# Internal Audit Program

Author: Sven Piechottka
Published: 2023-05-24
Updated: 2024-04-26
Source: https://openregulatory.com/document_templates/internal-audit-program

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