Continuous and dynamic progress in all segments of transfusion medicine has significantly improved the quality, safety and efficacy of transfusion therapy. In addition to the scientific and technological innovations, implementation of the quality system and haemovigilance in blood establishments significantly contributed to this progress. Despite the fact that most of the activities in transfusion chain take place without problems, some risks are still present and even the best organized and managed systems are sometimes faced with quality problems and complaints. In transfusion medicine, their causes are mostly related to the biological origin of blood products, while the complexity of the process and a large number of participants in transfusion chain facilitates the occurrence of errors. Some quality problems are caused by materials and equipment used in product realization, inadequate education or skills of the staff, suboptimal planning and organization of work. The best approach to managing quality problems is preventative approach, including comprehensive risk management, education, defining critical control points, permanent quality monitoring and audits. Quality problems and complaints should be resolved in a timely manner, following the standardized protocol with clearly defined responsibilities. All procedures and decisions should be documented and traceable. The root cause analysis of the problem should be carried out and followed by appropriate corrective actions. The ultimate goal is to increase quality, safety, productivity, efficiency and customer satisfaction, while reducing defects and costs.