ISO 45001
International standard for occupational health and safety management
EU AI Act
EU regulation for risk-based AI governance
Quick Verdict
ISO 45001 provides voluntary OHS management for global safety improvement, while EU AI Act mandates risk-based AI controls for EU compliance. Companies adopt ISO 45001 for certification and culture; AI Act to avoid fines and access markets.
ISO 45001
ISO 45001:2018 Occupational Health and Safety Management Systems
Key Features
- Leadership accountability with worker participation
- Risk-based planning and hierarchy of controls
- Annex SL alignment for integrated management systems
- Operational controls for change and contractors
- PDCA cycle for continual improvement
EU AI Act
Regulation (EU) 2024/1689 Artificial Intelligence Act
Key Features
- Risk-based four-tier AI classification framework
- Prohibitions on unacceptable-risk AI practices
- High-risk conformity assessments and CE marking
- GPAI model systemic risk obligations
- Post-market monitoring and incident reporting
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 45001 Details
What It Is
ISO 45001:2018 is the international standard for Occupational Health and Safety Management Systems (OHSMS). It provides a framework to prevent work-related injury and ill health, improve OH&S performance, using a risk-based approach aligned with Annex SL (HLS) for integration with other ISO standards like ISO 9001 and 14001.
Key Components
- Clauses 4-10 cover context, leadership, planning, support, operation, performance evaluation, and improvement.
- Emphasizes hierarchy of controls, worker participation, and PDCA cycle.
- No fixed number of controls; outcome-focused requirements.
- Optional third-party certification via audits.
Why Organizations Use It
- Reduces incidents, legal risks, and costs (e.g., 22-29% incident reductions reported).
- Enhances resilience, insurance savings, talent retention, and supply-chain competitiveness.
- Builds stakeholder trust through demonstrated leadership and continual improvement.
Implementation Overview
- Phased approach: gap analysis, policy/objectives, controls, audits, certification (6-12 months typical).
- Scalable for all sizes/sectors; requires leadership commitment and worker involvement.
EU AI Act Details
What It Is
The EU Artificial Intelligence Act (Regulation (EU) 2024/1689) is a comprehensive regulation establishing the first horizontal framework for AI in the EU. It entered into force on 1 August 2024 with phased applicability. Its primary purpose is to ensure AI systems are safe, transparent, and respect fundamental rights, applying a risk-based approach across prohibited, high-risk, limited-risk, and minimal-risk categories.
Key Components
- **Four risk tiersProhibitions (Article 5), high-risk obligations (Articles 6-15, Annexes I/III), transparency duties (Article 50), GPAI rules (Chapter V).
- Core requirements: risk management, data governance, documentation, human oversight, cybersecurity.
- Built on product safety principles with conformity assessments, CE marking, EU database registration.
- Compliance via self-assessment or notified bodies, presumption through harmonized standards.
Why Organizations Use It
- Mandatory for EU-market AI providers/deployers, avoiding fines up to 7% global turnover.
- Enhances risk management, builds trust, enables market access.
- Competitive edge in regulated sectors like healthcare, finance.
Implementation Overview
Phased rollout (6-36 months); inventory AI assets, classify risks, build QMS/RMS, conduct assessments. Applies to all sizes targeting EU, cross-sector; audits by national authorities/AI Office. (178 words)
Key Differences
| Aspect | ISO 45001 | EU AI Act |
|---|---|---|
| Scope | Occupational health & safety management systems | Risk-based AI systems regulation |
| Industry | All sectors worldwide, scalable to size | All sectors using AI, EU-focused high-risk uses |
| Nature | Voluntary international management standard | Mandatory EU regulation with fines |
| Testing | Internal audits, management reviews | Conformity assessments, notified bodies |
| Penalties | Loss of certification, no legal fines | Up to 7% global turnover fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 45001 and EU AI Act
ISO 45001 FAQ
EU AI Act FAQ
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