Measurement uncertainty in testing of biologicals in national control laboratories for ISO/IEC 17025: practical approaches

Abstract

The challenges in estimating measurement uncertainty in the complex matrix of biological systems, while doing compliance testing by National Control Laboratories and its importance in meeting ISO/IEC 17025 requirements are emphasised. Two primary approaches for MU, the bottom-up and top-down approaches, are discussed. Highlighting the significance of accurate estimations in NCLs, it advocates the use of a top-down approach by leveraging available quality control data and control charts for precision and bias assessment and balancing regulatory compliance to ensure the product quality and its timely release into the market, while complying with accreditation standards.