临床和实验室标准协会文件EP23-A——基于风险管理的实验室质量控制；批准的指南为实验室制定测量系统的质量控制计划提供指导。使用风险管理原则，评估监管要求、制造商提供的信息、与实验室环境有关的信息以及测试结果的医疗要求，以制定适合测量系统、实验室环境和临床应用的特定组合的质量控制计划。监控实验室质量控制计划的有效性，以检测趋势，确定纠正措施，并提供持续的质量改进。考虑了各种质量控制过程的优点和局限性。

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.