Isitifiketi se-ISO 13485 sohlelo lokuphathwa kwekhwalithi yedivayisi yezokwelapha

ISO

Liyini izinga le-ISO13485?

Izinga le-ISO13485 liyisimiso sokuphathwa kwekhwalithi elisebenza ezindaweni ezilawula idivayisi yezokwelapha. Igama layo eliphelele lithi "Isistimu Yokulawula Ikhwalithi Yedivayisi Yezokwelapha Yezimfuneko Zokulawula." Yamukela imiqondo efanelekile esekelwe ku-PDCA kuzinga le-ISO9001. Uma kuqhathaniswa nezinga le-ISO9001, elisebenza kuzo zonke izinhlobo zezinhlangano, i-ISO13485 ingochwepheshe kakhulu futhi igxile ekwakhiweni nasekuthuthukisweni, ekukhiqizeni, ekugcinweni nasekusatshalalisweni, ukufakwa, isevisi kanye nokuyekiswa kokugcina kwemishini yezokwelapha. kanye nezinye izinhlangano zemboni ezihlobene. Okwamanje, izinhlangano zingasungula amasistimu noma zifune isitifiketi ngokusekelwe kuzinga le-ISO13485:2016.

I-ISO13485: Okuqukethwe okubalulekile kwezinga lika-2016

1. Leli zinga lithatha izimfuneko zokulawula njengomugqa oyinhloko futhi liqinisa umthwalo wemfanelo oyinhloko wamabhizinisi ukuze ahlangabezane nezidingo zokulawula;
2. Leli zinga ligcizelela indlela esekelwe engcupheni ezinqubweni zokuphatha futhi liqinise ukusetshenziswa kwenhlangano kwezindlela ezisekelwe engozini ezinqubweni ezifanele ezidingekayo ukuze kulawulwe uhlelo lokuphatha ikhwalithi;
3. Leli zinga ligcizelela izidingo zokuxhumana kanye nokubika nama-ejensi alawulayo;
4. Ngokusekelwe ku-ISO9001, leli zinga ligcizelela kakhulu izidingo zokubhalwa nokuqoshwa.

Izinhlobo zebhizinisi ezisebenzayo

Izinhlobo eziyinhloko zezinhlangano ezibandakanyekayo esitifiketini se-ISO13485 zifaka: abaklami nabakhiqizi bemishini yezokwelapha, opharetha bemishini yezokwelapha, abahlinzeki besevisi yedivayisi yezokwelapha, isofthiwe yedivayisi yezokwelapha nabathuthukisi bezingxenyekazi zekhompuyutha, nezingxenye/abahlinzeki bezinto ezibonakalayo zedivayisi yezokwelapha.

abathuthukisi behadiwe

Ububanzi bomkhiqizo obuhlobene busebenza esitifiketini se-ISO13485:

Imikhiqizo ehlobene embozwe yisitifiketi se-ISO13485 ihlukaniswe ngemikhakha yezobuchwepheshe eyi-7

1. Imishini yezokwelapha engasebenzi
2. Imishini yezokwelapha esebenzayo (engafakeki).
3. Imishini yezokwelapha esebenzayo (efakelwayo).
4. Imishini yezokwelapha yokuxilonga ye-in vitro
5. Izindlela zokuvala inzalo zemishini yezokwelapha
6. Imishini yezokwelapha equkethe/esebenzisa izinto/ubuchwepheshe obuthile
7. Amasevisi ahlobene nedivaysi yezokwelapha

Imibandela yokufaka isicelo sesitifiketi se-ISO13485:

Abafake izicelo kufanele babe nezimo ezingokomthetho ezicacile

Abafakizicelo kufanele babe neziqu ezihambisanayo zamalayisensi

1. Ngamabhizinisi okukhiqiza, imikhiqizo Yekilasi I idinga ukuhlinzeka ngezitifiketi zokubhaliswa komkhiqizo wedivayisi yezokwelapha kanye nezitifiketi zokubhaliswa kokukhiqiza; Imikhiqizo ye-Class II kanye ne-III idinga ukuhlinzeka ngezitifiketi zokubhaliswa komkhiqizo wedivayisi yezokwelapha kanye namalayisense ebhizinisi okukhiqiza idivayisi yezokwelapha;

2. Emabhizinisini asebenzayo, leyo mikhiqizo esebenza ku-Class II idinga ukuhlinzeka ngesitifiketi sokubhaliswa kwebhizinisi ledivayisi yezokwelapha; labo abasebenzisa imikhiqizo ye-Class III badinga ukuhlinzeka ngelayisense yebhizinisi yokusebenza kwemishini yezokwelapha;

3. Ezinkampanini ezithekelisa kuphela, ngokuya ngamadokhumenti akhishwe uMnyango Wezohwebo, Customs kanye Nokuphathwa Kwezokudla Nezidakamizwa ngomhla ka-31 Mashi, ukuthunyelwa kwamanye amazwe kwezinto zokuvikela ubhubhane kufanele futhi zithole izitifiketi zokubhaliswa komkhiqizo wedivayisi yezokwelapha yasekhaya/izitifiketi zokuqopha ku- isisekelo sokuhlangabezana nezidingo zezwe elingenisayo. Nelayisense yebhizinisi yokukhiqiza idivayisi yezokwelapha/isitifiketi sokuqopha;

Umfakisicelo usungule uhlelo lokuphatha olubhalwe phansi ngokuhambisana namazinga (okuhlanganisa imanyuwali yekhwalithi, imibhalo yezinqubo, izinto zokucwaninga zangaphakathi, izinto zokubuyekeza abaphathi kanye namanye amafomu ahlobene adingwa imibhalo yenqubo)

Ngaphambi kokufaka isicelo sokuthola isitifiketi, ngokuyisisekelo, uhlelo lokuphatha locwaningwayo lusebenze ngempumelelo okungenani izinyanga ezintathu futhi lwenze ucwaningo lwangaphakathi oluphelele nokubuyekezwa kokuphatha (ukukhiqiza imikhiqizo yemishini yezokwelapha efakelwayo, isistimu ibisebenza okungenani izikhathi ezi-6 izinyanga, kanye neminye imikhiqizo Uhlelo lokuphatha lusebenze okungenani izinyanga ezi-3)

Ukubaluleka kwesitifiketi se-ISO13485:

1. Bonisa ukuzibophezela kwenhlangano ekugcwaliseni imithetho nezimiso ezifanele
2. Siza izinhlangano zithuthukise izinga lazo lokuphatha nokusebenza kwazo, futhi zidlulisele ukuzethemba emphakathini nasezikhungweni ezilawulayo.
3. Izinga ligcizelela izimfuneko zokulawulwa kwezinhlekelele ukuze kusizwe izinhlangano zinciphise amathuba ezingozi zekhwalithi noma izehlakalo ezimbi ngokulawulwa okuphumelelayo kobungozi.


Isikhathi sokuthumela: Jan-04-2024

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