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Internal Audit Program

Sven Piechottka · ISO 13485 Templates · Published May 24, 2023

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Template preview

This template is best implemented in an excel / sheets file. Note that an audit program most commonly covers
all ISO 13485 requirements in the course of three years at minimum.

Audit Program <Company Name> 2023 - 2026

1. General Information

Auditing Interval 01/2023 - 01/2026
Auditing objective: <e.g. "13485 compliance" or "preparation for MDR conformity assessment" or "supplier surveillance">
Chances and risks: <for example: chances - "small company, planning to be audited by an external party to avoid blind spots">

2. Audit Program Plan

Audit ID #1 #2 #3 (...)
Date <dd.mm.2023> <dd.mm.2024> <dd.mm.2025> <dd.mm.2026>
Lead auditor (...) (...) (...) (...)
ISO 13485:2016, para. 4.1, 4.21:General QMS requirements x x
ISO 13485:2016, para. 4.2.2, 5.3, 5.4:Quality manual and QMS planning x x
ISO 13485: 2016, para. 4.2.3:Medical device file x x
ISO 13485:2016, para. 4.2.4, 4.2.5:Control of documents and records x x
ISO 13485:2016, para. 5.1, 5.2, 5.3., 5.4, 5.5:Management responsibility x x
ISO 13485:2016, para. 5.6:Management review x x
ISO 13485:2016, para. 6.1, 6.3:Resource management x x
ISO 13485:2016, para. 6.2:Human resources management x x
ISO 13485:2016, para. 6.4:Work environment and contamination control n/a n/a n/a n/a
ISO 13485:2016, para. 7.1:Planning product realization x
ISO 13485:2016, para. 7.2:Customer-related processes x
ISO 13485:2016, para. 7.3:Design and development x
ISO 13485:2016, para. 7.4:Purchasing x
ISO 13485:2016, para. 7.5:Production and service provision x
ISO 13485:2016, para. 7.6:Measuring equipment x
ISO 13485:2016, para. 8.1, 8.2.1, 8.2.2:Feedback and complaints handling x
ISO 13485:2016, para. 8.1, 8.2.3:Reporting to authorities x
ISO 13485:2016, para. 8.1, 8.2.4:Internal auditing x
ISO 13485:2016, para. 8.1, 8.2.5, 8.2.6:Measurement of products and processes x
ISO 13485:2016, para. 8.3:Nonconforming products x
ISO 13485:2016, para. 8.4:Analysis of data x
ISO 13485:2016, para. 8.5:Improvement x
Reg. (EU) 2017/745, Chapter VII, Art. 83-86:Post-Market Surveillance x
Reg. (EU) 2017/745, Chapter VII, Art. 87-90:Vigilance x

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Sven Piechottka

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.
More about me