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IG-AIMS-HC-001 v1.0
CAL-AIMS-HC-001 v1.0
ISO 42001 × CQC Well-Led
Healthcare Edition
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One Evidence Trail, Two Frameworks: The ISO 42001 and CQC Well-Led Integration Guide

Both files are available below. Download the Integration Guide first, then the Governance Calendar — print the calendar at A2 for your governance office or project it at your next governance committee meeting.

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Getting Started

How to Use Both Deliverables Effectively

01
Read the mapping matrix first — understand the full intersection picture

The guide opens with the full 9-gap × 6-key-question mapping matrix. This is the most important section to read before the chapters. It gives you the complete picture of where ISO 42001 and CQC Well-Led intersect — and where they don't. Mark the intersections most relevant to your current inspection preparation or AI governance programme and use those to prioritise which chapters to implement first.

02
Use the evidence gap analysis template before implementing any chapter

The evidence gap analysis template (in the guide's appendix) allows you to self-assess your current position against all 6 consolidated artefacts before you start implementing. Complete this first — it tells you which artefacts you already have (partially or fully), which are absent, and which require the most urgent attention. Use the readiness scoring to prioritise your implementation sequence.

03
Display the Governance Calendar in your governance office before your next committee

Print the calendar at A2 and display it in your governance office or governance team workspace. At your next governance committee meeting, project it and use it to anchor the annual planning session — assigning owners to each activity and setting the committee's standing agenda around the quarterly governance committee rhythm (Q1/Q2/Q3/Q4). The calendar is most valuable when it is visible and used operationally, not filed.

04
Implement chapters in the order that matches your inspection timeline

If you have a CQC inspection anticipated in the next 6 months, prioritise Chapters 1 (leadership accountability), 3 (risk assessment as Safe evidence), and 6 (human oversight) — the three chapters most likely to surface during a Well-Led deep dive. If you are building the programme from scratch with no immediate inspection pressure, implement in chapter order — the architecture builds sequentially and each chapter's artefacts feed subsequent ones.

05
Bring Chapter 8 (continual improvement loop) to the governance committee as the standing AI governance agenda structure

Chapter 8 designs the quarterly governance committee AI review structure — the reporting format, the evidence items reviewed each quarter, and the improvement decision record. Present this chapter to the governance committee chair before implementing it, so the committee adopts the structure rather than having it imposed. Once the quarterly rhythm is adopted by the committee, the continual improvement loop is self-evidencing — it generates Well-Led improvement evidence automatically, every quarter.

Implementation Sequence

Suggested Chapter Implementation Sequence

Full sequencing guidance is in the guide's introduction. This summary maps chapters to implementation phases based on inspection risk priority and dependency order.

Phase 1 — Days 1–30 · Inspection-Critical

Chapters 1, 3 & 6

Ch.1: AI Governance Policy approved and communicated (closes CQC Well-Led KQ1)
Ch.3: AI Risk & Impact Assessment for each AI system in clinical use (closes CQC Safe)
Ch.6: Human Oversight Procedure drafted, approved, staff trained (closes CQC Effective)
Phase 2 — Days 31–60 · Governance Structure

Chapters 2, 7 & 4

Ch.2: AI System Register completed for all AI systems (closes CQC Well-Led KQ2)
Ch.7: AI Vendor Evaluation Framework completed for all AI suppliers (closes CQC third-party)
Ch.4: AI Data Governance documentation completed (closes CQC info gov + DSP Toolkit)
Phase 3 — Days 61–90 · Transparency & Disclosure

Chapter 5

Ch.5: AI Disclosure policy and patient disclosure statement implemented (closes CQC Caring + EU AI Act Art. 50)
Patient information materials updated to include AI disclosure where applicable
Staff trained on when and how to disclose AI involvement in care
Phase 4 — Month 4 onwards · Continual Improvement

Chapter 8

Ch.8: Quarterly governance committee AI review structure adopted (closes CQC Well-Led Learning)
Governance Calendar operational — all activities assigned to owners
Annual internal audit of AI governance programme scheduled
Annual management review structured against ISO 42001 Cl. 9.3
Chapter Reference

8 Intersection Chapters — Quick Reference

01
Leadership Accountability — AI Policy to Governance Structure
ISO Cl. 5.1–5.3 × CQC Well-Led KQ1 (Vision & Strategy) · ITIL 4: Policy Management
02
AI System Register as CQC Governance Evidence
ISO Cl. 6.1.2 × CQC Well-Led KQ2 (Governance Structures) · ITIL 4: Service Configuration Management
03
AI Risk Assessment as CQC Safe Domain Evidence
ISO Cl. 6.1 × CQC Safe KLoE · ITIL 4: Risk Management
04
AI Data Governance — DSP Toolkit Gap Closed Simultaneously
ISO Cl. 6.2 × CQC Well-Led (Info Gov) × DSP Toolkit · ITIL 4: Information Security Management
05
AI Disclosure to Patients — Transparency Across All Three Frameworks
ISO Cl. 6.3 × CQC Caring KLoE × EU AI Act Art. 50 · ITIL 4: Relationship Management
06
Human Oversight — The Accountability Intersection
ISO Cl. 8 × CQC Effective KLoE × EU AI Act Art. 14 · ITIL 4: Service Validation & Testing
07
AI Vendor Governance — Supply Chain Accountability
ISO Cl. 6.6 × CQC Well-Led (Third-Party Assurance) · ITIL 4: Supplier Management
08
Continual Improvement Loop — Making AI Governance Self-Evidencing
ISO Cl. 9–10 × CQC Well-Led (Learning & Improvement) · ITIL 4: Continual Improvement