State Hygienic Laboratory Iso/iec 17025:2005 Accreditation

Project Summary/AbstractStatement of Objectives: The State Hygienic Laboratory (SHL) proposes to develop and implementprocesses within the laboratory to achieve ISO/IEC 17025:2005 accreditation for the microbiological andchemical 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 managementsystem relative to the requirements of ISO/IEC 17025:2995 standard to identify and address gaps inpreparation for submitting accreditation application. The SHL will identify, develop, implement and validatemethods according to ISO/IEC 17025:2005 standard requirements for microbiological and chemical analysesof food samples. The SHL will utilize methods provided by the FDA FERN program or methods availablethrough the Association of Official Analytical Chemists International (AOAC International) and FDABacteriological Analytical Manual (BAM) for the determination of specific analytes. The SHL will identify andparticipate 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 willbe compiled, evaluated and approved for all microbiological and chemistry food testing technologiesimplemented at the SHL. The SHL will use an ISO 17025 certification checklist from selected accreditationprovider to conduct a self-evaluation of the laboratory's management and analytical systems to evaluate thepreparedness of the lab versus the standard prior to the on-site visit from the certifying body. This InternalAudit 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 theSHL to become an ISO/IEC 17025:2005 accredited food testing laboratory for the state's manufactured foodregulatory program. Successful accreditation will allow the SHL to develop and implement microbiological andchemical food testing methods to provide increased analytical capacity for the state and FDA to protect thefood supply. The SHL will serve as the state laboratory which will improve capacity to detect and respond tofood safety problems. By achieving ISO/IEC 17025:2005 accreditation, the SHL will provide food testing dataof known and consistent quality to the state to help meet the FDA's mission to protect the public from foodborne illness and injury.