Impumelelo ye-MericanIsitifiketi se-ISO 13485, okuyindinganiso yamazwe ngamazwe yamadivayisi ezokwelapha nemikhiqizo ehlobene nawo.
NgobaIminyaka eyi-18, sizibophezele ekuhlinzekeni ngezinsizakalo zobungcweti ngokuhambisana nezindinganiso zomhlaba wonke.
IMerican iyajabula ukumemezela ukuthi iphumelele ngempumeleloIsitifiketi se-ISO 13485, indinganiso yohlelo lokuphatha ikhwalithi eqashelwa emhlabeni wonke yamadivayisi ezokwelapha. Lesi sinyathelo siwubufakazi bokuzibophezela kweMerican okungapheli ekuphepheni komkhiqizo, ukugqwesa kwekhwalithi kanye nokuthobela imithetho yomhlaba wonke, okuqinisa kakhulu umkhiqizo.Iminyaka eyi-18yobuchwepheshe bemboni.
Ngicela unginike incazelo ye-ISO 13485?
I-ISO 13485kuyindinganiso eyaziwayo emhlabeni wonke echaza izidingo zesistimu yokuphathwa kwekhwalithi esebenza kumadivayisi ezokwelapha. Ibeka izidingo eziqinile ekuklanyweni nasekuthuthukisweni komkhiqizo, ekuphathweni kwezingozi, ekulawulweni komkhiqizo, ekulandeleni, ekubhalweni kwamadokhumenti, kanye nasekuthuthukisweni okuqhubekayo.
Ukuthola lesi sitifiketi kuwubufakazi bekhono leMerican lokuletha imikhiqizo ephephile, ethembekile, nekhwalithi ephezulu ehlangabezana nokulindelwe yimithetho yamazwe ngamazwe kanye namakhasimende.
Le nkampani ibilokhu iqashelwa ngamandla omkhiqizo wayo kanye nokuthembeka kwayo ngezitifiketi eziningi esikhathini esidluleIminyaka eyi-18.
NgobaIminyaka eyi-18, iMerican izinikele embonini yemishini yezempilo nokwelapha ngokukhanya. Lokhu kuzibophezela kuholele edumeleni eliqinile, elakhelwe emisha, ukuthembeka kanye nezindinganiso ezigxile kumakhasimende. Ngesikhathi sokwanda kwayo emhlabeni jikelele, iMerican ibilokhu ivumelanisa imisebenzi yayo nezindinganiso zekhwalithi nokuphepha zomhlaba wonke, ithola izitifiketi eziningi ezigunyaziwe kanye nokuqinisekiswa kule nqubo.
Ukuphumelela kokufinyelelaI-ISO 13485kuqinisa kakhulu uhlaka lwekhwalithi oluphelele lweMerican, lunikeza ubufakazi obuqinile bamakhono ayo ocwaningo nokuthuthukiswa okuvuthiwe, izinqubo zokukhiqiza ezijwayelekile, kanye nezinhlelo zokulawula ikhwalithi eziqinile.
Sizibophezele ekutshaleni imali okuqhubekayo kwikhwalithi kanye nokukhiqiza.
Ukuqinisekisa ukuphepha nokusebenza kahle komkhiqizo isikhathi eside, iMerican iyaqhubeka nokutshala imali enkulu ku:
- Le nkampani inezindawo zokukhiqiza zesimanje kanye nemigqa yokukhiqiza ezenzakalelayo.
- Le nkampani inezinhlelo zokuphatha ikhwalithi eziqinile kanye nokuhlolwa kwangaphakathi.
- Inkampani yethu iyaziqhenya ngokuba namaqembu ochwepheshe be-R&D kanye nokuqinisekisa ikhwalithi.
Ukuqinisekisa ukulandeleka kusukela ekuqaleni kuze kube sekupheleni kanye nokulawulwa kwezingozi kulo lonke umjikelezo wokuphila komkhiqizo kubaluleke kakhulu.
Yonke imininingwane yokusebenza kweMerican yakhelwe kucatshangelwa ikhasimende, okuqinisekisa ikhwalithi eqhubekayo, ubungozi obuncishisiwe kanye nokusebenza komkhiqizo okuthembekile.
Ukubheka phambili:Ukuthuthukisa amazinga ukuqinisekisa ukusebenza kahle
UkufezaI-ISO 13485isitifiketi akusona ukuphela kwenqubo, kodwa ukuqala kwentsha. Siqhubekela phambili, iMerican izoqhubeka nokugcina amazinga ekhwalithi yezinga lezokwelapha, ithuthukise izinhlelo zayo zokuphatha ikhwalithi, futhi ilethe imikhiqizo enikeza ukuthembeka okukhulu, ukuphepha, kanye nokuthula kwengqondo kumakhasimende emhlabeni jikelele.
NgobaIminyaka eyi-18, sigxile ekhwalithini.
Siyaziqhenya ngokuba nezitifiketi eziningi, esikholelwa ukuthi ziqinisa umuzwa wokuzethemba ngezinsizakalo zethu.
I-Merican izibophezele ekubekeni amazinga aphezulu okusebenza kahle embonini yezempilo yomhlaba wonke kanye nemishini yezokwelapha.
