Sisebenzisa isistimu yokuphatha ikhwalithi egunyazwe futhi yaqinisekiswa kumazinga e-ISO 9001:2015. Lokhu kubonisa ukuzibophezela kwethu ekuthuthukisweni kwekhwalithi okuqhubekayo nokwaneliseka kwamakhasimende.
Izitifiketi Ze-ISO Zisisiza Ukuzuza Ukwaneliseka Kwekhasimende
I-Guan Sheng iqinisekisiwe futhi iyahambisana ne-ISO 9001:2015.Lawa mazinga e-ISO acacisa izidingo zokuphatha zekhwalithi, impilo yasemsebenzini nokuphepha kanye nokuvikelwa kwemvelo. Babonisa ukuzibophezela kwethu ekukunikezeni ngokungaguquki nge-prototyping yekhwalithi ephezulu, ukukhiqizwa kwevolumu kanye nezinsizakalo ezihlobene.
Siphinde saqinisekisa i-lATF16949:2016, isistimu yokuphatha ikhwalithi eqondiswe ngqo imboni yezimoto.
Isitifiketi sethu sakamuva kakhulu yi-ISO 13485: 2016, esiqondisa ngokukhethekile isistimu yekhwalithi yokukhiqiza idivayisi yezokwelapha nezinye izinsizakalo eziphathelene nezempilo.
Lezi zinhlelo zokuphatha, kanye nemishini yethu yokuhlola ethuthukisiwe, yokulinganisa neyokuhlola, iqinisekisa ukuthi uyohlala uthola imikhiqizo ehlangabezana nedlula lokho okulindele.
ISO 9001: 2015
Ikhwalithi Engaphezu Kwalokho Okulindele
Sithole isitifiketi sethu sokuqala se-ISO: 9001 ngo-2013, futhi besilokhu sithuthukisa amasistimu ethu kusukela lapho. Ngokuhamba kweminyaka, isiyalo sokukhiqiza sokumiswa kwe-ISO sisisize ukugcina ubuholi emkhakheni wethu.
I-ISO: 9001 bekungenye yezinhlelo zokuphatha zokuqala ezasungula ukumisa, imibhalo kanye nokungaguquguquki njengokhiye wokulawula ikhwalithi yomkhiqizo oqediwe.
ISO 13485: 2016
Letha Umkhiqizo Wakho Wezokwelapha Ukumaketha Ngokushesha
U-Guan Sheng uzinikele ekubeni umhlinzeki osezingeni lomhlaba wezixazululo zokukhiqiza zabathuthukisi bemikhiqizo yezokwelapha. Isitifiketi sethu se-ISO 13485:2016 sikunikeza ukuthula kwengqondo ukuthi izinto zethu ezingavuthiwe, ukuhlola, ukuhlola kanye nezinqubo zokukhiqiza zithobela imihlahlandlela eqinile yokulawula ikhwalithi edingekayo ukuze kugunyazwe ngokomthetho.
Lokhu kukusiza uma usulungele ukuthumela imikhiqizo yakho ukuze ihlukaniswe ku-FDA e-United States noma i-European Medicines Agency (EMA).
lATF16949:2016
Inkampani yethu etholwe ngo-2020 Isitifiketi se-iATF16949:2016 ingaqinisekisa ukuthi izingxenye zezimoto zakho zithobelana namazinga omhlaba. I-IATF 16949:2016 iyi-ISO Technical Specification eqondanisa amazinga esistimu yekhwalithi yezimoto ekhona e-US, isiJalimane, isiFulentshi kanye ne-Italian ngaphakathi kwemboni yezimoto yomhlaba wonke.