Amaduli Ekhwalithi Kukukhetha Umphathi Wemfundo Ye-OEM Yeziboneleli ze-Orthopedic

Ukukhetha umphathi waseko we-orthopedic ophumelelayo uyaphawula esinye kwezinqumo ezibalulekile kakhulu ephakamiselwa ngamakhampini ezigaba zemedical, izihlalisi zezokwelapha, nezokwelapha zezixhobo zokuphakanyiswa. Izimo zokhangelwa ezibophelela kulolu daba ziyaphatha ngqo ekuphatsheleni kwempilo yomthwali, ukulandela izimvo, nokhulekwa kwezimali ngeminyaka. Ukwenza kwe-orthopedic kamanje kudinga ukulungiselela ngokucophele, ubufakazi bezimboni ezihle, nokulandela izimo ezihlakaniphile zangempela ezenzulwini ezingaqinisekisa ukuthi wonke umphathi, isixhobo, noma isixhobo siyafaka izimo ezihle kakhulu zezokwelapha.

Umongo wendawo yesilisa sendawo yokugcinwa kwezulu kusebenza ngaphansi kwemikhatshana engcono engcono, lapho izinkampani zokwakha kumele zibonise izinhlelo ezigcwele zokuphatha ubunzima, amathuba okhuthazayo wezobuchwepheshe, nokuthandana okungahlolwa komphathi wethemba lwabesifazane. Ukuqonda izimo ezibalulekile zokubaluleka eziyisisekelo sezinhlelo ezihle zokwakha kuvumela izinsiza zokwenza izinqumo ezizenzakalelayo eziphulaphula abantu ngelokhu kuthuthukisa ukuzalisa izinhlotshwa nezindlela zokuthengisa ezinhle.

Ukuxhomekeka Kwemikhatshana Nezimo Zezimali

ISO 13485 Inqanawa Yemfundo Yophando Lwesixhobo Sokubophephela

Ukusemo kwebandla lobunzima obugcwele bokwakha okubalulekile kuyisakhelo se-ISO 13485, esibekela izinhlelo zokuphatha ubunzima ezijwayele ngokukhethekile ekwakheni izixhumanisi zezokulungisa. Leli simiso siphatha ukuthi abakhi bezifundo eziphathelene nokukhula, ukuphatha izimono, imithetho yokulungisa nokulunga kwangaphambilini, nezindlela zokuthuthukisa ngokuphambene. Abakhi basebenzise amagama akhona ngezikhathi ezihlanu, abeke amafayela abalulekile nokuphatha izimiso eziphathelene nokushintjiswa okuhle kakhulu ukuze kube khona ubunzima obuphathelene.

Ngaphandle kwezidingo zokutholiwa kakhulu, abayikreleli base izinhlelo zokulima eziphephile bafaka imali kumakhemikhali wokuphatha ubunzima obungcono, kufakwa kwiindlela zokuphatha izimo ezihlanganisa, ukubuka ngqo kanye nokuzinza okuphakanyisiwe okuchaza amaphutha azinzileyo ngaphambi kokuba akuhlobane nezimali. Lezi ndlela zenzakalo yokuphatha ubunzima zibonisa ukuthembeka kakhulu kwababhili kakhulu futhi kusizenzele konke okwenzekayo ekugcineni kakhulu kanye nokuba yisiphi isimo esifanayo.

Umrhuli wokubhalisa kweFDA kanye NjengoRahma Lokuvikeleka

Abakhiqizi abasebenzisa ikhasimende leZiyunithi kumele bahlale bakhalekile kwi-FDA baze bakhombise ukuqonda okuphelele kwezimfuno zokulawula iqhaza lezimali ngaphansi kwe-21 CFR Part 820. Le ndlela yekhono ikhuluma ngokulawula kwebangeniso, imithetho yokwakha, izenzo zokulungisa, nezibalo zokulawula emva kokuthengwa okuyindlela ekhuluma ngokuphelele kwebuciko nokusebenza kwezinto ngokuphelele kwezinsuku zazo. Abakhiqizi abakhiwe kumele bahlale bakhalekile kumfanekiso wokudokolola, bakhusele izinyathelo ezibophaziywayo zokulawula izinguquko, baze bakhombise ukulawulwa okuphumelela ngokuphinde phinde ngokomlando kwebenguqulo kanye nezimchakacha zokuphatha.

