ISO 42001 AI Management System Consulting

AI QMS Consulting & ISO 42001 Implementation Services

Transform your AI systems into compliant, risk-managed assets with our specialized ISO 42001 consulting services. We bridge the gap between artificial intelligence innovation and regulatory compliance, bringing years of experience in ISO 13485, EU MDR 2017/745, IEC 62304, and ISO 14971 to the emerging field of AI management systems.

Management System for Your AI: Connecting Quality Management Worlds

Our AI management system consulting approach uniquely combines the proven frameworks of ISO 13485 and ISO 9001 with the specialized requirements of ISO 42001. We understand that quality management principles remain constant whether you're managing traditional medical devices or cutting-edge AI systems.

Core QMS Foundations Applied to AI

ISO 42001 introduces familiar concepts that align perfectly with established quality management practices:

AI policy development
Integrated with existing organizational policies
Management responsibility and leadership commitment
Unified management structure overseeing both traditional QMS and AI management systems
Document control and documentation management
Same systems managing both traditional device documentation and AI-specific technical files
Design and development controls
Enhanced design controls addressing both traditional device development and AI system lifecycle management

Continuous Oversight & Improvement for AI Systems

To ensure safe, compliant, and high-performing AI solutions, ISO 42001 enhances ongoing QMS processes:

Internal audits
Applied to AI system performance and compliance
Management reviews
Focused on AI objectives and risk assessments
Monitoring, measurement, analysis, and evaluation
Tailored for AI system performance
Continual improvement processes
Unified improvement processes covering both traditional QMS and AI management system performance
Nonconformities and CAPAs
Extended to AI-specific incidents and improvements

We will help you seamlessly integrate these ISO 42001 requirements with your existing ISO 13485 quality management system, creating one unified, functioning system rather than parallel compliance burdens. This integration ensures efficiency while maintaining the rigor required for both traditional QMS and AI management.

AI Risk Management: Applying Proven Risk Methodologies

Comprehensive Risk Assessment for AI Systems

AI systems present unique risks that require sophisticated management approaches. Our computer system validation of AI tools compliant with ISO 13485 methodology applies the same systematic risk management principles already known from ISO 14971 or IEC 80002-2, extended specifically for AI applications.

Our AI Risk Management Framework:

Hazard identification
Identify hazards for AI systems across their entire lifecycle, from design to post-market use.
Risk analysis
Consider both technical failures and societal impacts, such as bias, transparency issues, or unintended consequences.
Risk evaluation
Apply established acceptability criteria to determine which risks require mitigation.
Risk mitigation
Implement technical and procedural controls to reduce identified risks.
Residual Risk & Monitoring
Assess residual risk and maintain ongoing monitoring for continuous safety and compliance.

Connecting Risk Standards

We either integrate ISO 14971 medical device risk management with ISO 42001 AI risk requirements, or, where applicable, IEC 80002-2 for AI applications used in Quality Management System.

Whether your AI system operates within your QMS or functions as Software as a Medical Device (SaMD/MDSW), we ensure comprehensive risk coverage across all applicable standards.

Our experience with hazardous situations, harm analysis, and adverse impact assessment translates directly to AI system risks, including bias, transparency issues, data quality problems, and algorithmic failures.

AI System Design and Development Excellence

Technical Documentation and AI Lifecycle Management

Effective AI management requires the same systematic approach to technical documentation that drives success in traditional software development. Our expertise in IEC 62304 and IEC 12207 provides the foundation for comprehensive AI system lifecycle management.

AI Development Support Services:

Machine learning strategy documentation
Clear roadmaps for AI implementation
Data identification and management
Comprehensive data governance frameworks
Model training protocols
Systematic approaches to algorithm development
Hardware and software maintenance
Ongoing system reliability assurance
Interface and interoperability planning
Integration with existing systems
Verification and validation protocols
Rigorous testing methodologies
Test data selection and management
Representative and unbiased evaluation datasets
Monitoring and maintenance strategies
Including comprehensive logging systems

Technical Documentation and AI Lifecycle Management

We prepare all necessary technical documentation to support your AI system compliance, from initial concept through deployment and ongoing monitoring and maintenance.

AI and Information Security Integration

Data Protection and Ethical AI Implementation

AI systems are fundamentally data-driven, making information security and privacy protection critical success factors. Our ISO 42001 implementation includes comprehensive data governance that addresses both technical security and ethical considerations.

Key Security and Privacy Elements:

Data identification and classification
Comprehensive data mapping and categorization
Data safeguarding protocols
Technical and administrative security controls
GDPR compliance assessment
Privacy impact analysis for AI data processing
Ethical data use evaluation
Ensuring responsible AI development practices
ISO 27001 integration
Leveraging existing information security frameworks

Organizations already compliant with ISO 27001 find that significant portions of ISO 42001 requirements are already addressed through their information security management system. We help you identify these synergies and build upon existing security investments.

