Title: Formulation of an audit system for testing laboratories under the requirements of EN ISO/IEC 17025:2000

According to the fish export regulations published by the government of Sri Lanka, an approval complying with the applicable requirements of the standard ISO/IEC 17025:2000 is mandatory, when obtaining the services from the testing laboratories.

The objective of this project was to formulate an audit system for evaluation of testing laboratories by studying the criteria considered under the Intentional Standard EN ISO/IEC 17025:2000.

A common technique to guide an audit is by completing an evaluation list, which addresses all components of the system. Therefore, to formulate the audit system for testing laboratories, a checklist was constructed with a scientific base. The criteria for the checklist was established as clearly and unambiguously as possible, by analysing the pinpoints or critical control points for the management and technical requirements of the standard through literature review and by studying the quality system of an established chemical laboratory. Furthermore, a path for analysing histamine in fish, using High Performance Liquid Chromatography was observed by following a practical sample, from arrival at the chemical laboratory until the result report was issued. Vital knowledge gained for that part of the process is by personal communications and by comparison of the critical control points found in theory and practice. For the analysis of critical control points, a logical decision tree was used along with some practical experience. The identified critical control points and their elements were used to establish the criteria for the audit checklist.