Audit Plan <Date>
1. General Information
| 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> |
2. Audit Participants
| Name | Position / Role |
|---|---|
| Albert Dreary | CEO |
| Frodo Baggins | QMO |
| Samwise Gamgee | Assistant Director |
| (…) | (…) |
3. Audit Criteria
| No. | Audit Criterion |
|---|---|
| 1 | EN ISO 13485:2016 (ed3) |
| 2 | (EU) Medical Device Regulation 2017/745 |
4. Audit Activities
Day 1
| 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 |
Day 2
| Time | Topic / Operational Unit / QMS Process | Audit Criteria | Participants |
|---|---|---|---|
| (…) | (…) | (…) | (…) |
5. Release
| Auditor Name | |
| Release Date | |
| Auditor Signature |
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Please don’t remove this notice even if you’ve modified contents of this template.
Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.