I kēia mau lā, ua hoʻokō maikaʻi ʻia ka ʻenehana ʻo Shenzhen Zuowei i ka ISO13485: 2016 hōʻoia ʻōnaehana hoʻokele maikaʻi o ka ʻoihana olakino, ʻo ia hoʻi ua hōʻea ka ʻōnaehana hoʻokele maikaʻi o ka hui i nā kūlana honua a me nā koi hoʻoponopono.
ʻO ISO13485 ka mea mana loa o ka ʻōnaehana o ka honua i ka ʻoihana olakino, a ʻo kāna inoa Kina piha ʻo "Medical Device Quality Management System for Regulation Requirements", he kūlana kūʻokoʻa kūʻokoʻa kūʻokoʻa i kūkulu ʻia e ka International Organization for Standardization (ISO) a pili. i ka ʻoihana lāʻau lapaʻau. Hoʻokumu ʻia ʻo ISO13485 ma ISO9000 a hoʻohui i kekahi mau koi kūikawā no ka ʻoihana lāʻau lapaʻau, ʻo ia nā koi koʻikoʻi i ka ʻike huahana, ka mana kaʻina hana a me nā mea ʻē aʻe.
Ke nānā mau nei ʻo Shenzhen Zuowei i ka hoʻomohala ʻana i ka huahana, ka hana a me ka mana o ka maikaʻi ma ke ʻano he mea nui, ua hala i ka ISO13485, e hōʻailona ana i nā huahana o kā mākou ʻoihana i ka mana maikaʻi i nā kūlana honua, e hōʻike hou i ka ikaika o ka ʻoihana e hoʻolako i nā mea kūʻai aku o ka honua me ka ʻenehana. a me nā lawelawe huahana ʻenehana, no ka hoʻomohala ʻana o ka hui ma ke kahua o nā mea lapaʻau i kau i kahi kumu hou.
Ma mua, ua hala nā huahana o kā mākou hui i ka hoʻopaʻa inoa US FDA, ka hoʻopaʻa inoa EU MDR a me ka hōʻoia CE. ʻO kēlā mau palapala hōʻoia he hōʻailona ia o ka R&D a me ka ikaika hou o ka hui, ka ʻōnaehana maikaʻi o ka huahana a me ka ikaika holoʻokoʻa, ʻoiaʻiʻo e hāpai i kahi kūlana maikaʻi loa ma ke ʻano he ʻepekema a me ka ʻenehana ma ke kahua honua!
I ka wā e hiki mai ana, e lawe ʻo Shenzhen Zuowei i kēia palapala hōʻoia ma ke ʻano he manawa kūpono, e like me nā kūlana ʻōnaehana hoʻokele maikaʻi, e hoʻomau i ka hōʻoia e pili ana i ka hoʻokele hoʻomaʻemaʻe, hoʻomaikaʻi mau i ka mana o loko, hoʻomaikaʻi mau i nā pae lawelawe, a hāʻawi i nā huahana maikaʻi aʻe a me nā lawelawe ʻenehana. no kā mākou mea kūʻai.
Ka manawa hoʻouna: Mar-17-2023
