indawo yokuqala yokukhiqiza.
Ingabe amathuluzi okuhlinza angenziwa ngokwezifiso ngelebula yangasese?
Yebo, kodwa ukufaka uphawu, ukumiswa kwesethi, ukuguqulwa komkhiqizo, nokuthuthukiswa komkhiqizo omusha kudinga amazinga ahlukene okubhalwa kwemibhalo nokulawula ukulawula. Chaza ubunikazi bomklamo, ukuqinisekiswa, isibopho sokulebula, ukulawula ushintsho, nokugunyazwa kwemakethe ngaphambi kokuqala.
Umkhiqizi ogunyaziwe kufanele aphinde ahlolwe kangaki?
Setha isikhawu ngokuya ngengozi kanye nokusebenza kwangempela. Amaphutha, izikhalazo, ukwehluleka ukulethwa, izinguquko ezinkulu, izinguquko zesitifiketi, noma izinkinga zesenzo sokulungisa zingase ziqalise ukubuyekezwa kwangaphambilini noma ukuhlolwa.
Isiphetho
Ukuhlolwa komkhiqizi okusebenzayo kuguqula izimangalo zokumaketha zibe ubufakazi obuhlosiwe. Chaza izimfuneko, qinisekisa imininingwane yezomthetho nemithetho, landelela inkatho yangempela, amasampula okuhlola ngokumelene nemibandela egunyaziwe, futhi uhlole izilawuli ezigcina ukukhiqizwa kwesikhathi esizayo kungashintshi. Ikhadi lamaphuzu elibhaliwe lenza izinqumo zabahlinzeki zibe lula ukuvikela futhi linikeze isisekelo sokuqapha ukusebenza okuqhubekayo.
Izithenjwa ezigunyaziwe
- Inhlangano Yamazwe Ngamazwe Yokumisa: ISO 13485—Izinhlelo zokuphatha ikhwalithi yamadivayisi ezokwelapha.
- I-US FDA: Ukubhaliswa kwe-FDA kuqhathaniswa nokugunyazwa kwedivayisi, imvume, noma ukugunyazwa.
- I-US FDA: Ifundwa kanjani futhi imakethwe insiza yezokwelapha.
- I-European Commission: Imithetho yemishini yezokwelapha nezibopho zomkhiqizi.
