Poster: Professionalism Outreach: Outreach & Engagement
Implementation of a Quality Management System in an ISO 17025 Accredited Plant Pathogen Diagnostic Laboratory.
D. PICTON (1), A. Barth (1), K. Burch (2), P. Shiel (2) (1) USDA-APHIS-PPQ-S&T-CPHST, U.S.A.; (2) USDA-APHIS-PPQ-S&T-CPHST, U.S.A.
In 2015, the USDA-APHIS-PPQ-S&T Beltsville lab (Bldg 580) became the first ISO 17025:2005 accredited regulatory plant pathogen diagnostic lab in the United States. The ISO/IEC 17025 Standard is used world-wide by testing labs in the human clinical realm to the Federal Bureau of Investigation criminal analysis labs to ensure accuracy and reliability of test results. As a result of incorporating a system for technical and quality management, the diagnostics and results generated by the lab are internationally recognized to be technically competent, traceable, repeatable and statistically valid. The implementation of a Quality Management System (QMS) required the establishment of a systematic approach to control all laboratory processes as well as well-defined work instructions that were developed using statistically sound validation and verification data. The newly implemented Laboratory Information Management System (LIMS) has been integrated into the Laboratory QMS to provide complete sample, equipment, reagent and report tracking. This provides an added level of confidence that all data is sufficiently documented, reproducible, and traceable. An annual assessment by an accreditation body ensures that our laboratory continues to meet the requirements of technical competence. Continual improvements to the lab and its commitment to stakeholders through use of the QMS are now an operational component of the USDA-APHIS-PPQ-S&T Beltsville Lab.