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Implementation of ISO/IEC 17025 Practices in Small and Academic Laboratories
Food Manufacturers are facing challenging times due to regulations such as the Food Safety Modernization Act (FSMA) requiring them to provide evidence they are producing safe foods. Food testing laboratories aid in the mitigation of food safety issues providing evidence that a manufacturers food safety system is acceptable. To perform these activities laboratories are required to adhere to certain standards such as ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories. However, implementation of ISO/IEC 17025 practices is challenging, especially for small and academic laboratories, due to lack of available guidance. A long-term goal of the University of Nebraska Food Processing Center Laboratory Services (UNL-FPCLS) has been to prepare for ISO/IEC 17025 accreditation and provide accredited testing services to the food industry. This project included implementation of a quality management system including organizational structure, policies, support programs, and standard operating procedures. Over 63 SOPs, 103 forms, 19 manuals and lists, and 6 support programs were developed and implemented in this project. Media qualification verification procedures were developed for non-selective solid (Tryptic Soy Agar), non-selective liquid (Tryptic Soy Broth, Buffered Peptone Water), and selective liquid (Neogen Reveal® 20 Hour E. coli O157:H7, Romer RapidChek® Listeria) media to evaluate growth and quality parameters over the shelf life of the media. These procedures serve as a guide for implementing a media control program. Shelf life at room temperature and 2-8°C was determined for TSA (7 and 60 days), TSB/BPW (2 and 13 weeks), RapidChek® Listeria (3 and 12 hours), and Reveal® 20-Hour (6 hours both), respectively. Method verification of qualitative in-scope methods Neogen Reveal® 20-Hour for detection of E. coli O157:H7, Romer RapidChek® for detection of Listeria spp., and BioMérieux VIDAS® UP Salmonella SPT for detection of Salmonella spp. was also performed. All methods gave results of 100% for sensitivity. This project provides academic and small laboratories with methods and procedures that may be used as guides for implementing quality management systems and verifying methods to become ISO compliant and pursue ISO/IEC 17025 accreditation. Finally, the FPCLS completed all ISO compliance requirements and is positioned to pursue ISO/IEC 17025 accreditation.
Oliver, Eric Layne, "Implementation of ISO/IEC 17025 Practices in Small and Academic Laboratories" (2018). ETD collection for University of Nebraska-Lincoln. AAI10843766.