Prototype — this is a working draft, shared for feedback and discussion. Not a finished, certified, or officially adopted framework. Scope — not intended for use as, or in the development of, a regulated medical device.
Home / Key Artifacts Matrix / Cross-Cutting
Signatories Matrix
Excel
All 37 artifacts × 11 roles (Approves/Reviews); Tier 1/2/3 required-by-tier flags; GB escalation rule
Template coming soon
Regulations & Standards Coverage Matrix
Excel
Real, extracted citation data — which artifacts actually cite each of 19 regulations/standards, not estimated
Template coming soon
Governance Checkpoint Checklist
Excel
Entry/exit criteria per phase; a judgment-based Checkpoint Check before each gate, not a rubber-stamp box
Template coming soon
Instructions for Use
Word
EU AI Act Art. 13; deployer-facing document; explicit accountability note for internal/external/hybrid development teams
Template coming soon
Quality Management System
Word
EU AI Act Art. 17; Provider-level, not per-project; confirms existing artifacts add up to a real system
Template coming soon
Fundamental Rights Impact Assessment
Word
EU AI Act Art. 27; Deployer-side (not Provider-side); narrow applicability — public bodies, public services, or Annex III 5(b)/5(c) only
Template coming soon
Periodic Review Report
Word
Recurring GxP checkpoint; MLOps/steady-state-owned, not a one-time project deliverable
Template coming soon
Change Control Form
Word
Minor/Moderate/Major classification decides re-testing depth; MLOps/steady-state-owned
Template coming soon
Master Regulatory Crosswalk
Word
7 phases × 6+ frameworks; landscape summary + per-stage detail
Template coming soon
AI Governance Board Charter
Word
Chair separated from Executive Sponsor; decision-rights matrix
Template coming soon
AI System Audit Checklist
Word
8 pass/fail categories incl. Agentic/LLM Security (OWASP)
Template coming soon
Project Plan & Schedule
Excel
32 tasks, formula-driven Gantt chart
Template coming soon
AI Solutions FMEA Template
Excel
Severity×Occurrence×Detection scoring; AI-specific failure categories
Template coming soon
Bias Testing & Prevention Developer Guide
Word
Code-level checks (fairlearn); CI-gate pattern
Template coming soon
Compliance Report
Word
Project-specific counterpart to the Compliance Plan; delivered vs. non-delivered reconciliation
Template coming soon
AI Risk Register
Excel
Enterprise-level risk log; 5×5 heat map, distinct from system-level FMEA
Template coming soon
AI Incident Report
Word
EU AI Act Art. 73 serious-incident reportability test built in
Template coming soon
Conformity Assessment
Word
High-Risk systems only; Annex IV checklist + Declaration of Conformity
Template coming soon
Vendor / Third-Party AI Due Diligence
Word
AI-specific vendor questions (training-on-data policy, model deprecation)
Template coming soon
Retirement & Decommissioning Plan
Word
Data disposition, technical decommissioning, compliance closeout
Template coming soon
Acronym Glossary
Word
65 terms, alphabetical, with description + artifact-specific notes
Template coming soon
AI Application & Model Inventory
Excel
Org-wide register of every AI system, model, and vendor; EU AI Act risk tier and deployment status per row
Template coming soon
Statistical & Technical Methods Reference
Excel
How to actually calculate the metrics named elsewhere — PSI, KL Divergence, calibration, drift, and more
Template coming soon