Ubukhulu bekufakwa kwezimpendulo ze-FDA kudinga abakhi besivumelwano onemfuneko yokuphatha izimpendulo, okunempilo yezimpendulo, izimpendulo ezibonakalayo kumelwane wokuphatha, nokutholakala kwemvume yezinto. Abakhi abathuthela imfundo kumsebenzi wokuphatha izimpendulo bafana nesekela esibalulekile ngemva yokuthutha izinto, bafana nesekela ngemfundo yokuphatha, ukulungiselela ukuthunyelwa, nokusebenza emva kokuthengwa okuthulasela isikhathi sokuthengwa nokunciphisa izinkinga zokuphatha.

Ukulinganisa Kwezinhlobo ZaseNtshonalanga

Ukudilivula kwezixhobo zokulungisa izifo ze-joint kwizulu kufuna abaphathi bokwakha abazifundisa nokuhlakanipha nezimpendulo eziphathelene nendlela, kubandakanywa i-Medical Device Regulation yase-Eropi, imithetho yeHealth Canada, namathuba aphumlayo ezigaba se-Asia-Pacific. Abaphathi abahlukileyo banezibopho ezimbini, bakhombisa ubuqhubekayo bezempilo kwemfundo ephathelene nabanye, baze benzekeke inkxalabo ekuphileni kumathuba aphumlayo ngokuthuthela izixhobo ngaphandle kokutshintsha ubume bomthetho.

Ukuvumelanisa kwezimpendulo eziphathelene nazibuso kwenza amathuba abaphathi abawenzi abanamandla ekuhlakanipha ngokomoya, bamenyezelana ngendlela epholile ukuya kumathuba amabini ngokuthi abaphathi basebenzisa indlela eyodwa yokwakha. Le mithetho ephathelene ngokomoya iyanciphisa ubuchwepheshe, ibe yincinane imali yokuhlakanipha, yaye yenzekeke isikhathi sokunyuka kumathuba aphumlayo abaphathelene nabanye abafuna ukuba baziwa kumathuba azibuso.

Ukwenza Teknoloji kanye Nokuzinika Kwemisebenzi

Amahlelo entuthukiseni kwezimo zokusebenza

Ukwenza kwamanje kwezinhlelo zokulungisa izono kudinga imikhuba eminingi yokusebenzisa teknoloji, kufaka phakathi ukugcina kwe-computer numerical control, ukwakha okungezansi, izimo zokuhlakanipha, nezindlela zokudala okuhle. Abasebenzisi abaheadla bakhokhela kabongo kuze kube khona i-equipment ephumelelayo, izinhlelo zokuphatha ubunzima ngokuzenzakalelayo, nezindlela ezintsha zokwakha ezingeniso ubunzima bempilo ngenkathi baphula izindleko zokwakha. Ukudibanisa teknoloji ye-Industry 4.0, kufaka phakathi izihlwa ze-Internet of Things, ubuchule obukhethiwe, nezimiso ze-machine learning, kuvumela ukulungiswa kwezindlela ngexesha elilodwa nokuthuthela izinqumo eziphathekayo ezigcine ubunzima besivumelwano.

Ukwenza kahle kusaphila ngaphezu kweziko lokusebenza ukufaka phakathi ukuthiweka kwezindlela, inkontrola ekusetshenziswa kakhulu yezindlela, nezindlela zokuthuthukisa ngokuphambene okuthuthukisa ubunzima nokuthuthukisa kakhulu kwezinto ezitholakala. Abakhi kahle banikela indlela abakhona ngayo ngokusho kwemibhalo etholakele, ukubuyiselwa kwegunya, nokuthuthukisa izimali ezigcinwa kuzinkinga futhi zihlanze intando yokudala futhi zibanze imizwa yabantu.

