Posachedwapa, Haiyan Kangyuan MedicalChida Co., Ltd. adapambana chiphaso cha ISO13485:2016 pazida zachipatala.Ndemanga yonse imatenga masiku atatu,rokhudzidwa ndi kasamalidwe kaubwino, kuzindikiritsa ndi kusanthula ndondomeko, maudindo oyang'anira, kuwunikanso kasamalidwe, zolinga zabwino, kusanthula deta, zothandizira anthu, zomangamanga, njira zokhudzana ndi makasitomala, mapangidwe ndi chitukuko, kugula, kupanga ndi kupereka ntchito ndi malo osungiramo zinthu, kuyang'anira zoopsa, ndondomeko kutsimikizira, kutsimikizira kutsekereza, kufufuza, chizindikiritso, chitetezo chazinthu, kuyang'anira ndi kuwongolera zida zoyezera, kukhutitsidwa kwamakasitomala Ndemanga (kuphatikiza madandaulo), dongosolo lochenjeza, kafukufuku wamkati, kuwongolera kwazinthu zosagwirizana, njira zowongolera ndi zodzitetezera, kuwunika kwa chikalata chaukadaulo, ndi zina zambiri.

This kafukufuku, kutsimikiziridwa ndi gulu kafukufuku pa malo, anatsimikizira kuti njira zonse za kafukufuku Kangyuan Medical ndi chitukuko, kupanga ndi malonda ikuchitika motsatira makonzedwe a zikalata khalidwe kasamalidwe dongosolo, ndipo tikulimbikitsidwa kuti apereke satifiketi.

Monga muyezo wovomerezeka padziko lonse lapansi wamakampani opanga zida zamankhwala, mulingo watsopano wa ISO13485:2016 (kasamalidwe kabwino ka zida zachipatala pazofunikira zamalamulo) watulutsidwa mwalamulo pa Marichi 1, 2016.Mtundu wa 2016 wa muyezo watsopano wa ISO13485 umawonjezera njira zabwino kwambiri zamakampani azachipatala, zomwe zimagwirizana ndi zofunikira za malamulo ena a zida zamankhwala m'dziko, ndi kasamalidwe kabwino komanso kulembetsa ndi kuyang'anira miyezo yogwirizana kwambiri.

Kangyuan Medical adadutsa chiphaso kachitatu, zomwe sizimangowonetsa kuzindikira kwathunthu kwa zinthu za Kangyuan ndi mabungwe apadziko lonse lapansi, komanso zikuwonetsa kukhazikika, kukhazikika komanso kuyika mayiko ena a Kangyuan dongosolo lachipatala labwino.

Pakadali pano, Kangyuan Medical ikuchitanso US FDA, EU MDR certification application ndi ntchito zina.Tikukhulupirira kuti mothandizidwa ndi "pass" yochulukirachulukira padziko lonse lapansi, Kangyuan idzaphimba mitundu yonse ya ma catheters a silicone, ma catheters a kutentha, catheter ya laryngeal mask airway catheter, endochubu cha tracheal, kuyamwacatheter, chubu cham'mimba, masks osiyanasiyana ndi zinthu zina zachipatala padziko lonse lapansi, kuthandiza odwala ambiri padziko lonse lapansi, ndikuthandizira kuti zinthu zodyedwa zachipatala zikwezedwe bwino!