CLSI EP23-A (R2018)

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.