O le a le tulaga ISO13485?
O le ISO13485 faʻataʻitaʻiga o se faʻataʻitaʻiga o le pulega lelei e faʻatatau i siosiomaga faʻatonutonu masini faʻafomaʻi.O lona igoa atoa o le "Foma'i Fa'atonu Tulaga Fa'atonu Fa'atonu mo Manaoga Fa'atonutonu."E faʻaaogaina manatu talafeagai e faʻavae ile PDCA ile ISO9001 standard.Pe a faʻatusatusa i le ISO9001 standard, lea e faʻatatau i ituaiga uma o faʻalapotopotoga, ISO13485 e sili atu ona faʻapolofesa ma taulaʻi i le mamanu ma le atinaʻeina, gaosiga, teuina ma le faʻasalalau, faʻapipiʻiina, auaunaga ma le faʻaumatiaga mulimuli o masini faʻafomaʻi.ma le lafoaia ma isi fa'alapotopotoga fa'apisinisi fa'atatau.I le taimi nei, e mafai e faʻalapotopotoga ona faʻatuina faiga pe saili faʻamaonia e faʻavae ile ISO13485: 2016 standard.
ISO13485: O mea autu o le 2016 standard
1. O lenei tulaga e ave ai tulafono faatonutonu e avea ma laina autu ma faʻamalosia le matafaioi autu a atinaʻe e faʻafetaui manaoga faʻatonutonu;
2. O lenei faʻataʻitaʻiga e faʻamamafa ai le faʻaogaina o tulaga lamatia i faʻagasologa o pulega ma faʻamalosia le faʻaogaina e le faʻalapotopotoga o faʻataʻitaʻiga e faʻatatau i tulaga lamatia i faiga talafeagai e manaʻomia e pulea ai le faiga o pulega lelei;
3. O lenei tulaga o lo'o fa'amamafaina ai mana'oga mo feso'ota'iga ma lipoti fa'atasi ma lala sooupu fa'atonutonu;
4. Faʻavae i luga ole ISO9001, o lenei faʻataʻitaʻiga e sili atu le faamamafa i manaʻoga mo faʻamaumauga ma faʻamaumauga.
Tulaga pisinisi talafeagai
O ituaiga autu o faʻalapotopotoga o loʻo aʻafia i le ISO13485 faʻamaonia e aofia ai: faʻataʻitaʻiga masini ma gaosiga, faʻatautaia masini faʻafomaʻi, tuʻuina atu auaunaga masini fomaʻi, masini komepiuta ma mea faʻapipiʻi meafaigaluega, ma mea tau masini ma mea e tuʻuina atu.
Fa'asologa o oloa fa'atatau e fa'atatau ile fa'ailoga ISO13485:
O oloa fa'atatau o lo'o ufiufiina e le ISO13485 fa'amaonia ua vaevaeina i 7 vaega fa'apitoa
1. Mea faigaluega fa'afoma'i e le fa'aogaina
2. Mea fa'afoma'i fa'agaoioi (e le mafai ona fa'apipi'iina).
3. Mea faigaluega fa'afoma'i (implantable).
4. In vitro masini fa'afoma'i fa'ama'i
5. Fa'amama auala o masini fa'afoma'i
6. Mea fa'afoma'i o lo'o i ai/fa'aogaina mea fa'apitoa/tekinolosi
7. Au'aunaga fa'atatau i masini fa'afoma'i
Tulaga mo le talosaga mo le ISO13485 certification:
O tagata talosaga e tatau ona manino le tulaga faaletulafono
E tatau i tagata talosaga ona iai fa'ailoga fa'amaonia talafeagai
1. Mo atina'e gaosiga, Vasega I oloa e mana'omia ona tu'uina atu tusi pasi resitala oloa masini ma tusi pasi resitalaina;Vasega II ma III oloa e mana'omia le tu'uina atu o tusi pasi resitalaina o oloa masini fa'afoma'i ma laisene atina'e masini fa'afoma'i;
2. Mo pisinisi o lo'o fa'agaioia, e mana'omia e i latou o lo'o fa'agaoioia le Vasega II se tusi resitalaina o atina'e e fa'aogaina masini fa'afoma'i;oi latou o lo'o fa'aogaina oloa Vasega III e mana'omia le tu'uina atu o se laisene fa'apitoa mo masini fa'afoma'i;
3. Mo pisinisi e na'o le auina atu i fafo, e tusa ai ma pepa na tuʻuina atu e le Matagaluega o Pisinisi, Tiute ma Meaʻai ma Fualaau Faʻasaina i le aso 31 o Mati, o oloa auina atu i fafo o mea faʻafomaʻi ma faʻamaʻi pipisi e tatau foi ona maua tusi resitala oloa / tusi faʻamaumau i totonu o le fale. nofoaga e ausia ai manaoga o le atunuu e faaulufale mai.Ma laisene gaosi masini fa'afoma'i/tusi fa'amaumauga;
Ua fa'atūina e le tagata talosaga se faiga fa'atonutonu fa'amaumauga e tusa ai ma tulaga fa'ata'atia (e aofia ai tusi lesona lelei, fa'asologa o fa'amaumauga, mea e su'e su'e ai totonu, mea e toe iloilo ai le pulega ma isi fomu fa'atatau e mana'omia e pepa fa'atino)
Aʻo leʻi talosaga mo le faʻamaonia, i le mataupu faavae, o loʻo faʻaogaina lelei le faiga o le pulega a le suʻetusi mo le itiiti ifo ma le tolu masina ma faʻatautaia se suʻesuʻega atoa i totonu ma le pulega o iloiloga (mo le gaosiga o mea faʻapipiʻi masini faʻafomaʻi, o loʻo faʻaogaina le faiga mo le itiiti ifo i le 6. masina, ma mo isi oloa O loʻo faʻaogaina le pulega mo le itiiti ifo ma le 3 masina)
Le taua ole ISO13485 certification:
1. Ia atagia le tautinoga a le faalapotopotoga i le faataunuuina o tulafono ma tulafono faatonutonu talafeagai
2. Fesoasoani i fa'alapotopotoga e fa'aleleia le tulaga tau pulega ma le fa'atinoga o galuega, ma fa'ailoa atu le talitonuga i tagata lautele ma lala sooupu fa'atonutonu
3. O le faʻataʻitaʻiga e faʻamamafaina ai manaʻoga o le faʻalavelave faʻalavelave e fesoasoani ai i faʻalapotopotoga e faʻaitiitia le lamatiaga o faʻalavelave faʻafuaseʻi poʻo faʻalavelave faʻalavelave e ala i le pulea lelei o tulaga lamatia.
Taimi meli: Ian-04-2024