Template: Internal Audit Program

Updated April 26, 2024

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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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