Ubuciko bezimodi nezobuchwepheshe

Ukukhetha nokusebenzisa imithombo yomlando kumisebenzi wokugaya kudinga ukufunda okuningi ngokuthi kuyaphilile, amathuba wasekhanda, nezimfundo zokusebenza ngokudala. Abayikreleli abagqamile bahlala nabakhubazi bezimali ebalulekile, izidingo zokuxhasana nezimali ezibekiwe, nezinyathelo eziphathelene nokulandela izimali kuwo wonke umsebenzi. Izindlela ezininzi zokuchazwa kwemithombo, kungenxa yokuchaza isivinini, ukuchazwa kwesihlangothi, nokulinganisa kokuthi kuyaphilile, kusidla ngokuthi bonke amakamponi ayethulwa kizindalo eziningi zezimali ezigcinwe ngokushesha.

Ukuvutha kwezinhlelo kusayensi yomthelela kuthuthukisa ukusebenza kwesithwala, imiphumela yomndeni, nokusebenza kahle kwesibhedele. Abayikhi bezinsizwa bazibambana nabasebenzisi bomthelela, izinkolobo zokufunda, nezinqubomgomo zokugcina ukuthuthukisa izinhlelo ezihle kanye nezimfashanyawo zokuhlanganisa ezingcono, zokuthula izinkinga, nokuthuthukisa ukuthuthukisa kwezibhedele ngokudala. Lezi zinhlalo zokubamba kubonisa ukuthi abayikhi bayethemba ekuthuthukiseni isayensi yezibhedele kanye nokuthuthukisa ukugcina komndeni ngokuvutha kwezobuchwepheshe.

Ukuphatha kwezinto nokuthathela Amasiko

Amathemu akhulu okulawula ubunzima awuyisikhathi esigcwele sokukhokha izinto evela kuzo, ukubheka phakathi kwesikhathi, ukuchaza isiphumo sakugcina, nokuthi inkulumo ihlaziywa ukuze kuthintelwe ukuthi zonke izixhobo zifihla izidingo ezitholakalayo. Amathemu amehlo ekuxhasa awuyisahluko ngaphandle kwebala, ukulinganisa inani lokomfanekiso, ukubheka indlela yokusebenza, ukulinganisa indlela efudumele, nokuhlaziywa kakhulu ukuthi kuhlaziywe ngempela futhi kuqinisekisiwe ukuthi iprodukthi ihlakaniphelela nokusebenza kahle. Ababhengezi abanelungelo bethembeka kumashine ebhekene nokuchazwa, iyalaborithori enezimali, nezimali zakampani eziphathelene nokulawula ubunzima abazenzela ukugcina amabhuku angcono nokunikezela imininingwane yonke engxoxweni ngobunzima.

Ukuqaliswa kwezindlela zokulawula izinqubo zezibalo kwenza abakhiqizi bakwazi ukuqapha ukusebenza kwenqubo, ukukhomba izitayela, nokusebenzisa izinyathelo zokulungisa ngaphambi kokuba izinkinga zekhwalithi zithinte ukulethwa komkhiqizo. Lezi zindlela zokuphatha ikhwalithi eziqalayo zibonisa ukuzibophezela komkhiqizi ekwenzeni kahle futhi zinikeza amakhasimende ukuzethemba ngokuvumelana komkhiqizo nokwethenjelwa kulo lonke uchungechunge lokuphakelayo.

Ukuphathwa Kwezokuphakelayo Nokunciphisa Izingozi

Ukufaneleka Nokuphathwa Kwabahlinzeki

Ukuphatha kahle kwe-inthanethi yokunikezela kusisa ngamathuluzi okukhethwa kwegcine akubaluleki kakhulu, ukulungiselela imbono yezimali, ukuqinisekisa izimo zokulawula, isimo esiqinile sokufakwa, nokutholakala kwesikhathi eside. Ababhali ababili bahlakaniphaya izibonelo ezithuthukisiweyo, baphatha izinyathelo ephinde-phindwayo yokuhlola, bavela izimvo eziyisisekelo eziqinisekisa ubomi bomlando, ukulethelwa kwezinto, nokuthuthukiswa phambili. Ukudala kwebandla eliqhubekayo libandla abafundi abaningi, bafinyelela izici ezilungile, bafinyelela izinkundla ezintsha, bahlale beziziphatheka njengoba bahlala bezifakela izinto ngenhla futhi bahlale bezinikezela ngendlela efanelekile.

