Peb ua tiav kev tshuaj xyuas txhua xyoo ntawm ISO 13485

Peb ua tiav qhov kev tshuaj xyuas txhua xyoo ntawm ISO13485 lub lim tiam dhau los, cov ntawv pov thawj yog siv tau:

Ntau lawm thiab muag khoom ntawm cov ntaub qhwv tsis-qias neeg uas tsis-qhwv cov khaub ncaws, cov kaus mom, khau looj ntsej muag, aprons, pw, tawm xwb); Kev muag khoom ntawm cov ntaub ntawv pov tseg tsis-santile yas (khaub ncaws, pam npog, khau npog, khau npog) (export xwb).

ISO 13485 yog tus qauv thoob ntiaj teb lees paub rau cov kab ke tswj hwm zoo hauv kev tsim qauv thiab tsim cov khoom siv kho mob. Nws qhia txog cov cai tshwj xeeb uas pab cov koom haum kom ua tau lawv cov cuab yeej siv kho mob tau raws li cov neeg siv khoom thiab kev tswj hwm kev nyab xeeb thiab kev ua tau zoo.

Thaum oos 9001 siv rau ntau hom kev lag luam, ISO 13485 yog tshwj xeeb ua rau cov kev tswj hwm thiab kev nyab xeeb ntawm kev lag luam kho mob. Nws hais txog kev txiav txim siab raws li cov neeg siv khoom xav tau, kev tswj hwm pheej hmoo, thiab txheej txheem tsim nyog tau txais ntau dua ISO 9001.

Peb siv ISO 13485 system los xaiv thiab tswj cov neeg muag khoom hauv nroog, thiaj li ua kom ntseeg tau tias muaj txiaj ntsig zoo, cov nqi zoo thiab cov nqi zoo dua qub. Txhua yam khoom yuav mus dhau ntawm QC cov txheej txheem, peb kev muag khoom kuj tau soj ntsuam ua ntej ua zaub mov xa tuaj. Peb qhov kev muag khoom ntim nce ntxiv 50% hauv 2024, feem ntau nce los ntawm cov neeg siv khoom qub, vim tias lawv tau cuam tshuam tias peb cov neeg siv khoom tau nce lub ntim, ib yam nkaus.