ISO 42001 × CQC Well-Led › Healthcare Series › Gap Severity Matrix — £19
Also in this series: Free Guide · £47 Guide · £167 Guide
ISO 42001 × CQC Well-Led Framework · Gap Severity Matrix · Healthcare Edition · £19

All 9 ISO 42001 Gaps.
Every CQC Key Question.
One Reference Page.

Your governance committee needs to know where the AI governance risks are — not read a report to find out. The Gap Severity Matrix puts all nine gaps, their CQC mapping, severity ratings, and EU AI Act cross-references on a single, high-resolution reference sheet.

Designed for governance committee agendas, internal audit dashboards, and inspection preparation. Pin it. Project it. Print it. The complete ISO 42001 × CQC Well-Led picture in one place, in the format governance professionals actually use.

One-time purchase · No subscription · Instant download · Print-ready PDF + high-res PNG

All 9 ISO 42001 Gaps CQC 5 KLoEs Mapped Severity: Critical / High / Medium EU AI Act Articles ITIL 4 Practice Column Print-Ready A3 Landscape
Live Preview

The Complete Matrix — 9 Gaps, All Frameworks, One View

The first three rows are shown in full below. Rows 4–9 are available on purchase. Each row contains the gap, its ISO 42001 clause, the CQC Well-Led KLoE mapping, severity rating, EU AI Act article reference, and ITIL 4 practice.

MAT-AIMS-HC-001 v1.0 · ISO 42001 × CQC Well-Led Gap Severity Matrix · Healthcare Edition

ISO 42001 × CQC Well-Led: Gap Severity Matrix

Rows 4–9 visible on purchase
#
Gap
CQC Well-Led Mapping
EU AI Act Cross-Reference
Severity
ITIL 4 Practice
G1
AI PolicyClause 5.2 — AI Policy
Well-Led: Vision & StrategyIs there a clear vision, a credible strategy and appropriate governance and management of quality?
Art. 9 — Risk Management System
Recital 9 — Governance commensurate with risk
Critical
Policy Management
G2
Internal OrganisationClause 5.3 — Roles, Responsibilities & Authorities
Well-Led: Governance StructuresAre there clear lines of accountability and governance within the organisation?
Art. 26(1) — Deployer Obligations
Appropriate technical & organisational measures
High
Workforce & Talent Management
G3
AI System RegisterClause 6.1.2 — AI System Inventory
Well-Led: Information & IntelligenceIs information used effectively to monitor and improve the quality and safety of care?
Art. 11 — Technical Documentation
Annex IV — System documentation requirements
High
Service Configuration Management
G4
Risk AssessmentClause 6.1 — Risk & Opportunity Planning
Safe: Risk ManagementAre risks to patients and others assessed and managed?
Art. 9 — Risk Management System
Clinical risk obligations for high-risk AI
Critical
Risk Management
G5
AI Lifecycle ManagementClause 6.1.3 — Lifecycle Planning
Well-Led: Learning CultureIs there a culture of continuous improvement?
Art. 13 — Transparency Obligations
Medium
Service Lifecycle Mgmt
Gaps 5 – 9 · Severity ratings · EU AI Act articles · ITIL 4 practices — Unlock for £19 →
The Deliverable

One Document. Everything Your Committee Needs to See.

A single-page reference document engineered for governance use — not reading. Designed to be printed at A3, projected in a committee meeting, or used as a dashboard anchor for your AI governance review.

📊 Complete Coverage

All 9 ISO 42001 Gaps — No Gaps Left Off

Every gap in the ISO 42001 Nine-Gap Audit framework is mapped. Including the three not covered in the free lead magnet — Internal Organisation (G2), AI System Register (G3), and AI Lifecycle Management (G5). The free guide shows you where your biggest risks are. The matrix shows you the complete picture.

🏥 CQC Mapping

CQC KLoE for Every Gap — Exact Question Text

Each gap is mapped to the CQC Well-Led (and where applicable, Safe, Effective, Responsive) Key Line of Enquiry it intersects. The exact CQC question wording is reproduced — not paraphrased — so you can show inspectors the direct linkage between your ISO governance evidence and the CQC criterion it satisfies.

🔴 Severity Ratings

Critical / High / Medium — CQC Inspection Risk Calibrated

Severity is calibrated to CQC inspection risk, not abstract compliance score. A Critical gap is one where absence of governance evidence is most likely to contribute to an "Inadequate" or "Requires Improvement" Well-Led rating. Use severity to prioritise your remediation roadmap and governance committee agenda.

🇪🇺 EU AI Act

EU AI Act Article Cross-Reference for Each Gap

The EU AI Act creates obligations that parallel ISO 42001 requirements. For healthcare providers using or procuring AI systems, these obligations may apply directly. Each gap includes the relevant EU AI Act article — so your governance committee can see where ISO 42001 compliance also closes EU AI Act exposure.

⚙️ ITIL 4 Alignment

ITIL 4 Practice Column — Assign Ownership Immediately

Each gap is mapped to its primary ITIL 4 practice — the service management framework that governs how the gap should be addressed operationally. This allows you to assign remediation ownership to the correct practice owner rather than treating AI governance as a standalone compliance exercise.

