Updated May 18, 2022

Template: Checklist: Stakeholder Requirements Review

Sven Piechottka

Template Download

This is a free template, provided by OpenRegulatory.

You can download it as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don't remove the copyright at the bottom).

Don't Miss Updates to This Template

Subscribe to our newsletter and we'll keep you posted on which templates we've changed.

Questions? Still Lost in Regulation?

Good news! Our goal is to provide lots of stuff for free, but we also offer consulting if you need a more hands-on approach. We get stuff done really fast. Have a look!

Template preview

Stakeholder Requirements Review Checklist

ISO 13485:2016 Section Document Section
7.3.2 (Al)
Classes IEC 62304:2006 Section Document Section
A, B, C 5.1.8 (All)

1. Summary

With this checklist we verify the completeness and consistency of Stakeholder Requirements.

Relevant documents:

2. Checklist

Checklist Items Yes No Comment
The stakeholder requirements are complete.      
The stakeholder requirements address all relevant stakeholders.      
The stakeholder requirements take all relevant use scenarios of the intended use into account.      
The stakeholder requirements cover all relevant categories (e.g. technical, regulatory, organizational, market).      
The stakeholder requirements are not ambiguous, self-contradicting or conflicting with each other.      
The stakeholder requirements are traceable.      
The stakeholder requirements are testable (if required).      


<Insert comments if applicable>

4. Result

[ ] Stakeholder Requirements passed
[ ] Stakeholder Requirements not passed
[ ] Stakeholder Requirements passed with the following obligations: <Insert if applicable>\

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.