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ISO 13485/PCBA o le tulaga fa'ava-o-malo mo faiga fa'afoe lelei o masini fa'afoma'i.

I legaosiga PCBAfaagasologa, o le faʻaogaina o ISO 13485 faʻataʻitaʻiga e mafai ona faʻamautinoa le lelei ma le saogalemu o oloa.Ole faiga ole pulega lelei ile ISO 13485 e mafai ona aofia ai laasaga nei:

Fa'ata'ita'i ma fa'atino tusi lesona ma faiga fa'atonu.Atia'e sini lelei ma ta'iala e mautinoaPCBA oloatausisia tulafono ma tulaga faataatitia o alamanuia masini faafomai.

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Fuafua ma iloilo faʻamatalaga o oloa e faʻamautinoaPCBA oloafaʻafeiloaʻi manaʻoga o le falemaʻi masini masini.

Fa'atau mea mata ma vaega e fetaui ma mana'oga, fa'atūina faiga fa'atonutonu fa'atau, ma fa'amautinoa o mea mata ma vaega e fetaui ma tulaga lelei.

Faʻamautinoa o le gaosiga ma le suʻega meafaigaluega e fetaui ma tulaga lelei ma faʻatino le tausiga o meafaigaluega ma faʻavasegaina.Atia'e faiga fa'atonutonu fa'agasologa o le gaosiga ina ia fa'amautinoaina o la'asaga ta'itasi o le gaosiga o lo'o mulimulita'i ma fa'atonuga ma fa'atonuga.

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Fa'atino fa'amaoniga fa'agasologa ma fa'amaoniga o oloa ina ia mautinoaPCBA oloafaʻafeiloaʻi faʻamatalaga mamanu ma manaʻoga faʻatinoga.

Fuafua ma fa'atino faiga su'esu'e oloa e fa'amautinoa ai e mafai ona su'esu'e le amataga, faiga o gaosiga ma fa'amaumauga o felauaiga o oloa.

Fa'atino su'etusi fa'alotoifale ma iloiloga fa'afoe e toe iloilo ma fa'aleleia atili le faiga o pulega lelei.Ia mautinoa e mafai ona ausia manaoga o tagata faatau ma faamoemoega i le faagasologa atoa o le gaosiga ma le tilivaina o le PCBA.

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O loʻo i luga o se faiga faʻavae ISO 13485 pulega lelei e mafai ona faʻaaogaina i legaosiga PCBAfaiga.I le faʻaaogaina moni, e manaʻomia foi ona fetuunai ma faʻapitoa e tusa ai ma tulaga faʻapitoa ma manaʻoga.


Taimi meli: Tes-12-2023