ISO 13485:2016 Active
v1.0
DocumentsProduction OperationsPO-003
Document Number
PO-003
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
8.5.1
Tier Level
Tier 2 — SOP/Plan

Incident handling procedures including severity classification and response timelines.

#incident-response#security#hipaa
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 13485:2016HIPAA

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release