Summary. The severe clotting defects associated with the diagnosis of severe haemophilia A and B require a quality management and quality assurance system designed to avoid both bleeding sequelae (such as damaged joints) through early on‐demand or prophylactic treatment in a home‐care setting, and side‐effects such as infectious diseases (hepatitis A–G and human immunodeficiency virus), allergic reactions, haemolysis and if possible inhibitor formation, by using highly purified, virus‐inactivated or recombinant products in which the factor VIII and IX proteins are as natural as possible. As the intravenous injection of the required clotting factor is entrusted to the patients in home treatment, the haemophilia centre has to check treatment protocols and, when necessary, joint and muscle status. In addition, it is imperative to ensure the safety of the product, and checks must be carried out to make sure that batch numbers are recalled as soon as possible if side‐effects are observed. These are the reasons for several Acts of Parliament in Germany requiring special treatments and regular checks (the Disabled Act, recommendations by the German Medical Council, the Transfusion Act). Thus, at the haemophilia centre in Bonn we have established a special quality management and quality assurance system taking into account the great number of patients (> 800), the often considerable distance between the centre and the patient, and the aforementioned regulations and laws. Quality management involves dealing with daily practicalities such as 24‐h availability of a physician, medical technologist and nurse, careful instruction of patient and family in home care, genetic counselling, regular laboratory tests (especially recovery time, half‐life, inhibitors and gene defects, clinical chemistry and serology) and clinical investigations (especially joint and muscle status). It also includes co‐operation with family doctors and different departments at our university hospital (e.g. orthopaedic, microbiology), daily conferences with staff, information for nursery schools, schools, training institutions and/or the workplace in case of emergency, and cooperation with German haemophilia foundations. For quality assurance, several self‐controlling systems are in place, such as distribution of concentrate, laboratory data, treatment protocols, joint and muscle status and bleeding tendencies. All these and more are double‐checked and interactive, controlling data and activities with the help of EDP. Exceptional staff motivation and patient compliance are important for this quality system.