Joytech izamura ireme hamwe na ISO 13485 kubikorwa bishya hamwe nibicuruzwa byiciro

Joytech yavuguruye Iso 13485 Icyemezo hamwe numusaruro mushya wemewe nibicuruzwa bishya.

Ibi bivuze ko ibishya byose Ibicuruzwa bya Joytech bigurishwa bikorerwa munsi ya sisitemu yo gucunga Iso 13485.

Iso 13485 ni iki?

ISO 13485 ni urwego rwemewe ku rwego mpuzamahanga muri sisitemu yo gucunga ubuziranenge bwihariye ku nganda z'ibikoresho. Yashizweho kugirango ikemeza ko ibikoresho byubuvuzi buringaniye byujuje ibyangombwa byabakiriya nibisabwa. Ibipimo ngenderwaho bikubiyemo ibintu byose byigikoresho byubuvuzi, harimo gushushanya, iterambere, umusaruro, kubika, gukwirakwiza, kwishyiriraho, gukora.

Ibyingenzi bya ISO 13485:

Sisitemu yo gucunga ubuziranenge (qms): ishyiraho qms ikomeye yo gucunga inzira no kwemeza ubuziranenge.

· Kubahiriza ubuyobozi: birashoboka ko byubahiriza ibisabwa n'amategeko.

· Gucunga ingaruka: bikubiyemo amahame yo gucunga ingaruka mubuzima bwose.

· Kumenya ibicuruzwa: Gupfuka ibyiciro byose biva ku gishushanyo n'iterambere ku musaruro no gukora ibicuruzwa nyuma y'isoko.

Ntabwo igenzura ritunganya: ishimangira akamaro ko kugenzura inzira kugirango zikomeze ubuziranenge bwibicuruzwa.

· Gukomeza gutera imbere, yibanda ku buryo buhoraho butunganya inzira na sisitemu.

Icyemezo na ISO 13485:

Iyo isosiyete yemejwe na ISO 13485, bivuze ko umurambo wigenga wagenzuye uburyo bwo gucunga neza isosiyete kandi bigenzurwa ko byujuje ibisabwa byimibare ya ISO 13485. Iri shimwe ryerekana ko isosiyete yashyizeho inzira nziza kandi igenzura kugirango umutekano n'imikorere birebire byayo.

Ingaruka za ISO 13485 Icyemezo:

· Kwemera kwemerwa: bifasha mu nama ibisabwa mu masoko atandukanye ku isi, ari ngombwa mu kwamamaza kwamamaza.

· Icyizere cyabakiriya: Kuzamura ikizere nicyizere mubakiriya nabafatanyabikorwa bijyanye nubwiza n'umutekano wibicuruzwa.

· Kwinjira mu mashanyarazi: Korohereza kwinjira mu masoko mashya aha aho Iso 13485 ari impamyabumenyi igamije kwemerwa.

· Gukora neza: Guteza imbere inzira zurutonde no gukomeza gutera imbere, biganisha ku gukora imikorere.

· Gucunga ingaruka: Gukemura ko ibikorwa byo gucunga bishobora gutera imbere muburyo bwo gutunganya ibicuruzwa byose.

Niki Ikigo gishya cya Joytech cyemewe na ISO 13485?

Ikigo gishya cya Joytech muri No 502 Shunda cyakozwe kuva 2023. 

Gupfukaho ubuso bwa metero kare 69.000 hamwe nubuso bwubatswe na metero kare 260.000, Ikigo gishya gifite umusaruro wikora, Inteko, hamwe nububiko bwibikoresho bitatu-byikora. Ibicuruzwa byinshi bya Joytech kuri ubu bigurishwa ubu birimo gukorwa kuri iki kigo gishya.

Kubindi bisobanuro, turamwakira gusura Ikigo cyacu !