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State Hygienic Laboratory ISO/IEC 17025:2005 Accreditation

Wichman, Michael; Pentella, Michael Anthony
University of Iowa
Start date
End date

Project Summary/Abstract: Statement of Objectives: The State Hygienic Laboratory (SHL) proposes to develop and implement processes within the laboratory to achieve ISO/IEC 17025:2005 accreditation for the microbiological and chemical analysis of food testing from an impartial and internationally recognized body within five years or by2016.Research Design and Methods to be Employed: The SHL is currently a FERN FDA chemistry and FERNFSIS Microbiology laboratory. The SHL will utilize the just completed evaluation of the quality management system relative to the requirements of ISO/IEC 17025:2995 standard to identify and address gaps in preparation for submitting accreditation application. The SHL will identify, develop, implement and validate methods according to ISO/IEC 17025:2005 standard requirements for microbiological and chemical analyses of food samples. The SHL will utilize methods provided by the FDA FERN program or methods available through the Association of Official Analytical Chemists International (AOAC International) and FDA Bacteriological Analytical Manual (BAM) for the determination of specific analytes. The SHL will identify and participate in appropriate proficiency testing (PT) programs as available for all techniques implemented. Standard operating procedures will be developed, reviewed and approved and all method validation data will be compiled, evaluated and approved for all microbiological and chemistry food testing technologies implemented at the SHL. The SHL will use an ISO 17025 certification checklist from selected accreditation provider to conduct a self-evaluation of the laboratory's management and analytical systems to evaluate the preparedness of the lab versus the standard prior to the on-site visit from the certifying body. This Internal Audit shall be conducted by the QA Coordinator's for SHL's Ankeny and Coralville facilities. Broad, Long-term Objectives and Specific Aims: The broad, long-term objectives for this project are for the SHL to become an ISO/IEC 17025:2005 accredited food testing laboratory for the state's manufactured food regulatory program. Successful accreditation will allow the SHL to develop and implement microbiological and chemical food testing methods to provide increased analytical capacity for the state and FDA to protect the food supply. The SHL will serve as the state laboratory which will improve capacity to detect and respond to food safety problems. By achieving ISO/IEC 17025:2005 accreditation, the SHL will provide food testing data of known and consistent quality to the state to help meet the FDA's mission to protect the public from foodborne illness and injury.

Funding Source
Food and Drug Administration
Project source
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Project number
Bacterial Pathogens
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