🖨️ Format

High-Res PDF · Print-Ready A3 · Committee-Ready

Delivered as a high-resolution PDF at A3 landscape — the format governance committees and quality teams use for reference documents. Print and laminate for your governance office. Project from a laptop in a committee meeting. Use as a standing agenda item backdrop. The design is engineered for these use cases, not general reading.

9 ISO 42001 Gaps
All Covered
5 CQC KLoEs
Mapped
A3 Print Format
High-Res PDF
Who It's For

Built for the People Who Run the Governance Committee, Not the People Who Brief It.

The matrix is a working document, not a reading document. It's for the people who need a complete picture of AI governance risk at a glance — and who need to produce that picture for others quickly.

Primary

Governance Leads

✓Use as the standing AI governance agenda item in quality and governance committee meetings
✓Show which gaps are remediated, in-progress, and open — update quarterly
✓Demonstrate to CQC inspectors that AI governance is monitored systematically, not reactively
✓Use severity ratings to build the remediation priority order for the board
Primary

Quality Managers

✓Incorporate into the internal audit programme as the AI governance scope document
✓Map evidence against each gap for the annual quality report
✓Use the CQC KLoE column to link AI governance evidence to the inspection framework directly
✓Share with the DSP Toolkit lead to identify overlap between AI governance and information governance obligations
ISO 42001 × CQC Well-Led · Healthcare Edition · MAT-AIMS-HC-001 v1.0

ISO 42001 × CQC Well-Led: Gap Severity Matrix

Single-page high-res reference PDF. Instant download. One-time purchase.

£19
One-time purchase
No subscription
Instant access
VAT may apply
✓All 9 ISO 42001 gaps mapped — no gaps omitted
✓CQC Well-Led KLoE exact question text for each gap
✓Severity ratings: Critical / High / Medium — CQC inspection risk calibrated
✓EU AI Act article cross-reference for every gap
✓ITIL 4 practice column for remediation ownership assignment
✓High-res PDF at A3 landscape — print-ready for governance committee use
✓UNUS London design system — consistent with the full healthcare series
Purchase & Download — £19 →

Processed by ClickBank · Secure checkout · 60-day money-back guarantee · Instant download after purchase

Instant download 60-day guarantee One-time purchase No subscription
ISO 42001 × CQC Well-Led Framework — Healthcare Series

Complete the Series

Free 5 CQC AI Gaps
Lead magnet — 5 gaps, inspection scenarios, checklists. 15–20pp PDF.
Download Free →
You are here £19 Gap Severity Matrix
All 9 gaps · CQC mapping · severity · EU AI Act. Single-page A3 PDF.
£47 Human Oversight Guide
Clause 8 in depth · EU AI Act Art. 14 · evidence checklist. 20–25pp.
Learn More →
£167 Integration Guide
Full dual-framework integration · 8 chapters · governance calendar. 50–70pp.
Learn More →
Questions

Frequently Asked Questions

The matrix is delivered as a high-resolution PDF file formatted at A3 landscape (420 × 297 mm / 16.5 × 11.7 inches). It is print-colour-adjusted to reproduce correctly on both colour and mono printers. A high-resolution PNG is also included in the download package for digital use — presentations, intranets, and screen projection.

The free guide covers five gaps (G1, G4, G6, G8, G9) in long-form — with inspection scenarios, clause analysis, and evidence checklists. It is designed for reading and self-assessment. The matrix covers all nine gaps in a single-page reference format — designed for governance committee use, internal audit scope documentation, and inspection preparation. They serve different purposes and different audiences. The matrix is the logical second step after the free guide: you know what the gaps are, now you need the complete picture in committee-ready format.

Severity ratings are calibrated against CQC inspection methodology and published Well-Led evidence requirements — specifically the CQC's Key Lines of Enquiry, the Well-Led Inspection Framework, and publicly available inspection reports. They reflect the CQC inspection risk — the likelihood that absence of governance evidence for a given gap will contribute to an "Inadequate" or "Requires Improvement" Well-Led rating. They are governance judgements, not statistical measures based on enforcement data.

EU AI Act references are current to Regulation (EU) 2024/1689 as enacted. The matrix includes article references and brief descriptions. For full EU AI Act compliance assessment, the matrix is a cross-reference tool, not a compliance programme. Healthcare providers with EU AI Act obligations should take qualified legal advice on the extraterritorial application of the regulation to their specific circumstances.

Yes. The purchase licence permits internal organisational use — printing, projection, sharing with governance committee members, quality teams, and clinical leads within the purchasing organisation. It does not permit resale, redistribution to third parties, or use as a deliverable in consulting engagements. Multi-organisation licences and consultant licences are available — contact support@unuslondon.com.

ISO 42001 × CQC Well-Led · All 9 Gaps · One Page

Your governance committee can't manage what it can't see. Give it the complete picture.

Nine gaps. Five KLoEs. Severity ratings. EU AI Act references. ITIL 4 practice ownership. One reference document. £19.

Get the Matrix — £19 →

One-time · Instant download · A3 high-res PDF · 60-day guarantee