Both reactive and proactive customer feedback can be recorded in AuditMan and followed up. This is one of the QMS processes that affects several other processes that are centralised in the platform.
In some cases, product complaints or adverse events lead to minor/major design changes to fix inherent design shortcomings.
In several cases, complaints can hint to process changes such as manufacturing or quality inspection processes.
Incidents and adverse events form a special kind of feedback that – if not handled appropriately – can lead to major nonconformances. AuditMan has a dedicated component for recording adverse events.
It is a requirement of both ISO 9001 and ISO 13485 that issues must be analysed to reveal any negative trends. These become more evident in AuditMan.
Each regulatory jurisdiction has its own specific criteria for determining if an adverse event is reportable. AuditMan helps keeping track of these events.