Yintoni umgangatho we-ISO13485?
Umgangatho we-ISO13485 ngumgangatho wenkqubo yolawulo lomgangatho osebenza kwiindawo zolawulo lwezixhobo zonyango. Igama layo elipheleleyo "yiNkqubo yoLawulo loMgangatho weSixhobo seMedical kwiiMfuno zoLawulo." Yamkela iikhonsepthi ezifanelekileyo ezisekwe kwiPDCA kumgangatho we-ISO9001. Xa kuthelekiswa nomgangatho we-ISO9001, osebenza kuzo zonke iintlobo zemibutho, i-ISO13485 inobuchule ngakumbi kwaye igxile kuyilo kunye nophuhliso, imveliso, ukugcinwa kunye nokusasazwa, ukufakwa, inkonzo kunye nokupheliswa kokugqibela kwezixhobo zonyango. kunye nokulahlwa kunye neminye imibutho yoshishino enxulumeneyo. Okwangoku, imibutho inokuseka iinkqubo okanye ifune isatifikethi esekwe kwi-ISO13485: umgangatho we-2016.
ISO13485: Imixholo ephambili yomgangatho we-2016
1. Lo mgangatho uthatha iimfuno zolawulo njengowona mgca uphambili kwaye womeleza uxanduva oluphambili lwamashishini ukuhlangabezana neemfuno zolawulo;
2. Lo mgangatho ugxininisa indlela esekelwe kumngcipheko kwiinkqubo zolawulo kunye nokuqinisa ukusetyenziswa kwentlangano yeendlela ezisekelwe kwingozi kwiinkqubo ezifanelekileyo ezifunekayo ukulawula inkqubo yokulawula umgangatho;
3. Lo mgangatho ugxininisa iimfuno zonxibelelwano kunye nokunika ingxelo kunye nee-arhente ezilawulayo;
4. Ngokusekelwe kwi-ISO9001, lo mgangatho ubeka ugxininiso olungakumbi kwiimfuno zokubhalwa kwamaxwebhu kunye nokurekhoda.
Iintlobo zoshishino ezisebenzayo
Iindidi eziphambili zemibutho ebandakanyekayo kwisiqinisekiso se-ISO13485 ziquka: abaqulunqi kunye nabavelisi bezixhobo zonyango, abaqhubi bezixhobo zonyango, ababoneleli ngenkonzo yezixhobo zonyango, isoftwe yesixhobo sonyango kunye nabaphuhlisi bezixhobo zonyango, kunye namalungu esixhobo zonyango/ababoneleli ngezinto eziphathekayo.
Uluhlu lweemveliso ezinxulumeneyo lusebenza kwisiqinisekiso se-ISO13485:
Iimveliso eziyeleleneyo zigutyungelwe sisiqinisekiso se-ISO13485 zohlulwe zibe ziinkalo ezisi-7 zobugcisa
1. Izixhobo zonyango ezingasebenzisiyo
2. Izixhobo zonyango ezisebenzayo (ezingenakufakelwa).
3. Izixhobo zonyango ezisebenzayo (ezifakelwayo).
4. Izixhobo zonyango zokuxilongwa kwe-in vitro
5. Iindlela zokuvala inzala kwizixhobo zonyango
6. Izixhobo zonyango eziqulethe/ezisebenzisa izinto/iteknoloji ethile
7. Iinkonzo ezinxulumene nezixhobo zonyango
Iimeko zokufaka isicelo sesiqinisekiso se-ISO13485:
Abafake izicelo kufuneka babe nobume obucacileyo obusemthethweni
Abafake izicelo kufuneka babe nemigangatho yemfundo engqinelanayo yelayisenisi
1. Kumashishini emveliso, iimveliso zeKlasi I kufuneka zibonelele ngezatifikethi zokubhaliswa kwemveliso yesixhobo sonyango kunye nezatifikethi zobhaliso lwemveliso; Iimveliso zeClass II kunye ne-III kufuneka zibonelele ngezatifikethi zobhaliso lwemveliso yesixhobo sonyango kunye neelayisensi zeshishini lokuvelisa isixhobo sonyango;
2. Kumashishini asebenzayo, ezo zisebenzayo zeemveliso zeClass II kufuneka zibonelele ngesixhobo sonyango esisebenzayo isatifikethi sobhaliso lweshishini; ezo zisebenzayo iimveliso zeKlasi III kufuneka zibonelele ngelayisenisi yeshishini lokusebenza isixhobo sonyango;
3. Kumashishini athumela ngaphandle kuphela, ngokwamaxwebhu akhutshwe nguMphathiswa wezoRhwebo, iCustoms kunye noKutya kunye noLawulo lweDrugs nge-31 kaMatshi, ukuthunyelwa ngaphandle kwezinto zonyango kunye nokuthintela ubhubhane kufuneka kwakhona bafumane izatifikethi zokubhaliswa kwemveliso yesixhobo sonyango / iziqinisekiso zokurekhoda isiseko sokuhlangabezana neemfuno zelizwe elingenisayo. Kunye nelayisenisi yeshishini lokuvelisa isixhobo sonyango/isatifiketi sokurekhoda;
Umfaki-sicelo useke inkqubo yolawulo ebhaliweyo ngokungqinelana nemigangatho (kubandakanywa nencwadana yomgangatho, amaxwebhu enkqubo, imathiriyeli yophicotho-zincwadi lwangaphakathi, izixhobo zokuphonononga ulawulo kunye nezinye iifom ezinxulumeneyo ezifunwa ngamaxwebhu enkqubo)
Phambi kokuba ufake isicelo soqinisekiso, ngokomgaqo, inkqubo yolawulo yencwadi ephicothwayo ibisebenza ngokufanelekileyo kangangeenyanga ezintathu ubuncinci kwaye yenze uphicotho olupheleleyo lwangaphakathi nophononongo lolawulo (ukwenzela ukuveliswa kwemveliso yesixhobo sonyango esifakelwayo, inkqubo ibisebenza ubuncinci kangangezihlandlo ezi-6 ubuncinane. iinyanga, kunye nezinye iimveliso Inkqubo yolawulo sele isebenza ubuncinane iinyanga ezi-3)
Ukubaluleka kwesiqinisekiso se-ISO13485:
1. Bonisa ukuzinikela kombutho ekuzalisekiseni imithetho nemimiselo efanelekileyo
2. Imibutho yoncedo iphucule inqanaba labo lolawulo kunye nokusebenza komsebenzi, kwaye idlulisele ukuzithemba kuluntu kunye neearhente ezilawulayo.
3. Umgangatho ugxininisa iimfuno zolawulo lomngcipheko ukunceda imibutho ukunciphisa umngcipheko weengozi ezisemgangathweni okanye iziganeko ezimbi ngolawulo olusebenzayo lomngcipheko.
Ixesha lokuposa: Jan-04-2024