Maps to
FDA QMSR (Part 820): §820.180 (now inspectable)
ISO 13485: ISO 13485 §8.2.4
Requirement text
Internal audits shall be conducted at planned intervals to determine whether the QMS conforms to planned arrangements and is effectively maintained.
Atomic constraints
- •Audit program must be planned
- •Audit criteria and scope must be defined
- •Auditor independence must be ensured
- •Audit results must be recorded
- •Corrective actions must be tracked to closure
Evidence signals
- •
FILE_EXISTS
(Internal.*Audit|Audit.*Schedule|Audit.*Report|Audit.*Finding|Audit.*SOP)
- •
CONTENT_MATCH
Does this document describe internal audit planning, execution, findings, or corrective action tracking?
Audit defense
Internal audits for our QMS are documented in [your document ID]. The audit program covers all QMS elements at planned intervals with independent auditors. Findings are formally recorded and corrective actions tracked to verified closure per ISO 13485 8.2.4.