I-JoyTech ithuthukisa ikhwalithi nge-ISO 13485 isitifiketi sezindawo ezintsha zokukhiqiza nezigaba zomkhiqizo

UJoyTech uvuselele i-ISO yethu engu-13485 Isitifiketi ngesizinda esisanda kuvunywa sokukhiqiza kanye nezigaba ezintsha zomkhiqizo.

Lokhu kusho ukuthi konke okusha Imikhiqizo yeJoyTech ethengiswayo yenziwa ngaphansi kohlelo lokuphatha oluqinisekisiwe lwe-ISO 13485.

Yini i-ISO 13485?

I-ISO 13485 iyindinganiso ehlonishwa umhlaba wonke yezinhlelo zokulawulwa kwekhwalithi ethize embonini yedivayisi yezokwelapha. Kuklanyelwe ukuqinisekisa ukuthi amadivaysi ezokwelapha ahlangabezana njalo ahlangabezana nezidingo zokulawula. I-Standard ihlanganisa zonke izici zomjikelezo wempilo yezokwelapha, kufaka phakathi design, ukuthuthukiswa, ukukhiqizwa, ukugcinwa, ukusatshalaliswa, ukufakwa, ukuhambisa, nokulahlwa.

Izici ezibalulekile ze-ISO 13485:

Uhlelo Lokuphathwa Kwezezisekweni (QMS): Isungula i-QEST QMS ukuphatha izinqubo futhi iqinisekise ikhwalithi yomkhiqizo.

Ukulandela umthetho wokulawula : Ukuqinisekisa ukuhambisana nezidingo ezifanele zokulawula.

· Ukulawulwa kwengozi: Kufaka imigomo yokulawulwa kwengozi kuyo yonke indawo yomkhiqizo.

Kuhlanganisa Ukuqaphela Komkhiqizo: zonke izigaba kusuka ekwakhiweni nasekuthuthukisweni kuya ekukhiqizweni nasemisebenzini yangemva kwemakethe.

Ukulawulwa Kwenqubo: Kugcizelela ukubaluleka kwezinqubo zokulawula ukugcina ikhwalithi yomkhiqizo.

Ukuthuthuka okuqhubekayo: Kugxile ekuthuthukisweni okuqhubekayo kwezinqubo nezinhlelo.

Isitifiketi nge-ISO 13485:

Lapho inkampani iqinisekiswe yi-ISO 13485, kusho ukuthi umzimba ozimele wokuqinisekisa uhlole uhlelo lokuphathwa kwekhwalithi yenkampani futhi luqinisekisile ukuthi luhlangabezana nezidingo ze-ISO 13485 standard. Lesi sitifiketi sibonisa ukuthi inkampani isungule izinqubo ezisebenzayo kanye nezilawuli ukuqinisekisa ukuphepha nokusebenza kahle kwamadivayisi wawo wezokwelapha.

Imiphumela yesitifiketi se-ISO 13485:

Ukwemukelwa okulawulwa : Kusiza ekufezeni izidingo zokulawula ezimakethe ezahlukahlukene zomhlaba, ezibalulekile kumadivayisi wezokwelapha.

Ukuzethemba kwamakhasimende : Kuthuthukisa ukwethembana nokuzethemba phakathi kwamakhasimende nababambiqhaza maqondana nekhwalithi nokuphepha kwemikhiqizo.

Ukufinyelela Kwemakethe: Kusiza ukungena ezimakethe ezintsha lapho isitifiketi se-ISO 13485 siyimfuneko yokuthola imvume yokulawula.

· Ukusebenza kahle kwe-Operational: Kukhuthaza izinqubo ezihleliwe kanye nokwenza ngcono okuqhubekayo, okuholela ekusebenzeni kahle kokusebenza.

· Ukulawulwa kwengozi: Kuqinisekisa ukuthi imikhuba yokulawulwa kwengozi ihlanganiswa ngempumelelo kulo lonke i-Lifecycle yomkhiqizo.

Yini Isikhungo esisha sikaJoytech siqinisekiswe yi-ISO 13485?

Isikhungo esisha sikaJoytech ku-No. 502 Shunda Road bebelokhu bekhiqizwa kusukela ngo-2023. 

Ukumboza indawo enamamitha-skwele angama-69,000 anendawo eyakhelwe ngaphakathi yokusebenza kwamamitha-skwele angaphezu kuka-260,000, indawo entsha ifakwe ukukhiqizwa okuzenzakalelayo, umhlangano, kanye nemigqa yokufaka okuzenzakalelayo, kanye nezindawo zokugcina ezenzakalelayo ezintathu. Iningi lemikhiqizo kaJoyTech ethengiswayo njengamanje iyathengiswa manje kulesi sikhungo esisha.

Ngemininingwane engaphezulu, siyakwamukela ukuthi uvakashele Isikhungo sethu !