Verification and Validation of Examination Procedures as per ISO 15189:2022

Introduction to Verification and Validation Planning the Verification and Validation Process, Validation Process(Accuracy, Precision (repeatability and reproducibility) Specificity/selectivity, Sensitivity/limit of detection (LOD) and quantitation (LOQ) Linearity and range, Robustness, Measurement uncertainty) Verification Process: (Instrument capability, comparing results with reference standards or inter-laboratory comparisons) Documentation and Record-Keeping