ISO 42001 Consulting Services – Artificial Intelligence Management Systems (AIMS)

Artificial Intelligence is no longer experimental — it is operational, regulated, and scrutinized.

ISO 42001 is the world’s first international management system standard for Artificial Intelligence (AI). It provides a structured framework to establish, implement, maintain, and continually improve an Artificial Intelligence Management System (AIMS).

At Wintersmith Advisory, we help organizations design and implement ISO 42001 systems that are practical, risk-based, and aligned with business strategy — not bloated compliance exercises.

What Is ISO 42001?

ISO/IEC 42001:2023 establishes requirements for managing AI systems responsibly. It follows the Annex SL structure used by other ISO standards, making integration straightforward for organizations already certified to:

  • ISO 9001 (Quality)

  • ISO 27001 (Information Security)

  • ISO 27701 (Privacy)

  • ISO 31000 (Risk Management)

  • ISO 22301 (Business Continuity)

The standard focuses on:

  • AI governance and accountability

  • Risk and impact assessment

  • Transparency and justification

  • Bias mitigation

  • Security and resilience

  • Monitoring and continual improvement

ISO 42001 is particularly relevant for organizations that develop, deploy, or rely heavily on AI systems.

Who Needs ISO 42001?

You may benefit from ISO 42001 if you:

  • Develop AI software or AI-enabled products

  • Use machine learning for decision-making

  • Deploy AI in regulated sectors (finance, healthcare, defense, utilities)

  • Handle sensitive personal or biometric data

  • Want to demonstrate responsible AI governance to customers and regulators

  • Are preparing for EU AI Act alignment or emerging AI regulations

Increasingly, customers are asking:
“How are you managing AI risk?”

ISO 42001 gives you a defensible answer.

What an ISO 42001 AIMS Includes

An effective Artificial Intelligence Management System includes:

1. Context & Governance

  • Defined AI scope and system boundaries

  • Roles, responsibilities, and accountability

  • Ethical principles embedded in policy

2. AI Risk Management

  • AI-specific risk identification

  • Impact assessments (safety, bias, security, privacy)

  • Risk treatment plans

3. Operational Controls

  • Data quality and integrity controls

  • Model validation and testing protocols

  • Monitoring and drift detection

4. Transparency & Documentation

  • Traceability of models and training data

  • Decision logic documentation

  • Incident and escalation processes

5. Continual Improvement

  • Internal audits

  • Performance metrics

  • Management review

Our ISO 42001 Consulting Approach

As management system consultants — not certification auditors — we focus on implementation that works operationally, not just for the audit.

Phase 1: Gap Assessment

  • Review current AI governance structure

  • Evaluate risk management approach

  • Identify documentation and control gaps

  • Deliver prioritized remediation roadmap

Phase 2: System Design & Documentation

  • Develop AI policy and governance framework

  • Create AI risk assessment methodology

  • Define monitoring and performance metrics

  • Integrate with existing ISO systems (if applicable)

Phase 3: Implementation Support

  • Facilitate risk workshops

  • Establish operational controls

  • Support tool and dashboard configuration

  • Train leadership and technical teams

Phase 4: Internal Audit & Certification Readiness

  • Conduct ISO 42001 internal audit

  • Identify residual nonconformities

  • Prepare leadership for certification audit

  • Support corrective action closure

Integration With Existing ISO Systems

If you already maintain an ISO 9001, ISO 27001, or integrated management system, ISO 42001 can be layered efficiently.

Because it follows the Annex SL structure, we can integrate:

  • Risk management processes

  • Internal audit programs

  • Management review structure

  • Corrective action systems

  • Document control frameworks

This avoids duplication and keeps your system lean.

Benefits of ISO 42001 Certification

Organizations pursuing ISO 42001 typically gain:

  • Increased customer trust

  • Demonstrable responsible AI governance

  • Reduced AI-related operational risk

  • Improved model reliability and monitoring

  • Alignment with emerging regulatory frameworks

  • Competitive advantage in AI-driven markets

It shifts AI from “innovation risk” to controlled strategic capability.

Common Challenges We Help Solve

  • Undefined AI system boundaries

  • Lack of model traceability

  • Bias and fairness risk uncertainty

  • Inconsistent validation practices

  • No formal AI risk register

  • Disconnect between technical and executive oversight

We bring structure, clarity, and defensible documentation.

Why Work With Wintersmith Advisory?

We specialize in management systems, risk frameworks, and regulatory alignment. Our background in ISO 9001, ISO 27001, and enterprise risk systems allows us to design AI governance that integrates cleanly with your broader operational model.

We do not over-engineer systems.
We build practical, certifiable, operationally embedded frameworks.

Start Your ISO 42001 Journey

Whether you are exploring ISO 42001 for strategic positioning or preparing for formal certification, we can:

  • Perform a readiness assessment

  • Build your Artificial Intelligence Management System

  • Conduct your internal audit

  • Prepare you for certification

If AI is part of your business model, AI governance must be part of your management system.

ISO 42001 provides the framework.
We help you implement it correctly.

Contact us.

info@wintersmithadvisory.com
(801) 558-3928