I kēia mau lā, Haiyan Kangyuan MedicalMea hana Ua holo pono ʻo Co., Ltd. i ka ISO13485: 2016 palapala hōʻoia ʻōnaehana hoʻokele maikaʻi.ʻEkolu lā ka loiloi holoʻokoʻa,rʻoliʻoli i ka ʻōnaehana hoʻokele maikaʻi, ka ʻike ʻana a me ka nānā ʻana, nā kuleana hoʻokele, ka loiloi hoʻokele, nā pahuhopu maikaʻi, ka nānā ʻana i ka ʻikepili, nā kumuwaiwai kanaka, nā ʻōnaehana, nā kaʻina pili i nā mea kūʻai aku, ka hoʻolālā a me ka hoʻomohala ʻana, ke kūʻai ʻana, ka hana a me ka hoʻolako lawelawe a me ka hale kūʻai, hoʻokele pilikia, kaʻina hana. hōʻoia, sterilization hōʻoia, traceability, identification status, product protection, monitoring and ana ana lako mana, Customer satisfaction Manaʻo (me ka hoʻopiʻi hoʻopiʻi), ʻōnaehana hoʻolaha, loiloi kūloko, nonconforming product control, corrective and preventive measures, technical document review, etc.

This ka loiloi, hōʻoia ʻia e ka hui loiloi ma ka pūnaewele, ua hōʻoia i nā kaʻina hana a pau o ka Kangyuan Medical noiʻi a me ka hoʻomohala ʻana, ka hana ʻana a me ke kūʻai aku e hana ʻia e like me nā ʻōlelo o nā palapala ʻōnaehana hoʻokele maikaʻi, a ua ʻōlelo ʻia e hoʻopuka i kahi palapala.

Ma ke ʻano he ʻōnaehana hoʻokele maikaʻi i ʻike ʻia ma ka honua no ka ʻoihana lāʻau lapaʻau, ua hoʻokuʻu ʻia ka maʻamau hou ISO13485:2016 (pūnaewele hoʻokele maikaʻi o ka lāʻau lapaʻau no nā koi hoʻoponopono) i ka lā Malaki 1, 2016.Hoʻohui ka mana 2016 o ka ISO13485 hou i ka helu nui o nā hana maikaʻi loa o ka ʻoihana lāʻau lapaʻau, kūpono me nā koi o kekahi mau hoʻoponopono lāʻau lapaʻau aupuni, he ʻōnaehana hoʻokele maikaʻi a me ka hoʻopaʻa inoa ʻana a me ka nānā ʻana i nā maʻamau i hui pū ʻia.

Ua hala ʻo Kangyuan Medical i ka palapala hōʻoia no ke kolu o ka manawa, ʻaʻole ia e hōʻike wale i ka ʻike piha ʻana o nā huahana Kangyuan e nā hui kūlana honua, akā e hōʻailona pū ana i ka standardization, standardization a me ka internationalization o Kangyuan medical quality management system.

I kēia manawa, ke lawe nei ʻo Kangyuan Medical i ka US FDA, EU MDR palapala noi a me nā hana ʻē aʻe.Lana ko mākou manaʻo me ke kākoʻo o ka "pass" honua hou aʻe, e uhi ʻo Kangyuan i nā ʻano catheters silicone āpau, nā catheters wela, ka laryngeal mask airway catheter, endoʻūhā ʻūhā, ʻūhāʻūhā, ʻōpū opu, nā makamaka like ʻole a me nā huahana lāʻau lapaʻau ʻē aʻe i ka honua, e lawelawe ana i nā mea maʻi hou aʻe a puni ka honua, a me ke kōkua ʻana i nā huahana lāʻau lapaʻau e hoʻonui piha ʻia!