Plan systematic audit activities defining scope, objectives, timing, and logistics for quality system evaluation.
Audit Information | Details |
---|---|
Audit Date | March 15, 2024 |
Audit Time | 09:00 - 17:00 |
Audit Location | Main Office, Conference Room B |
Auditor Information | Details |
---|---|
Lead Auditor Name | Sarah Johnson |
Lead Auditor Position & Company | Quality Manager, MedDevice Solutions Inc. |
Auditor Name | Michael Chen |
Auditor Position & Company | Senior Process Engineer, MedDevice Solutions Inc. |
Name | Position / Role |
---|---|
Emily Rodriguez | Document Control Specialist |
David Kim | Risk Management Lead |
Jennifer Martinez | Regulatory Affairs Manager |
Thomas Anderson | Software Development Manager |
Audit Criterion | Covered in this Audit |
---|---|
EN ISO 13485:2016 | Yes |
ISO 14971:2019 | Yes |
(EU) Medical Device Regulation 2017/745 | Partially (Articles 10, 61) |
IEC 62304:2006 | No |
IEC 62366-1:2015 | No |
FDA Quality System Regulation (21 CFR 820) | No |
Internal SOP-003 Document Control | Yes |
Internal SOP-007 Risk Management | Yes |
Date | Time | Topic / Process / Requirement | Audit Criteria | Participants |
---|---|---|---|---|
March 15, 2024 | 09:00 - 09:30 | Opening Meeting & Audit Plan Review | ISO 13485:2016, cl 8.2.4 | All participants |
March 15, 2024 | 09:30 - 11:30 | Document Control Process Review | ISO 13485:2016, cl 4.2.4, 4.2.5; SOP-003 | Emily Rodriguez, Jennifer Martinez |
March 15, 2024 | 11:30 - 11:45 | Break | N/A | N/A |
March 15, 2024 | 11:45 - 13:00 | Document Control Records Review | ISO 13485:2016, cl 4.2.5 | Emily Rodriguez |
March 15, 2024 | 13:00 - 14:00 | Lunch | N/A | N/A |
March 15, 2024 | 14:00 - 15:30 | Risk Management Process Review | ISO 14971:2019, cl 4-8; SOP-007 | David Kim, Thomas Anderson |
March 15, 2024 | 15:30 - 15:45 | Break | N/A | N/A |
March 15, 2024 | 15:45 - 16:30 | Risk Management Files Review | ISO 14971:2019, cl 9; MDR Art 61 | David Kim, Jennifer Martinez |
March 15, 2024 | 16:30 - 17:00 | Closing Meeting & Next Steps | ISO 13485:2016, cl 8.2.4 | All participants |
How often should I conduct internal audits of my QMS?
Who can perform internal audits in my organization?
What should I do if my audit reveals non-conformities?
How detailed should my audit activities schedule be?
What documents should auditors review during the audit?
How do I prepare my team for an internal audit?