Template: Internal Audit Plan

Sven Piechottka ISO 13485 Templates Published May 24, 2023 Internal Audit

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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 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,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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Sven Piechottka avatar

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.