ISO 13485 tus qauv yog dab tsi?
ISO 13485 tus qauv yog tus qauv kev tswj hwm zoo siv tau rau cov khoom siv kho mob kev tswj hwm ib puag ncig. Nws lub npe tag nrho yog "Kev Tswj Xyuas Khoom Siv Kho Mob Zoo rau Kev Tswj Xyuas Cov Cai." Nws txais cov ntsiab lus tseem ceeb raws li PDCA hauv ISO9001 tus qauv. Piv nrog rau ISO9001 tus qauv, uas muaj feem xyuam rau txhua hom ntawm cov koom haum, ISO13485 yog cov kws tshaj lij thiab tsom mus rau kev tsim thiab kev tsim kho, tsim khoom, khaws cia thiab ncig, kev teeb tsa, kev pabcuam thiab kev tshem tawm zaum kawg ntawm cov khoom siv kho mob. thiab pov tseg thiab lwm cov koom haum kev lag luam ntsig txog. Tam sim no, cov koom haum tuaj yeem tsim cov tshuab lossis nrhiav ntawv pov thawj raws li ISO13485: 2016 tus qauv.
ISO 13485: Cov ntsiab lus tseem ceeb ntawm 2016 tus qauv
1. Cov qauv no siv cov kev cai tswj hwm raws li txoj kab tseem ceeb thiab ntxiv dag zog rau lub luag haujlwm tseem ceeb ntawm cov tuam txhab kom ua tau raws li cov cai tswj hwm;
2. Tus qauv no hais txog kev pheej hmoo raws li txoj hauv kev rau kev tswj hwm cov txheej txheem thiab ntxiv dag zog rau lub koom haum kev siv cov kev pheej hmoo raws li cov txheej txheem tsim nyog uas yuav tsum tau ua los tswj cov txheej txheem tswj kom zoo;
3. Tus qauv no qhia txog cov kev xav tau ntawm kev sib txuas lus thiab kev tshaj tawm nrog cov koom haum tswj hwm;
4. Raws li ISO9001, tus qauv no tseem ceeb dua rau cov kev xav tau ntawm cov ntaub ntawv thiab kev kaw cia.
Muaj hom kev lag luam
Lub hom phiaj tseem ceeb ntawm cov koom haum koom nrog hauv ISO13485 ntawv pov thawj suav nrog: cov kws tsim khoom siv kho mob thiab cov chaw tsim khoom, cov neeg ua haujlwm kho mob, cov chaw muab kev pabcuam kho mob, cov cuab yeej kho mob software thiab kho vajtse tsim kho, thiab cov khoom siv kho mob / cov khoom siv.
Cov khoom lag luam muaj feem cuam tshuam rau ISO13485 ntawv pov thawj:
Cov khoom lag luam cuam tshuam los ntawm ISO13485 daim ntawv pov thawj tau muab faib ua 7 qhov chaw ua haujlwm
1. Cov khoom siv kho mob tsis ua haujlwm
2. Cov khoom siv kho mob ua haujlwm (tsis yog cog tau).
3. Active (implantable) cov cuab yeej kho mob
4. Cov khoom siv kho mob hauv vitro diagnostic
5. Txoj kev ua kom tsis muaj menyuam ntawm cov khoom siv kho mob
6. Cov khoom siv kho mob uas muaj / siv cov tshuaj tshwj xeeb / thev naus laus zis
7. Cov kev pab cuam txog kev kho mob
Cov xwm txheej rau kev thov rau ISO13485 ntawv pov thawj:
Cov neeg thov yuav tsum muaj kev cai lij choj meej
Cov neeg thov yuav tsum muaj daim ntawv tso cai sib xws
1. Rau cov tuam txhab tsim khoom, cov khoom siv hauv chav kawm I yuav tsum tau muab cov khoom siv kho mob cov ntawv pov thawj thiab cov ntawv pov thawj kev tsim khoom; Cov khoom siv hauv chav kawm II thiab III yuav tsum muab daim ntawv pov thawj ntawm cov khoom siv kho mob thiab cov ntawv tso cai tsim khoom siv kho mob;
2. Rau cov lag luam khiav lag luam, cov khoom lag luam Class II yuav tsum tau muab cov cuab yeej siv kho mob ua haujlwm daim ntawv pov thawj rau npe lag luam; cov khoom lag luam hauv Chav Kawm III yuav tsum tau muab cov khoom siv kho mob ua haujlwm ua lag luam daim ntawv tso cai;
3. Rau cov lag luam uas tsuas yog xa tawm, raws li cov ntaub ntawv tshaj tawm los ntawm Ministry of Commerce, Customs thiab Food and Drug Administration thaum Lub Peb Hlis 31, kev xa tawm cov khoom kho mob thiab kev tiv thaiv kab mob sib kis yuav tsum tau txais cov khoom siv kho mob hauv tsev cov khoom lag luam sau npe / ntawv pov thawj ntawm cov khoom siv kho mob. premise ntawm ua tau raws li qhov yuav tsum tau ntawm lub teb chaws importing. Thiab cov cuab yeej kho mob tsim khoom lag luam daim ntawv tso cai / ntawv pov thawj;
Tus neeg thov kev pabcuam tau tsim kom muaj kev tswj xyuas cov ntaub ntawv raws li cov qauv (xws li phau ntawv zoo, cov ntaub ntawv txheej txheem, cov ntaub ntawv tshawb xyuas sab hauv, cov ntaub ntawv tshuaj xyuas kev tswj xyuas thiab lwm yam ntaub ntawv uas xav tau los ntawm cov ntaub ntawv txheej txheem)
Ua ntej thov daim ntawv pov thawj, hauv paus ntsiab lus, cov neeg soj ntsuam kev tswj hwm tau ua haujlwm tau zoo tsawg kawg yog peb lub hlis thiab tau ua tiav kev tshuaj xyuas sab hauv thiab kev tswj xyuas (rau kev tsim cov khoom siv kho mob cog qoob loo, lub kaw lus tau ua haujlwm tsawg kawg 6. lub hlis, thiab rau lwm yam khoom Cov kev tswj hwm tau ua haujlwm tsawg kawg 3 lub hlis)
Qhov tseem ceeb ntawm ISO13485 ntawv pov thawj:
1. Xav txog lub koom haum txoj kev cog lus kom ua tiav cov cai thiab cov kev cai uas cuam tshuam
2. Pab cov koom haum txhim kho lawv qib kev tswj hwm thiab kev ua haujlwm ntawm kev ua haujlwm, thiab qhia kev ntseeg siab rau pej xeem thiab cov koom haum tswj hwm
3. Tus qauv hais txog qhov yuav tsum muaj ntawm kev tswj hwm kev pheej hmoo los pab cov koom haum txo cov kev pheej hmoo ntawm kev raug xwm txheej zoo lossis cov xwm txheej tsis zoo los ntawm kev tswj hwm kev pheej hmoo.
Post lub sij hawm: Jan-04-2024