ISO 13485:2016 Active
v1.0
Document Number
SEC-001
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Management Representative
Owner
Management Representative
ISO Clause
4.1, 7.5
Tier Level
Tier 2 — SOP/Plan

Data classification scheme defining public, internal, confidential, and PHI data categories.

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

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Management RepresentativeInitial release