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Templates ISO 13485 Templates

May 24, 2023

Template: Internal Audit Program

Sven Piechottka

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Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.

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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 <> <> <> <>  
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
ISO 13485:2016, para. 7.2:
Customer-related processes
ISO 13485:2016, para. 7.3:
Design and development
ISO 13485:2016, para. 7.4:
ISO 13485:2016, para. 7.5:
Production and service provision
ISO 13485:2016, para. 7.6:
Measuring equipment
ISO 13485:2016, para. 8.1, 8.2.1, 8.2.2:
Feedback and complaints handling
ISO 13485:2016, para. 8.1, 8.2.3:
Reporting to authorities
ISO 13485:2016, para. 8.1, 8.2.4:
Internal auditing
ISO 13485:2016, para. 8.1, 8.2.5, 8.2.6:
Measurement of products and processes
ISO 13485:2016, para. 8.3:
Nonconforming products
ISO 13485:2016, para. 8.4:
Analysis of data
ISO 13485:2016, para. 8.5:
Reg. (EU) 2017/745, Chapter VII, Art. 83-86:
Post-Market Surveillance
Reg. (EU) 2017/745, Chapter VII, Art. 87-90:

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