Izinqumo zokuphepha okungcono kufundiswa ukuthi kuneziphumano zomnuni, ukuphatha izinombolo ngendlela efanele, nokwakha izinqumo ezifake inhlaka engaphandle kokulungele. Abafana abanamandla okuphatha umbuthano bempahla ngendlela ephathelene njalo bathola konke okudingekayo ukuze bangconothe abathengi ngokuthatha iqiniso lokulethwa nokubhubha kwempahla ngemva kokuguquka komthombo wempahla.

Izinketho Zokulandelela Nezibonelo

Imithombo engcono kakhulu ivumela izakhamuzi ukulandela izinto, iingcinga, nezakhiwo ezigqityiweyo ngokupheleleyo kwinqobo yokwakha, ekunika iifayili ezibalulekileyo ukuziphilisa kwiindlela ezivumelana nokuphulaphula kwaye noklanywa emva kokuthengwa. Iinkqubo ezininzi zokuphatha izindlela zokuthengisa zihlanganisa idatha yokhangelelwa, iimfazwe yokwakha, kwaye inxalenye yesupply chain ukunika umbuzo onke wokwakha kwaye ukunika impilo kakhulu kwiingcinga zokhangelelwa okanye iingxaki zokuziphilisa. Iizakhamuzi ezinezinkalo eziphucukileyo zibandakanya iinkcazelo ezityhileyo zezigidi, zinikele amandla okubhalisa, kwaye zinikele iifayili ezibonakalayo ezinokunciphisa iingcinga zabasebenzisi kwaye ukuziphilisa kwiindlela ezivumelana.

Ukuthunyelwa kwezinhlelo zedijithali, kufana nokuthunyelwa kwebhulokheni, ukuchazwa kwegalvini yesikhu, nezinhlelo zokuphatha idatha ezisebenzisa ikhodi, kuyakhula amandla okulandelela ngendlela futhi kuyabuyekeza ubumbane bezimali nezimali. Lezi zinhlelo eziphuculiwe zokudokolozela zibonisa ukuthembeka kwesivumelwano sokuthengisa futhi kubize izinkampani ngebhizinisi enkulu ngemfundo yezinhlelo zokwakha kanye nezigaba zebhizinisi.

Ukuplanisha Ukuphila Kwesivikeli

Ukuplaniswa kwezimali ephathelene nokuhlola imingcindezi, izibuko zokuphendula ngokushesha, nezindlela zokubuyisa ukuqina okuhle kumisebenzi ngemvula yezulu, ukungcono kwegunyazana, noma izinyathelo ezimbi zokusebenza. Abamakhemikali abahambili bahlala banalo indawo eyodwa yokwakha, bazamele isistimu esigcwele sokugcina, nabeka amathuluzi akhuluma ngokucacileyo abomvu ukukhula kwesimo sokusebenza kwabasebenzisi ngemva kwezigaba. Ukuthuthuka kwebuciko obudide buhlinza ukuthembeka kwabamakhemikali ekuthuthukweni kwebandla elidide futhi kunciphise konke okujwayelekayo kuqiniso lwesikhwama sangaphandle.

Ukuthuthuka kwezimali ekuphileni kwemisebenzi kufaka phakathi ukubuyisela indawo, izinhlelo zokugcina iminikelo, nokuthuthukiswa okuphakanyisiwe kuncedo lokusebenza ngokushesha emva kokuchithwa okungalindelekile. Lezi zindlela zokusimulula zibonisa ubomi bomthombo futhi zinikeza ukuphepha okubalulekile abaseshameni abadlala isikhathi esiqophelelayo sokunika izinto ezifanelekileyo kumaphrojekthi akhethekileyo.

