Glossary
Change Control
Related processes: ECR, ECN, Deviation
Category
Process & Change Management
Industry
Manufacturing, Medical Device, Pharma
Required By
ISO 9001:2015 clause 8.5.6 · FDA 21 CFR Part 820
Related Terms
ECR · ECN · Deviation · Document Control
Change control is a formal quality management process that ensures changes are reviewed, approved, documented, and controlled before implementation.
What is change control?
Change control prevents unauthorized changes from introducing quality risks.ECR vs ECN
An ECR proposes a change while an ECN authorizes implementation.Frequently Asked Questions
What is the difference between an ECR and ECN?
An ECR requests a change while an ECN formally approves implementation.
Does ISO 9001 require change control?
Yes. ISO 9001 clause 8.5.6 requires organizations to review and control changes.
Related quality management terms
Last reviewed: May 19, 2026