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AI Governance · ISO/IEC 42001

ISO/IEC 42001 consulting and certification readiness

ISO/IEC 42001 is the international standard that defines an AI management system (AIMS): auditable AI policy, risk management, lifecycle governance and accountability. Berghem prepares your organization for certification — from gap analysis to internal audit — integrating the standard into your security and compliance program.

What is ISO/IEC 42001?

ISO/IEC 42001 is the first international standard for an AI Management System (AIMS). It defines requirements to govern the AI lifecycle responsibly — policy, impact assessment, Annex A controls and continual improvement — letting organizations demonstrate trustworthy, auditable use of AI and pursue accredited certification.

Unlike a one-off technical checklist, an AIMS is a management system: it defines how the organization governs AI end to end, produces auditable evidence and sustains certification by an accredited body. Berghem builds that system and connects it to your AI offensive-security work, ensuring governance on paper matches how models and agents actually behave in production.

What's included

•Gap analysis against ISO/IEC 42001 requirements
•AIMS design — policy, scope, roles and objectives
•AI risk and impact-assessment process
•Annex A control mapping and statement of applicability
•Internal audit and readiness for the Stage 1 and Stage 2 audits
•Integration with ISO 27001, LGPD and the EU AI Act
Module 01 · Program

Certification journey: how Berghem prepares your certification

The path to ISO/IEC 42001 is a management-system project, not an isolated test: gap analysis › AIMS implementation › internal audit › Stage 1 › Stage 2 › maintenance. We run the phases that take you from the current state to certification-audit readiness.

Phase 01 · Diagnosis

AIMS gap analysis

We assess your current AI governance maturity against ISO/IEC 42001, mapping gaps in policy, risk, documentation and operational controls. The output is a gap report prioritized by effort and risk, with an adequacy roadmap.

Phase 02 · Structure

Management-system implementation

We define scope, AI policy, roles and responsibilities, objectives and the AIMS documentation structure — tailored to your context as an AI provider, integrator or user, and aligned to business goals rather than a generic model.

Phase 03 · Risk

AI risk and impact management

We stand up the AI risk-assessment process and the AI system impact assessment required by the standard. Every model, agent or use case gets documented, treated and re-evaluated risk across its lifecycle.

Phase 04 · Validation

Internal audit and Stage 1 & 2 readiness

We operationalize the Annex A controls, produce auditable evidence and run the internal audit that precedes the certification body. We close nonconformities before the Stage 1 and Stage 2 audits, reducing the risk of failure.

Structure

Structure: clauses 4–10 and Annex A (38 controls)

ISO/IEC 42001 follows the high-level structure (HLS) shared by ISO management-system standards. The auditable requirements sit in clauses 4 to 10 — context of the organization, leadership, planning, support, operation, performance evaluation and improvement — the same backbone as ISO/IEC 27001.

Annex A of ISO/IEC 42001:2023 lists 38 controls, grouped into control objectives, which the organization selects and justifies in a statement of applicability based on the AI risks identified. Berghem maps every clause and Annex A control to your context, producing the evidence the certification body requires.

Module 02 · Requirements

What an AI management system (AIMS) requires

ISO/IEC 42001 organizes AI governance around a set of domains reflected in the Annex A controls. We build each one with policy, process and evidence.

Leadership

AI policy and governance

A leadership-approved AI policy with objectives, responsible-use principles and a commitment to continual improvement — the foundation of the management system.

Risk

AI risk management

A formal process to identify, analyze, treat and monitor AI risk over time, integrated with existing enterprise risk management.

Impact

AI system impact assessment

Analysis of AI systems' impact on individuals and groups — bias, transparency, contestability and consequences — documented and re-assessed.

Lifecycle

Responsible lifecycle

Governance of data, development, validation, deployment and monitoring of models and agents, with controls at every lifecycle stage.

Transparency

Transparency and documentation

Technical documentation, information to interested parties and records that sustain traceability of automated decisions and accountability.

People

Roles, competence and awareness

Defined responsibilities, required competencies and awareness for the teams that design, operate and oversee AI systems.

Comparison

ISO 42001 vs ISO 27001 vs ISO 27701

The three standards share the same management-system structure and can be integrated. Each governs a different object.