Comprehensive Standards Integration

Navigating the Complex AI Regulatory Landscape

The AI regulatory environment includes numerous interconnected standards: ISO/IEC 5259, ISO/IEC 5338, ISO/IEC 23053, ISO/IEC 23894, and many others. Rather than treating each standard in isolation, which would make AI implementation practically impossible, we provide integrated solutions that address multiple requirements efficiently.

Our Integration Approach:

Holistic standard mapping
Understanding interconnections and overlaps
Risk-based implementation
Focusing on requirements that matter for your specific AI applications
Operational efficiency
Streamlined processes that work in real-world environments
Compliance sustainability
Systems designed for long-term maintenance and evolution

EU AI Act Readiness

We stay current with evolving regulations including the EU AI Act, ensuring our solutions are forward-compatible with emerging requirements. Our approach delivers compliance frameworks that are lean enough to be operational while comprehensive enough to meet all applicable requirements.

Why Choose Our ISO 42001 Consulting Services?

Proven Expertise Across Quality Management Disciplines

Unique Value Proposition:

Multi-standard expertise
Deep knowledge across ISO 13485, EU MDR, IEC 62304, ISO 14971, and now ISO 42001
Medical device specialization
Understanding of regulated industry requirements
Integration focus
Creating unified management systems rather than parallel compliance tracks
Practical implementation
Solutions designed for operational efficiency
Ongoing support
Partnership through implementation and beyond

Comprehensive ISO 42001 AI Compliance Services & Implementation Support

Service Delivery:

Gap analysis and AI readiness assessment
Customized AI implementation roadmaps
Staff training on AI and competency development
AI Documentation development and review
Internal audit support and management review facilitation
Ongoing AI compliance monitoring and improvement

Your Partner in AI QMS Excellence

Contact us today to discover how our AI QMS consulting expertise can transform your AI initiatives into compliant, risk-managed business assets that drive innovation while meeting the highest regulatory standards.

Frequently Asked Questions (FAQ)

Q: Is ISO 42001 mandatory for medical device companies?

A: No, ISO 42001 is not mandatory, but it provides essential guidance for using AI while staying compliant with mandatory standards like ISO 13485 and IEC 62304. Traditional standards don’t fully address AI-specific challenges, such as AI lifecycle or computer system validation of AI tools. ISO 42001 fills this gap, offering a structured framework to responsibly manage AI in both QMS and medical devices.

Q: How does ISO 42001 relate to ISO 13485?

A: ISO 42001 and ISO 13485 are more similar than many think. While ISO 42001 also includes more details focused on risk management, technical documentation, and AI lifecycle monitoring (closer to IEC 62304), its core aligns closely with ISO 13485. Setting AI policy, defining responsibilities, raising awareness, running internal audits, management reviews, and driving improvement through CAPA aligns closely with ISO 13485. The structure and intent are compatible, making integration both natural and effective.

Q: If I use AI only for supporting QMS processes (e.g., complaint triage or document control), do I still need ISO 42001?

A: Yes, if AI is part of your QMS (even if not part of the medical device), ISO 42001 offers a clear framework to manage that tool responsibly — including risk assessments, monitoring, governance, and overall validation. This supports compliance with requirements on computer system validation as defined by the ISO 13485 or IEC 80002-2.

Q: What if my AI is part of a medical device software (SaMD)?

A: If AI is embedded in your medical device (Software as a Medical Device / MDSW), you must comply with:

ISO 13485 (QMS)
IEC 62304 (software lifecycle)
ISO 14971 (risk management)
ISO 42001 can support AI-specific governance, traceability, risk, and documentation.

We guide you in connecting these frameworks effectively.

Q: Does ISO 42001 include risk management like ISO 14971?

A: Yes, ISO 42001 requires identifying and mitigating risks — not only for health/safety but also for business, ethical, regulatory, and data-related impacts. We help you:

Apply ISO 14971-style risk processes
Incorporate AI-specific hazards and uncertainties
Manage risk across the entire AI lifecycle

Q: Is ISO 42001 certification possible?

A: Yes. Like ISO 27001 or ISO 13485, ISO 42001 is certifiable. If your organization needs to demonstrate responsible AI use to clients, regulators, or partners, certification is a strong signal of trust and readiness.

Q: We already follow ISO 27001 for information security — does that help?

A: Absolutely. ISO 42001 shares several controls and clauses with ISO 27001, particularly regarding data governance, access controls, logging, and risk assessment. We can help you leverage your ISO 27001 ISMS to fulfill large parts of ISO 42001 with minimal extra effort.