医学实验室质量要求

NATIONALPATHOLOGYACCREDITATIONADVISORYCOUNCILREQUIREMENTSFORQUALITYMANAGEMENTINMEDICALLABORATORIES(2007Edition)RequirementsforQualityManagementinMedicalLaboratoriesiiFirstpublished2001Secondedition2007reprintedwithmajorrevisionsandnamechangefromGuidelinesforQualitySystemsinMedicalLaboratoriesPublicationsProductionUnitAustralianGovernmentDepartmentofHealthandAgeingISBN:1741861608OnlineISBN:1741861616PublicationsApprovalNumber:3958©CommonwealthofAustralia2007Thisworkiscopyright.ApartfromanyuseaspermittedundertheCopyrightAct1968,nopartmaybereproducedbyanyprocesswithoutpriorwrittenpermissionfromtheCommonwealthavailablefromtheDepartmentofCommunications,InformationTechnologyandtheArts.RequestsandinquiriesconcerningreproductionandrightsshouldbeaddressedtotheCommonwealthCopyrightAdministration,IntellectualPropertyBranch,CopyrightLawBranch,Attorney-General’sDepartment,RobertGarranOffices,NationalCircuit,BaronACT2600orpostedat Organisation and management...........................................................................2G2 Quality management system...............................................................................5G3 Document control.............................................................................................8G4 Review of contracts for medical test requests...................................................10G5 Examination by referral laboratories................................................................13G6 External services and supplies...........................................................................15G7 Advisory services..............................................................................................17G8 Resolution of complaints.................................................................................19G9 Identification and control of nonconformities ................................................21G10 Corrective action..............................................................................................23G11 Preventive action..............................................................................................27G12 Continual improvement...................................................................................29G13 Quality and technical records..........................................................................31G14 Internal audits.................................................................................................33G15 Management review..........................................................................................37Bibliography.................................................................................................................39RequirementsforQualityManagementinMedicalLaboratoriesivNationalPathologyAccreditationAdvisoryCouncilTheNationalPathologyAccreditationAdvisoryCouncil(NPAAC)wasestablishedin1979toconsiderandmakerecommendationstotheAustralian,stateandterritorygovernmentsonmattersrelatedtotheaccreditationofpathologylaboratoriesandtheintroductionandmaintenanceofuniformstandardsofpracticeinpathologylaboratoriesthroughoutAustralia.AnongoingfunctionofNPAACistoformulatestandards,andinitiateandpromoteguidelinesandeducationprogramsaboutpathologytests.PublicationsproducedbyNPAACareissuedasaccreditationmaterialtoprovideguidancetolaboratoriesandaccreditingagenciesaboutminimumstandardsconsideredacceptableforgoodlaboratorypractice.Failuretomeettheseminimumstandardsmayposearisktopublichealthandpatientsafety.RequirementsforQualityManagementinMedicalLaboratoriesIntroductionThisdocumentisintendedtosupplementandtobeusedasapracticalguidetotheapplicationofAustralianStandardAS4633:2004,Particularrequirementsforqualityandcompetence.ThisStandardhasbeenreproducedfrom,andisidenticalto,theInternationalOrganizationforStandardization(ISO)standardISO15189:2003,MedicalLaboratories-ParticularRequirementsforQualityandCompetence.Itisforuseintheaccreditationprocess,andaimstohelplaboratoriestointerprettheISOstandard,ratherthantoprovideadditionalrequirements.TheserequirementsfocusonallpartsofSection4(Managementrequirements)ofAS4633(ISO15189).RequirementsandguidelinesforSection5(Technicalrequirements)ofthestandardareavailableinotherNationalPathologyAccreditationAdvisoryCouncil(NPAAC)documentsandtheNationalAssociationofTestingAuthorities,Australia(NATA)AS4633(ISO15189)ApplicationDocument-SupplementaryRequirementsforAccreditationintheFieldofMedicalTesting.Thisrequirementprovidesthefollowinginformationforeachsubsectionofthestandard:•acrossreferencetoshowwhichpartofAS4633(ISO15189)therequirementsapplyto•asummaryoftherelevantISOstandardthatexplainstheareathatthestandardcovers,itspurposeandsoon•anindicationofwhetherthecontenthaschangedbetweenAS4633(ISO15189)andthepreviousstandard-ISO/IEC17025(1999)•i