[Quality assurance in transfusion medicine: organization of a quality assurance system exemplified by the Heidelberg University Blood Bank].

The 'Pharmabetriebsverordnung' requires a quality assurance system for the manufacturing of blood products. The quality assurance system of the university blood bank at Heidelberg is founded on the components 'quality of structure', 'quality of process' and 'quality of result'. The internal quality standard, based on national law and national/international guidelines, is specified in written form for every aspect of structure, process and result by standard operating procedures (SOPs). The SOPs are the basis for the quality system manual and the laboratory reference books. The quality assurance system integrates a programme for carrying out internal quality audits as well as a concept for updating SOPs at regular intervals.