Samfura masu dogaro da kwanciyar hankali sune layin rayuwar kamfani.Tun lokacin da aka kafa shi kusan shekaru 5 da suka gabata, Epiprobe koyaushe yana sanya inganci a gaba, yana ba masu amfani da ingantaccen ingantaccen kuma amintaccen samfuran gwajin cutar kansa.A ranar 9 ga Mayu, 2022, bayan nazari mai tsauri da ƙwararru daga BSI British Standards Institution Certification (Beijing) Co., Ltd., Epiprobe ya yi nasara ya wuce takardar shedar tsarin kula da ingancin kayan aikin likita na "ISO 13485:2016".Iyakar aikace-aikacen da ke tattare da shi shine ƙira, haɓakawa, masana'anta, da rarraba kayan gwajin gano kwayoyin halittar methylation (hanyar PCR-fluorescence).
Muhimmancin aiwatar da takaddun shaida na ISO 13485
Wannan cikakkiyar takaddun shaida ce ta dukkan tsarin bincike da haɓaka samfura, samarwa da tallace-tallace a cikin kamfani, wanda ke nuna cewa tsarin gudanarwar ingancin kamfani ya dace da ƙa'idodin duniya na ISO 13485: 2016 don tsarin sarrafa ingancin kayan aikin likita.Kamfanin yana da ikon ci gaba da samarwa da samar da kayayyaki masu inganci waɗanda suka dace da bukatun abokan cinikin na'urar likitanci, kuma ya kai matsayin ƙasashen duniya cikin ƙirar samfura, haɓakawa, samarwa, da tallace-tallace.Wannan yana nuna ƙarin ci gaba a matakin sarrafa ingancin Epiprobe wanda ke rufe duk tsawon rayuwar samfurin da kuma yunƙurin daidaitawa, daidaitawa, da haɓaka ingancin sarrafa sa na duniya.
Game da ISO 13485 Tsarin Takaddun Shaida
TS EN ISO 13485: 2016 ma'aunin gudanarwa mai inganci ne wanda Kungiyar Kasa da Kasa ta Kasa da Kasa (ISO) ta haɓaka musamman don masana'antar na'urorin likitanci (gami da in vitro diagnostic reagents), aiwatar da tsari kamar ƙira da haɓakawa, samarwa, da rarraba na'urorin likitanci.Wannan ma'auni shine ma'aunin tsarin ingancin ƙasa da ƙasa da aka fi amfani dashi a cikin masana'antar na'urorin likitanci kuma yana wakiltar mafi kyawun ayyuka a cikin gudanarwa mai inganci don masana'antar na'urar likitancin duniya.
Tsarin Takaddun Takaddun Takaddun Takaddun shaida na Epiprobe's ISO 13485 Takaddun shaida
A cikin watan Agusta 2021, hukumar ba da takaddun shaida ta karɓi aikace-aikacen Epiprobe bisa ƙa'ida don takaddun tsarin sarrafa inganci.Daga ranar 1 ga Maris zuwa 3 ga Maris, 2022, membobin tawagar binciken sun gudanar da tsauraran bincike a wurin da tantance ma'aikata, kayan aiki da tsarin kayan aiki, da takaddun da ke da alaƙa da bayanan samarwa, inganci, bincike da haɓaka kamfanin, gudanar da kasuwanci, da sassan tallace-tallace.Bayan binciken da aka yi da hankali, kwararrun tawagar binciken sun yi imanin cewa an kammala tsarin tsarin sarrafa ingancin na Shanghai Epiprobe Biology Co., Ltd. (Xuhui) da Shanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan), takardun da suka dace sun kasance. isasshe, kuma aiwatar da ingantacciyar jagorar, takaddun tsari, binciken cikin gida, bita na gudanarwa, da sauran hanyoyin sun kasance masu kyau kuma sun dace da buƙatun ma'aunin ISO 13485.
Cikakken ingantaccen gudanarwa yana taimaka wa Epiprobe cimma sakamako mai amfani
Tun lokacin da aka kafa shi, Epiprobe ya bi darajar "tsaye akan samfuran" kuma ya kafa ƙungiyar masu duba na cikin gida don aiwatar da shirye-shiryen takaddun tsarin gudanarwa, bincike na ciki da sauran ayyuka masu amfani don tabbatar da cewa samfuran sun cika ka'idodin ka'idoji da ƙa'idodi. Takaddun ciki a cikin duk tsarin gudanarwa na rayuwa, a hankali yana fahimtar ingantaccen gudanarwa mai inganci.Kamfanin ya sami 4 Class I kayan aikin likitanci filings (Albishir! Epiprobe Biology Get Two Class I Medical Device Filings for Nucleic Acid Extraction Reagents!) da 3 European CE certifications for cancer gene methylation detection kits (Epiprobe's Three Cancer Gene Methylation Kits Get. Takaddar CE ta Turai), kuma ta jagoranci shiga kasuwan cutar sankara ta methylation.
A nan gaba, Epiprobe za ta bi ka'idodin ISO 13485: 2016 ingantacciyar tsarin sarrafa inganci, tare da bin ka'idodin ingancin "Madaidaicin Samfura, Tsakanin Fasaha, da Sabis".The quality management tawagar za su ci gaba da inganta ingancin dabarun raga, m sarrafa kowane mahada daga reagent ci gaban zuwa samar da tsari, da kuma ko da yaushe tsananin aiwatar da tsari iko da hadarin management bukatun kayyade a ingancin tsarin takardun don tabbatar da aminci da daidaito na kayayyakin.Kamfanin zai ci gaba da haɓaka matakin sarrafa ingancinsa, tabbatar da ingancin kayayyaki da sabis, haɓaka ikon ci gaba da biyan buƙatun abokin ciniki da tsammanin, da samar wa abokan ciniki mafi ingancin cutar kansa da wuri da samfurori da ayyuka.
Lokacin aikawa: Afrilu-28-2023