1. General Information
| Field | Details |
|---|---|
| Audit Program | \ |
| Year | |
| Audit Number |
| Field | Details |
|---|---|
| Audit Team | \<list auditors’ names> |
| Audit Type | \<e.g., internal (first-party) audit> |
| Audit Scope | In accordance with audit plan, para. 4 |
| Audit Date | |
| Audit Time | \<e.g., 09:00 – 17:00> |
2. Audit Participants
| Name | Position / Role |
|---|---|
| Albert Dreary | CEO |
| Frodo Baggins | QMO |
| Samwise Gamgee | Assistant Director |
| (…) | (…) |
3. Audit Criteria
| No. | Criterion |
|---|---|
| 1 | EN ISO 13485:2016 (ed. 3) |
| 2 | EU Medical Device Regulation 2017/745 |
4. Audit Activities
Day 1
| Time | Topic / Process Reviewed | Audit Criteria | Participants |
|---|---|---|---|
| 08:00 – 08:15 | Introduction | n/a | Dreary (CEO), Baggins (QMO) |
| 08:15 – 09:15 | QMS Overview, Documentation Requirements | EN ISO 13485:2016, paras. 4.1 and 4.2 | Dreary (CEO), Baggins (QMO) |
| 09:15 – 10:00 | Management Responsibility | EN ISO 13485:2016, paras. 5.1 – 5.3, 5.5, 5.6 | Dreary (CEO), Baggins (QMO) |
| 10:00 – 10:45 | Resource Management | EN ISO 13485:2016, paras. 6.1 – 6.3 | Dreary (CEO), Baggins (QMO) |
| 10:45 – 11:00 | Break | ||
| 11:00 – 11:45 | Product Realization | EN ISO 13485:2016, para. 7.1 | Baggins (QMO), Gamgee (As. Director) |
| 11:45 – 12:00 | Summary |
Day 2
| Time | Topic / Process Reviewed | Audit Criteria | Participants |
|---|---|---|---|
| (…) | (…) | (…) | (…) |
5. Release
| Field | Details |
|---|---|
| Auditor Name | |
| Release Date | |
| Auditor Signature |