Clause 6.1.2
Risk assessment
What could go wrong for the organisation, whether regulatory, reputational, operational, security or financial, and how likely and severe would it be?
The standard
Published in December 2023, ISO/IEC 42001:2023 is the world's first certifiable AI Management System standard. It takes a risk-based approach to AI Governance and follows the same High-Level Structure as the management systems you may already run, so it builds on what you have.
4–10
If you hold ISO 9001 or ISO/IEC 27001, you already have a risk register, document control, an internal audit programme and a management review. 42001 extends them to AI rather than duplicating them.
It adds what no other standard covers: the AI System Impact Assessment, data quality and bias management, controls across the model lifecycle, and explainability requirements. Current risks are structured, and future ones are looked for deliberately.
One structure, shared across the family
Shared
4–10
High-Level Structure clauses
Your ISO 9001, 27001 and 27701 controls still apply to AI, but these five areas need extra attention.
Clause 6.1.2
What could go wrong for the organisation, whether regulatory, reputational, operational, security or financial, and how likely and severe would it be?
Clause 6.1.4 / Annex B
What is the real-world footprint on the people it affects: human rights, fairness, safety, privacy, and environmental and societal effects? Both are required. Risk is the forecast. Impact is the footprint.
Why certify
Boards sign this off for 4 reasons. Each one turns into evidence you can hand to whoever is asking.
01
Proportionate controls for the risks AI creates, such as bias, privacy, security and safety, so failures are less frequent, less severe and cheaper when they do happen.
02
A certificate from an accredited body is a statement your board, investors and insurers can rely on. Governed AI reads as a lower risk profile, because it is one.
03
Customers, partners and procurement teams increasingly ask how you govern AI. A certificate from an accredited body answers in one document.
04
Already law in the EU under the AI Act, and developing in the UK through existing regulators. A management system means the rules land on a structure that is ready for them.