The purpose of the present project was to analyse the costs incurred by the implementation of JACIE standards at a University Hospital with 1000 beds, performing some 40 autologous transplants per year. The cost analysis was performed on the basis of a prospective assessment of the time spent by all staff members involved with the implementation over a 14-month period of the quality management system (QMS) required by the JACIE standards. Two physicians worked on JACIE Section A (management=82 h), one physician and two nurses for section Ba (clinical unit adults=125.75 h), two physicians and three nurses for section Bp (clinical unit paediatrics=206 h), one physician, two nurses and one technician for section C (progenitor cell collection facility=105.75 h), and one physician and two technicians for section D (progenitor cell processing facility=426 h). The total time spent on the project amounted to 945.5 h with a total salary cost of \[euro]150 000. We concluded that implementation of the JACIE standards was accomplished within a 14-month period with a financial impact of approximately \[euro]150 000. The impact on quality parameters (eg clinical and laboratory end points, side effects) on HPC transplantation will be assessed in a second report after the first year of practical implementation.