临床检验在医疗卫生工作中发挥越来越重要作用，保证检验质量是有效开展医疗卫生工作的需要，外部质量控制是保证检验质量的必要机制。外部质量控制体系包括质量控制规范（法规、规程或标准等）、实施机构和实施机制等要素。我国经30余年努力，逐步建立临床检验质量控制规范，成立外部质量控制机构体系，不断改进质量控制机制，开展多种形式的质量控制活动，取得明显质量控制效果，临床检验规范化水平不断提高。临床检验学科发展迅速，临床检验质量控制也面临新的挑战，进一步完善质量控制体系，顺应学科发展趋势，是临床检验质量控制的重要任务。

Laboratory medicine plays an increasingly important role in clinical and health care activities. It is essential that the quality of clinical laboratories is assured to allow meaningful utilization of the laboratory services. External quality assurance is essential for the quality assurance of clinical laboratories.The external quality assurance system is composed of quality contral specification (regulations, procedures and standards), implementation organizations and processes. Over the last 30 years, a series of standards and regulatory requirements, a network of organizations and various programs for the quality assurance in laboratory medicine have been established in China. Implementation of such a system has resulted in significant improvements in the standardization of laboratory medicine. Laboratory medicine is fast advancing and new challenges have emerged for its quality assurance. Further efforts are needed for the construction of the external quality assurance system.