Implementation of a quality management system (QMS) in European blood establishments (BEs) is a requirement under EU Directives 2002/98/EC and 2005/62/EC and is also prescribed in the Council of Europe's Guide to the preparation, use and quality assurance of blood components.

However, the implementation of a QMS is often perceived as a burden, and the concept of a QMS itself is not always fully understood, mainly due to a lack of appropriate support. This was confirmed in a survey performed by the EDQM in 2012, in which data collected from 186 blood establishments located in 33 countries provided evidence about the difficulties encountered by BEs in understanding quality concepts, implementing requirements and developing an integrated QMS. The survey results also highlighted that the systems in place in BEs were mostly blood component quality-oriented. In addition, the reported extent of the use of existing standards and guidelines varied between and even within countries. This was confirmed by observations made during on-site visits to BEs. It was this situation and to help BEs overcome their difficulties, that prompted the development of the Blood Quality Management (B-QM) Programme.

The B-QM Programme started with a pilot phase in April 2012 that ran until December 2013. The outcome of the pilot phase was assessed and the necessary adjustments made before the full Programme was launched.

The B-QM Programme is aimed at supporting European BEs in developing, implementing and improving their QMS. It also takes into account the specificities of the blood transfusion field.

The B-QM Programme is an assistance and educational programme delivering virtual / on-site training and assessment schemes open to BEs from the European Union and Council of Europe member states.

B-QM Programme