IJoytech Yongeza uMgangatho nge-ISO 13485 yeSiqinisekiso seZibonelelo eziNtsha zeMveliso kunye neeNdidi zeMveliso

IJoytech ihlaziye i-ISO 13485 yethu isiqinisekiso esinesiseko esitsha esivunyiweyo semveliso kunye neendidi zemveliso entsha.

Oku kuthetha ukuba zonke ezintsha Iimveliso zeJoytech ezithengiswayo zenziwa phantsi kwenkqubo yolawulo eqinisekisiweyo ye-ISO 13485.

Yintoni ISO 13485?

I-ISO 13485 kumgangatho owamkelwa kwihlabathi jikelele weenkqubo zolawulo lomgangatho ezijoliswe kushishino lwezixhobo zonyango. Yenzelwe ukuqinisekisa ukuba izixhobo zonyango zihlala zihlangabezana neemfuno zabathengi kunye nolawulo. Umgangatho ubandakanya yonke imiba yomjikelo wobomi besixhobo sonyango, kubandakanya uyilo, uphuhliso, imveliso, ukugcinwa, ukuhanjiswa, ukufakela, ukusevisa, kunye nokulahlwa.

Imiba ephambili ye-ISO 13485:

· Inkqubo yoLawulo loMgangatho (QMS): Iseka i-QMS eyomeleleyo yokulawula iinkqubo nokuqinisekisa umgangatho wemveliso.

· Ukuthotyelwa kweMimiselo: Kuqinisekisa ukuthotyelwa kweemfuneko zolawulo ezifanelekileyo.

· Ulawulo loMngcipheko: Lubandakanya imigaqo yolawulo lomngcipheko kuwo wonke umjikelo wobomi bemveliso.

· Ukuqondwa kweMveliso: Ibandakanya onke amanqanaba ukusuka kuyilo kunye nophuhliso ukuya kwimveliso kunye nemisebenzi yasemva kwentengiso.

· Ulawulo lweNkqubo: Ugxininisa ukubaluleka kokulawula iinkqubo zokugcina umgangatho wemveliso.

· Uphuculo oluthe gqolo: Ujolisa kuphuculo oluqhubekayo lweenkqubo kunye neenkqubo.

Ukuqinisekiswa yi-ISO 13485:

Xa inkampani iqinisekisiwe yi-ISO 13485, oko kuthetha ukuba iqumrhu elizimeleyo lezatifiketi lihlole inkqubo yolawulo lomgangatho wenkampani laza laqinisekisa ukuba liyahlangabezana neemfuno zomgangatho we-ISO 13485. Esi satifikethi sibonisa ukuba inkampani iseke iinkqubo ezisebenzayo kunye nokulawula ukuqinisekisa ukhuseleko kunye nokusebenza kakuhle kwezixhobo zayo zonyango.

Iziphumo zeSiqinisekiso se-ISO 13485:

· Ulwamkelo loLawulo: Inceda ekuhlangabezaneni neemfuno zolawulo kwiimarike ezahlukeneyo zehlabathi, nto leyo ibalulekileyo ekuthengisweni kwezixhobo zonyango.

· Ukuzithemba koMthengi: Kwenyusa ukuthembana kunye nokuzithemba phakathi kwabathengi kunye nabachaphazelekayo malunga nomgangatho kunye nokhuseleko lweemveliso.

· Ukufikelela kwiMakethi: Iququzelela ukungena kwiimarike ezintsha apho isiqinisekiso se-ISO 13485 siyimfuneko yokuvunywa ngokolawulo.

· Ucikizeko lokuSebenza: Ukukhuthaza iinkqubo ezilungelelanisiweyo kunye nokuphuculwa okuqhubekayo, okukhokelela ekusebenzeni kakuhle.

· Ulawulo loMngcipheko: Uqinisekisa ukuba izenzo zolawulo lomngcipheko zidityaniswa ngokufanelekileyo kubomi bonke bemveliso.

Yintoni i Iziko elitsha likaJoytech eliqinisekiswe yi-ISO 13485?

Indawo entsha kaJoytech ekwiNombolo ye-502 Shunda Road ikwimveliso ukususela ngo-2023. 

Igubungela ummandla oziskwemitha ezingama-69,000 enendawo yokusebenza eyakhiweyo ngaphezulu kwe-260,000 yesikwemitha, eli ziko litsha lixhotyiswe ngomatshini wokuvelisa, ukudibanisa, kunye nemigca yokupakisha, kunye neendawo zokugcina iimpahla ezinemigangatho emithathu. Uninzi lweemveliso zeJoytech ezithengiswayo ngoku ziveliswa kweli ziko litsha.

Ngeenkcukacha ezithe vetshe, siyakwamkela ukuba undwendwele isixhobo sethu !