CAPA-002
Complaint Handling 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
8.4.2
Category
CAPA
Complaint receipt, evaluation, investigation, and reporting procedures.
#complaint#vigilance#customer-feedback
Regulatory Standards
ISO 13485:201621 CFR Part 820
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | QA Engineer | Initial release |