Nyob rau hauv lub ntiaj teb no kev kho mob cov cuab yeej tswj lub moj khaum, bloodletting koob, raws li kev kho mob cov cuab yeej uas tuaj rau hauv kev sib cuag nrog tib neeg lub cev, hais txog kev ua tau zoo raws li lub hauv paus tseem ceeb rau kev ua lag luam tawm thiab ncig. Tsuas yog los ntawm kev tau txais daim ntawv pov thawj thoob ntiaj teb kev ua haujlwm zoo tuaj yeem nkag mus rau hauv lub ntiaj teb kev lag luam kho mob thiab ua kom cov neeg mob muaj kev nyab xeeb.

 

Tam sim no, cov ntawv pov thawj tseem ceeb rau kev kho mob ntshav koob yogISO 9001: 2015 thiab ISO 13485 dual - ntawv pov thawj system, uas tau lees paub tias yog universal zoo nkag mus rau hauv kev lag luam koob tshuaj kho mob thoob ntiaj teb. Ua kom muaj kev sib koom ua ke, ob tus qauv tsim kom muaj tag nrho -lub neej- voj voog tswj kev ua haujlwm zoo rau cov koob txhaj ntshav.

 

ISO 9001: 2015 yog lub ntiaj teb kev tswj hwm kev tswj hwm tus qauv tsim nyog rau txhua qhov kev lag luam tsim khoom. Rau kev tsim cov koob txhaj ntshav, nws xav kom cov tuam txhab tsim kom muaj tag nrho - txheej txheem kev tswj hwm kev ua haujlwm zoo suav nrog cov khoom siv raw, kev tsim khoom thiab kev ua haujlwm, kev tshuaj xyuas zoo, kev xa khoom tiav, thiab tom qab- kev muag khoom. Nws tsim cov txheej txheem kev khiav hauj lwm rau txhua qhov kev sib txuas ntau lawm, qhia meej txog kev tswj hwm tus qauv zoo, ua kom ruaj khov thiab ua haujlwm zoo ib yam ntawm txhua pawg ntawm cov koob txhaj tshuaj ntshav, thiab tiv thaiv cov khoom tsis raug cai los ntawm kev nkag mus rau hauv lub khw. Tuav ISO 9001: 2015 daim ntawv pov thawj qhia tias cov koob txhaj tshuaj ntshav muaj cov txheej txheem thiab tswj kev tsim khoom thiab tswj kev muaj peev xwm, tso ib qho tseem ceeb lav rau cov khoom zoo.

 

TS EN ISO 13485 Kev Tswj Xyuas Kev Tswj Xyuas Kev Tswj Xyuas Zoo yog tus qauv tsim tshwj xeeb rau kev lag luam khoom siv kho mob, ua haujlwm raws li kev tswj hwm kev tswj hwm zoo.tub ntxhais passportrau cov khoom siv kho mob kom nkag mus rau lub ntiaj teb kev lag luam. Piv nrog ISO 9001: 2015, nws teeb tsa cov kev cai nruj dua thiab kev tshaj lij rau kev nyab xeeb, kev tswj hwm kev pheej hmoo thiab kev taug qab ntawm cov cuab yeej kho mob. Rau cov koob txhaj ntshav, ISO 13485 system qhia meej meej rau cov lag luam los tsim kom muaj kev tswj hwm kev pheej hmoo ntawm cov cuab yeej siv kho mob, ua kev ntsuam xyuas thiab tswj xyuas cov khoom siv kev nyab xeeb, kev nyab xeeb, kev ua kom tsis muaj menyuam thiab kev pheej hmoo ntawm kev siv. Nws tsim cov ntaub ntawv thiab cov ntaub ntawv khaws tseg- khaws cia thoob plaws hauv cov khoom tsim thiab kev tsim kho, kev tsim khoom, kev ua kom tsis muaj menyuam thiab ntim khoom, nrog rau kev muag khoom thiab kev faib tawm, ua kom tiav tag nrho - txheej txheem khoom traceability. Lub caij no, nws muab cov kev cai tshwj xeeb rau kev tsim khoom ib puag ncig, kev ua kom tsis muaj menyuam thiab cov khoom siv kuaj, kom ntseeg tau tias cov koob txhaj tshuaj ua raws li cov txheej txheem kho mob tsis muaj menyuam.

 

Rau cov koob txhaj tshuaj uas tau lees paub los ntawm ob lub tshuab, txhua qhov txuas los ntawm kev tshuaj xyuas cov khoom siv raw mus rau cov khoom tiav tiav yog nyob rau hauv kev tswj hwm nruj: cov khoom siv raw yuav tsum tau ua tiav nrog daim ntawv pov thawj tsim nyog; ntau lawm yuav tsum ua raws li cov txheej txheem kev khiav hauj lwm; cov txheej txheem sterilization yuav tsum muaj kev paub tseeb; thiab cov khoom tiav yuav tsum xeem dhau ntau qhov kev ntsuam xyuas kev nyab xeeb. Tsis tas li ntawd, cov tuam txhab lag luam yuav tsum ua cov kev tshuaj xyuas sab hauv thiab kev tswj xyuas tsis tu ncua, txhim kho kev tswj xyuas kom zoo, kho cov kev pheej hmoo zoo raws sij hawm, thiab xyuas kom cov khoom ua tau raws li cov qauv kev cai.

 

Rau cov koob txhaj tshuaj ntshav, kev ua raws cai tsis yog tsuas yog kev nkag mus rau kev lag luam xwb, tab sis kuj yog cov kab hauv qab ntawm kev nyab xeeb ntawm kev kho mob. Dual- daim ntawv pov thawj system ua tau zoo zam qhov kev pheej hmoo ntawm cov koob tshuaj ntshav ib txwm muaj xws li cov khoom siv tsis tsim nyog, kev ua kom tsis muaj menyuam tsis tiav thiab tsis ruaj khov zoo, tiv thaiv kev ua haujlwm nyab xeeb ntawm cov neeg ua haujlwm kho mob thiab kev kuaj mob thiab kev nyab xeeb ntawm cov neeg mob. Lub caij no, cov koob txhaj tshuaj ntshav uas ua tau raws li cov qauv zoo thoob ntiaj teb tuaj yeem nkag mus rau hauv kev lag luam kho mob thoob ntiaj teb, ua raws li cov kev xav tau ntawm cov tsev kho mob thiab cov koom haum kho lub cev ntawm txhua qib, thiab txhawb kev thoob ntiaj teb ntawm siab - cov khoom siv koob tshuaj zoo.

 

Raws li kev txhim kho tus qauv ntawm kev lag luam, ISO 9001: 2015 thiab ISO 13485 dual daim ntawv pov thawj tau dhau los ua lub cim tseem ceeb ntawm cov khoom siv koob txhaj tshuaj zoo, nrog rau qhov tseem ceeb ntawm kev ua haujlwm siab - kev loj hlob zoo hauv kev lag luam koob tshuaj. Nws ua rau kev kho mob puncture ntaus ntawv kev lag luam mus rau standardization, kev nyab xeeb thiab ua raws li.