Sikuqinisekisa njani ukuba ngumgangatho ogqwesileyo we-IVD Laboratory?

Sikuqinisekisa njani ukuba ngumgangatho ogqwesileyo we-IVD Laboratory?

Suzhou ace biomedicalUyazi ukuba umgangatho ubalulekile kwicandelo le-IVD. I-Ladratory yethu idyhumane, enxibelelana ngokuthe ngqo neesampulu zesigulana kunye neRegents, zinefuthe ngqo ekuchanekeni nasekuthembekeni kovavanyo. Ke ngoko, sinebhongo ngokwazisa ukuba izidlo zethu ze-IVD ze-IVD ziye zafikelela kwimigangatho ephezulu kwishishini ngokwemigangatho.

Siyaqonda ukuba isiqinisekiso semigangatho sivela kulawulo olungqongqo lwenkqubo nganye yemveliso. Kungenxa yoko le nto sisebenzisa imigca ezenzekelayo yokuvelisa i-omenzele kwaye landela inkqubo yolawulo lwe-ISO13484. Ngokusebenzisa ezona zixhobo zihambileyo ezingenisiweyo kunye nezinto ezingafunekiyo, sinokuqinisekisa ukuba inyathelo ngalinye lenkqubo yemveliso ihlangabezana nemigangatho ephezulu.

Iimveliso zethu zibandakanya izicelo ezahlukeneyo eziyimfuneko kwiilebhu ze-IVD, ezinjengeengcebiso zepayitha, iipleyiti ezinzulu, iipcr zokuzonwabisa, kunye neebhotile zokusebenzela. Ngohlobo ngalunye lwemveliso, sivelisa kwaye silawule umgangatho wayo ngendlela eyahlukileyo yokuhlangabezana neemfuno ezithile zovavanyo olwahlukileyo.

Umzekelo, iingcebiso zethu zepayiphu zenziwa kwizinto ezizodwa kwaye zenzelwe ukuqinisekisa ukuhanjiswa okuchanekileyo komhlaba kwaye kunciphise iimpazamo. Iipleyiti ezinzulu-zenziwa ngokuqina okukhethekileyo kunye nokuzinza kuqinisekisa ukuthembeka kweziphumo zovavanyo. Izidumbu zePCR ziveliswa phantsi kolawulo olusemgangathweni ukuqinisekisa ukuchaneka kunye nokuzala kwendlela yePRR. Kwaye iibhotile zethu zokuSebenza zaziwa ngentsebenzo yabo ebalaseleyo yokutywina kunye nokuzinza, okuqinisekisa ukugcinwa kwexesha elide kunye nokuzinza kwe-regeents.

I-IVD yethu yeLebhu ayikwazi ukuhlangabezana neyona migangatho iphezulu kwishishini ngokubhekisele kumgangatho kodwa ikwaphumelele ukuthembana kunye nokudumisa iilebhu ezininzi kwihlabathi lonke ngokusebenza kakuhle kunye nokuqina kweelebhu zabo ngokuziphatha okuhle kunye nokuqina. Sikholelwa ngokuqinileyo ukuba kuphela komgangatho onokuphumelela ukuthembela kwabathengi kunye nobuchule kuphela obunokuphumelela kwimbeko yentengiso.

Kwixa elizayo, siza kuqhubeka nokugxila ekuphuculeni umgangatho wemveliso kunye nentsebenzo yokuhlangabezana neemfuno zentengiso yentengiso yeshishini le-IVD. Sikholelwa ukuba kuphela kukuphuculwa okuqhubekayo kunye nokuphuculwa kwethu kunokubonelela ezona mveliso zisemgangathweni kunye neenkonzo zokuhlangabezana neemfuno zabathengi kunye nolindelo.

Okokugqibela, uSuzhou Ace Biomedical ungathanda ukubulela bonke abathengi bethu ngokukhetha nokusixhasa. Kuthemba nenkxaso yakho esisinika inkuthazo yokuqhubekeka ukuphucula umgangatho wemveliso kunye nokusebenza nokwenza igalelo elikhulu kuphuhliso lweshishini le-IVD.

I-10001 (4)

 


IXESHA LOKUQALA: I-NoV-02-2023