Imikhiqizo ethembekile futhi ezinzile iwumugqa wempilo wenkampani.Kusukela yasungulwa cishe eminyakeni engu-5 edlule, i-Epiprobe ibilokhu ibeka ikhwalithi kuqala, ihlinzeka abasebenzisi ngemikhiqizo yokuhlola umdlavuza esezingeni eliphezulu nethembekile.Ngomhla ziyisi-9 kuNhlaba, 2022, ngemva kokubuyekezwa okuqinile kochwepheshe abavela ku-BSI British Standards Institution Certification (Beijing) Co., Ltd., i-Epiprobe yaphasisa ngempumelelo isitifiketi se-"ISO 13485:2016" sohlelo lokuphatha idivayisi yezokwelapha.Ububanzi besicelo esihilelekile ukuklama, ukuthuthukiswa, ukukhiqizwa, kanye nokusatshalaliswa kwamakhithi okuhlola i-gene methylation (indlela ye-PCR-fluorescence).
Ukubaluleka kokusebenzisa isitifiketi se-ISO 13485
Lesi isitifiketi esiphelele sayo yonke inqubo yocwaningo nokuthuthukiswa komkhiqizo, ukukhiqizwa, nokudayiswa ngaphakathi kwenkampani, okubonisa ukuthi uhlelo lokuphatha ikhwalithi yenkampani luthobelana nezinga lamazwe ngamazwe le-ISO 13485:2016 lezinhlelo zokuphatha ikhwalithi yedivayisi yezokwelapha.Le nkampani iyakwazi ukuqhubeka ikhiqiza futhi ihlinzeke ngemikhiqizo yekhwalithi ephezulu ehlangabezana nezidingo zamakhasimende emishini yezokwelapha, futhi isifinyelele ezindinganisweni zamazwe ngamazwe ekwakhiweni komkhiqizo, ekuthuthukisweni, ekukhiqizeni nasekuthengisweni.Lokhu kuphawula ukuthuthuka okwengeziwe ezingeni lokuphatha ikhwalithi le-Epiprobe elihlanganisa wonke umjikelezo wempilo womkhiqizo kanye nokuqhubekela phambili ekumisweni okujwayelekile, ukwenziwa kujwayelekile, kanye nokwenziwa kwamazwe ngamazwe kokuphathwa kwekhwalithi yayo.
Mayelana ne-ISO 13485 Certification System
I-ISO 13485:2016 izinga lokuphathwa kwekhwalithi elithuthukiswe yi-International Organisation for Standardization (ISO) ikakhulukazi embonini yemishini yezokwelapha (okuhlanganisa ama-in vitro diagnostic reagents), ehlanganisa izinqubo ezifana nokuklanywa nokuthuthukiswa, ukukhiqizwa, nokusatshalaliswa kwemishini yezokwelapha.Leli zinga liyizinga lesistimu yekhwalithi yamazwe ngamazwe elisetshenziswa kakhulu embonini yemishini yezokwelapha futhi limelela izinqubo ezingcono kakhulu zokuphatha ikhwalithi embonini yamazwe ngamazwe yamadivayisi wezokwelapha.
Inqubo Yokuqinisekisa Yesitifiketi Se-Epiprobe's ISO 13485
Ngo-Agasti 2021, i-ejensi enikeza izitifiketi yasamukela ngokusemthethweni isicelo se-Epiprobe sokuthola isitifiketi sohlelo lokuphathwa kwekhwalithi.Kusukela mhla lu-1 kuNdasa kuya kumhla zizi-3, 2022, amalungu ethimba lokucwaninga amabhuku enza uphenyo olunzulu kanye nokucwaninga kwabasebenzi, izakhiwo nemishini, kanye nemibhalo ehlobene namarekhodi okukhiqizwa kwenkampani, ikhwalithi, ucwaningo nentuthuko, ukuphathwa kwebhizinisi, kanye iminyango yokumaketha.Ngemva kokucwaninga ngokucophelela nangokucophelela, ochwepheshe bethimba lokucwaninga bakholelwa ukuthi izinhlaka zesistimu yokuphatha ikhwalithi ye-Shanghai Epiprobe Biology Co., Ltd. (Xuhui) kanye ne-Shanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan) zase ziphelele, imibhalo efanele kwanele, kanye nokusebenza kwebhukwana lekhwalithi, imibhalo yezinqubo, ukuhlolwa kwamabhuku kwangaphakathi, ukubuyekezwa kwabaphathi, nezinye izinqubo bekukuhle futhi kuthobelana ngokugcwele nezimfuneko zezinga le-ISO 13485.
Ukuphathwa kwekhwalithi okuphelele kusiza i-Epiprobe ukuthi ithole imiphumela enezithelo
Kusukela yasungulwa, i-Epiprobe iye yabambelela enanini “lokuma emikhiqizweni” futhi yasungula ithimba labahlaziyi bamabhuku bangaphakathi ukuze lenze amalungiselelo emibhalo yesistimu yokuphatha ikhwalithi, ukucwaninga kwamabhuku kwangaphakathi kanye nomunye umsebenzi ongokoqobo ukuze kuqinisekiswe ukuthi imikhiqizo ihambisana ngokuqinile nezindinganiso zokulawula futhi imibhalo yangaphakathi kuyo yonke inqubo yokuphatha umjikelezo wempilo, kancane kancane ibona ukuphathwa kwekhwalithi okuphelele.Le nkampani ithole ukufakwa kwemishini yezokwelapha ye-Class I ye-4 (Izindaba Ezinhle! I-Epiprobe Biology Ithola Ukugcwaliswa Kwedivayisi Yezokwelapha Yekilasi I Ema-Nucleic Acid Extraction Reagents!) kanye nezitifiketi ezi-3 zase-European CE zezinsiza zokuthola umdlavuza wofuzo lwe-methylation (I-Epiprobe's Three Cancer Gene Methylation Detection Kits Obtain European CE Certification), futhi uye wahola ekungeneni emakethe yokuxilongwa kofuzo lwe-methylation yomdlavuza.
Ngokuzayo, i-Epiprobe izolandela ngokuqinile izimfuneko ze-ISO 13485:2016 yohlelo lokuphatha ikhwalithi, ithobela inqubomgomo yekhwalithi "Yokuthambekele Emkhiqizweni, Okugxile Ezobuchwepheshe, Nokugxile Ensizeni".Ithimba lokuphatha ikhwalithi lizoqhubeka nokuthuthukisa imigomo yamasu ekhwalithi, lilawule ngokuphelele zonke izixhumanisi kusukela ekuthuthukisweni kwe-reagent kuya enqubweni yokukhiqiza, futhi lihlale lisebenzisa ngokuqinile ukulawulwa kwenqubo kanye nezimfuneko zokulawula ubungozi ezishiwo kumadokhumenti esistimu yekhwalithi ukuze kuqinisekiswe ukuphepha nokunemba kwemikhiqizo.Inkampani izoqhubeka ithuthukisa izinga layo lokuphatha ikhwalithi, iqinisekise ikhwalithi yemikhiqizo namasevisi, ithuthukise ikhono lokuhlangabezana nezidingo zamakhasimende ngokuqhubekayo nokulindelwe, futhi inikeze amakhasimende ngemikhiqizo yokuhlola umdlavuza wekhwalithi ephezulu kanye nezinsizakalo.
Isikhathi sokuthumela: Apr-28-2023