IJoytech iphucula umgangatho nge-ISO 13485 isiqinisekiso samaziko amatsha emveliso kunye neendidi zemveliso

UJoytech uhlaziye i-ISO YOS 13485 Isiqinisekiso esinemveliso esandula ukuvunywa kunye neendidi ezintsha zemveliso.

Oku kuthetha ukuba yonke intsha Iimveliso zeJoytech kwintengiso zenziwa phantsi kwenkqubo yolawulo lwe-ISO 13485.

Yintoni i-ISO 13485?

I-ISO 13485 ngumgangatho owamkelweyo kwihlabathi jikelele weenkqubo zolawulo lomgangatho ezikhethekileyo kwishishini lezonyango. Yenzelwe ukuqinisekisa ukuba izixhobo zonyango zihlala zidibana nabathengi kunye neemfuno zolawulo. Umgangatho oqhelekileyo ugubungela yonke imiba yobomi bomnxeba wezonyango, kubandakanya uyilo, uphuhliso, imveliso, ukuhambisa, ukuhambisa, ukunikezelwa, kunye nokunikezelwa.

Izinto eziphambili ze-ISO 13485:

Inkqubo yoLawulo lweMPICISO (QMS): Ukuseka i-QMS eyomeleleyo ukulawula iinkqubo kwaye kuqinisekiswe umgangatho wemveliso.

Ukuthotyelwa komthetho : kuqinisekisa ukuthotyelwa kweemfuno ezifanelekileyo zolawulo.

Ulawulo lweOfisi yoMngcipheko: kubandakanya imigaqo yolawulo lomngcipheko kuyo yonke imiphefumlo yemveliso.

Ukuqonda ukuqonda kwemveliso: Igubungela yonke imigangatho yoyilo kunye nophuhliso kwimisebenzi yentengiso yentengiso.

Ukulawulwa kolawulo: kugxininisa ukubaluleka kokulawula iinkqubo zokugcina umgangatho wemveliso.

Uqhubeka ukuphuculwa okuqhubekayo: igxile ekunyukeni kweenkqubo kunye neenkqubo.

Isatifikethi se-ISO 13485:

Xa inkampani iqinisekisiwe yi-ISO 13485, oko kuthetha ukuba iqumrhu elizimeleyo liyiphicothi iNkampani yeNkcazo yoLawulo loMgangatho kwaye iqinisekiswe ukuba ihambelane neemfuno ze-ISO 13485. Esi siqinisekiso sibonisa ukuba inkampani iseke iinkqubo ezifanelekileyo kunye nolawulo lokuqinisekisa ukhuseleko kunye nokusebenza kakuhle kwezixhobo zonyango.

Iimpembelelo ze-ISO 13485 isiqinisekiso:

Ukwamkelwa kolawulo olulawulwayo: kunceda ekufezekisweni kweemfuno zolawulo kwiimarike ezahlukeneyo zehlabathi, ezibaluleke kakhulu kwizixhobo zonyango.

Intembelo yabathengi : yandisa ukuthembana nokuzithemba kwabathengi kunye nabathathi-nxaxheba malunga nomgangatho kunye nokhuseleko lweemveliso.

Ukufikelela kwizamente: Ukuqhutywa kwemarike entsha apho isiqinisekiso se-ISO 13485 sisiqinisekiso sokuvunywa ngokusemthethweni.

Ukusebenza ngokukuko ngempumelelo: khuthaza iinkqubo zokuhambisa kunye nokuphucula rhoqo, okukhokelela ekusebenzeni kakuhle.

Ulawulo lomngcipheko kwi- Workwene: qinisekisa ukuba iinkqubo zolawulo lomngcipheko zidityaniswa ngokufanelekileyo kuwo wonke umboniso wemveliso.

Yintoni i IZiko elitsha laseGuytech liqinisekisiwe yi-ISO 13485?

Indawo entsha kaJoytech kwi-502 shiunda yenziwa kwimveliso ukusukela ngo-2023. 

Ukugubungela indawo yeemitha ezingama-69,000 kunye nendawo eyakhiweyo eyakhiwe ngaphezulu kwe-260,000 yeemitha, indawo entsha ixhotyiswe ngemveliso ezenzekelayo, iNdibano, kunye nemigca yephakheji emithathu. Uninzi lweemveliso zikaJoytech okwangoku zithengiswa ngoku ziveliswa kule ndawo intsha.

Ngeenkcukacha ezithe kratya, sakuthathela ingqalelo ukuba undwendwele Indawo yethu !