Siyajabula ukuthola isitifiketi se-ISO 13485.
Lesi sitifiketi siqinisekisa ukuthi i-Quality Management System ye-Suzhou Sinomed Co., Ltd.
Isitifiketi siyasebenza kulezi zinsimu:
Ukuthengiswa kwamadivayisi ezokwelapha angahlanzekile/angenamagciwane (imishini yokulinganisa kanye nemishini, amashubhu angenawo awemithambo yegazi (ama-plug), amathuluzi okuhlinza abesifazane, amashubhu kanye namamaski okubulala izinzwa zokuphefumula, amathuluzi okuhlinza emizwa kanye nenhliziyo, amadivayisi okufaka imithambo yegazi ngaphakathi, amabhandeshi ezokwelapha, izinto ezisetshenziswayo zelebhu yezokwelapha, amathuluzi angaphandle ama-catheter angenawo awemithambo yegazi, amathuluzi okujova kanye nokubhoboza) kanye nemishini yokuhlaziya amapharamitha okuphila kanye nokulinganisa (ukuthunyelwa eYurophu naseMelika).
I-Suzhou Sinomed ihlolwe futhi yabhaliswa yi-NQA ngokuhambisana nemibandela ye-ISO 13485: 2016. Lokhu kubhaliswa kuncike enkampanini egcina uhlelo lokuphatha ikhwalithi, ngokwezinga elingenhla, oluzoqashwa yi-NQA.
Sizokwamukela ukuhlolwa kokuqapha okuvamile, ukufaneleka kwezitifiketi kuzogcinwa ukuze kube nomphumela omuhle wokuhlolwa.
Isikhathi sokuthunyelwe: Novemba-08-2019
