I-Joytech Ithuthukisa Ikhwalithi NgeSitifiketi Se-ISO 13485 Sezindawo Ezintsha Zokukhiqiza Nezigaba Zomkhiqizo

IJoytech ibuyekeze i-ISO 13485 yethu isitifiketi esinesizinda sokukhiqiza esisanda kuvunywa kanye nezigaba zemikhiqizo emisha.

Lokhu kusho ukuthi konke okusha Imikhiqizo ye-Joytech edayiswayo ikhiqizwa ngaphansi kohlelo lokuphatha oluqinisekisiwe lwe-ISO 13485.

Iyini i-ISO 13485?

I-ISO 13485 iyindinganiso eyaziwa umhlaba wonke yezinhlelo zokuphatha ikhwalithi eziqondene ngqo nemboni yemishini yezokwelapha. Iklanyelwe ukuqinisekisa ukuthi imishini yezokwelapha ihlangabezana ngokungaguquki nezimfuneko zokulawula. Izinga lihlanganisa zonke izici zomjikelezo wempilo yedivayisi yezokwelapha, okuhlanganisa ukuklama, ukuthuthukiswa, ukukhiqizwa, ukugcinwa, ukusatshalaliswa, ukufakwa, ukusevisa, nokulahlwa.

Izici ezibalulekile ze-ISO 13485:

· I-Quality Management System (QMS): Isungula i-QMS eqinile ukuze ilawule izinqubo futhi iqinisekise ikhwalithi yomkhiqizo.

· Ukuthobela Umthetho: Iqinisekisa ukuthotshelwa kwezidingo ezifanele zokulawula.

· Ukulawulwa Kobungozi: Kuhlanganisa izimiso zokulawula ubungozi kuwo wonke umjikelezo wokuphila womkhiqizo.

· Ukuqashelwa Komkhiqizo: Ihlanganisa zonke izigaba kusukela ekuklanyweni nasekuthuthukisweni kuya ekukhiqizeni nasemisebenzini yangemva kwemakethe.

· Ukulawulwa Kwenqubo: Kugcizelela ukubaluleka kokulawula izinqubo ukuze kugcinwe ikhwalithi yomkhiqizo.

· Ukuthuthukiswa Okuqhubekayo: Kugxile ekuthuthukisweni okuqhubekayo kwezinqubo nezinhlelo.

Ukuqinisekiswa kwe-ISO 13485:

Uma inkampani iqinisekiswa yi-ISO 13485, kusho ukuthi inhlangano ezimele enikeza izitifiketi ihlole uhlelo lokuphathwa kwekhwalithi yenkampani futhi yaqinisekisa ukuthi ihlangabezana nezimfuneko zezinga le-ISO 13485. Lesi sitifiketi sibonisa ukuthi inkampani isungule izinqubo nezilawuli ezisebenzayo zokuqinisekisa ukuphepha nokusebenza kahle kwemishini yayo yezokwelapha.

Imithelela yesitifiketi se-ISO 13485:

· Ukwemukelwa Okungokomthetho: Kusiza ekuhlangabezaneni nezimfuneko zokulawula ezimakethe zomhlaba ezihlukene, okubalulekile ekukhangiseni kwemishini yezokwelapha.

· Ukuzethemba Kwekhasimende: Kuthuthukisa ukwethembana kanye nokuzethemba phakathi kwamakhasimende nababambiqhaza mayelana nekhwalithi nokuphepha kwemikhiqizo.

· Ukufinyelela Emakethe: Kwenza kube lula ukungena ezimakethe ezintsha lapho isitifiketi se-ISO 13485 siyimfuneko ukuze kugunyazwe ngokomthetho.

· Ukusebenza kahle Kokusebenza: Kuthuthukisa izinqubo ezilula kanye nokwenza ngcono okuqhubekayo, okuholela ekusebenzeni kahle.

· Ukulawulwa Kobungozi: Iqinisekisa ukuthi izinqubo zokulawula ubungozi zihlanganiswa ngempumelelo kuwo wonke umjikelezo wempilo womkhiqizo.

Yini Isikhungo Esisha se-Joytech Sigunyazwe yi-ISO 13485?

Isikhungo esisha sakwaJoytech esiku-No. 502 Shunda Road besilokhu sikhiqizwa kusukela ngo-2023. 

Imboza indawo engamamitha-skwele angama-69,000 enendawo eyakhelwe ukusebenza isiyonke engaphezu kuka-260,000 wamamitha-skwele, lesi sikhungo esisha sifakwe okuzenzakalelayo kokukhiqiza, ukuhlanganisa, nemigqa yokupakisha, kanye nezindawo zokugcina impahla ezinezinhlangothi ezintathu ezizenzakalelayo. Iningi lemikhiqizo yakwaJoytech edayiswayo manje isikhiqizwa kulesi sikhungo esisha.

Ukuze uthole imininingwane eyengeziwe, siyakwamukela ukuthi uvakashele indawo yethu !