Iimveliso ezithembekileyo nezizinzileyo ziyindlela yokuphila yenkampani.Ukusukela ekusekweni kwayo phantse iminyaka emi-5 eyadlulayo, i-Epiprobe ibisoloko ibeka umgangatho kuqala, ibonelela abasebenzisi ngemveliso yomhlaza ekumgangatho ophezulu kunye nothembekileyo kwangethuba.Ngomhla we-9 kaMeyi, i-2022, emva kokuphononongwa ngokungqongqo kweengcali ezivela kwi-BSI yaseBritani yeSatifikethi seZiko leMigangatho (Beijing) Co., Ltd., i-Epiprobe iphumelele ngempumelelo i-"ISO 13485:2016" isiqinisekiso senkqubo yolawulo lwesixhobo sonyango.Umda wesicelo esibandakanyekayo kuyilo, uphuhliso, ukuveliswa, kunye nokuhanjiswa kwezixhobo zokuvavanya i-gene methylation (indlela ye-PCR-fluorescence).
Ukubaluleka kokuphumeza isiqinisekiso se-ISO 13485
Esi sisiqinisekiso esipheleleyo sayo yonke inkqubo yophando lwemveliso kunye nophuhliso, imveliso, kunye neentengiso ngaphakathi kwenkampani, ebonisa ukuba inkqubo yolawulo lomgangatho wenkampani ihambelana nomgangatho wehlabathi we-ISO 13485:2016 weenkqubo zolawulo lwezixhobo zonyango.Inkampani iyakwazi ukuvelisa ngokuqhubekayo kwaye ibonelela ngeemveliso ezikumgangatho ophezulu ezihlangabezana neemfuno zabathengi bezixhobo zonyango, kwaye ifikelele kwimigangatho yamazwe ngamazwe kuyilo lwemveliso, uphuhliso, imveliso kunye nokuthengisa.Oku kuphawula uphuculo olongezelelekileyo kwinqanaba lolawulo lomgangatho we-Epiprobe oquka umjikelo wemveliso yonke kunye nokuya ekubekweni emgangathweni, ekuhleni, kunye nokulungelelaniswa komgangatho wolawulo lwamazwe ngamazwe.
Malunga neNkqubo yeSiqinisekiso se-ISO 13485
I-ISO 13485: I-2016 ngumgangatho wolawulo lomgangatho ophuhliswe nguMbutho weZizwe ngeZizwe woMgangatho (ISO) ngokukodwa kwishishini lesixhobo sonyango (kubandakanywa ne-in vitro diagnostic reagents), equka iinkqubo ezifana noyilo kunye nophuhliso, ukuveliswa kunye nokusasazwa kwezixhobo zonyango.Lo mgangatho ngowona mgangatho wenkqubo womgangatho usetyenziswa kakhulu kwihlabathi kushishino lwezixhobo zonyango kwaye umele ezona zenzo zilungileyo kulawulo lomgangatho kushishino lwezixhobo zonyango lwamazwe ngamazwe.
Inkqubo yeSiqinisekiso se-Epiprobe's ISO 13485 Certification
Ngo-Agasti ka-2021, i-arhente yoqinisekiso yamkele ngokusesikweni isicelo se-Epiprobe sesiqinisekiso senkqubo yolawulo lomgangatho.Ukusukela ngomhla woku-1 ukuya kumhla wesi-3 kuMatshi ka-2022, amalungu eqela lophicotho-zincwadi aqhube uhlolo nophicotho olungqongqo kwisiza sabasebenzi, amaziko kunye nolungelelwaniso lwezixhobo, kunye namaxwebhu anxulumeneyo kunye neerekhodi zemveliso yenkampani, umgangatho, uphando kunye nophuhliso, ulawulo lweshishini, kunye. amasebe ezentengiso.Emva kophicotho olucokisekileyo nolucokisekileyo, iingcali zeqela lophicotho-zincwadi zikholelwa ukuba izakhiwo zenkqubo yolawulo lwekhwalithi ye-Shanghai Epiprobe Biology Co., Ltd. (Xuhui) kunye ne-Shanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan) zigqityiwe, amaxwebhu afanelekileyo ayenziwe. ngokwaneleyo, kunye nokuphunyezwa kwencwadana esemgangathweni, amaxwebhu enkqubo, uphicotho-zincwadi lwangaphakathi, uphononongo lolawulo, kunye nezinye iinkqubo bezilungile kwaye zihambelana ngokupheleleyo neemfuno zomgangatho we-ISO 13485.
Ulawulo lomgangatho olubanzi lunceda i-Epiprobe ifumane iziphumo ezineziqhamo
Ukususela ekusekweni kwayo, i-Epiprobe iye yabambelela kwixabiso "lokuma kwiimveliso" kwaye yaseka iqela lophononongo lwangaphakathi ukuba liqhube amalungiselelo amaxwebhu enkqubo yolawulo lomgangatho, uphicotho-zincwadi lwangaphakathi kunye nomnye umsebenzi osebenzayo ukuqinisekisa ukuba iimveliso zithobela ngokungqongqo imigangatho yolawulo amaxwebhu angaphakathi kuyo yonke inkqubo yolawulo lomjikelo wobomi, ngokuthe ngcembe ukuqonda ulawulo olubanzi lomgangatho.Inkampani ifumene iifayili ze-4 zeDidi ye-I yesixhobo sonyango (Iindaba ezilungileyo! I-Epiprobe Biology ifumana iiFilings ezimbini zeDivayisi yezoNyango zeNucleic Acid Extraction Reagents!) kunye ne-3 yaseYurophu CE izitifiketi zokufumanisa umhlaza we-methylation kits (Epiprobe's Three Cancer Gene Methylation Detection Kits Fumana Isatifikethi se-CE yaseYurophu), kwaye ukhokele ekungeneni kwimarike yokuxilongwa komhlaza we-methylation.
Kwixesha elizayo, i-Epiprobe iya kulandela ngokungqongqo iimfuno ze-ISO 13485: inkqubo yolawulo lwekhwalithi ye-2016, ithobela umgaqo-nkqubo womgangatho othi "I-Product-oriented, Technology-centered, and Service-oriented".Iqela lolawulo lomgangatho liya kuqhuba ngokuqhubekayo umgangatho weenjongo ezicwangcisiweyo, zilawule ngokubanzi zonke ikhonkco ukusuka ekuphuhlisweni kwe-reagent ukuya kwinkqubo yokuvelisa, kwaye zihlala zizalisekisa ngokungqongqo inkqubo yokulawula kunye neemfuno zokulawula umngcipheko ezichazwe kumaxwebhu enkqubo yomgangatho ukuqinisekisa ukhuseleko kunye nokuchaneka kweemveliso.Inkampani iya kuqhubeka iphucula inqanaba lolawulo lomgangatho wayo, iqinisekise umgangatho weemveliso kunye neenkonzo, iphucule amandla okuhlangabezana ngokuqhubekayo neemfuno zabathengi kunye nolindelo, kwaye ibonelele abathengi ngemveliso yovavanyo oluphezulu lomhlaza kunye neenkonzo.
Ixesha lokuposa: Apr-28-2023