Ibicuruzwa byizewe kandi bihamye nubuzima bwikigo.Kuva yashingwa hashize hafi imyaka 5, Epiprobe yamye ishyira imbere ubuziranenge, iha abakoresha ibicuruzwa byiza kandi byizewe bya kanseri hakiri kare.Ku ya 9 Gicurasi 2022, nyuma y’isuzuma rikomeye ryakozwe n’inzobere zo muri BSI British Standard Institution Certificate (Beijing) Co., Ltd., Epiprobe yatsinze neza "ISO 13485: 2016" icyemezo cy’imicungire y’ibikoresho by’ubuvuzi.Ingano yo gusaba irimo ni igishushanyo, iterambere, gukora, no gukwirakwiza ibikoresho byo gupima gene methylation (uburyo bwa PCR-fluorescence).
Akamaro ko gushyira mubikorwa ISO 13485
Iki nicyemezo cyuzuye cyibikorwa byose byubushakashatsi niterambere, ibicuruzwa, nigurisha muri sosiyete, byerekana ko sisitemu yo gucunga neza isosiyete ikurikiza amahame mpuzamahanga ya ISO 13485: 2016 kuri sisitemu yo gucunga neza ibikoresho byubuvuzi.Isosiyete ifite ubushobozi bwo gukomeza gukora no gutanga ibicuruzwa byujuje ubuziranenge byujuje ibyifuzo by’abakiriya b’ubuvuzi, kandi bigeze ku rwego mpuzamahanga mu bijyanye no gushushanya ibicuruzwa, iterambere, umusaruro, no kugurisha.Ibi birerekana ko hari byinshi byateye imbere murwego rwo gucunga ubuziranenge bwa Epiprobe bikubiyemo ubuzima bwose bwibicuruzwa ndetse no kugana ku bipimo ngenderwaho, bisanzwe, ndetse no kumenyekanisha imiyoborere myiza.
Sisitemu ya ISO 13485
ISO 13485: 2016 ni igipimo cy’imicungire y’ubuziranenge cyateguwe n’umuryango mpuzamahanga wita ku bipimo ngenderwaho (ISO) cyane cyane mu nganda zikoreshwa mu buvuzi (harimo na vitro diagnostic reagents), gikubiyemo inzira nko gushushanya no guteza imbere, gukora, no gukwirakwiza ibikoresho by’ubuvuzi.Ibipimo ngenderwaho nuburyo bukoreshwa cyane muri sisitemu yubuziranenge mpuzamahanga mubikorwa byubuvuzi kandi byerekana uburyo bwiza bwo gucunga neza inganda mpuzamahanga zikoreshwa mubuvuzi.
Uburyo bwo Kwemeza ISO 13485 Icyemezo cya Epiprobe
Muri Kanama 2021, ikigo gishinzwe gutanga ibyemezo cyakiriye ku mugaragaro icyifuzo cya Epiprobe cyo kwemeza sisitemu yo gucunga neza.Kuva ku ya 1 kugeza ku ya 3 Werurwe 2022, abagize itsinda ry’ubugenzuzi bakoze igenzura rikomeye ku rubuga no kugenzura abakozi, ibikoresho n’ibikoresho, hamwe n’inyandiko zijyanye n’umusaruro w’isosiyete, ubuziranenge, ubushakashatsi n’iterambere, imicungire y’ibigo, na amashami yo kwamamaza.Nyuma yubugenzuzi bwitondewe kandi bwitondewe, impuguke zitsinda ryubugenzuzi zemeje ko inzego zishinzwe gucunga ubuziranenge bwa Shanghai Epiprobe Biology Co., Ltd. (Xuhui) na Shanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan) zuzuye, ibyangombwa bireba byari bihagije, no gushyira mu bikorwa imfashanyigisho nziza, inyandiko zikorwa, ubugenzuzi bwimbere, isuzuma ryubuyobozi, nibindi bikorwa byari byiza kandi byujuje byuzuye ibisabwa na ISO 13485.
Gucunga neza ubuziranenge bifasha Epiprobe kugera kubisubizo byera
Kuva yashingwa, Epiprobe yubahirije agaciro ko "guhagarara ku bicuruzwa" kandi ishyiraho itsinda rishinzwe gusuzuma ubugenzuzi bw’imbere kugira ngo ritegure inyandiko z’imicungire y’ubuziranenge, ubugenzuzi bw’imbere n’ibindi bikorwa bifatika kugira ngo ibicuruzwa byubahirize neza amahame ngenderwaho kandi inyandiko zimbere mubikorwa byose byubuzima bwubuzima, buhoro buhoro bumenya gucunga neza ubuziranenge.Isosiyete yabonye ibikoresho byo mu rwego rwa 4 byo mu rwego rwa mbere (Amakuru meza! Ibinyabuzima bya Epiprobe Bifite Ibyiciro By’ubuvuzi By’icyiciro cya mbere byo mu bwoko bwa Nucleic Acide Extraction Reagents!) Hamwe n’impamyabumenyi 3 zo mu Burayi CE zerekana ibikoresho bya kanseri ya methylation (Epiprobe's Three Cancer Methylation Detection Kits Kubona Icyemezo cy’iburayi CE), kandi yafashe iyambere mu isoko rya kanseri ya methylation ya kanseri.
Mu bihe biri imbere, Epiprobe izakurikiza byimazeyo ibisabwa na sisitemu yo gucunga ubuziranenge ISO 13485: 2016, yubahiriza politiki y’ubuziranenge ya "Ibicuruzwa bishingiye ku bicuruzwa, bishingiye ku ikoranabuhanga, kandi bishingiye kuri serivisi".Itsinda rishinzwe gucunga ubuziranenge rizakomeza kunoza intego z’ubuziranenge, kugenzura byimazeyo buri sano kuva iterambere ryongeye kugera ku musaruro, kandi buri gihe rishyira mu bikorwa byimazeyo kugenzura ibikorwa no gucunga ibyago bisabwa mu nyandiko za sisitemu y’ubuziranenge kugira ngo ibicuruzwa n’umutekano bibe byiza.Isosiyete izakomeza kunoza urwego rw’imicungire y’ubuziranenge, yizere ko ibicuruzwa na serivisi byujuje ubuziranenge, bizamura ubushobozi bwo gukomeza guhaza ibyo abakiriya bakeneye ndetse n’ibyo bategerejweho, kandi biha abakiriya serivisi nziza za kanseri yo mu rwego rwo hejuru gusuzuma ibicuruzwa na serivisi.
Igihe cyo kohereza: Apr-28-2023