In short: Change control ensures that changes to products, processes, systems or organization are planned, assessed for risk, approved, implemented and verified, so that the management system stays effective.
What changes should be controlled?
Changes to design, materials, suppliers, equipment, software, procedures, organization and key people.
What does a good change process include?
- Request and description of the change
- Impact and risk assessment
- Approval by the right authority
- Implementation plan and communication
- Verification and closure
Key takeaways
- Assess risks before approving changes.
- Communicate changes to everyone affected.
- Verify the change worked.
Frequently asked questions
What does ISO 9001 say about change?
Clause 6.3 requires changes to the QMS to be planned; clause 8.5.6 covers control of changes to production and services.
Is change control only for manufacturing?
No. It applies to any process or system.
Who approves changes?
The authority defined in the change process, based on risk and impact.