Intshayelelo:
Kwicandelo lezonyango,Izirinjisi ezinokuchithekaDlala indima ebalulekileyo ekuphathweni kwamayeza kunye nezitofu zokugonya, ukuqinisekisa ukhuseleko kunye nentlalo-ntle yezigulana kunye neengcali zempilo ngokufanayo. Ndikunye neChina ukuba ngumdlali ophambili kwishishini lemveliso yehlabathi, ukufumana efanelekileyoUmvelisi wesirinji we-Siringe kunye nomthengisiinokuba ngumsebenzi otyhafisayo. Eli nqaku lijolise ekukhokeleni ngenkqubo yokukhetha iqabane elithembekileyo kwaye iqaqambe iQela leQela leQela leShanghai njengomthengisi onamava kunye nonokwazi ukudimazeka.
I-1. Uphando kunye nokujonga ngasemva:
Ngaphambi kokuba isebenzisane naye nawuphi na umvelisi wesirinji okanye umthengisi, uphando oluchanekileyo lubalulekile. Qala ngokudala uluhlu lweenkampani ezinokubakho kwaye uqokelele ulwazi malunga nodumo lwabo, amava, iziqinisekiso, kunye nomgangatho wemveliso. Amaqonga ekwi-Intanethi, iibrowudi zorhwebo, kunye nemibutho yoMveliso zinokuba zizibonelelo ezixabisekileyo zokuchonga amaqabane anokubakho. Nika ingqalelo ngokukodwa kuphononongo lwabathengi kunye nobungqina bokulinganisa ukuthembeka kwabo.
2. Umgangatho kunye neziqinisekiso:
Isiqinisekiso somgangatho sibaluleke kakhulu xa ujongene nezinto zonyango. Qinisekisa ukuba umenzi ulandela ukuba imigangatho yamazwe aphesheya kwaye ibeka iziqinisekiso ezinjengeSO 13485: 2016, ebonisa ukuthotyelwa kweenkqubo zolawulo olufanelekileyo kwizixhobo zolawulo. Jonga iziqinisekiso ezivela kubasemagunyeni abalawulayo njengeendawo zokutya zase-US kunye nolawulo lweziyobisi (i-FDA) okanye i-Europer yaseYurophu (CE) Marko.
I-3. Uluhlu lwemveliso kunye nokukhetha ngokweziko:
Vavanya imveliso yemveliso yomenzi ukuqinisekisa ukuba iyongqinelana neemfuno zakho ezithile. Umthengisi obonelela ngoluhlu olwahluka lwezigidikazi ezilahliweyo kunye neemveliso ezinxulumene nazo zinokubakho ngakumbi ekuhlangabezeni iimfuno zakho. Ukongeza, buza malunga nokukwazi kwabo ukubonelela ngeendlela zokhetho, njengoko oku kunokuba luncedo xa unemigaqo eyahlukileyo.
I-4. Iindawo zokuvelisa kunye nomthamo:
Umthamo wemveliso ongumenzi ubalulekile, ngakumbi ukuba ufuna isixa esikhulu semidlalo. Buza ngezixhobo zabo zokwenza, iinkqubo zemveliso, kunye netekhnoloji abayiquqelayo. Ubukho bamaziko anamhlanje kwaye ogcinwe kakuhle babonisa ukuzibophelela kumgangatho kunye nokusebenza kakuhle.
5. Ukuthobela umthetho kunye nokhuseleko:
Ukubambelela ngokungqongqo kwimigangatho yokhuseleko kubalulekile xa ujongene nezixhobo zonyango. Qinisekisa ukuba umenzi uyahambelana nayo yonke imimiselo efanelekileyo neyamanye amazwe. Cela amaxwebhu anxulumene novavanyo lwemveliso, iinkqubo zokwenza intsholongwane, kunye nokwakhiwa kwezixhobo ukuqinisekisa ukhuseleko kunye nokuthembeka kweesirinjisi ezilahlekileyo.
