ISO 13485:2016 Active
v1.0
DocumentsAI ML GovernanceAI-001
Document Number
AI-001
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
ISO 14971
Tier Level
Tier 2 — SOP/Plan

AI lifecycle management covering model development, validation, deployment, and monitoring.

#ai-governance#ml-lifecycle#model-management
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release