ISO 13485:2016 Active
Guest
·
Role
v1.0
SEC-005
Third-Party Vendor Management
Draft
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Management Representative
Owner
Management Representative
ISO Clause
7.4, 4.1
Category
Security Privacy

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

#vendor#third-party#baa#supplier
Regulatory Standards
HIPAAISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Management RepresentativeInitial release