Table of Contents
Abstract
CommitteeMembership
Foreword
1Scope
2Introduction
3Terminology
4PlanningforNewEquipmentImplementation
5EquipmentSelection,Acquisition,andIdentification
6EquipmentValidationPlan
7CalibrationandMaintenance
8QualityControlofExamination(Analytical)Equipment
9Use
10Troubleshooting,service,andRepair
11DecommissioningofEquipment
12ManagingEquipmentRecords
13Conclusion
References
AppendixA-ImplementationPlanforLaboratory
InstrumentationTemplate
AppendixB-ExampleofUsingtheQualitySystemEssentials
asCriteriaforComparingEquipmentOptions
andQualifyingtheBestOptionforSelection
AppendixC-ExampleofUsingWeightedChecklistCriteria
forComparingEquipmentOptionsandQualifying
theBestOptionforSelection
AppendixD-ValidationDocumentationMatrixExample
AppendixE-InstallationQualificationProtocolExample
AppendixF-TemplateforInstallationQualificationChecklist
AppendixG-ProtocolforOperationalQualificationExample
AppendixH-TemplateforOperationalQualificationof
LaboratoryEquipmentChecklist
AppendixI-TemplateforOperationalQualificationof
LaboratoryInstrumentationChecklist
AppendixJ-ProtocolforPerformanceQualificationExample
AppendixK-TemplateforPerformanceQualificationfor
LaboratoryInstrumentationChecklist
AppendixL-TemplateforEquipmentRevivificationChecklist
AppendixM-TemplateforHazardAnalysisChecklist
AppendixN-TemplateforaCalibrationSchedule
AppendixO-TemplateforNonconformingEventActionChecklist
AppendixP-TemplateforEquipmentDecommissioningPlan
AppendixQ-TemplateforEquipmentDecontaminationLabel
AppendixR-TemplateforEquipmentMasterFile-HistoryForm
TheQualityManagementSystemApproach
RelatedCLSIReferenceMaterials Abstract
Gives recommendations for establishing equipment management processes from selection through decommission of all items of equipment used in the provision of laboratory services.
