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Templates ISO 13485 Templates

May 24, 2023

Template: Internal Audit Plan

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.

Template preview

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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