ISO 37301
International standard for compliance management systems
ISO/IEC 42001:2023
International standard for AI management systems
Quick Verdict
ISO 37301 provides certifiable compliance management for all obligations and risks, while ISO/IEC 42001:2023 governs AI-specific risks like bias and ethics. Companies adopt them for structured governance, certification credibility, risk reduction, and stakeholder trust.
ISO 37301
ISO 37301:2021 Compliance management systems – Requirements
Key Features
- Certifiable requirements replacing guidance-only ISO 19600
- High-Level Structure for IMS integration
- Risk-based compliance obligations assessment
- Leadership commitment and culture emphasis
- Confidential whistleblowing protections required
ISO/IEC 42001:2023
ISO/IEC 42001:2023 Artificial Intelligence Management System
Key Features
- PDCA cycle for continual AI governance improvement
- Mandatory AI Impact Assessments for high-risk systems
- Annex A with 38 AI-specific risk controls
- Full AI lifecycle management from inception to retirement
- Seamless integration with ISO 27001 and HLS standards
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 37301 Details
What It Is
ISO 37301:2021 is a certifiable international standard specifying requirements with guidance for establishing, implementing, maintaining, and improving Compliance Management Systems (CMS). It applies to all organization sizes and sectors using a risk-based PDCA approach to identify obligations and manage risks.
Key Components
- Leadership commitment, compliance policy, roles/responsibilities
- Risk assessment, objectives, operational controls including whistleblowing
- Support (resources, competence, awareness, communication)
- Performance evaluation (monitoring, audits, reviews)
- Continual improvement via corrective actions Built on ISO High-Level Structure (HLS); companion standards like ISO 37302/37303 provide guidance.
Why Organizations Use It
Drives regulatory compliance, reduces risks/fines, builds culture of integrity. Enhances stakeholder trust, supports ESG/SDGs, enables certification for competitive edge and investor confidence.
Implementation Overview
Phased: context analysis, obligation register, controls/training, audits/certification. Scalable for SMEs/enterprises; accredited bodies (e.g., ANAB) conduct 3-year cycle audits. Integrates with ISO 9001/27001.
ISO/IEC 42001:2023 Details
What It Is
ISO/IEC 42001:2023 is the world's first international standard for establishing, implementing, maintaining, and improving an Artificial Intelligence Management System (AIMS). It provides a risk-based framework using the Plan-Do-Check-Act (PDCA) methodology and High-Level Structure (HLS) to govern AI responsibly across the full lifecycle, applicable to any organization regardless of size, sector, or AI role (developer, provider, user).
Key Components
- Clauses 4-10 cover context, leadership, planning, support, operations, evaluation, and improvement.
- Annex A includes 38 AI-specific controls for risks like bias, transparency, and third-party management.
- Built on PDCA and HLS for integration with ISO 9001/27001.
- Certification via accredited third-party audits, with 3-year validity and surveillance.
Why Organizations Use It
- Mitigates AI risks (bias, drift, ethics) while enabling innovation.
- Aligns with EU AI Act, NIST RMF; builds trust and compliance.
- Enhances reputation, procurement advantages, insurance discounts.
Implementation Overview
- Phased gap analysis, AIIAs, training, audits.
- 6-12 months typical; integrates with existing MSS.
- Universal applicability; tools like ISMS.online accelerate.
Key Differences
| Aspect | ISO 37301 | ISO/IEC 42001:2023 |
|---|---|---|
| Scope | Compliance obligations, risks, culture across operations | AI lifecycle risks, ethics, bias in AI systems |
| Industry | All sectors, sizes worldwide | All sectors using AI worldwide |
| Nature | Certifiable management system standard | Certifiable AI management system standard |
| Testing | Internal audits, management reviews, certification audits | AI impact assessments, audits, management reviews |
| Penalties | Loss of certification, no legal penalties | Loss of certification, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 37301 and ISO/IEC 42001:2023
ISO 37301 FAQ
ISO/IEC 42001:2023 FAQ
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