This training is designed to provide laboratories with a comprehensive understanding of how method validation and verification establish the technical credibility of testing and calibration activities. It explains the intent of ISO/IEC 17025 Clause 7.2 and highlights why validated and verified methods are essential for generating reliable, reproducible, and fit-for-purpose results, particularly in regulated and accreditation-driven environments.
Participants will gain detailed insight into the distinction between method validation and method verification, including when each activity is required and how they apply to standard, non-standard, laboratory-developed, and modified methods. The training covers selection of appropriate performance characteristics such as accuracy, precision, specificity, linearity, range, detection limits, robustness, and measurement uncertainty, ensuring alignment with the method’s intended use.
The course emphasizes practical planning and execution of validation and verification studies, including experimental design, sample selection, statistical evaluation, and establishment of acceptance criteria. Participants will learn how to generate meaningful data, avoid common pitfalls, and apply risk-based thinking to determine the depth and extent of studies required.
By the end of the training, participants will be equipped to implement robust, defensible method validation and verification practices that support technical competence, regulatory confidence, and sustained compliance with ISO/IEC 17025 Clause 7.2, while enhancing the overall reliability of laboratory results.