Ngwaahịa a pụrụ ịdabere na ya ma kwụsie ike bụ usoro ndụ nke ụlọ ọrụ.Ebe ọ bụ na e hiwere ya ihe fọrọ nke nta ka ọ bụrụ afọ 5 gara aga, Epiprobe na-ebute ịdịmma mbụ, na-enye ndị ọrụ ngwaahịa nyocha ọrịa kansa dị elu na ntụkwasị obi.Na Mee 9, 2022, ka nyochachara siri ike nke ndị ọkachamara sitere na BSI British Standards Institution Certification (Beijing) Co., Ltd., Epiprobe gafere asambodo sistemu njikwa ogo ngwaọrụ ahụike "ISO 13485:2016".Oke ngwa etinyere aka bụ imepụta, mmepe, nrụpụta na nkesa ngwa nyocha nchọpụta mkpụrụ ndụ ihe nketa methylation (usoro PCR-fluorescence).
Ihe dị mkpa iji mejuputa Asambodo ISO 13485
Nke a bụ asambodo zuru oke nke usoro nyocha na mmepe ngwaahịa, mmepụta na ire ahịa n'ime ụlọ ọrụ ahụ, na-egosi na usoro njikwa ogo ụlọ ọrụ na-agbaso ụkpụrụ mba ụwa nke ISO 13485: 2016 maka sistemụ njikwa ogo ngwaọrụ ahụike.Ụlọ ọrụ ahụ nwere ike ịga n'ihu na-emepụta ma na-enye ngwaahịa dị elu nke na-egbo mkpa nke ndị ahịa ngwaọrụ ahụike, ma rute ụkpụrụ mba ụwa n'ichepụta ngwaahịa, mmepe, mmepụta na ahịa.Nke a na-egosi ọganihu n'ihu na ọkwa njikwa ogo Epiprobe na-ekpuchi usoro ndụ ngwaahịa niile yana ịkwaga n'ịhazi nhazi, nhazigharị na nhazi nke njikwa mma ya na mba ụwa.
Ihe gbasara Sistemụ Asambodo ISO 13485
ISO 13485: 2016 bụ ọkọlọtọ njikwa mma nke International Organisation for Standardization (ISO) mepụtara maka ụlọ ọrụ ngwaọrụ ahụike (gụnyere in vitro diagnostic reagents), na-ekpuchi usoro dị ka imewe na mmepe, mmepụta na nkesa ngwaọrụ ahụike.Ọkọlọtọ a bụ ọkọlọtọ sistemụ ogo mba ụwa nke a na-ejikarị na ụlọ ọrụ ngwaọrụ ahụike ma na-anọchite anya omume kachasị mma na njikwa ogo maka ụlọ ọrụ ngwaọrụ ahụike mba ụwa.
Usoro asambodo nke Epiprobe's ISO 13485 Asambodo
N'August 2021, ụlọ ọrụ asambodo nabatara ngwa Epiprobe maka asambodo sistemụ njikwa mma.Site na Machị 1 ruo 3rd, 2022, ndị otu nyocha ahụ mere nyocha siri ike na saịtị na nyocha nke ndị ọrụ, akụrụngwa na nhazi akụrụngwa, yana akwụkwọ na ndekọ metụtara ya nke mmepụta, ịdịmma, nyocha na mmepe nke ụlọ ọrụ, njikwa ụlọ ọrụ, yana ngalaba ahịa.Mgbe nyochachara nke ọma na nke ọma, ndị ọkachamara na-ahụ maka otu nyocha ahụ kwenyere na usoro njikwa sistemu njikwa nke Shanghai Epiprobe Biology Co., Ltd. (Xuhui) na Shanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan) zuru oke, akwụkwọ ndị dị mkpa bụ. zuru oke na mmezu nke akwụkwọ ntuziaka dị mma, akwụkwọ usoro, nyocha nke ime, nyocha njikwa na usoro ndị ọzọ dị mma ma kwekọọ n'ụzọ zuru ezu n'ihe achọrọ nke ọkọlọtọ ISO 13485.
Njikwa ogo zuru oke na-enyere Epiprobe aka nweta nsonaazụ na-amị mkpụrụ
Ebe ọ bụ na e hiwere ya, Epiprobe agbasowo uru nke "iguzo na ngwaahịa" wee guzobe otu ndị na-enyocha nyocha nke ime ụlọ iji mepụta nkwadebe nke akwụkwọ njikwa usoro njikwa mma, nyocha nke ime na ọrụ ndị ọzọ bara uru iji hụ na ngwaahịa na-agbaso ụkpụrụ iwu na ụkpụrụ. akwụkwọ dị n'ime n'ime usoro njikwa usoro ndụ niile, jiri nwayọ na-achọpụta njikwa ogo zuru oke.Ụlọ ọrụ ahụ enwetala akwụkwọ ndekọ ngwaọrụ ahụike 4 Class I (Ozi Ọma! Epiprobe Biology Na-enweta Ngwakọta Ngwakọta Abụọ nke Mbụ nke Nucleic Acid Extraction Reagents!) na 3 European CE certifications maka ọrịa cancer gene methylation detection kits (Epiprobe's Three Cancer Gene Methylation Kits Get Asambodo CE nke European), ma bute ụzọ n'ịbanye n'ahịa nke nchọpụta mkpụrụ ndụ mkpụrụ ndụ cancer.
N'ọdịniihu, Epiprobe ga-agbasosi ike nke ISO 13485: 2016 njikwa njikwa mma, na-agbaso usoro iwu dị mma nke "Product-based, Technology-based, and Service-oriented".The àgwà management otu ga-anọgide na-ebuli àgwà atụmatụ ebumnuche, comprehensively ịchịkwa ọ bụla njikọ si reagent mmepe ka mmepụta usoro, na mgbe nile ike mejuputa usoro akara na ihe ize ndụ management chọrọ kpọmkwem na àgwà usoro akwụkwọ iji hụ na nchekwa na izi ezi nke ngwaahịa.Companylọ ọrụ ahụ ga-aga n'ihu na-emeziwanye ọkwa njikwa ogo ya, hụ na ngwaahịa na ọrụ dị mma, kwalite ikike iji gboo mkpa na atụmanya ndị ahịa, ma nye ndị ahịa ngwaahịa na ọrụ nyocha ọrịa kansa dị elu n'oge.
Oge nzipu: Eprel-28-2023