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

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Project Summary: The Food Safety Modernization Act (FSMA), signed into law on January 11, 2011, was designed to enable the Food and Drug Administration to better protect public health by helping ensure safety and security of the food and animal feed supplies. One of the goals of FSMA is to ensure there is sufficient capacity of high quality laboratories in the United States to provide food safety and animal feed testing as well as effective response to outbreaks. The following key goals were identified. To establish a foundation for high quality laboratory results from animal health testing laboratories and assist in implementation of the FSMA, the FDA formally partnered with veterinary medical diagnostic laboratories in 2012 through the formation of the Veterinary Laboratory Investigation and Response Network (Vet‐LIRN). Most laboratories in the Vet-LIRN are accredited by the American Association of Veterinary Laboratory Diagnostician Accreditation Program, which accredited laboratories using a laboratory accreditation standard that is congruent with the international laboratory accreditation standard ISO/IEC 17025, “General requirements for the competence of testing and calibration laboratories”. In 2016, a joint FDA-AAVLD White paper was published detailing the alignment of the AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory with ISO/IEC 17025:2005. The purpose of this 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 the competence of testing and calibration”.