Ukuvutha kanye Nokuthuthuka Kwemfundo

Ubungako Kukudala Kanye Nokulungisa

Abasebenzisi abakhulu basezintambo basebenzisa izinkundla ezijwayelekile zokudala nokulungisa okuthuthukisa ukuthuthukisa izinhlelo zokuthuthukisa izinhlelo kusuka kumkhiqizo kuya kumkhiqizo ohlelwe. Lezi zinkundla kufaka phakathi ukudala ngosilimi sezixhumanisi, ukuchazwa kwezilinganiso, ukudala ngokushesha, nezinkundla zokuchaza izinhlelo ezingcwele ngokushesha izikhathi zokuthuthukisa izinhlelo, ngelokho kuhlinzeka ukulungiswa kwezimali nezinhlelo zokugcinwa kwezintambo. Ukuthuthuka kwezinhlelo ezihle, ukuthula kwezimali, nokunciphisa isikhathi kuya kumkhiqizo wezinhlelo ezintsha zezintambo kuyenzeka ngokuthuthuka kwezinhlelo ezihle, izinkundla zokuchazwa, nezixhobo zokuchazwa.

Ukusebenzisana nozingcinza zokugcina izifo, izihlalo zokwabiwa, nezokuthuthukisa izinto zokusebenza kuyakhula iminikelo yokudizayina bese kuyaqinisa ukuthi izimboni ezintsha ziphulaphakala izidingo eziphatha ngokuzithembela kwizifo zokugcina izifo nasekuveliseni izinto ezisha zezibonakude zokugcina izifo. Lezi zinxenye zokusebenzisana zibonisa ukuthembeka kwegcabani ekuthuthukiseni futhi kuvulela abathengi ukufinyelela kutechnologies ezigcwele kanye nezewokwaziya okungcono okuphucuntisana ukuqeqesha kwezimali kanye nezimo zomthwalo.

Inkxaso Yekhono Lokubaluleka

Inkambo ephelele yokukhuthaza ulwazi olungethelwano kufaka phakathi inkolo yophawu lwezimali, inkambo yokuphatha idatha, inqubano yokuxhumana nokunikezela izimpendulo, nezindlela zokulandela emva kokuthengwa okubonisa ukusafekile kanye nokusebenza kwezinto. Abasebenzisi abakhulu bahlala banezithembiso ngabahlinzeki bezempilo, abahloli beziphiqo, nabakhungo bezempilo abathuthukisa ukusebenzisa iziphawu zempilo futhi bathole imininingwane engcono mayelana nesimo sezimpahla kanye nezidingo zomkhakha. Ukudibanisa izinkambo zempilo nezobuchwepheshe kwenza ukuthi kube khona isimo sokushisa ukuthuthukisa izinto kanye nokapheleka kwizimo zempilo.

Ukuthuthela kwezimali kumfundiso wokulungisa kwezokwelapha kubonisa ukuthembekile kwegciniwe kwezobuchwepheshe kanye nokunikezela abathengi inkxaso eyamkelekile ekuboniseni iqiniso lezinto kanye nokwamkelwa kwemercati. Lezinkundla zonke zokufunda zinika amakhemikhali amandla okunikezela idatha ephathelene nokuthile kwezokwelapha ngelinye kanye nokuthuthela inkxaso kumphumela wabathengi ngokuthi kubonise iqiniso lezinto kanye nokuthuthela idatha yokufunda.

Ukuphatha Kwemali Yenkcubeko

Ukuphatha kahle umthombo wokwakha kusungula izinto ezintsha zomniki, ngelinye ihlathi likwaqasha ukuthi abafumene amandla okwakha izinto ezintsha ezenza ukuthi inkampani ibe yinxalenye yezimchakacha. Abafumene abahlukene bakhumbula izinqumo ezibonakalayo, baphatha izibopho eziphathelene nokugcina isici, futhi babeka izimo eziphathelene nomthombo wokwakha okwenzela ukuthi izinto zomniki zilindelwe ngenkathi kuchitha ukuxhumana kwizinto ezintsha. Ukudala izinhlelo zokufaka, izimboni ezinzulu, nezinhlelo ezintsha zokuhlaza kwenza ukuthi abafumene basebenzise amandla akhona okwakha izinto ezintsha okunakekela abaqashi bezifazi nabazali.

Ukusebenza kuhlanganweni kwezimali ezivalekileyo kuvikela ukuthi abayimfundi nebazalwane bahlukanise izinkinga nezimpumelelo ephathelene nokuvutha izinto, ngelinye igunya likhuphuke ngokuthuthana kwezimali zokuthuthana. Lezi zihlukanweni zibonisa ukuthembeka kwezimali kumlando ophakade wokuphila kwezihlukanweni, futhi kubonelela abazalwane ngokufinyelela kuzo zonke izimali ezisha nezibophelelela okuphucula indlela abazalwane abaphathelana ngayo nokuphumelela kwabo.

