State Hygienic Laboratory ISO/IEC 17025:2017 Accreditation and Sample Surveillance

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Project Summary/Abstract: The State Hygienic Laboratory (SHL) at the University of Iowa proposes three objectives for the ISO/IEC 17025:2017 Accreditation and Sample Surveillance project: First, the laboratory will maintain the current scope of ISO/IEC 17025:2005 accreditation for the microbiological and chemical analysis of food testing; Second, SHL will maintain and improve upon the current Quality Management Systems (QMS), specifically by applying an approach based on the iterative four-step PDCA (Plan-Do-Check-Act; also known as the “Shewhart cycle”) management method. SHL will improve traceability practices emphasized in the ISO 17025- 2017 standards and continue to develop risk assessment tools and implement risk management practices to address high-risk areas in the laboratory quality system. The laboratory will continue to conduct internal audits and management reviews, actively engage and evaluate customer feedback, utilize best practices to improve upon service quality, and identify and participate in appropriate proficiency testing (PT) programs as available for all techniques implemented; Third, the laboratory will continue to collaborate with the Iowa Department of Inspection and Appeals (IDIA) to perform surveillance sampling and testing for FDA's Manufactured Food Regulatory Program. We will continue to develop strategic, targeted, comprehensive surveillance sampling and inspection on products with a history of challenges, broadly distributed products, and products that are of significance to the local food commerce. Sampling will follow the methods outlined in Chapter 4 of the FDA Investigations Operations Manual (IOM), and any supplementary FDA guidance on sample collection. The successful completion of this project will help the FDA advance the National Integrated Food Safety System (IFSS) and enhance efforts to protect the food supply.