Quality management in blood establishments

Abstract

Transfusion medicine has a specific position relative to other fields of medical science. A series of laboratory and clinical medicine activities and pharmaceutical‐like manufacture, with tight interaction of various professionals are involved in the complex chain of transfusion medicine, from the promotion of blood donation through the utilization of blood products. Maintaining constant high quality and safety of the products and services required by blood donors, patients and public at large are the prime and foremost goals to be pursued in transfusion medicine. These supreme goals can only be achieved through efficient quality management in all segments and with due support from all those involved in this complex system. Recognizing quality as a necessity, transfusion services all over the world have introduced or are just being introducing quality management systems according to particular standards and regulations. In EU countries, quality management in blood establishments is legal obligation defined by the 2005/62/EC Directive. Only a comprehensive and integrated quality management system can guarantee quality in a continuous way. Standard requirements and specifications of such an integrated system based on GMP and ISO 9000 series standards are elaborated in this paper.

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