Document audit findings and corrective actions providing objective evidence of quality system performance.
Audit Information | Details |
---|---|
Date(s) of Audit | March 15, 2024 |
Lead Auditor Name | Sarah Johnson |
Lead Auditor Title and Company | Quality Manager, MedDevice Solutions Inc. |
Other Auditor(s) Name(s) | Michael Chen, Senior Process Engineer |
Site of Audit (or remote) | Main Office, Conference Room B |
Person Participating in Audit | Responsibilities |
---|---|
Emily Rodriguez / Document Control Manager | Document control procedures, training records management |
David Kim / Risk Manager | Risk management processes, risk assessment documentation |
Jennifer Martinez / Quality Coordinator | Cross-functional quality processes, CAPA coordination |
Thomas Anderson / Software Lead | Software development processes, design control implementation |
Regulation or Standard | Section | Description | Major NC | Minor NC | Rec |
---|---|---|---|---|---|
ISO 13485:2016 | 4.2.4, 4.2.5 | Control of documents and records | 0 | 1 | 0 |
ISO 13485:2016 | 6.2 | Human resources management | 0 | 1 | 1 |
ISO 14971:2019 | 4-8 | Risk management process | 0 | 0 | 1 |
ISO 14971:2019 | 9 | Risk management file | 0 | 1 | 0 |
ISO 13485:2016 | 8.2.4 | Internal audit process | 0 | 0 | 1 |
How often do I need to create audit reports?
Who should review and approve audit reports?
What's the difference between major and minor nonconformities?
How do audit findings connect to the CAPA system?
What should I do if an audit finds no nonconformities?
How long should I retain audit reports?