Glossary
FMEA
Quality Management Glossary Term
Category
Risk Management
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
Failure Mode and Effects Analysis (FMEA) is a structured risk assessment methodology used to identify potential failure modes, evaluate their impact, and prioritize corrective actions. FMEA is widely used in manufacturing, medical devices, aerospace, and quality management systems.
What is FMEA?
FMEA is a key process or concept used within quality management systems to support compliance and operational excellence.Why is FMEA important?
FMEA helps organizations improve traceability, maintain compliance, reduce risk, and support continuous improvement initiatives.Frequently Asked Questions
What does FMEA mean in quality management?
FMEA refers to a quality management concept commonly used in regulated manufacturing industries.
How is FMEA used?
FMEA is typically used within a quality management system to improve process control and regulatory compliance.
Related quality management terms
Last reviewed: May 19, 2026