Joytech Yongera Ubwiza hamwe na ISO 13485 Icyemezo cyibikorwa bishya byumusaruro nibyiciro byibicuruzwa

Joytech yavuguruye ISO 13485 Icyemezo hamwe nibikorwa bishya byemejwe nibyiciro bishya.

Ibi bivuze ko byose bishya Ibicuruzwa bya Joytech bigurishwa bikozwe muri sisitemu yo kuyobora ISO 13485.

ISO 13485 ni iki?

ISO 13485 ni amahame azwi ku rwego mpuzamahanga kuri sisitemu yo gucunga neza umwihariko w'inganda zikoreshwa mu buvuzi. Yashizweho kugirango harebwe niba ibikoresho byubuvuzi byujuje ibisabwa byabakiriya nibisabwa. Ibipimo bikubiyemo ibintu byose bigize ubuzima bwigikoresho cyubuvuzi, harimo igishushanyo, iterambere, umusaruro, kubika, gukwirakwiza, kwishyiriraho, gutanga serivisi, no kujugunya.

Ibintu by'ingenzi bya ISO 13485:

Sisitemu yo gucunga ubuziranenge ( QMS ): Ishiraho QMS ikomeye yo gucunga inzira no kwemeza ubuziranenge bwibicuruzwa.

· Kubahiriza amabwiriza: Yemeza kubahiriza ibisabwa bijyanye n'amategeko.

· Gucunga ibyago: Harimo amahame yo gucunga ibyago mubuzima bwibicuruzwa.

· Kumenyekanisha ibicuruzwa: Hindura ibyiciro byose uhereye kubishushanyo mbonera no kwiteza imbere kugeza kumusaruro nibikorwa nyuma yisoko.

· Igenzura ryibikorwa: Ashimangira akamaro ko kugenzura inzira kugirango ubungabunge ibicuruzwa.

· Gukomeza Gutezimbere: Yibanze ku gukomeza kunoza imikorere na sisitemu.

Icyemezo cya ISO 13485:

Iyo isosiyete yemejwe na ISO 13485, bivuze ko urwego rwigenga rwigenga rwagenzuye sisitemu yo gucunga ubuziranenge bwikigo kandi rugenzura ko rwujuje ibisabwa na ISO 13485. Iki cyemezo cyerekana ko isosiyete yashyizeho uburyo bunoze kandi bugenzura kugirango umutekano w’ibikorwa by’ubuvuzi bigerweho neza.

Ingaruka za ISO 13485 Icyemezo:

· Kwemererwa kugenzura: Ifasha mukuzuza ibisabwa byubuyobozi kumasoko atandukanye yisi, aringirakamaro mugucuruza ibikoresho byubuvuzi.

· Icyizere cyabakiriya: Kongera ikizere nicyizere mubakiriya nabafatanyabikorwa kubijyanye nubwiza numutekano wibicuruzwa.

· Kwinjira ku isoko: Korohereza kwinjira mu masoko mashya aho icyemezo cya ISO 13485 gisabwa kugira ngo umuntu yemererwe n'amategeko.

· Imikorere ikora: Itezimbere inzira yoroheje no guhora utezimbere, biganisha kumikorere.

· Gucunga ibyago: Iremeza ko uburyo bwo gucunga ibyago bwinjizwa neza mubuzima bwibicuruzwa.

Niki Ikigo gishya cya Joytech cyemejwe na ISO 13485?

Ikigo gishya cya Joytech kuri No 502 Umuhanda Shunda cyatangiye gukorwa kuva 2023. 

Ifite ubuso bwa metero kare 69.000 hamwe nubuso bwubatswe bwubatswe bwa metero kare 260.000, ikigo gishya gifite ibikoresho byikora, guteranya, no gupakira, hamwe nububiko bwububiko bwa metero eshatu. Ibyinshi mu bicuruzwa bya Joytech bigurishwa ubu birimo gukorerwa muri iki kigo gishya.

Kubindi bisobanuro, twishimiye kubasura ikigo cyacu !