Abstract: Quality assurance is the responsibility of Organ Procurement Organization (OPO). The establishment of OPO quality management system is a novel task for implementing high-quality human organ donation. At present, the quality management of OPO still has certain problems, such as lack of comprehensive management organization, standardized management process, scientific evaluation index, qualified professionals and strong safety culture atmosphere, etc. It is necessary to deliver top-level design from three perspectives of ideological concept change, quality management system construction and process implementation management in combination with the actual situation of OPO and reference to the criteria of international general quality management system. More importantly, the managers of OPO should play a leading role in ensuring the efficient operation of OPO in the persistent improvement of quality management system.