Module 1: Introduction to Non-Conformance Management

This first module introduces non-conformance management for laboratory personnel, quality teams, and healthcare professionals. It explains how to identify departures from ISO 15189, local SOPs, regulatory requirements, and manufacturer instructions; distinguish incidents, non-conformances, and near misses; and understand their effect on patient safety, laboratory operations, accreditation, and reputation. Learners will follow the non-conformance lifecycle from identification through corrective and preventive action, practise reviewing realistic laboratory scenarios, and assess how a positive reporting culture supports risk reduction and continual improvement.