Kodi muyezo wa ISO13485 ndi chiyani?
Muyezo wa ISO 13485 ndi mulingo wa kasamalidwe kabwino womwe umagwira ntchito m'malo owongolera zida zamankhwala.Dzina lake lonse ndi "Medical Device Quality Management System for Regulatory Requirements."Imatengera mfundo zoyenera kutengera PDCA muyeso wa ISO9001.Poyerekeza ndi muyezo wa ISO9001, womwe umagwira ntchito ku mabungwe amitundu yonse, ISO13485 ndi yaukadaulo ndipo imayang'ana kwambiri mapangidwe ndi chitukuko, kupanga, kusungirako ndi kufalitsa, kuyika, ntchito ndi kuchotsedwa komaliza kwa zida zamankhwala.ndi kutaya ndi mabungwe ena okhudzana ndi mafakitale.Pakadali pano, mabungwe amatha kukhazikitsa machitidwe kapena kufunafuna satifiketi potengera ISO13485:2016 muyezo.
ISO 13485: Zomwe zili mulingo wa 2016
1. Mulingo uwu umatenga zofunikira pakuwongolera ngati mzere waukulu ndikulimbitsa udindo wamabizinesi kuti akwaniritse zofunikira pakuwongolera;
2. Vutoli likugogomezera njira yoopsa yoyang'anira njira ndikulimbitsa njira zomwe gulu limakhala chiopsezo chovomerezeka pamachitidwe oyenera kuwongolera dongosolo;
3. Muyezo uwu ukutsindika zofunikira pakulankhulana ndi kupereka malipoti ndi mabungwe olamulira;
4. Kutengera ndi ISO9001, muyezo uwu umatsindika kwambiri zofunikira pakulemba ndi kujambula.
Mitundu yamabizinesi ogwira ntchito
Mitundu yayikulu yamabungwe omwe akukhudzidwa ndi satifiketi ya ISO 13485 ndi: opanga ndi opanga zida zamankhwala, opangira zida zamankhwala, opereka chithandizo chamankhwala, mapulogalamu a zida zachipatala ndi opanga ma hardware, ndi zida zachipatala/opereka zinthu.
Zogwirizana ndizomwe zimagwira ntchito ku chiphaso cha ISO13485:
Zogulitsa zofananira zophimbidwa ndi certification ya ISO13485 zimagawidwa m'magawo 7 aukadaulo
1. Zida zamankhwala zosagwira ntchito
2. Zipangizo zamankhwala zogwira ntchito (zosalowetsedwa).
3. Zipangizo zachipatala zogwira ntchito (zolowetsedwa).
4. In vitro diagnostic mankhwala zipangizo
5. Njira zotsekera pazida zamankhwala
6. Zipangizo zachipatala zomwe zili ndi / kugwiritsa ntchito zinthu zenizeni / teknoloji
7. Ntchito zokhudzana ndi chipangizo chachipatala
Zofunikira pakufunsira chiphaso cha ISO13485:
Olembera ayenera kukhala ndi mbiri yomveka bwino yovomerezeka
Olembera ayenera kukhala ndi ziyeneretso zofananira zamalayisensi
1. Kwa mabizinesi opanga zinthu, zinthu za Class I zikuyenera kupereka ziphaso zolembetsera zida zachipatala ndi ziphaso zolembetsa;Zogulitsa za Class II ndi III zikuyenera kupereka ziphaso zolembera zida zachipatala ndi zilolezo zamabizinesi opanga zida zachipatala;
2. Kwa mabizinesi ogwira ntchito, omwe akugwiritsa ntchito zinthu za Gulu II ayenera kupereka chiphaso cholembetsa mabizinesi a chipangizo chachipatala;omwe amagwiritsa ntchito zinthu za Class III ayenera kupereka chiphaso chamakampani ogwiritsira ntchito zida zachipatala;
3. Kwa mabizinesi omwe amatumiza kunja kokha, malinga ndi zikalata zoperekedwa ndi Unduna wa Zamalonda, Customs and Food and Drug Administration pa Marichi 31, zotumiza kunja kwa zinthu zachipatala ndi kupewa miliri ziyeneranso kupeza ziphaso zolembetsa za chipangizo chachipatala chapanyumba/masetifiketi ojambulira pa kukwaniritsa zofunikira za dziko lotumiza kunja.Ndipo chiphaso chamakampani opanga zida zamankhwala / satifiketi yojambulira;
Wopemphayo wakhazikitsa dongosolo loyang'anira zolembedwa molingana ndi milingo (kuphatikiza buku labwino, zolemba zamachitidwe, zida zowunikira mkati, zida zowunikira kasamalidwe ndi mitundu ina yofananira ndi zikalata zamachitidwe)
Musanapemphe chiphaso, makamaka, kasamalidwe ka wowerengerayo wakhala akugwira ntchito bwino kwa miyezi yosachepera itatu ndipo achita kafukufuku wathunthu wamkati ndikuwunikanso kasamalidwe (popanga zida zachipatala zomwe zingalowetsedwe, dongosololi lakhala likugwira ntchito kwa zaka zosachepera 6). miyezi, ndi zinthu zina Dongosolo loyang'anira lakhala likuyenda kwa miyezi yosachepera 3)
Kufunika kwa chiphaso cha ISO13485:
1. Kuwonetsa kudzipereka kwa bungwe pakukwaniritsa malamulo ndi malamulo oyenera
2. Thandizani mabungwe kuwongolera kasamalidwe kawo ndi momwe amagwirira ntchito, ndikupereka chidaliro kwa anthu ndi mabungwe omwe amawongolera
3. Muyezowu ukugogomezera zofunikira pakuwongolera zoopsa kuti athandize mabungwe kuchepetsa mwayi wa ngozi zabwino kapena zochitika zoyipa kudzera pakuwongolera zoopsa.
Nthawi yotumiza: Jan-04-2024