ISO 13485:2016 Active
v1.0
DocumentsSecurity PrivacySEC-003
Document Number
SEC-003
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Management Representative
Owner
Management Representative
ISO Clause
HIPAA
Tier Level
Tier 2 — SOP/Plan

PHI handling procedures for acquisition, storage, processing, transmission, and disposal.

#phi#hipaa#patient-data
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
HIPAAGDPRISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Management RepresentativeInitial release