ISO 37301
International certifiable standard for compliance management systems
EU AI Act
EU regulation for risk-based AI safety and governance
Quick Verdict
ISO 37301 provides voluntary CMS certification for global compliance culture, while EU AI Act mandates risk-based AI regulation for EU markets with strict conformity and fines. Companies adopt ISO 37301 for integrated governance, AI Act to access EU legally.
ISO 37301
ISO 37301:2021 Compliance management systems – Requirements with guidance
EU AI Act
Regulation (EU) 2024/1689 Artificial Intelligence Act
Key Features
- Risk-based classification into four AI risk tiers
- Prohibitions on unacceptable AI practices (Article 5)
- Conformity assessments and CE marking for high-risk AI
- GPAI model obligations and systemic risk mitigations
- Post-market monitoring and tiered enforcement penalties
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 37301 Details
What It Is
ISO 37301:2021 Compliance management systems – Requirements with guidance for use is a certifiable international standard for establishing, implementing, maintaining, and improving effective compliance management systems (CMS). Applicable to all organization sizes and sectors, it uses a risk-based PDCA cycle and High-Level Structure (HLS) for integration with standards like ISO 9001 and ISO 27001.
Key Components
- Core clauses: context, leadership, planning, support, operation, performance evaluation, improvement.
- Emphasizes leadership commitment, risk assessment, whistleblowing channels, internal audits, and continual improvement.
- Built on HLS; supports companion standards like ISO 37302 (effectiveness) and ISO 37002 (whistleblowing).
- Certification via accredited bodies (e.g., ANAB).
Why Organizations Use It
Drives regulatory compliance, reduces risks/fines, builds integrity culture, enhances stakeholder trust, and supports ESG/SDGs. Provides third-party validation for investors/partners, integrates with IMS for efficiency.
Implementation Overview
Phased approach: gap analysis, compliance register, training, audits. Scalable for SMEs/enterprises; 3-year certification cycle with surveillance audits. Focuses on resources, competence, and operational controls.
EU AI Act Details
What It Is
The EU Artificial Intelligence Act (Regulation (EU) 2024/1689) is a comprehensive EU regulation providing a horizontal, risk-based framework for governing AI systems. Published in the Official Journal on 12 July 2024 and entering force on 1 August 2024, it ensures AI safety, transparency, and fundamental rights protection across sectors, with extraterritorial reach for EU-used outputs.
Key Components
- **Four risk tiersunacceptable (prohibited, Article 5), high-risk (Annexes I/III, Articles 9-15), limited-risk (transparency, Article 50), minimal-risk.
- High-risk requirements: risk management, data governance, documentation, human oversight, cybersecurity; conformity assessments, CE marking.
- GPAI obligations (Chapter V): documentation, systemic risk mitigations.
- Hybrid enforcement: AI Office, national authorities, fines up to 7% global turnover.
Why Organizations Use It
- Mandatory compliance for providers/deployers of in-scope AI to avoid penalties/market exclusion.
- Enhances risk management, trust, and market access in high-impact sectors like healthcare, finance.
- Builds reputation, supports innovation via sandboxes/standards.
Implementation Overview
- **Phased approachprohibitions (6 months), GPAI (12 months), high-risk (24-36 months).
- Inventory/classify AI, build QMS/RMS, conduct assessments, monitor post-market.
- Applies to multinationals targeting EU; cross-functional, audit-heavy.
Key Differences
| Aspect | ISO 37301 | EU AI Act |
|---|---|---|
| Scope | Compliance management systems (CMS) across all obligations | AI systems by risk tiers (prohibited, high-risk, GPAI) |
| Industry | All sectors, sizes, global applicability | All sectors using AI, EU market focus |
| Nature | Voluntary certifiable standard (HLS-based) | Mandatory EU regulation with fines |
| Testing | Internal audits, management reviews, certification audits | Conformity assessments, notified bodies, post-market monitoring |
| Penalties | Loss of certification, no legal fines | Up to 7% global turnover or €40M fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 37301 and EU AI Act
ISO 37301 FAQ
EU AI Act FAQ
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