# Internal Audit Plan

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

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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,<br\>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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