KwiUkwenziwa kwePCBAinkqubo, ukusetyenziswa kwemigangatho ye-ISO 13485 kunokuqinisekisa umgangatho wemveliso kunye nokhuseleko.Inkqubo yolawulo lomgangatho esekwe kwi-ISO 13485 inokubandakanya la manyathelo alandelayo:
Ukuyila kunye nokuphumeza iimanyuwali zolawulo lomgangatho kunye neenkqubo.Phuhlisa iinjongo zomgangatho kunye nezicwangciso zokuqinisekisaPCBA iimvelisoukuthobela imimiselo yoshishino lwezixhobo zonyango kunye nemigangatho.
Yila kwaye uvavanye iinkcukacha zemveliso ukuqinisekisaPCBA iimvelisoukuhlangabezana neemfuno zoshishino lwezixhobo zonyango.
Thenga imathiriyeli ekrwada kunye neenxalenye ezihlangabezana neemfuno, misela iinkqubo zolawulo lomthengisi, kwaye uqinisekise ukuba imathiriyeli ekrwada kunye neenxalenye ziyahlangabezana nemigangatho yomgangatho.
Qinisekisa imveliso kunye nezixhobo zokuvavanya zihlangabezana nemigangatho yomgangatho kwaye zenze ukugcinwa kwezixhobo kunye nokulinganisa.Ukuphuhlisa iinkqubo zokulawula inkqubo yemveliso ukuqinisekisa ukuba inyathelo ngalinye lokuvelisa lihambelana nemigangatho kunye neenkqubo ezichaziweyo.
Ukuphumeza inkqubo yokuqinisekisa kunye nokuqinisekisa imveliso ukuqinisekisaPCBA iimvelisoukuhlangabezana neenkcukacha zoyilo kunye neemfuno zokusebenza.
Yila kwaye uphumeze iinkqubo zokulandelelwa kwemveliso ukuqinisekisa ukuba imvelaphi, inkqubo yokuvelisa kunye neerekhodi zokuthunyelwa kweemveliso zinokulandelwa.
Ukuphumeza uphicotho-zincwadi lwangaphakathi kunye nophononongo lolawulo ukuphonononga rhoqo nokuphucula inkqubo yolawulo lomgangatho.Qinisekisa ukuba iimfuno zabathengi kunye nokulindelweyo kunokufezekiswa kuyo yonke inkqubo yePCBA yokwenziwa nokuhanjiswa.
Oku kungasentla yinkqubo esisiseko yolawulo lwe-ISO 13485 enokwamkelwa kwiUkwenziwa kwePCBAinkqubo.Kwisicelo sokwenyani, ifuna ukulungiswa kwaye ilungiswe ngokweemeko ezithile kunye neemfuno.
Ixesha lokuposa: Dec-12-2023