6. Amaxabiso kunye neMeko yokuhlawula:
Ngelixa iindleko yinto ebalulekileyo, akufuneki ibe yeyona nto ibalulekileyo ekukhetheni umthengisi. Ixabiso eliphantsi kakhulu linokubonisa umgangatho ophathekayo. Cela ulwazi oluneenkcukacha kwaye uthelekisa nabanye abathengisi kwintengiso. Kananjalo, ukucacisa amagama entlawulo, njengentlawulo yokuqala, intlawulo yeMisestone, kunye nemali eseleyo ngenxa yokuhanjiswa.
7. Unxibelelwano nenkxaso:
Unxibelelwano olusebenzayo nomenzi wesirile onyuliweyo ubalulekile ukuze uphumelele. Vavanya ukuphendula kwabo kwimibuzo kunye nokukwazi kwabo ukubonelela ngolwazi olucacileyo nolumfutshane. Umthengisi onokuthenjwa uya kuba nenkxaso yabathengi abaphendulayo ukulungisa nayiphi na inkxalabo ngokukhawuleza.
I-8. Ubonelelo kunye nexesha lokuhambisa:
Vavanya i-chain yoncedo lomelo kunye nezakhono zezinto. I-chain yokuhambisa kakuhle inokunceda ukunqanda ukulibaziseka kwaye uqinisekise ekunikezelweni ngexesha elifanelekileyo. Xoxa ngamaxesha okuhambisa kwaye uqwalasele izinto ezinje ngokwenza iinketho zokuhambisa kunye nemigaqo yesiko, ngakumbi ukuba u-odola phesheya.
Iqela leQela leShanghai: Umthengisi othembekileyo nonamava:
Phakathi kwabavelisi abahlukeneyo besirinji kunye nabathengisi eChina, iQela leQela leQela leShanghai limi ngaphandle kweqabane elinokuthenjwa nelinamava. Ngerekhodi eqatha yokuhambisa iimveliso zezonyango ezisemgangathweni, baye baqonda kwaye bethembele kwishishini.
IQumrhu leQela leShanghai yaziwa ngokuzibophelela kwayo kwimigangatho yemveliso kunye nokuthobela imigangatho yamazwe. Izithole zabo ezilahlayo zisebenzisa uvavanyo olungqongqo kunye neenkqubo zokucoca i-sterilic yokuqinisekisa ukhuseleko kunye nokuthembeka. Inkampani iphethe i-ISO 13485: 2016 iSiqinisekiso sangokuzinikezela kwabo ekugcineni imigangatho ephezulu kwinkqubo yokuphuhlisa.
Ngaphaya koko, uluhlu lwabo lweemveliso zabo zesirinji lokuhla kwezalathiso kwiimfuno ezahlukeneyo zonyango, kwaye banikezela ngeendlela zokwenza ngokweziko ukuhlangabezana neemfuno ezithile. Nokuba ufuna amasingiso kunyango ngokubanzi okanye izicelo ezizodwa, iQumrhu Iqela leqela linokuhambisa iimveliso ezifanelekileyo.
ISIQINISEKISO:
Ukukhetha i-Syringer efanelekileyo yokulahlwa kunye nomthengisi e-China kufuna ukuqwalaselwa ngononophelo kunye nophando olucokisekileyo. Ibeka phambili umgangatho wemveliso, iziqinisekiso, ukuthotyelwa kolawulo kunye nonxibelelwano xa kuvavanywa amaqabane anokubakho. I-shangstai yeqela leqela lomsebenzi onokuthenjwa kwaye onamava wokudibanisa okulahlwayo libenza babe lukhetho olufanelekileyo kwabo bafuna iqabane elinokuthenjwa kwishishini lezonyango. Ngokulandela izikhokelo ezichazwe kweli nqaku, unokwenza isigqibo esiwazizisayo kwaye useke intsebenziswano ephumeleleyo nenganyamezeliyo.
I-Post Time: Aug-01-2023