CLSI M52-2015(R2020) Verifcation of Commercial Microbial Identifcation and Antimicrobial Susceptibility Testing Systems 工业微生物鉴定和药敏试验系统的验证.pdf
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ClinicalandLaboratorvStandardsInstitute
k忱的gthe拭目ndardforqualityinclinicallabor,日orytestingaroundtheworld.
TheClinicalandLaboratoryStandardsInstitute(CLSI)isanot-for-profitmembershiporganizationthatbrings
togetherthevariedperspectivesandexpertiseoftheworldwidelaboratorycommunityfortheadvancementof
acommoncause:tofosterexcellenceinlaboratorymedicinebydevelopingandimplementingclinicallabo旧tory
standardsandguidelinesthathelplaboratoriesfulfilltheirresponsibilitieswithe简ciency,e仔ectiveness,andglobal
applicability.
ι。nsensusProcess
Consensus-thesubstantialagreementbymateriallya仔ected,competent,andinterestedparties-iscoretothe
developmentofallCLSId。cuments.Itdoesnotalwaysconnoteunanimousagreement,butdoesmeanthatthe
participantsinthedevelopmentofaconsensusdocumenthaveconsideredandresolvedallrelevantobjections
andaccepttheresultingagreement.
E。mmentingonD。cuments
CLSIdocumentsundergoperiodicevaluationandmod而cationtokeeppacewithadvancementsintechnologies,
procedures,methods,andprotocolsa仔ectingthelaboratoryorhealthcare
CLSlsconsensusprocessdependsonexpertswhovolunteertoserveascontributingauthorsand/orasparticipants
inthereviewingandcommentingprocess.Attheendofeachcommentperiod,thecommitteethatdeveloped
thedocumentisobligatedtoreviewallcomments,respondinwritingtoallsubstantivecomments,andrevisethe
draftdocumentasappropriate.
ζommentsonpublishedCLSIdocumentsareequallyessential,andmaybesubmittedbyanyone,atanytime,on
anydocument.Allcommentsareaddressedaccordingtotheconsensusprocessbyacommitteeofexperts.
AppealsProcess
Ifitisbelievedthatanobjecti。nhasnotbeenadequatelyaddressed,theprocessforappealsisdocumentedinthe
CLSIStandardsDevelopmentPoliciesandProcesses.
Allcommentsandresponsessubmittedondraftan
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