ISO 13485:2016 Active
v1.0
DocumentsCAPACAPA-002
Document Number
CAPA-002
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
QA Engineer
Owner
QA Engineer
ISO Clause
8.4.2
Tier Level
Tier 2 — SOP/Plan

Complaint receipt, evaluation, investigation, and reporting procedures.

#complaint#vigilance#customer-feedback
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 13485:201621 CFR Part 820

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026QA EngineerInitial release