OIE Quality Standard and Guidelines for Veterinary Laboratories: infectious diseases

Recognising the essential need for such a standard targeted specifically at laboratories conducting tests for infectious diseases of animals, the Biological Standards Commission of the OIE undertook to develop an interpretation of the generally stated requirements of ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. Since the first edition of this booklet (2002) the parent standard has been updated as ISO/IEC 17025:2005 to include a harmonised approach that also complements the requirements of the ISO 9000 series, particularly ISO 9001:2000, Quality management systems. Requirements.

This new edition of the OIE booklet brings the OIE Quality Standard into line with the 2005 version of the ISO/IEC standard. As it is an interpretation of ISO/IEC 17025, laboratories that comply with the OIE quality standard also operate in accordance with the ISO requirements for testing laboratories.

This booklet also contains companion guidelines developed by the Biological Standards Commission and approved by the International Committee of the OIE. They provide, in a convenient booklet format, practical texts that complement the Terrestrial and Aquatic Manuals. The previous guidelines on test method validation, reference reagents and laboratory proficiency testing have been updated, and a new one added on validation of tests using the polymerase chain reaction.