Feedback and complaints
A system to gather and analyze information on whether the product meets requirements, including formal complaint handling.
Post-market surveillance
Proactive collection of information in production and post-production, with a procedure to report to authorities when regulation requires it.
Nonconformity and corrective action
Control of nonconforming product, with corrective and preventive actions based on root-cause analysis and the associated risk.
What an auditor usually asks for
- A complaint log with its analysis and closure
- A post-market surveillance and regulatory reporting procedure
- A nonconforming product log recording root cause
- Internal audits and a review of action effectiveness
How to cover measurement and improvement in Kimobox
- 1Log every complaint with its analysis, root cause and linked action.
- 2Manage post-market surveillance with regulatory reporting alerts.
- 3Open every nonconformity with a mandatory root cause and effectiveness check.
Every complaint stays linked to its batch, its cause and its action, ready for a notified-body inspection.
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- ISO 13485:2016 — Medical devices. Quality management systems ISO · March 2016
- Regulation (EU) 2017/745 on medical devices EUR-Lex · 5 April 2017
- ISO 14971:2019 — Application of risk management to medical devices ISO · 2019 ed.