ISO 13485 / PCBA ni amahame mpuzamahanga ya sisitemu yo gucunga neza ibikoresho byubuvuzi.

MuriGukora PCBAinzira, ikoreshwa rya ISO 13485 rishobora kwemeza ubwiza bwibicuruzwa n'umutekano.Uburyo bwiza bwo gucunga neza bushingiye kuri ISO 13485 bushobora kubamo intambwe zikurikira:

Tegura kandi ushyire mubikorwa imfashanyigisho nuburyo bwiza.Gutegura intego nziza ningamba zo kwemezaIbicuruzwa bya PCBAkubahiriza amabwiriza yinganda zikoreshwa mubuvuzi.

Gutegura no gusuzuma ibicuruzwa byihariye kugirango ubyemezeIbicuruzwa bya PCBAkuzuza ibisabwa mu nganda zikoreshwa mu buvuzi.

Gura ibikoresho fatizo nibice byujuje ibisabwa, ushyireho uburyo bwo gucunga ibicuruzwa, kandi urebe ko ibikoresho fatizo nibice byujuje ubuziranenge.

Menya neza ko ibikoresho byo gupima no gupima byujuje ubuziranenge kandi bigakora ibikoresho byo kubungabunga no guhitamo.Gutegura uburyo bwo kugenzura umusaruro kugirango harebwe ko buri ntambwe yumusaruro yubahiriza ibipimo ngenderwaho.

Shyira mubikorwa kugenzura no kugenzura ibicuruzwa kugirango wemezeIbicuruzwa bya PCBAkuzuza ibishushanyo mbonera n'ibisabwa gukora.

Gutegura no gushyira mubikorwa sisitemu yo gukurikirana ibicuruzwa kugirango umenye neza inkomoko, inzira yo gukora no kohereza ibicuruzwa bishobora gukurikiranwa.

Shyira mubikorwa ubugenzuzi bwimbere nubuyobozi bwo gusuzuma buri gihe no kunoza sisitemu yo gucunga neza.Menya neza ko ibyifuzo byabakiriya nibiteganijwe bishobora kuzuzwa mugihe cyose cyo gukora no gutanga PCBA.

Ibyavuzwe haruguru nuburyo bwibanze ISO 13485 bwo gucunga ubuziranenge bushobora kwemerwa muriGukora PCBAinzira.Mubikorwa nyabyo, birakenewe kandi guhinduka no guhindurwa ukurikije ibihe byihariye nibisabwa.