Objectives

The overall objective of the project is to contribute to good quality management (QM) in blood services, based on the requirements set out in Directive 2002/98/EC and its technical annexes.

The project is cofunded by the European Commission, Directorate C - Public Health and Risk Assessment, 'Health & Consumer protection' and will support the public health programme on 'quality and safety of blood' in delivering a manual that will assist blood services to implement or expand their standard operating procedures (SOPs).

The EU-SOP Manual will contribute to the understanding and management of quality processes in blood services and assist blood establishments in preparing for the inspection of their services related to the implementation of quality relevant elements required by the EU directive 2002/98/EC.

The EU-SOP Manual will address the responsibilities of blood establishments, including those that carry out routine activities and those that are highly specialised, as well as hospital blood banks. Specifically the project will

• assess the existence of SOP manuals and guidelines currently used in the 16 blood services involved in the project in order to identify (A) international and national SOP manuals already in place and (B) the current inspection practice


• develop a manual to assist blood establishments to develop and implement their own SOPs.


• test this new SOP methodology among the partner institutions.


• produce this manual in 5 languages and distribute it to the participating blood establishments.