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QMS Software Requirements Checklist

This QMS software requirements checklist helps you compare offers from different vendors in a structured way. Mark which criteria are mandatory for you and use the list as the basis for your RFP and vendor calls.

Updated 4 October 202661 checkpoints

How to use this checklist

  1. 1

    Define must-haves and nice-to-haves

    Go through the list with quality, IT and one business department and mark what is essential. Fewer must-haves make the comparison clearer.

  2. 2

    Pre-filter vendors

    Send the must-haves to three to five vendors. Anyone who does not answer clearly drops out.

  3. 3

    Test with real scenarios

    In the demo or trial, test your own processes: approve a document, assign a training, record a deviation.

  4. 4

    Compare total cost

    Compare licence, implementation, data migration, training and internal effort over three years.

Detailed advice is in our guide on how to choose QMS software.

Requirements catalogue

Document control

Training and competence

Improvement and deviations

Standards and compliance

Evidence and integrity

AI features

Usability

IT, security and data protection

Vendor and cost

Download the checklist as PDF

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Frequently asked questions

How many vendors should I compare?

Three to five vendors are usually enough. More vendors increase the effort without improving the decision much.

How long does a QMS implementation take?

For SMEs a few weeks is realistic if templates can be used and documents imported. Complex data migrations and validation extend the timeline.

Do I need validated software?

In regulated areas such as medical devices or pharmaceuticals, computerised systems must be validated for their intended use. Ask the vendor for validation documentation.

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