Glossary
Batch Record
Quality Management Glossary Term
Category
Manufacturing Quality
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 Batch Record is a controlled document that captures the complete manufacturing history of a specific production batch or lot. Batch records provide traceability, demonstrate compliance, and document all activities performed during production.
What is Batch Record?
Batch Record is a key process or concept used within quality management systems to support compliance and operational excellence.Why is Batch Record important?
Batch Record helps organizations improve traceability, maintain compliance, reduce risk, and support continuous improvement initiatives.Frequently Asked Questions
What does Batch Record mean in quality management?
Batch Record refers to a quality management concept commonly used in regulated manufacturing industries.
How is Batch Record used?
Batch Record is typically used within a quality management system to improve process control and regulatory compliance.
Related quality management terms
Last reviewed: May 19, 2026