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