8.3 Control of nonconforming product

Clause 8.3 of ISO 13485:2016 mandates that manufacturers identify, document and evaluate any product that fails to meet specified requirements and implement controls to prevent its unintended use or delivery. The organization must segregate the nonconforming item, decide on disposition such as rework, acceptance under concession or scrap, record the decision and any corrective actions, and maintain traceability throughout the process.