Abstract

The reliability of the results released by the test laboratories that participate in the Sanitary Control Programs is essential. The Sanitary Control Programs are intended for safety monitoring and verification of mollusks and other analyses. The validity of the results of each laboratory, which is shown in a test report, is very important, since it allows deciding on how to proceed in the Sanitary Control Program. Therefore, the laboratories that participate in sanitary control programs for shellfish, they must meet the terms with quality regulations, that ensure that they perform with the minimum requirements to demonstrate their competence. The standard ISO/IEC 17025:2017 “General requirements for the competence of testing and calibration laboratories” specifies the general requirements for the competence, impartiality and consistent operation of laboratories. According to the standard ISO/IEC 17025:2017, the test laboratory may possibly accomplish comparisons with reference material or certified reference material to observe its performance. In this way, the laboratory can compare its results with other test laboratories. The activities can be done across proficiency tests or be part on a interlaboratory comparisons. The Ministry of Health of Chile (MINSAL) and the National Fisheries and Aquaculture Service of Chile (SERNAPESCA) established the External Quality Assessment Program (PEEC) at the Public Health Institute of Chile (ISP) since 1998. The PEEC is an annual proficiency testing program focused on the support of the National Surveillance Program of Red Tide (Algal Blooms) and the Bivalve Mollusc Sanitization Program. The PEEC performs proficiency tests in the determination of Marine Biotoxins in Bivalve Molluscs, Metals in hydrobiological products and Enumeration of E. coli. Consequently, the PEEC allows to the authorities to annually evaluate the performance of public and private laboratories, which are part of the Sanitary Control Program. The authorities may request direct actions in the quality systems of the laboratories evaluated if there is any unsatisfactory or questionable performance. In this manner, laboratories can improve their comparability and reliability of their measurements, and they can avoid the risk of erroneous results. After years of studies, it is possible to visualize the detection of training needs in laboratories, as well as the increase in the number of national laboratories that participate in proficiency tests focused on safety control of hydrobiological products and water quality. Similarly, there are improvements in the performance of public and private laboratories, which participate in the programs