The EuBIS manual and training guide. Guidelines and standards for quality management and inspection of blood establishments

Background and Objectives  The Public Health Programme (Directorate General Sanco) gave impetus to the need for equivalent recognition of inspections of blood establishments among European Member States (MS) through the development and implementation of commonly accepted criteria and standards by funding the European Blood Inspection Project (EuBIS) (HYPERLINK “http://www.eubis-europe.eu”http://www.eubis-europe.eu). EuBIS is a collaborative effort of 27 representatives from 19 MS, including governmental institutions, blood establishments and competent authorities. It has cooperative working partnerships with five organisations, three projects, and is supported by the European Blood Alliance (EBA). Materials and Methods  EuBIS is the first project that has brought together regulators (competent authorities) and manufacturers (blood establishments) to jointly develop criteria and standards aimed to assist: •  blood establishments in need to optimise their quality system and self-inspection process •  blood establishments to prepare for regulatory inspections by competent authorities •  competent authorities, which wish to use the manuals and training guide as a reference for the implementation process of legislative requirements related to regulatory inspections. Results  These standards and criteria have been finalised and published in a EuBIS Manual and Training Guide. The manual and training guide are available through the EuBIS homepage. In addition, EuBIS has developed educational material and to be used for seminars and courses. Based on regulatory standards applicable within the European Union (EU), the manual and training guide give references to commonly used internationals standards, such as GMP standards, the PIC/S guideline and the CoE (EDQM) guide. Thus, the EuBIS material should also be useful for those working in the field of quality management in other countries/areas world wide. In order to give practical assistance, the structure of the EuBIS guide follows critical aspects of quality management systems to be addressed in order to achieve good practice. For each of these critical points, a criterion description, examples evidence and references to relevant standards and legislative requirements are given. Conclusion  The EuBIS manuals have been used by its partners organising national and international seminars, experimental and regulatory audits assisting the national implementation and further harmonisation of quality standards. In some member states elements of EuBIS have been adapted to national or local quality management systems. The implementation of good practice will improve the quality of blood and ensure that patients receiving blood transfusions are given safe blood.