Template: Internal Audit Plan

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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 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

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