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