ISO 13485:2016 Active
v1.0
DocumentsAI ML GovernanceAI-002
Document Number
AI-002
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
AI/ML Engineer
Owner
AI/ML Engineer
ISO Clause
ISO 14971
Tier Level
Tier 2 — SOP/Plan

Training data management including annotation standards, dataset versioning, and bias mitigation.

#training-data#dataset#annotation#bias
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026AI/ML EngineerInitial release