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Based on ISO 15189 Standard for laboratories' technical competence, management, and continual improvement.
October 31, 2024
By: Kristin Brooks
Managing Editor, Contract Pharma
The College of American Pathologists (CAP) has awarded Navigate BioPharma Services, Inc. accreditation to the ISO15189 standard under the CAP 15189SM Accreditation Program. The accreditation is based on the International Organization for Standardization (ISO) 15189 Standard for laboratories’ technical competence, management, and continual improvement. It focuses on improved patient safety and risk reduction, outlining standards for quality, and competence particular to medical laboratories. CAP 15189SM is a voluntary, non-regulatory accreditation to the ISO 15189:2012 Standard as published by ISO. The program does not replace the CAP’s Clinical Laboratory Improvement Amendments (CLIA)-based Laboratory Accreditation Program but complements CAP accreditation and other quality systems. The program aims to optimize processes to improve quality standards while reducing institutional errors and risks, and controls costs. “The ISO 15189 standard helps laboratories achieve a framework to continuously work on improving themselves,” said Vipul Trivedi, MD FCAP and Chair of the CAP 15189 Committee. “Through the use of risk assessment and process improvement, we are able to achieve the highest levels of laboratory care for patients.” “This accreditation underscores our commitment to the highest standards of quality and patient care,” said Shannon Sykes, Head of Quality at Navigate BioPharma Services, Inc. “Achieving ISO 15189:2012 accreditation demonstrates our dedication to continuous improvement and excellence in laboratory services.”
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