ISO 10002 customer complaints management
When complaints remain in separate inboxes, ownership and progress become difficult to see. QMOS keeps the complaint, investigation and response steps in a traceable record.
Start with a clear complaint record
Record the source, subject and supporting evidence and assign an owner. Distinguish the customer’s reported experience from the facts confirmed during investigation.
Investigate, respond and learn
Keep the investigation outcome and evidence of the customer response. Where a recurring or systemic problem calls for corrective action, link a CAPA to follow root cause and effectiveness.
- Registration and ownership
- Investigation and response evidence
- Linked corrective action where needed
Define your own operating rules
Your organisation determines response targets and decision authority. ISO 10002 is guidance on complaints handling; QMOS use does not guarantee customer satisfaction or a certification outcome.
QMOS supports records and workflows; it is neither an ISO certificate nor a certification guarantee. In-app approvals are not qualified electronic signatures. The ISO 13485 module is in pilot; authorised people remain responsible for regulatory, conformity and release decisions.
Frequently asked questions
Does every complaint require a CAPA?
No. Make a reasoned decision based on findings, impact and recurrence risk. Separate an immediate correction from systemic corrective action.
What about medical device complaints?
The ISO 13485 pilot adds a separate medical device and regulatory reporting assessment; module access and responsibilities must be confirmed.