Table of Contents
Abstract
CommitteeMembership
Foreword
1Scope
2Introduction
3Terminology
4NeedforNewDocument
5DocumentTypeisDetermined
6DocumentIsDrafted
7DraftIsEvaluated,EditedasNeeded,andVerified
8Approval
9TrainingRequirementsDeterminedandTrainingVerified
10DocumentIsDistributedandImplemented
11DocumentMaintenance
12ControlofReferenceDocuments
13ProceduresManuals
14KeyFeaturesofElectronicsDocumentManagementSystem
15HowtoGetStarted
16Conclusion
References
AppendixA-SamplePolicy:"QualitySystemEssential
FacilitiesandSafetyPolicy"
AppendixB-SamplePolicy:"QualitySystemEssential
NonconformingEventManagementpolicy"
AppendixC-SampleQualityProcessforQualitySystem
EssentialAssessments:"Unannounced
InspectionDayProcess"
AppendixD-SamplePreexaminationProcess:"Blood
SampleCollectionProcess"
AppendixE1-SampleExaminationProcess:"Analyzer
SetupandRunProcess"
AppendixE2-SampleExaminationProcess:"Surgical
PathologyProcess"
AppendixF-SamplePostexaminationProcess:"Critical
ValueHandlingProcess"
AppendixG1-SampleQualityProcedure:"Correcting
aLaboratoryPaperRecordProcedure"
AppendixG2-SamplePreexaminationProcedure:"Identifying
thePatientforSampleCollectionProcedure"
AppendixG3-SampleMicrobiologyExaminationProcedure:
"UrineCulture:ReadingandInterpreting
Procedure"
AppendixG4-SampleTransfusionMedicineExamination
Procedure:"WeakD(D[u])Determination
Procedure"
AppendixG5-SampleHistologyExaminationProcedure:
"HematoxylinandEosinStainingProcedure:
ManualMethod"
AppendixG6-SamplePostexaminationProcedure:
"CriticalValuesReportingProcedure"
AppendixH1-SampleJobAid:"SharedTestingJobAid"
AppendixH2-SampleJobAid:"DrawTubesandMinimumFill"
AppendixI1-SampleForm:"DocumentManagementForm"
AppendixI2-sampleForm:"ABO/RhDiscrepancyWorksheet"
AppendixJ-SuggestedContentsofTemplatesforLaboratory
Documents
AppendixK1-HowtoConstructaProcessFlowChart
AppendixK2-SampleProcessFlowChart:"LaboratorySample
ReceivingProcess"
AppendixK3-SampleProcessFlowChart:"Bacteriology
CultureProcess"
AppendixK4-TableFormatfortheDocumentManagementProcess
AppendixL1-SampleAttributesforaSingleAnalyteona
SingleAnalyzer
AppendixL2-AttributesforMultipleAnalytesonaSingle
Analyzer
AppendixL3-AttributesforaSingleAnalyteonaMultiple
Analyzers
AppendixM-SampleChecklist:DocumentReviewChecklist
AppendixN-SampleForm:"GroupTrainingRecord"
AppendixO1-SampleProceduresManualTableofContents:
"TransfusionReactionInvestigationProcess"
AppendixO2-SampleProceduresManualTableofContents:
"AutomatedAnalyzerOperationsProcess"
AppendixP-TenRulesforLaboratoryDocumentManagement
TheQualityManagementSystemApproach
RelatedCLSIReferenceMaterials Abstract
Specifies guidance on the processes needed for document management, including creating, controlling, changing, and retiring a laboratory's policy, process, procedure, and form documents in both paper and electronic environments.
