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 developmentIntegrated with existing organizational policies
- Management responsibility and leadership commitmentUnified management structure overseeing both traditional QMS and AI management systems
- Document control and documentation managementSame systems managing both traditional device documentation and AI-specific technical files
- Design and development controlsEnhanced 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 auditsApplied to AI system performance and compliance
- Management reviewsFocused on AI objectives and risk assessments
- Monitoring, measurement, analysis, and evaluationTailored for AI system performance
- Continual improvement processesUnified improvement processes covering both traditional QMS and AI management system performance
- Nonconformities and CAPAsExtended to AI-specific incidents and improvements
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 identificationIdentify hazards for AI systems across their entire lifecycle, from design to post-market use.
- Risk analysisConsider both technical failures and societal impacts, such as bias, transparency issues, or unintended consequences.
- Risk evaluationApply established acceptability criteria to determine which risks require mitigation.
- Risk mitigationImplement technical and procedural controls to reduce identified risks.
- Residual Risk & MonitoringAssess 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 documentationClear roadmaps for AI implementation
- Data identification and managementComprehensive data governance frameworks
- Model training protocolsSystematic approaches to algorithm development
- Hardware and software maintenanceOngoing system reliability assurance
- Interface and interoperability planningIntegration with existing systems
- Verification and validation protocolsRigorous testing methodologies
- Test data selection and managementRepresentative and unbiased evaluation datasets
- Monitoring and maintenance strategiesIncluding 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 classificationComprehensive data mapping and categorization
- Data safeguarding protocolsTechnical and administrative security controls
- GDPR compliance assessmentPrivacy impact analysis for AI data processing
- Ethical data use evaluationEnsuring responsible AI development practices
- ISO 27001 integrationLeveraging existing information security frameworks
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 mappingUnderstanding interconnections and overlaps
- Risk-based implementationFocusing on requirements that matter for your specific AI applications
- Operational efficiencyStreamlined processes that work in real-world environments
- Compliance sustainabilitySystems 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 expertiseDeep knowledge across ISO 13485, EU MDR, IEC 62304, ISO 14971, and now ISO 42001
- Medical device specializationUnderstanding of regulated industry requirements
- Integration focusCreating unified management systems rather than parallel compliance tracks
- Practical implementationSolutions designed for operational efficiency
- Ongoing supportPartnership 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
Frequently Asked Questions (FAQ)
Answer:
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.
Testimonials | Our Expertise in MedTech
Temedica
Vaclav did support our journey to become ISO 13485 certified with relentless work put into great processes, great communication and detailed and to the point conversations with the teams, individual members - but also our external auditors. He was of great support to move our QMS to the next level. He was the key person behind the move away from paper / scan based documents towards a digital setup.If you are in need for a structured person with great communication skills, a good understanding of the regulatory environment, I can only recommend to reach out to Vaclav. Lucky you if he's not booked ;-) Besides all the success he's an enjoyable and humble character. Great experience to having worked with him.
Ypsomed
Risk Manager | Cybersecurity
Vaclav and I worked together on risk management activities of medical device development projects. His ability to quickly grasp the challenges and to accomplish a task/project is remarkable. Additionally, his ability to propose and develop software solutions to improve projects’ efficiency is commendable. I find Vaclav to be flexible, dependable, and quality centric. Hence, I really enjoyed working with Vaclav and looking forward to associate with him again.