AspectISO/IEC 42001ISO/IEC 27001ISO/IEC 27701
ObjectAI management (AIMS)Information security (ISMS)Information privacy (PIMS)
FocusResponsible governance of the AI lifecycleConfidentiality, integrity and availabilityPersonal-data processing and privacy
Control annexAnnex A — 38 controlsAnnex A — 93 controlsPrivacy extension of ISO 27001
CertifiableYes, by an accredited bodyYes, by an accredited bodyYes, as an ISO 27001 extension
RelationshipReuses the existing ISMSInformation-security baselineExtends ISO 27001/27002
Regulatory landscape

ISO 42001 and the Brazilian regulatory landscape

Certification does not replace the law, but it builds the governance, risk and evidence base that AI regulation increasingly requires — in Brazil and abroad.

PL 2338

The Brazilian bill proposing the country's AI legal framework, with governance, risk-assessment and transparency duties. The AIMS anticipates much of what it will require.

BACEN

Central Bank of Brazil rules on risk management and technology use apply to AI models and agents in financial institutions. The AIMS organizes the governance supervisors expect.

EU AI Act

The European AI regulation classifies systems by risk and imposes management obligations. ISO/IEC 42001 is the leading organizational compliance route recognized by the market.

NIST AI RMF

The NIST AI Risk Management Framework (US) is voluntary and complements ISO/IEC 42001: the AIMS operationalizes the governance functions the RMF describes.

By sector

ISO 42001 by sector

The AIMS impact varies with the sector and the risk profile of the AI systems in use.

Financial services

Banks, fintechs and insurers use AI in credit, fraud prevention and service. The AIMS structures the model governance that regulators and clients increasingly require, integrating with the existing ISMS and risk management.

Healthcare

AI systems in diagnosis, triage and clinical management handle sensitive data and high-impact decisions. The AIMS documents impact assessment, human oversight and traceability, sustaining LGPD compliance and patient safety.

Readiness

ISO 42001 readiness checklist

Use this initial checklist to gauge how close your organization is to the certification audit:

  • •AIMS scope defined (which AI systems, units and processes)
  • •AI policy approved by leadership
  • •AI-governance roles and responsibilities assigned
  • •AI risk-management process in place
  • •AI system impact assessment documented
  • •Annex A controls selected and justified in the statement of applicability
  • •Model and agent lifecycle governance operating
  • •Auditable evidence and records maintained
  • •Internal audit and management review completed
  • •Accredited certification body selected for Stage 1 and Stage 2
Glossary

ISO/IEC 42001 glossary

Key terms used across the standard and the certification journey.

AIMS

AI Management System — the artificial-intelligence management system defined by ISO/IEC 42001, analogous to the ISO 27001 ISMS.

Annex A

The normative annex of ISO/IEC 42001:2023 with 38 AI controls, from which the organization selects the applicable ones in the statement of applicability.

Impact assessment

Analysis of AI systems' impact on individuals, groups and society — bias, transparency and consequences — required by the standard.

Accredited body

An independent, accredited certification body that runs the Stage 1 and Stage 2 audits and issues the ISO/IEC 42001 certificate.

FAQ

Frequently asked questions about ISO/IEC 42001

How do I certify my company to ISO 42001?
Certification follows a structured journey: gap analysis, AIMS design and implementation, AI risk and impact assessment, operation of the Annex A controls, internal audit and management review, then the Stage 1 and Stage 2 audits by an accredited body. Berghem prepares your organization through the whole path up to the certification audit.
What is the difference between ISO 42001 and ISO 27001?
ISO 27001 manages information security; ISO 42001 manages artificial intelligence specifically. Both share the same management structure and complement each other: the AIMS reuses your existing ISMS and adds the AI-specific requirements for risk, impact and lifecycle.
Does Berghem do the certification or the preparation?
Berghem does the preparation: gap analysis, AIMS implementation, Annex A mapping and internal audit. Certification is issued by an independent accredited body, with which we coordinate the Stage 1 and Stage 2 audits.
Do I need ISO 27001 before ISO 42001?
It is not mandatory, but it helps. Because the standards share the same high-level structure, organizations already running an ISO 27001 ISMS reduce their adequacy effort. Berghem can run both in an integrated way or implement the AIMS on its own.
Does ISO 42001 help with the EU AI Act and LGPD?
Yes, indirectly. The AIMS structures the governance, risk management and impact assessment the EU AI Act and LGPD demand for AI processing and use. It does not replace legal analysis, but it builds the evidence and process base that sustains compliance.
How long does ISO 42001 certification take?
It depends on scope, current maturity and whether an ISMS exists. After the gap analysis we deliver a roadmap with design, implementation, internal-audit and certification-audit phases. Timelines vary by organization — we do not work with generic estimates.

Ready to structure your AIMS?

In a 30-minute conversation we map your AI-governance maturity and design the path to ISO/IEC 42001 certification — from gap analysis to audit.

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