Standards Comparison

    ISO 45001

    Voluntary
    2018

    International standard for occupational health and safety management

    VS

    EU AI Act

    Mandatory
    2024

    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.

    Occupational Health & Safety

    ISO 45001

    ISO 45001:2018 Occupational Health and Safety Management Systems

    Cost
    €€€
    Complexity
    High
    Implementation Time
    6-12 months

    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
    Artificial Intelligence

    EU AI Act

    Regulation (EU) 2024/1689 Artificial Intelligence Act

    Cost
    €€€
    Complexity
    Medium
    Implementation Time
    18-24 months

    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

    Scope

    ISO 45001
    Occupational health & safety management systems
    EU AI Act
    Risk-based AI systems regulation

    Industry

    ISO 45001
    All sectors worldwide, scalable to size
    EU AI Act
    All sectors using AI, EU-focused high-risk uses

    Nature

    ISO 45001
    Voluntary international management standard
    EU AI Act
    Mandatory EU regulation with fines

    Testing

    ISO 45001
    Internal audits, management reviews
    EU AI Act
    Conformity assessments, notified bodies

    Penalties

    ISO 45001
    Loss of certification, no legal fines
    EU AI Act
    Up to 7% global turnover fines

    Frequently Asked Questions

    Common questions about ISO 45001 and EU AI Act

    ISO 45001 FAQ

    EU AI Act FAQ

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