tsamba_banner

nkhani

Epiprobe idapambana chiphaso cha ISO13485 Quality Management System

Zogulitsa zodalirika komanso zokhazikika ndizo moyo wa kampani.Chiyambireni kukhazikitsidwa pafupifupi zaka 5 zapitazo, Epiprobe nthawi zonse imayika zabwino kwambiri, kupatsa ogwiritsa ntchito mankhwala apamwamba komanso odalirika owunika khansa.Pa Meyi 9, 2022, ataunikanso mozama ndi akatswiri ochokera ku BSI British Standards Institution Certification (Beijing) Co., Ltd., Epiprobe adapambana chiphaso cha "ISO 13485:2016" chiphaso cha kasamalidwe ka zida zamankhwala.Kuchuluka kwa ntchito yomwe ikukhudzidwa ndi kupanga, kupanga, kupanga, ndi kugawa zida zoyesera za gene methylation (njira ya PCR-fluorescence).

Kufunika kokhazikitsa ISO 13485 certification

Ichi ndi chiphaso chokwanira cha ndondomeko yonse ya kafukufuku wazinthu ndi chitukuko, kupanga, ndi malonda mkati mwa kampani, zomwe zimasonyeza kuti kasamalidwe kabwino ka kampani kamagwirizana ndi muyezo wapadziko lonse wa ISO 13485:2016 wamakina oyang'anira zida zamankhwala.Kampaniyo imatha kupanga mosalekeza ndikupereka zinthu zapamwamba kwambiri zomwe zimakwaniritsa zosowa za makasitomala a zida zamankhwala, ndipo zafika pamiyezo yapadziko lonse lapansi pakupanga zinthu, chitukuko, kupanga, ndi kugulitsa.Izi zikuwonetsa kusintha kwina kwa kasamalidwe kabwino ka Epiprobe komwe kumakhudza nthawi yonse yazinthu zomwe zimapangidwira komanso kusunthira kokhazikika, kukhazikika, komanso kupititsa patsogolo kayendetsedwe kabwino kake.

Za ISO 13485 Certification System

ISO 13485: 2016 ndi mulingo wa kasamalidwe kabwino wopangidwa ndi International Organisation for Standardization (ISO) makamaka makampani azachipatala (kuphatikiza ma in vitro diagnostic reagents), okhudza njira monga mapangidwe ndi chitukuko, kupanga, ndi kugawa kwa zida zamankhwala.Mulingo uwu ndi womwe umagwiritsidwa ntchito kwambiri padziko lonse lapansi pamakampani opanga zida zamankhwala ndipo umayimira njira zabwino kwambiri zoyendetsera zida zachipatala padziko lonse lapansi.

Njira Yotsimikizira za Epiprobe's ISO 13485 Certification

Mu Ogasiti 2021, bungwe lochitira certification lidavomera mwalamulo pempho la Epiprobe la satifiketi yoyendetsera bwino.Kuyambira pa Marichi 1 mpaka 3, 2022, mamembala a gulu lofufuza adafufuza mozama ndikuwunika kwa ogwira ntchito pamalowo, zida ndi masinthidwe a zida, komanso zolemba zofananira ndi zolemba zamakampani opanga, mtundu, kafukufuku ndi chitukuko, kasamalidwe kamakampani, ndi madipatimenti zamalonda.Pambuyo pofufuza mosamala komanso mosamala, akatswiri a gulu lofufuza adakhulupirira kuti machitidwe a kasamalidwe kabwino a Shanghai Epiprobe Biology Co., Ltd. (Xuhui) ndi Shanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan) anali athunthu, zolemba zoyenera zinali zokwanira, ndipo kachitidwe ka buku labwino, zikalata zamachitidwe, zowunikira zamkati, kuwunika kwa oyang'anira, ndi njira zina zinali zabwino komanso zogwirizana ndi zofunikira za muyezo wa ISO 13485.

Kasamalidwe kokwanira kabwino kumathandiza Epiprobe kupeza zotsatira zabwino

Chiyambireni kukhazikitsidwa kwake, Epiprobe yakhala ikutsatira kufunika kwa "kuyima pazinthu" ndikukhazikitsa gulu lowunikira kafukufuku wamkati kuti likonzekere zikalata zamadongosolo a kasamalidwe kaubwino, kafukufuku wamkati ndi ntchito zina zothandiza kuwonetsetsa kuti malonda akutsatira mosamalitsa miyezo yoyendetsera bwino komanso zikalata zamkati panthawi yonse yoyendetsera kayendetsedwe ka moyo, pang'onopang'ono kuzindikira kasamalidwe kabwino kathunthu.Kampaniyo yapeza zolemba za zida zachipatala za 4 Class I (Uthenga Wabwino! Epiprobe Biology Ipeza Zolemba Zazida Zamankhwala Zamagulu Awiri a Nucleic Acid Extraction Reagents!) European CE Certification), ndipo adatsogola polowa msika wa khansa gene methylation diagnosis.

M'tsogolomu, Epiprobe idzatsatira mosamalitsa zofunikira za ISO 13485:2016 kasamalidwe kabwino kachitidwe, kutsatira mfundo za "Zopangira, Zopanga Zaukadaulo, ndi Zothandizira".Gulu loyang'anira khalidwe lidzapitirizabe kukhathamiritsa zolinga zabwino, kuwongolera momveka bwino ulalo uliwonse kuchokera ku chitukuko cha reagent mpaka kupanga, ndipo nthawi zonse tsatirani mosamalitsa zowongolera ndi kuwongolera zoopsa zomwe zafotokozedwa muzolemba zamadongosolo kuti zitsimikizire chitetezo ndi kulondola kwazinthu.Kampaniyo ipitiliza kuwongolera kasamalidwe kabwino, kuwonetsetsa kuti zogulitsa ndi ntchito, kukulitsa luso lokwaniritsa zosowa ndi zomwe makasitomala amayembekeza mosalekeza, ndikupatsa makasitomala zinthu ndi ntchito zowunikira khansa yapamwamba kwambiri.


Nthawi yotumiza: Apr-28-2023