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About This Item
Full Description
Clinical and Laboratory Standards Institute document EP23-A - Laboratory Quality Control Based on Risk Management; Approved Guideline provides guidance to laboratories on the development of quality control plans for measuring systems. Regulatory requirements, information provided by the manufacturer, information pertaining to the laboratory environment, and medical requirements for the test results are evaluated, using risk management principles, to develop a quality control plan tailored to the particular combination of measuring system, laboratory environment, and clinical application. The effectiveness of the laboratory quality control plan is monitored to detect trends, identify corrective actions, and provide continuous quality improvement. The advantages and limitations of various quality control processes are considered.
Document History
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CLSI EP23Ed2E
Laboratory Quality Control Based on Risk Management, Second Edition, EP23Ed2E- Most Recent
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CLSI EP23-A (R2018)
currently
viewing
Laboratory Quality Control Based on Risk Management; Approved Guideline, EP23AE- Historical Version
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CLSI EP23-P
Laboratory Quality Control Based on Risk Management; Proposed Guideline, EP23PE- Historical Version