| Audit Program | <reference record here> |
| Year | |
| Audit Number |
| Auditor Team | <name auditor participants here> |
| Audit Type | <e.g. internal (first-party) audit> |
| Audit Scope | Pursuant to audit plan, para. 4 |
| Audit Date | |
| Audit Time | <e.g. 09.00 - 17.00> |
| Name | Position / Role |
|---|---|
| Albert Dreary | CEO |
| Frodo Baggins | QMO |
| Samwise Gamgee | Assistant Director |
| (…) | (…) |
| No. | Audit Criterion |
|---|---|
| 1 | EN ISO 13485:2016 (ed3) |
| 2 | (EU) Medical Device Regulation 2017/745 |
| Time | Topic / Operational Unit / QMS Process | Audit Criteria | Participants |
|---|---|---|---|
| 08.00 - 08.15 | Introduction | n/a | Dreary (CEO), Baggins (QMO) |
| 08.15 - 09.15 | QMS General Information,<br>Documentation Requirements | EN ISO 13485:2016, para. 4.1 and 4.2 | Dreary (CEO), Baggins (QMO) |
| 09.15 - 10.00 | Management Responsibility | EN ISO 13485:2016, para. 5.1 - 5.3, 5.5, 5.6 | Dreary (CEO), Baggins (QMO) |
| 10.00 - 10.45 | Resource Management | EN ISO 13485:2016, para. 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 |
| Time | Topic / Operational Unit / QMS Process | Audit Criteria | Participants |
|---|---|---|---|
| (…) | (…) | (…) | (…) |
| Auditor Name | |
| Release Date | |
| Auditor Signature |
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