Abstract: Human organ transplantation is an effective method to treat organ failure and save the life of patients. The practicing qualification certification of human organ transplantation is recognized as an administrative examination and approval item of the national health authority. National health authorities shall organize experts to conduct on-site audit of medical institutions that have applied for practicing qualification certification and have passed preliminary supervision at the provincial level. In this article, the management of on-site audit on the practicing qualification certification of human organ transplantation was illustrated and discussed from the practical significance, principles and highlights of on-site audit, and key points during on-site audit, aiming to provide reference for ensuring high-quality development of organ transplantation and strengthening the management of practicing qualification certification of human organ transplantation in medical institutions.