Free download

A simple guide to types of non-conformity

Definitions of non-conformity you can use in your Quality Management System (PDF format)


How to categorise non-conformities

This PDF download includes definitions for 4 severity levels that you can use to categorise non-conformities that arise in your products and process

  • Critical: Existential risk to customers or your business.

  • Major: Significant risk to final product or service quality.  

  • Minor: No significant risk to final product or service quality. 

  • Opportunity for improvement: Non-critical, non-systemic. 

Download and use the definitions to assess the risk of non-conformances and trigger corrective action when required.


Set up consistent criteria for assessing potential risk of NC

Distinguish between major and minor non-conformances

Trigger appropriate correction and investigation

Ensure action taken is proportional to risk 

Easy for everyone to read and understand

Meet quality management requirements of ISO 13485 and ISO9001

Get the definitions now