CEEB TOOM TSHIAB NTAU TSHAJ PLAWS
Cov txheej txheem ntawm kev tsim thiab tso tawm ib yam khoom tshiab entails ib tug uas nws kim heev series ntawm theem, los ntawm thawj lub tswv yim tiam mus rau kev ua lag luam tso tawm. Cov txheej txheem nyuaj no tuaj yeem tsim kho kom haum rau ntau txoj hauv kev, suav nrog cov uas tsom mus rau cov neeg xav tau, kev sib koom ua ke, lossis cov txheej txheem tsim.
CONFORMITY THIAB REGULATORY FACTORS yuav xav txog thaum lub sij hawm cov khoom tshiab ADVANCEMENT
Cov neeg tsim khoom yuav tsum ua raws li ntau txoj cai lij choj thaum tsim cov khoom tshiab. Kev saib xyuas zoo tshaj plaws (QMS) tau lees paub tias cov tuam txhab ua tiav txhua yam kev tswj hwm. Qhov no yog ua tiav los ntawm:
Khaws cov ntaub ntawv kom txhawb nqa qhov kev teeb tsa thiab kev loj hlob ntawm cov khoom xws li cov tswv yim tsim, cov tswv yim, cov txiaj ntsig, cov ntaub ntawv tus tswv cov ntaub ntawv (DMRs), cov ntaub ntawv keeb kwm style (DHFs), cov neeg muag khoom / cov ntawv txheeb xyuas (ASLs / AVLs), thiab cov ntaub ntawv qhia cov neeg ua haujlwm.
Tsim cov kev kho mob hais txog kev sau cov ntaub ntawv adn tswj, kev ruaj ntseg zoo, cov khoom sib dhos thiab kev saib xyuas, thiab software program validation.
Kev ntsuas qhov zoo thiab cov cuab yeej taug qab (piv txwv li, kev soj ntsuam cov neeg siv khoom, kev tshuaj xyuas sab hauv, cov ntaub ntawv tsis raug cai, kev kho thiab kev tiv thaiv).
QMS ua rau muaj kev tshuaj xyuas kev hem thawj, kev soj ntsuam kev sib raug zoo tsis tu ncua, thiab kev tswj xyuas kev hloov kho txuas ntxiv yooj yim dua. Nws ua kom paub tseeb tias cov khoom muaj kev ruaj ntseg, muaj kev ntseeg siab, thiab zoo tshaj plaws, uas yog qhov tseem ceeb rau kev txais kev lag luam thiab khaws cov neeg siv khoom.
Kev lees paub qhov zoo ntawm cov khoom hauv cov txheej txheem tsim khoom lag luam tshiab yog qhov tseem ceeb. Kev tswj hwm zoo (QMS) ua lub luag haujlwm tseem ceeb hauv kev lees paub kev txhawb nqa, thiab ua kom muaj kev ruaj ntseg thiab ua haujlwm ntawm cov khoom. QMS yog lub hauv paus rau kev sau cov txheej txheem tseem ceeb koom nrog hauv kev tsim, tsim, thiab tsim cov khoom zoo tshaj. Cov txheej txheem no suav nrog cov kev kuaj xyuas zoo tshaj plaws, txheeb xyuas cov qauv, thiab kev soj ntsuam xyuas, txhua yam txhawm rau ua kom tau raws li cov neeg siv khoom xav tau thiab ua raws li cov kev xav tau ntawm kev lag luam. Los ntawm txoj kev lees paub thiab daws cov kev tsis zoo thiab qhov tsis zoo, QMS yuav pab txo qis kev ua yuam kev thiab txhawb cov khoom lag luam kev ntseeg siab. Txhawm rau kom muaj nuj nqis, cov kev pabcuam yuav tsum tau ua raws li QMS cov khoom, uas tsis tsuas yog ua kom cov khoom lag luam zoo dua qub tab sis kuj tseem tswj hwm kev lag luam cov ntaub ntawv teev tseg rau kev ua lag luam zoo.