CAPA-001
CAPA Procedure
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
QA Engineer
Owner
QA Engineer
ISO Clause
8.5.2, 8.5.3
Category
CAPA
Corrective and preventive action SOP including investigation, root cause analysis, and effectiveness checks.
#capa#corrective-action#preventive-action#root-cause
Regulatory Standards
ISO 13485:201621 CFR Part 820
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | QA Engineer | Initial release |