Resources - MDSAP Nonconformity Management & Reporting - Decision Tree

MDSAP Nonconformity Management & Reporting - Decision Tree

When a nonconformity is identified during an MDSAP audit or internal quality review, knowing how to respond—quickly and correctly—can be the difference between smooth certification and regulatory setbacks. This decision tree lays out a structured workflow for managing nonconformities under the Medical Device Single Audit Program (MDSAP). It guides quality and regulatory teams through a series of practical steps: from identifying whether the issue is minor or major, to assigning responsibility, initiating CAPA, conducting root cause analysis, and ultimately verifying the effectiveness of corrective actions. The goal is to ensure consistent, traceable decisions that meet jurisdictional expectations across all five participating MDSAP countries—without unnecessary escalation or wasted effort.