Inkhandleko Yabazalwane Nenhlaka Yomphakathi

Inkxokolo Yentekithela Nokuxhumanisa

Ukuthuthukisa okuphambili kwezobuchwepheshe kufaka phakathi inqaku yokulungiselela, ukuthuthukisa kokwenza, inqaku yekhono, nokuxhumana ngemiphumela yokuthengwa okusinika umphumela wokuphila kwesinqumo. Abahlinzeki abakhulu bahlala baneqembu lezingenje ezinezinsizakalo, abalinganiswa ngekhono, nabakhonzi bezobuchwepheshe ababonisela ukuthuthukisa okuphathelene nokuthuthukisa isinqumo, ukuthuthukisa indlela yokwenza, nokuzimisela ekukhethweni kwezobuchwepheshe. Ubukhona bekugciniwe kwezigaba zokuphatha, amagugu ethamsanqa, namakholomo ethamsanqa akunye asibonisa ukuthembeka kwegaziwe ukuphila komgcini wezigaba nokuzimisela ekugcineni izigaba.

Ukuthuthuka kwezigaba zokuxhumana kufaka phakathi amabhroshele amafundisa, amadokhumenti ethamsanqa, neziphatha zedijithali zokxhumana okunikeza inkathi yokuxhumana nokuthintana kwezobuchwepheshe. Le zinkathi eziphambili zikusiza abagcini ukusebenzisa ubungako bezigaba zokuthuthukisa ngexabiso lokucophelela kuzo zodwa futhi nokuzimisela kuzo.

Ukuxhumana Ngezinkinga Nezobuchwepheshe

Ukuxhumana okunempilo kufaka phakathi ingxoxo engezinkinga yokhwebela ubunzima, ukushela izinkinga ngokuphelele, kanye nokuxoxa ngobuchwepheshe ngokwaziwa kwezinkinga zokwakha kanye nezimali zokuthuthukisa. Abakhiqizi abahlukumezi bakhuselela izindlela zokuxhumana ezingezansi, baphinde bakhuselela iportal yekheliwe ngokushesha kudatha ngobunzima, baphinde bamenyezelwe izilinganiso ezihlanu ezenza ukuthuthukisa kanye nesilinganiso sokuxhumana. Ukuma kwezimiso eziphathelene nokuxhumana kusivumela ukuthi abasebenzisi bathole ulwazi ngokushesha mayelana nobunzima bezinto, isimo sezokuthunyelwa, kanye nezibonelo zokwakha ezingenziwa kuzo izinto ezingenziwa. umphathi wemfanelo yezokulawula izono zomzimba ukuma kwezimiso eziphathelene nokuxhumana kusivumela ukuthi abasebenzisi bathole ulwazi ngokushesha mayelana nobunzima bezinto, isimo sezokuthunyelwa, kanye nezibonelo zokwakha ezingenziwa kuzo izinto ezingenziwa.

Ukubonakala kwezinkinga zokuthembekileyo kuyakha ukuthemba, kuthuthukisa ukusolveka komdla ngokusebenzana, nokunciphisa imisebenzi yokuthuthukisa ngokuphambene okunikeza inhloso ezimbili zomphathi wokwakha nebangani babo. Lezo zindlela zokuxhumana zibonisa ubungcobo bezinhlekele zomphathi futhi zenike izikhathi ukuthemba ekuthinteleni kwesifiso nesimilo sesimilo eside.

