Glossary
Deviation
Quality Management Glossary Term
Category
Process & Change
Industry
Manufacturing, Medical Device, Aerospace, Life Sciences
Required By
ISO 9001 · ISO 13485 · FDA 21 CFR Part 11
Related Terms
CAPA · Audit Management · Risk Assessment
A deviation is a documented and approved departure from an established procedure, specification, or requirement. Deviations are typically temporary, limited in scope, and evaluated to ensure they do not negatively impact product quality, safety, or compliance.
What is Deviation?
Deviation is a key process or concept used within quality management systems to support compliance and operational excellence.Why is Deviation important?
Deviation helps organizations improve traceability, maintain compliance, reduce risk, and support continuous improvement initiatives.Frequently Asked Questions
What does Deviation mean in quality management?
Deviation refers to a quality management concept commonly used in regulated manufacturing industries.
How is Deviation used?
Deviation is typically used within a quality management system to improve process control and regulatory compliance.
Related quality management terms
Last reviewed: May 19, 2026