The Guidelines have been published as a report Radiation Protection No. 159. (

Background information for the Guidelines:
European Commission project 2007-2008

Contract N TREN/07/NUCL/S07.71512

The EC directive 97/43/EURATOM (MED-directive) introduced the concept of Clinical Audit for the assessment of medical radiological practices. The Member States are required to implement clinical audits in accordance with national procedures. There has been high variation between the approaches of the Member States in the implementation of clinical audits and the need for further guidance has been evident since the conclusions from the first international symposium on clinical audit in Tampere 2003 (The Proceedings of the symposium).

In 2007-2008 the EC conducted a special project to prepare guidance on clinical audit. The purpose of the project was to provide clear and comprehensive information on existing procedures and criteria for clinical audits in radiological practices (diagnostic radiology, nuclear medicine and radiotherapy) and to provide guidance on clinical auditing for an improved implementation of Article 6.4 of the MED-directive. The guidance will enable the member States to adopt the model of clinical audit with respect to their national legislation and administrative provisions.

The first step of the project was to review the status of the implementation of clinical audits in the Member States through a questionnaire. Besides clinical audit, the questionnaire reviewed other systems of quality assesments (such as certification of quality systems and accreditations) and also regulatory inspections and their relationship with clinical audit. The next step was to prepare draft European Guidelines on clinical audit, based on the results of the questionnaire and discussions among the project partners and the Panel of Scientific Experts.

Finally, the summary of the questionnaire and the draft European Guidelines were introduced for critical review and open discussion in an International workshop 8-10 September 2008 at Tampere, Finland. Based on the feedback from the workshop, the final Guidelines were completed and submitted to EC for approval at the end of November 2008. After formal approval by the EC, the draft document has been approved by the Working Party on Medical Exposure at their meeting on 1-2 April 2009 and following their recommendation submitted for discussion and approval to Article 31 Group of Experts meeting on 9-11 June 2009. The Article 31 Group of Experts endorsed the document and recommended it for publication by the Commission.