Mission

The service Quality of medical laboratories is responsible for the control and participates in the improvement of quality in clinical biology laboratories in Belgium. In this context, its main (statutory) missions are to accredit, on behalf of the Minister, clinical biology laboratories, after checking compliance with the statutory requirements; inspect those laboratories in accordance with the Royal Decrees; organise external quality assessments (EQAs) for clinical biology analyses; act as a competent Belgian authority for in vitro diagnostic medical devices for the purposes of the European directive.

Tasks

In order to carry out its mission, the division performs the following tasks:

• Manage clinical biology laboratory accreditations
• By carrying out general audits and on-site monitoring, check that the accredited laboratories have put in place a quality control system for the purposes of INAMI-RIZIV (National Institute of Sickness and Invalidity Insurance)
• Act as the secretariat for the Clinical Biology Commission, the Appeals Board and its various working groups
• Propose and organise, in conjunction with the Clinical Biology Commission, expert groups and other EQA organisers, a mandatory external quality evaluation programme in all fields of clinical biology in order to guarantee, in the interest of public health, the reliability and proper performance of analyses
• Provide each laboratory with an opportunity, during the external quality assessments, to test and compare the techniques and methods it uses with those of other laboratories
• Notify incidents during the monitoring of in vitro diagnostic medical devices
• Organise oversight of the market in in vitro diagnostic medical devices
• Register in vitro devices produced by Belgian manufacturers and agents
• Represent Belgium at international meetings as the Belgian authority for in vitro devices

Forms of collaboration

The service is a member of the European Committee for External Quality Assurance Programmes in Laboratory Medicine (EQALM), the European association of organisations which perform external assessment programmes in terms of clinical laboratory quality. In connection with the control of IVD products, the division works with colleagues from the competent authorities of other Member States, and also represents Belgium at meetings of the European Commission and competent authorities.