ISO 13485:2016 Active
v1.0
Document Number
SEC-005
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Management Representative
Owner
Management Representative
ISO Clause
7.4, 4.1
Tier Level
Tier 2 — SOP/Plan

Vendor qualification SOP including security assessment, BAA requirements, and monitoring.

#vendor#third-party#baa#supplier
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
HIPAAISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Management RepresentativeInitial release