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.rmai farin ciki da tsarin gudanarwa mai inganci, ganewar tsari da bincike, alhakin gudanarwa, nazarin gudanarwa, maƙasudin inganci, nazarin bayanai, albarkatun ɗan adam, abubuwan more rayuwa, hanyoyin da suka shafi abokin ciniki, ƙira da haɓakawa, sayayya, samarwa da samar da sabis da sito, sarrafa haɗari, tsari. tabbatarwa, tabbatarwa ba haifuwa, ganowa, matsayin ganowa, kariyar samfur, kulawa da sarrafa kayan aikin aunawa, gamsuwar abokin ciniki Feedback (ciki har da sarrafa ƙararraki), tsarin faɗakarwa, duban cikin gida, sarrafa samfur mara daidaituwa, matakan gyara da kariya, bitar takaddun fasaha, da 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!