Zvigadzirwa zvinovimbika uye zvakagadzikana ndiwo mararamiro ekambani.Kubva payakavambwa angangoita makore mashanu apfuura, Epiprobe yagara ichiisa mhando yekutanga, ichipa vashandisi nemhando yepamusoro uye yakavimbika kenza zvigadzirwa zvekutanga kuongorora.Musi wa9 Chivabvu 2022, mushure mekuongorora kwakasimba kwakaitwa nenyanzvi kubva kuBSI British Standards Institution Certification (Beijing) Co., Ltd., Epiprobe yakabudirira kupasa "ISO 13485:2016" chitupa chekurapa kwemhando yehutano system system.Chiyero chekushandisa chinosanganisirwa dhizaini, kusimudzira, kugadzira, uye kugovera gene methylation yekuongorora kits (PCR-fluorescence nzira).
Iko kukosha kwekuita ISO 13485 certification
Ichi chitupa chakakwana chese maitiro ekutsvagisa chigadzirwa nekusimudzira, kugadzira, uye kutengesa mukati mekambani, zvichiratidza kuti hurongwa hwekambani hwemhando yepamusoro hunoenderana neyakajairwa pasi rose ye ISO 13485:2016 yemasisitimu ekurapa emhando yepamusoro.Kambani iyi inokwanisa kuenderera mberi nekugadzira nekupa zvigadzirwa zvemhando yepamusoro zvinosangana nezvinodiwa nevatengi vemidziyo yekurapa, uye yasvika pasi rose mukugadzirwa kwechigadzirwa, kusimudzira, kugadzira, uye kutengesa.Izvi zvinoratidza kumwe kuvandudzwa kweEpiprobe's quality management level inofukidza hupenyu hwese hwechigadzirwa uye nhanho yakanangana nekumisikidzwa, kugarisa, uye kudyidzana nedzimwe nyika kwehutongi hwayo.
Nezve ISO 13485 Certification System
ISO 13485: 2016 chiyero chemhando yepamusoro chakagadzirwa neInternational Organisation for Standardization (ISO) chakanangana neindasitiri yemidziyo yekurapa (kusanganisira in vitro diagnostic reagents), inovhara maitiro akadai sedhizaini nekusimudzira, kugadzira uye kugovera kwemidziyo yekurapa.Iyi chiyero ndiyo inonyanya kushandiswa yepasirese yemhando system chiyero muindasitiri yemidziyo yekurapa uye inomiririra maitiro akanakisa mukutonga kwemhando yeindasitiri yepasi rose yemidziyo yekurapa.
Iyo Setifiketi Maitiro eEpiprobe's ISO 13485 Certification
Muna Nyamavhuvhu 2021, sangano rinopa zvitupa rakatambira zviri pamutemo chikumbiro cheEpiprobe chekupihwa zvitupa zvemhando yepamusoro.Kubva Kurume 1 kusvika 3, 2022, nhengo dzechikwata chekuongorora dzakaita ongororo yakasimba pa-saiti uye ongororo yevashandi, zvivakwa uye magadzirirwo emidziyo, uye magwaro ane hukama nemarekodhi ekugadzirwa kwekambani, mhando, kutsvagisa nekusimudzira, manejimendi emabhizinesi, uye. madhipatimendi ekutengesa.Mushure mekunyatsoongorora uye nekuchenjera, nyanzvi dzechikwata chekuongorora dzakatenda kuti zvimiro zvehutongi hwemhando dzeShanghai Epiprobe Biology Co., Ltd. (Xuhui) neShanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan) dzaive dzakakwana, magwaro akakodzera aive zvakakwana, uye kuitwa kwebhuku remhando yepamusoro, magwaro emaitiro, ongororo yemukati, ongororo yemanejimendi, uye mamwe maitiro aive akanaka uye achinyatsoenderana nezvinodiwa zveISO 13485 standard.
Yakazara mhando manejimendi inobatsira Epiprobe kuwana zvibereko
Kubva payakavambwa, Epiprobe yakatevedzera kukosha kwe "kumira pane zvigadzirwa" uye yakamisa timu yemukati yekuongorora yekuongorora kuti iite gadziriro yezvinyorwa zvemhando yepamusoro system, ongororo yemukati uye rimwe basa rinoshanda kuti ive nechokwadi chekuti zvigadzirwa zvinoteedzera zvimiro zvekutonga uye. zvinyorwa zvemukati mukati mese lifecycle manejimendi maitiro, zvishoma nezvishoma kuona yakakwana yemhando manejimendi.Kambani yakawana 4 Class I mishonga yekurapa mafilings (Nhau Dzakanaka! Epiprobe Biology Inowana Maviri eClass I Medical Device Filings yeNucleic Acid Extraction Reagents!) uye 3 European CE certification yekenza gene methylation yekuongorora kits (Epiprobe's Matatu Cancer Gene Methylation Detection Kits Yawana. European CE Certification), uye yakatungamira kupinda mumusika wegomarara gene methylation kuongororwa.
Mune ramangwana, Epiprobe ichanyatso kutevedzera zvinodiwa zve ISO 13485: 2016 quality management system, ichitevedzera mutemo wemhando ye "Product-oriented, Technology-centered, and Service-oriented".Chikwata che manejimendi chemhando chinoramba chichikwiridzira zvibodzwa zvemhando yepamusoro, kudzora zvizere chinongedzo chese kubva pakuvandudza reagent kusvika kumaitiro ekugadzira, uye chinogara chichinyatsoita kudzora maitiro uye njodzi dzekutonga zvinodiwa zvinotsanangurwa mumhando yemagwaro ehurongwa kuti ive nechokwadi chekuchengetedza uye chokwadi chezvigadzirwa.Iyo kambani icharamba ichivandudza hunhu hwayo hwekutarisira, kuve nechokwadi chemhando yezvigadzirwa nemasevhisi, kusimudzira kugona kuenderera mberi nezvinodiwa nevatengi uye zvinotarisirwa, uye nekupa vatengi vane-mhando yepamusoro kenza yekutanga yekuongorora zvigadzirwa nemasevhisi.
Nguva yekutumira: Kubvumbi-28-2023