Impumelelo yaseMericanIsiqinisekiso se-ISO 13485, eyindlela esemgangathweni yamazwe ngamazwe yezixhobo zonyango kunye neemveliso ezinxulumene noko.
NgokubaIminyaka eli-18, sizibophelele ekuboneleleni ngeenkonzo zobungcali ngokuhambelana nemigangatho yamazwe ngamazwe.
IMerican iyavuya ukuvakalisa ukuba iphumelele ngempumeleloIsatifikethi se-ISO 13485, umgangatho wenkqubo yolawulo lomgangatho owaziwayo kwihlabathi liphela wezixhobo zonyango. Eli nqaku libonisa ukuzinikela okungagungqiyo kweMerican kukhuseleko lwemveliso, ukugqwesa komgangatho kunye nokuthobela imithetho yehlabathi, nto leyo eqinisa ngakumbi uphawu lwemveliso.Iminyaka eli-18yobuchule kushishino.
Nceda undinike inkcazo ye-ISO 13485?
I-ISO 13485ngumgangatho owaziwayo kwihlabathi liphela ochaza iimfuno zenkqubo yolawulo lomgangatho osebenzayo kwizixhobo zonyango. Ubeka iimfuno ezingqongqo kuyilo lwemveliso nophuhliso, ulawulo lomngcipheko, ulawulo lwemveliso, ukulandeleka, amaxwebhu, kunye nophuculo oluqhubekayo.
Ukufikelela kwesi siqinisekiso bubungqina bokukwazi kweMerican ukubonelela rhoqo ngeemveliso ezikhuselekileyo, ezithembekileyo, nezisemgangathweni ophezulu ezihlangabezana nolindelo lwamazwe ngamazwe kunye nolwabathengi.
Le nkampani iqatshelwe ngamandla ophawu lwayo kunye nokuthembeka kwayo ngeziqinisekiso ezininzi kwixesha elidlulileyo.Iminyaka eli-18.
NgokubaIminyaka eli-18, iMerican izinikele kushishino lwezixhobo zempilo nonyango lokukhanya. Olu kuzinikela luye lwaphumela kwigama elihle, elakhelwe phezu kobuchule bokuvelisa izinto ezintsha, ukuthembeka kunye nexabiso elijolise kubathengi. Ngexesha lokwanda kwayo kwihlabathi liphela, iMerican ibisoloko ilungelelanisa imisebenzi yayo nemigangatho yomgangatho nokhuseleko lwamazwe ngamazwe, ifumana iziqinisekiso ezininzi ezisemthethweni kunye nokuqinisekiswa kule nkqubo.
Ukuphumelela kweI-ISO 13485iqinisa ngakumbi isakhelo somgangatho esibanzi saseMerican, inika ubungqina obuqinileyo bezakhono zayo zophando nophuhliso ezivuthiweyo, iinkqubo zokuvelisa ezisemgangathweni, kunye neenkqubo zokulawula umgangatho ezingqongqo.
Sizimisele ukuqhubeka notyalo-mali kumgangatho nakwimveliso.
Ukuqinisekisa ukhuseleko kunye nokusebenza kakuhle kwemveliso ixesha elide, iMerican iyaqhubeka nokwenza utyalo-mali olukhulu kwezi zinto zilandelayo:
- Le nkampani inezixhobo zokuvelisa ezikumgangatho ophezulu kunye nemigca yokuvelisa ezenzekelayo.
- Le nkampani ineenkqubo zolawulo lomgangatho eziqinileyo kunye nokuhlolwa kwangaphakathi.
- Inkampani yethu iyazingca ngokuba namaqela obuchwephesha ophando nophuhliso kunye nokuqinisekisa umgangatho.
Ukuqinisekisa ukulandeleka ukusuka ekuqaleni ukuya ekupheleni kunye nolawulo lomngcipheko kulo lonke ixesha lobomi bemveliso kubaluleke kakhulu.
Zonke iinkcukacha zokusebenza kweMerican ziyilelwe umthengi engqondweni, ukuqinisekisa umgangatho ohambelanayo, umngcipheko oncitshisiweyo kunye nokusebenza okuthembekileyo kwemveliso.
Ukujonga phambili:Ukuphucula imigangatho ukuqinisekisa ukugqwesa
UkufezekisaI-ISO 13485Isiqinisekiso asikokuphela kwenkqubo, kodwa kukuqala kwentsha. Ukuqhubeka phambili, iMerican iza kuqhubeka nokugcina imigangatho yomgangatho wezonyango, iphucule ngakumbi iinkqubo zayo zolawulo lomgangatho, kwaye inikezele ngeemveliso ezibonelela ngokuthembeka okukhulu, ukhuseleko, kunye noxolo lwengqondo kubathengi kwihlabathi liphela.
NgokubaIminyaka eli-18, sigxile kumgangatho.
Siyazingca ngokuba neesatifikethi ezininzi, esikholelwa ukuba zisenza sibe nokuzithemba kwiinkonzo zethu.
I-Merican izibophelele ekubekeni imilinganiselo ephezulu yokugqwesa kwishishini lezempilo nelezixhobo zonyango kwihlabathi liphela.
