Comparison of AAVLD Laboratory Accreditation Requirements V 2021.01 with ISO17025:2017

Project Summary: The Food Safety Modernization Act (FSMA), signed into law onJanuary 11, 2011, was designed to enable the Food and Drug Administration to betterprotect public health by helping ensure safety and security of the food and animal feedsupplies. One of the goals of FSMA is to ensure there is sufficient capacity of highquality laboratories in the United States to provide food safety and animal feed testing aswell as effective response to outbreaks. The following key goals were identified. Toestablish a foundation for high quality laboratory results from animal health testinglaboratories and assist in implementation of the FSMA, the FDA formally partnered withveterinary medical diagnostic laboratories in 2012 through the formation of theVeterinary Laboratory Investigation and Response Network (Vet?LIRN). Mostlaboratories in the Vet-LIRN are accredited by the American Association of VeterinaryLaboratory Diagnostician Accreditation Program, which accredited laboratories using alaboratory accreditation standard that is congruent with the international laboratoryaccreditation standard ISO/IEC 17025, ?General requirements for the competence oftesting and calibration laboratories?. In 2016, a joint FDA-AAVLD White paper waspublished detailing the alignment of the AAVLD Requirements for an AccreditedVeterinary Medical Diagnostic Laboratory with ISO/IEC 17025:2005. The purpose ofthis project is to update the previous 2016 document by comparing the current version of?AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory?with ISO/IEC 17025:2017, the updated version of ?General requirements for thecompetence of testing and calibration?.