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