Template: Internal Audit Program

Sven Piechottka
Updated April 26, 2024

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Audit Program <Company Name> 2023 – 2026

1. General Information

Auditing Interval01/2023 – 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		xx
ISO 13485:2016, para. 4.2.2, 5.3, 5.4:
Quality manual and QMS planning		xx
ISO 13485: 2016, para. 4.2.3:
Medical device file		xx
ISO 13485:2016, para. 4.2.4, 4.2.5:
Control of documents and records		xx
ISO 13485:2016, para. 5.1, 5.2, 5.3., 5.4, 5.5:
Management responsibility		xx
ISO 13485:2016, para. 5.6:
Management review		xx
ISO 13485:2016, para. 6.1, 6.3:
Resource management		xx
ISO 13485:2016, para. 6.2:
Human resources management		xx
ISO 13485:2016, para. 6.4:
Work environment and contamination control		n/an/an/an/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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