The final act of the Uruguay Round of the General Agreement on Tariffs and Trade, 1994, contains the Agreement on the Application of Sanitary and Phytosanitary Measures, which aims to reduce the negative effects of health barriers on international trade to a minimum. Therefore, the Office International des Epizooties (OIE) Regional Commission for Europe proposed that an accreditation system based on the EN 45000 standard should be applied to achieve international recognition of certificates and testing laboratories. To this end, the OIE Standards Commission published a series of guidelines for the evaluation of laboratory quality and proficiency testing. In 1995, the Food and Agriculture Organization European Commission for the Control of Foot and Mouth Disease recommended that the OIE proposal should be applied in all foot and mouth disease (FMD) diagnostic laboratories in Europe. This review summarises the EN 45001 standard and the OIE guidelines, and proposes that these guidelines should be taken as a basis for the implementation of a quality assurance programme in FMD laboratories.