Ni ubuhe buryo bwa ISO13485?
Ibipimo bya ISO13485 nuburyo bwiza bwo gucunga neza uburyo bukoreshwa mubikoresho byubuvuzi. Izina ryayo ryuzuye ni "Ubuvuzi Bwubuvuzi Bwiza bwo gucunga neza ibisabwa." Yemeza ibitekerezo bijyanye bishingiye kuri PDCA murwego ISO9001. Ugereranije na ISO9001 isanzwe, ikoreshwa muburyo bwose bwamashyirahamwe, ISO13485 ni umuhanga cyane kandi yibanda ku gishushanyo mbonera no guteza imbere, umusaruro, kubika no kuzenguruka, kwishyiriraho, serivisi no gusezerera burundu ibikoresho byubuvuzi. no kujugunya hamwe n’indi miryango ijyanye n’inganda. Kugeza ubu, amashyirahamwe arashobora gushyiraho sisitemu cyangwa gushaka ibyemezo bishingiye ku gipimo cya ISO13485: 2016.
ISO13485: Ibyingenzi byingenzi mubisanzwe 2016
1.Iyi ngingo ngenderwaho ifata ibyangombwa bisabwa nkumurongo wingenzi kandi bishimangira inshingano nyamukuru yinganda kugirango zuzuze ibisabwa n'amategeko;
2.Iyi ngingo ngenderwaho ishimangira uburyo bushingiye ku ngaruka ziterwa n’imicungire y’imicungire kandi bishimangira ishyirwa mu bikorwa ry’imikorere ishingiye ku ngaruka ku buryo bukenewe busabwa kugira ngo habeho uburyo bwo gucunga neza ubuziranenge;
3.Iyi ngingo ngenderwaho ishimangira ibisabwa mu itumanaho no gutanga raporo n'inzego zishinzwe kugenzura;
4. Ukurikije ISO9001, iki gipimo gishimangira cyane ibisabwa kubisobanuro no gufata amajwi.
Ubwoko bwubucuruzi bukoreshwa
Ubwoko bwingenzi bwamashyirahamwe agira uruhare mubyemezo bya ISO13485 harimo: abashushanya ibikoresho byubuvuzi nababikora, abakora ibikoresho byubuvuzi, abatanga serivisi zubuvuzi, porogaramu zikoreshwa mubuvuzi hamwe nabategura ibyuma, hamwe nibikoresho byubuvuzi / abatanga ibikoresho.
Ibicuruzwa bifitanye isano bijyanye na ISO13485 ibyemezo:
Ibicuruzwa bifitanye isano na ISO13485 byemejwe bigabanijwe mubice 7 bya tekiniki
1. Ibikoresho byubuvuzi bidakora
2. Ibikoresho byubuvuzi bifatika (bidashoboka)
3. Ibikoresho bifatika byubuvuzi
4. Muri vitro ibikoresho byo kwa muganga
5. Uburyo bwo kuboneza urubyaro ibikoresho byubuvuzi
6. Ibikoresho byubuvuzi birimo / ukoresheje ibintu byihariye / ikoranabuhanga
7. Serivisi zijyanye nibikoresho byubuvuzi
Ibisabwa kugirango usabe icyemezo cya ISO13485:
Abasaba bagomba kuba bafite ubuzima gatozi
Usaba agomba kuba afite impamyabumenyi ihanitse
1. Ku nganda zibyara umusaruro, ibicuruzwa byo mu cyiciro cya mbere bigomba gutanga ibyemezo byubuvuzi byubuvuzi hamwe nicyemezo cyo kwiyandikisha; Ibicuruzwa byo mu cyiciro cya II n'icya III bigomba gutanga ibyemezo byo kwandikisha ibicuruzwa byubuvuzi hamwe nimpushya zo gukora ibikoresho byubuvuzi;
2. Ku mishinga ikora, ibyo bicuruzwa byo mu cyiciro cya II bigomba gutanga ibikoresho byubuvuzi bikora icyemezo cyo kwandikisha ibigo; ibyo bicuruzwa byo mu cyiciro cya III bigomba gutanga ibikoresho byubuvuzi bikora uruhushya rwumushinga;
3. Ku bigo byohereza ibicuruzwa hanze gusa, nk’uko bigaragara mu nyandiko zatanzwe na Minisiteri y’ubucuruzi, gasutamo n’ibiribwa n’ibiyobyabwenge ku ya 31 Werurwe, kohereza ibicuruzwa byo mu rwego rw’ubuvuzi n’ibyorezo by’indwara bigomba no kubona ibyemezo by’ibikoresho by’ubuvuzi byo mu rugo / ibyemezo byo gufata amajwi kuri mbere yo kuzuza ibisabwa byigihugu gitumizwa mu mahanga. Kandi ibikoresho byubuvuzi bitanga uruhushya rwumushinga / icyemezo cyo gufata amajwi;
Usaba yashyizeho uburyo bwo kuyobora bwanditse bukurikije ibipimo ngenderwaho (harimo imfashanyigisho nziza, inyandiko zerekana inzira, ibikoresho by'ubugenzuzi bw'imbere, ibikoresho byo gusuzuma imiyoborere n'ubundi buryo bujyanye n'ibisabwa)
Mbere yo gusaba ibyemezo, mubisanzwe, sisitemu yo kugenzura abagenzuzi ikora neza byibuze amezi atatu kandi yakoze igenzura ryimbere ryimbere nubuyobozi (kugirango habeho umusaruro wibikoresho byubuvuzi byatewe, sisitemu ikora byibuze 6 amezi, no kubindi bicuruzwa Sisitemu yo kuyobora imaze nibura amezi 3)
Akamaro k'icyemezo cya ISO13485:
1. Kugaragaza ubwitange bwumuryango kubahiriza amategeko n'amabwiriza bijyanye
2. Fasha amashyirahamwe kuzamura urwego rwimicungire yimikorere nimikorere, no kugeza ikizere mubigo bya leta nubuyobozi
3. Igipimo gishimangira ibisabwa mu micungire y’ibyago kugirango bifashe amashyirahamwe kugabanya ingaruka ziterwa nimpanuka nziza cyangwa ibintu bibi binyuze mugucunga neza ingaruka.
Igihe cyo kohereza: Mutarama-04-2024