Ukuthuthukiswa Ngokuphambene Nenhlaka

Ukuthembeka kwezibophelelo eziyaphakade kufaka phakathi ukulungisa imisebenzi, ukuqina kwezobuchwepheshe, nokunweleza izinkundla ezayikwekisa iqiniso lezemfundo kanye nendima yokubonga kumsebenzi. Abasebenzi ababili nezimali zokuphatha kakhulu baphatha izinhlelo ezivumelekile zokuthuthukisa, bafaka imali kuhlaziywa kwabasebe kanye nokuthuthukiswa kwabo, kanti na kwenza izindlela zokulinganisa okusabalalisa isimo sokusebenza kanye nokwephila kwabantu. Ukudibanisa izimpendulo zabantu, ubuciko bezomnotho, kanye nokuthuthukisa kwebuchwepheshe kuthuthukisa izidingo kanti na kugcine izinkundla zemfundo ziqhubeka zilondoloza izidingo zomnotho kanye nezidingo zabantu.

Ukuthuthukiswa kwezimfihlakalo ekuphileni kumsebenzi wokuthuthukiswa kwenza into eqinile kanye nokukhanyisa izimfihlakalo ezide ngokuxhumana nokuxoxa izinkinga futhi nokwenza umthelelo ekuthuthukiseni amandla. Lezi zimfihlakalo zibonisa ukuthembeka kwekhiwane ekugcineni kakhulu futhi zinikeza abathengi ukufinyelela okuphinde kakhulu kumandla amasha nezimfihlakalo eziphathelene nokwemvelo okunciphisa okuthuthukisa izimfihlakalo zokuthuthukisa nokuthuthukisa izidingo.

Imibuzo Evame Ukubuzwa

Kungani ukuthi mina kufanele ngibone uma ngikhetha umntu othuthukisa izinto zokulungisa izwe?

Izibongo ezibalulekile kufumana kuzo ziqukethe ISO 13485 yokuphatha ububi bezinto zokulungisa izwe, ukubhalisa kweFDA ukuze kufakwe emazweni e-US, nezibongo ezihlobene nasezweni ngamazwe njenge-CE ukuze kubhaliswe emazweni e-Europe. Izibongo ezengeziwe kungase kuzo kufumana kuzo kungaba ngu-ISO 14001 yokuphatha umphakathi futhi nezinhlobo eziphethwe ngezici ngokwesici sezinto futhi nezimfihlakalo ezingathandwayo.

Ngani ngikwazi ngakha amandla ekuthuthukiseni kwezinye izinkampani ezingathandwayo

Vula amandla okwakha ngokuchazwa kwezikhundla, ukubalwa kwezobuchwepheshe, ukubheka izindlela, kanye nokubheka izimpendulo kumasesha abasebenzisa. Bheka uhlu lwezixhobo, imithetho yokulawula ubunzima, izindlela zokuphawula, kanye nezilinganiso zokwakha ukuqinisekisa ukuthi zihlanganiswe kuzidingo lwakho lweprodukthi kanye nezidingo zombuso. Sicela izimpendulo kanye nokwenza izinhlangano ezincane ukuqinisekisa ubunzima bezobuchwepheshe kanye nezobuchwepheshe.

Iziphi izinto ezibandla isayizi yemali yezihlathi zokwakha kwezokulungisa?

Izinto ezibandla imali kufana nesici sezindlu, ubuchwepheshe bezobuchwepheshe, izidingo zezilinganiso, izimo zokubulungisa, kanye nezidingo zezendlela. Imali engaphandle kungaba yizixhobo, ukubalwa, inkxaso yeziphikiswa, kanye nezobuchwepheshe. Abawakhi ababophelela bafakela izimali eziphathelene kakhulu baze basebenzisana ukuqhubeka kwezimali ngaphandle kokuthintela izimo zokubulungisa kanye nezidingo zokuletha.

Ngani angakwenzela ukuthuthuka kwezinhlanganisela zokwakha kwezokulungisa ngokudla?

Qinisekisa ukusecureka kwegunelo lokhuquzelela ngokubophezela izivumelwano zomthuthi, ukukhula kokuphila kwembono, ukulinganisa ubungako bezimali, nokwahlukaniswa kwezinqubomgomo. Dala amathuluzi okuxhumana avamile, sebenzisa izinhlelo zokulandela iphephandi, bese ugcine imbizo ezimiswe ukuqinisekisa nokushintshe izinkinga ezingaba khona ngaphambi koko zize zingcono kumsebenzi wakho. Caphuna ukwahlukaniswa kwegolide futhi uvume umthuthi osekela ukuqhuthuka kwegunelo lokhuquzelela.