TS EN ISO 13485 Cov Khoom Siv Kho Mob Chaw Tsim Khoom: Cov neeg yuav khoom yuav tsum paub dab tsi

Cov khoom siv kho mob tau txais kev tswj hwm nruj thiab cov kev xav tau zoo. Rau cov neeg yuav khoom thoob ntiaj teb, daim ntawv pov thawj ISO 13485 yog ib qho tseem ceeb tshaj plaws thaum xaiv cov chaw tsim khoom siv kho mob lossis lub Hoobkas.

ISO 13485 yog dab tsi?

ISO 13485 yog tus qauv thoob ntiaj teb tshwj xeeb tsim rau cov cuab yeej siv kho mob thiab cov chaw tsim khoom siv kho mob. Nws txhais cov kev cai rau kev tswj hwm kev tswj hwm zoo tsom rau kev tswj hwm kev pheej hmoo, traceability, thiab kev ua raws cai.

Vim li cas ISO 13485 Qhov Tseem Ceeb rau Cov Khoom Siv Kho Mob

ISO 13485-certified manufacturers siv kev tswj kom zoo thoob plaws hauv cov txheej txheem ntau lawm, suav nrog:

Raw khoom tsim nyog

Hauv - kev tshuaj xyuas

Batch traceability

Kev kho thiab tiv thaiv kev ua

Cov kev ntsuas no txo ​​cov kev pheej hmoo thiab ua kom cov khoom ua tau zoo ib yam.

ISO 13485 thiab ISO 9001

Thaum ISO 9001 tsom rau kev tswj hwm kev ua tau zoo, ISO 13485 hais txog kev kho mob - tshwj xeeb cov kev pheej hmoo thiab kev cia siab rau kev tswj hwm. Rau cov khoom siv kho mob, ISO 13485 daim ntawv pov thawj muab kev lees paub ntau dua.

Yuav Ua Li Cas Txheeb Xyuas ISO 13485 Chaw Tsim Tshuaj

Cov neeg yuav khoom tuaj yeem txheeb xyuas cov ntawv pov thawj los ntawm kev tshuaj xyuas cov ntawv pov thawj siv tau, cov ntaub ntawv txheeb xyuas, thiab cov ntaub ntawv zoo. Factory audits thiab kev tshuaj xyuas ntau lawm ntxiv txhim khu kev ntseeg tus neeg muag khoom.

Ua haujlwm nrog ISO-Certified Medical Consumables Supplier

Xaiv ISO 13485-cov chaw tsim khoom lossis cov chaw muag khoom muaj ntawv pov thawj muaj txiaj ntsig ntev, suav nrog kev ruaj khov zoo, kev tswj hwm kev tswj hwm, thiab txo cov kev pheej hmoo ntawm kev tsim khoom.

ISO 13485 daim ntawv pov thawj yog qhov ntsuas tseem ceeb rau kev tsim khoom siv kho mob. Kev koom tes nrog lub Hoobkas muaj ntawv pov thawj ua kom cov khoom muaj kev nyab xeeb, sib xws, thiab ua raws li kev lag luam kho mob thoob ntiaj teb.