Glossary
Root Cause Analysis
Quality Management Glossary Term
Category
Corrective Action
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
Root Cause Analysis is an important quality management concept used in regulated industries to improve compliance, traceability, and operational quality.
What is Root Cause Analysis?
Root Cause Analysis is a key process or concept used within quality management systems to support compliance and operational excellence.Why is Root Cause Analysis important?
Root Cause Analysis helps organizations improve traceability, maintain compliance, reduce risk, and support continuous improvement initiatives.Frequently Asked Questions
What does Root Cause Analysis mean in quality management?
Root Cause Analysis refers to a quality management concept commonly used in regulated manufacturing industries.
How is Root Cause Analysis used?
Root Cause Analysis is typically used within a quality management system to improve process control and regulatory compliance.
Related quality management terms
Last reviewed: May 19, 2026