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Template: Internal Audit Program

  • This is a free template by FDAToday

This template is best used within an Excel or Sheets document. Typically, an audit program encompasses all ISO 13485 requirements over a minimum duration of three years.

Audit Program \ 2021 – 2024

1. General Information

Auditing Period 01/2023 – 01/2026
Audit Objective \<e.g., “13485 compliance,” “preparation for MDR conformity assessment,” or “supplier surveillance”>
Opportunities and Risks \<e.g., opportunities – “small company aiming for external audit to address potential blind spots”>

2. Audit Program Overview

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, paras. 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, paras. 4.2.4, 4.2.5:
Document and record control		 x x
ISO 13485:2016, paras. 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, paras. 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, paras. 8.1, 8.2.1, 8.2.2:
Feedback and complaint management		 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, paras. 8.1, 8.2.5, 8.2.6:
Product and process measurement		 x
ISO 13485:2016, para. 8.3:
Nonconforming product management		 x
ISO 13485:2016, para. 8.4:
Data analysis		 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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