Cov khoom lag luam txhim khu kev qha thiab ruaj khov yog lub neej ntawm lub tuam txhab.Txij li thaum nws tsim muaj ze li ntawm 5 xyoos dhau los, Epiprobe yeej ib txwm muab qhov zoo tshaj plaws ua ntej, muab cov neeg siv khoom zoo thiab txhim khu kev qha mob qog noj ntshav thaum ntxov.Thaum lub Tsib Hlis 9, 2022, tom qab kev tshuaj xyuas nruj los ntawm cov kws tshaj lij los ntawm BSI British Standards Institution Certification (Beijing) Co., Ltd., Epiprobe tau ua tiav "ISO 13485: 2016" cov cuab yeej kho mob kev tswj xyuas cov ntawv pov thawj zoo.Cov peev txheej ntawm daim ntawv thov koom nrog yog tsim, kev tsim kho, tsim khoom, thiab kev faib tawm ntawm cov khoom siv kuaj ntshav methylation (PCR-fluorescence method).
Qhov tseem ceeb ntawm kev ua raws li ISO 13485 ntawv pov thawj
Qhov no yog daim ntawv pov thawj ntawm tag nrho cov txheej txheem ntawm kev tshawb fawb thiab kev tsim khoom, kev tsim khoom, thiab kev muag khoom hauv lub tuam txhab, qhia tias lub tuam txhab kev tswj hwm kev ua tau zoo ua raws li tus txheej txheem thoob ntiaj teb ISO 13485: 2016 rau cov cuab yeej kho mob zoo tswj kev tswj hwm.Lub tuam txhab muaj peev xwm ua tsis tu ncua thiab muab cov khoom lag luam zoo uas ua tau raws li cov kev xav tau ntawm cov neeg siv khoom siv kho mob, thiab tau mus txog thoob ntiaj teb cov qauv hauv cov khoom tsim, kev tsim kho, kev tsim khoom, thiab kev muag khoom.Qhov no yog ib qho kev txhim kho ntxiv hauv Epiprobe qhov kev tswj hwm qib zoo uas npog tag nrho cov khoom lag luam lub neej thiab kev txav mus rau cov qauv, normalization, thiab thoob ntiaj teb kev tswj hwm zoo.
Hais txog ISO 13485 Certification System
ISO 13485: 2016 yog tus qauv kev tswj hwm zoo tsim los ntawm Lub Koom Haum Thoob Ntiaj Teb rau Standardization (ISO) tshwj xeeb rau kev lag luam khoom siv kho mob (xws li hauv vitro diagnostic reagents), suav nrog cov txheej txheem xws li tsim thiab tsim kho, tsim khoom, thiab faib khoom siv kho mob.Cov qauv no yog cov qauv siv thoob ntiaj teb zoo tshaj plaws hauv kev lag luam khoom siv kho mob thiab sawv cev rau cov kev coj ua zoo tshaj plaws hauv kev tswj hwm kev lag luam thoob ntiaj teb cov cuab yeej kho mob.
Cov txheej txheem ntawv pov thawj ntawm Epiprobe's ISO 13485 Certification
Thaum Lub Yim Hli 2021, lub koom haum muab ntawv pov thawj tau lees paub Epiprobe daim ntawv thov rau kev tswj hwm kev tswj hwm tau ntawv pov thawj.Txij Lub Peb Hlis 1 txog rau Lub Peb Hlis 3, 2022, cov tswv cuab hauv pawg neeg soj ntsuam tau ua nruj me ntsis ntawm qhov chaw soj ntsuam thiab tshawb xyuas cov neeg ua haujlwm, cov chaw thiab cov khoom siv, thiab cov ntaub ntawv muaj feem xyuam thiab cov ntaub ntawv ntawm lub tuam txhab kev tsim khoom, zoo, kev tshawb fawb thiab kev loj hlob, kev tswj hwm kev lag luam, thiab kev lag luam department.Tom qab kev soj ntsuam xyuas kom zoo thiab ua tib zoo saib xyuas, cov kws tshaj lij pab pawg tshawb xyuas ntseeg tias cov qauv kev tswj xyuas zoo ntawm Shanghai Epiprobe Biology Co., Ltd. (Xuhui) thiab Shanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan) tau ua tiav, cov ntaub ntawv tseem ceeb yog txaus, thiab kev ua tiav ntawm phau ntawv zoo, cov ntaub ntawv txheej txheem, kev tshuaj xyuas sab hauv, kev tshuaj xyuas kev tswj hwm, thiab lwm yam txheej txheem tau zoo thiab ua tiav raws li ISO 13485 tus qauv.
Kev tswj xyuas kom zoo pab Epiprobe ua tiav cov txiaj ntsig zoo
Txij li thaum nws tsim, Epiprobe tau ua raws li tus nqi ntawm "sawv ntawm cov khoom" thiab tau tsim ib pab neeg soj ntsuam xyuas sab hauv los ua cov txheej txheem kev tswj xyuas cov ntaub ntawv zoo, kev tshuaj xyuas sab hauv thiab lwm yam kev ua haujlwm kom ntseeg tau tias cov khoom lag luam nruj me ntsis raws li cov qauv kev cai thiab cov ntaub ntawv sab hauv thoob plaws tag nrho cov txheej txheem tswj lub neej, maj mam paub txog kev tswj hwm zoo.Lub tuam txhab tau txais 4 Chav Kawm I cov cuab yeej kho mob filings (Zoo Xov Xwm! Epiprobe Biology Tau Txais Ob Chav Kawm I Medical Device Filings for Nucleic Acid Extraction Reagents!) thiab 3 European CE daim ntawv pov thawj rau cov kab mob qog noj ntshav methylation cov khoom siv (Epiprobe's Peb Cancer Gene Methylation Detection Kits Tau Txais European CE Certification), thiab tau coj tus thawj coj hauv kev nkag mus rau kev lag luam ntawm kev kuaj mob qog noj ntshav gene methylation.
Nyob rau hauv lub neej yav tom ntej, Epiprobe yuav nruj me ntsis ua raws li ISO 13485: 2016 kev tswj kev tswj kom zoo, ua raws li txoj cai zoo ntawm "Product-oriented, Technology-centered, and Service-oriented".Pab pawg tswj xyuas zoo yuav ua kom zoo dua cov hom phiaj zoo, tswj txhua qhov txuas los ntawm reagent txoj kev loj hlob mus rau cov txheej txheem ntau lawm, thiab ib txwm nruj me ntsis siv cov txheej txheem tswj thiab kev tswj hwm kev pheej hmoo uas yuav tsum tau teev tseg hauv cov ntaub ntawv ua haujlwm zoo kom muaj kev nyab xeeb thiab raug ntawm cov khoom.Lub tuam txhab yuav txuas ntxiv txhim kho nws qib kev tswj hwm zoo, ua kom cov khoom lag luam zoo thiab cov kev pabcuam zoo, txhim kho lub peev xwm ua kom tau raws li cov neeg siv khoom xav tau thiab kev cia siab, thiab muab cov neeg siv khoom zoo dua cov khoom siv tshuaj ntsuam xyuas thiab cov kev pabcuam.
Post lub sij hawm: Apr-28-2023