Kwanan nan, likitancin Haiyan KangyuanKayan aiki Co., Ltd. ya yi nasarar wuce ISO13485: 2016 takardar shaidar tsarin sarrafa ingancin kayan aikin likita.Dukkanin bita yana ɗaukar kwanaki uku.related to ingancin management system, tsari ganewa da bincike, management alhakin, management review, ingancin manufofin, data analysis, dan Adam albarkatun, kayayyakin more rayuwa, abokin ciniki da alaka da tsari, ƙira da kuma ci gaba, sayayya, samarwa da kuma samar da sabis da sito, hadarin management, tsari tabbatarwa, haifuwa tabbatarwa, traceability, ganewa matsayi, samfurin kariya, saka idanu da kuma auna kayan sarrafa, abokin ciniki gamsuwa tsarin ba da gunaguni na ciki, gunaguni na hannu samfurin, dubawa da kuma auna kayan sarrafawa, abokin ciniki gamsuwa tsarin Feedback. sarrafawa, gyaran gyare-gyare da matakan kariya, nazarin takardun fasaha, da dai sauransu.

This duba, tabbatar da tawagar duba a wurin, tabbatar da cewa duk matakai na Kangyuan Medical bincike da kuma ci gaba, samarwa da kuma tallace-tallace da aka za'ayi daidai da tanadi na ingancin management takardun, kuma an ba da shawarar bayar da takardar shaida.

A matsayin ma'auni na tsarin kula da ingancin inganci na duniya don masana'antar na'urorin likitanci, an fitar da sabon ma'aunin ISO13485:2016 (tsarin sarrafa ingancin kayan aikin likita don buƙatun tsari) bisa hukuma a ranar 1 ga Maris, 2016.Sigar 2016 na sabon ma'aunin ISO13485 yana ƙara ɗimbin mafi kyawun ayyuka na masana'antar na'urar likitanci, wanda ya dace da buƙatun wasu ƙa'idodin na'urar likitancin ƙasa, tsarin gudanarwa ne mai inganci da rajistar tsari da kulawa da ƙa'idodin haɗin gwiwa.

Kangyuan Medical ya wuce ba da takardar shaida a karo na uku, wanda ba wai kawai ya nuna cikakkiyar amincewa da samfuran Kangyuan ta ƙungiyoyin ka'idojin ƙasa da ƙasa ba, har ma yana nuna ƙarin daidaito, daidaito da kuma daidaita tsarin tsarin kula da ingancin kiwon lafiya na Kangyuan.

A halin yanzu, Kangyuan Medical yana kuma aiwatar da FDA ta Amurka, EU MDR takardar ba da takardar shaida da sauran ayyuka.Muna fatan cewa tare da tallafin "wucewa" na duniya da yawa, Kangyuan za ta rufe kowane nau'in catheters na silicone, catheters zafin jiki, laryngeal mask na iska catheter, karshentracheal tube, tsotsacatheter, bututun ciki, masks daban-daban da sauran samfuran kayan aikin likitanci ga duniya, suna ba da ƙarin marasa lafiya a duniya, da kuma taimakawa samfuran kayan aikin likita don haɓakawa sosai!