Table of Contents
Abstract
CommitteeMembership
Foreword
1Scope
2Introduction
3StandardPrecautions
4Terminology
5QualityControlToolbox
6InformationGatheringforRiskAssessment
7DevelopingtheQualityControlPlan
8PostimplementationMonitoringofthe
QualityControlPlan
References
AppendixA-QuickGuideChecklistforEstablishinga
QualityControlPlanBasedonRiskManagement
AppendixB-TheLaboratoryRiskAssessment:Example
GlucoseMeasurementUsinganAutomated
MeasuringSystem
AppendixC-SummaryofLaboratoryRiskAssessmentTable-
Example:GlucoseMeasurementonanAutomated
MeasuringSystem
AppendixD-TheQualityControlPlanDevelopedFromthe
IndividualComponentsoftheQualityControl
StrategiesFromAppendixesBandC-Example:
GlucoseMeasurementonanAutomatedMeasuring
System
AppendixE-ExampleofFailureInvestigationandCorrective
ActionforGlucoseMeasurementonanAutomated
MeasuringSystem
TheQualityManagementSystemApproach
RelatedCLSIReferenceMaterials Abstract
Specifies guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.
