Template: Internal Audit Plan

Sven Piechottka
Updated April 26, 2024

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This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, you can save a lot of time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, and then opening the relevant folder to find this template ready to load into Formwork.

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The template license applies (don’t remove the copyright at the bottom, don’t re-use this for commercial purposes).

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Audit Plan <Date>

1. General Information

Audit Program<reference record here>
Audit Number
Auditor Team<name auditor participants here>
Audit Type<e.g. internal (first-party) audit>
Audit ScopePursuant to audit plan, para. 4
Audit Date
Audit Time<e.g. 09.00 – 17.00>

2. Audit Participants

NamePosition / Role
Albert DrearyCEO
Frodo BagginsQMO
Samwise GamgeeAssistant Director

3. Audit Criteria

No.Audit Criterion
1EN ISO 13485:2016 (ed3)
2(EU) Medical Device Regulation 2017/745

4. Audit Activities

Day 1

TimeTopic / Operational Unit / QMS ProcessAudit CriteriaParticipants
08.00 – 08.15Introductionn/aDreary (CEO), Baggins (QMO)
08.15 – 09.15QMS General Information,<br>Documentation RequirementsEN ISO 13485:2016, para. 4.1 and 4.2Dreary (CEO), Baggins (QMO)
09.15 – 10.00Management ResponsibilityEN ISO 13485:2016, para. 5.1 – 5.3, 5.5, 5.6Dreary (CEO), Baggins (QMO)
10.00 – 10.45Resource ManagementEN ISO 13485:2016, para. 6.1 – 6.3Dreary (CEO), Baggins (QMO)
10.45 – 11.00Break
11.00 – 11.45Product RealizationEN ISO 13485:2016, para. 7.1Baggins (QMO), Gamgee (As. Director)
11.45 – 12.00Summary

Day 2

TimeTopic / Operational Unit / QMS ProcessAudit CriteriaParticipants

5. Release

Auditor Name
Release Date
Auditor Signature

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

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