EFQM

The European Federation of Quality Management is a not-for-profit membership based organisation committed to establishing ISO-9001 standards for management quality within Europe.

The Brain Monitoring with Information Technology (BrainIT) group recognizes its responsibility as a non-profit, trans-national collaborative organisation of clinicians, scientists and industry developing multi-centre, neuro-intensive care data collection and analysis methods and standards towards improving the monitoring and management of patients with brain Injury and to base all of its activities upon quality principles. To this end, BrainIT has developed and documented a quality management system. The quality system complies with the international standard ISO 9001:2000, Quality management systems – Requirements. The quality system also complies with the following actual standards/regulations:

{1} World medical association - declaration of Helsinki on ethical principles for medical research involving human subjects (http://www.wma.net/),

{2} European union - good clinical practice (GCP) in the conduct of clinical trials on medicinal products for human use (http://www.efgcp.org/),

{3} International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (http://www.ich.org),

{4} ISO 13488, and

{5} country specific legal and ethical issues.

The Brain-IT group has developed a draft "Quality Manual"Quality Manual and is currently applying for Level 1 EFQM membership.

The BrainIT group has appointed a Quality Manager (Karl Kienning).