Standards Comparison

    ISO 45001

    Voluntary
    2018

    International standard for occupational health and safety management systems

    VS

    ISO 37301

    Voluntary
    2021

    International standard for compliance management systems.

    Quick Verdict

    ISO 45001 provides OH&S management systems for workplace safety across industries, while ISO 37301 establishes compliance management systems for all legal/regulatory obligations. Companies adopt both for certification, risk reduction, and integrated governance under HLS.

    Occupational Health & Safety

    ISO 45001

    ISO 45001:2018 Occupational health and safety management systems

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

    ISO 37301

    ISO 37301:2021 Compliance management systems – Requirements

    Cost
    €€€€
    Complexity
    High
    Implementation Time
    12-18 months

    Key Features

    • Certifiable requirements for compliance management systems
    • High-Level Structure for easy integration with other ISO standards
    • Risk-based planning and compliance obligation identification
    • Strong emphasis on leadership commitment and culture
    • Mandatory whistleblowing channels with anti-retaliation protections

    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 injuries and ill health, improve OH&S performance, using a risk-based approach aligned with Annex SL high-level structure.

    Key Components

    • Clauses 4-10 covering context, leadership, planning, support, operation, evaluation, improvement.
    • Emphasizes hierarchy of controls, worker participation, change management.
    • Built on PDCA cycle; no fixed controls but process-oriented requirements.
    • Optional third-party certification via audits.

    Why Organizations Use It

    • Reduces incidents, legal risks, costs; enhances resilience, reputation.
    • Meets stakeholder expectations, supply-chain demands.
    • Drives culture shift, integrates with ISO 9001/14001 for efficiency.
    • Improves insurance, talent retention, market competitiveness.

    Implementation Overview

    • Phased: gap analysis, policy/objectives, controls, audits (6-12 months typical).
    • Scalable for all sizes/sectors; focuses leadership, training, monitoring.
    • Involves worker consultation, KPIs, continual improvement.

    ISO 37301 Details

    What It Is

    ISO 37301:2021, officially titled Compliance management systems – Requirements with guidance for use, is a certifiable international standard for establishing, implementing, maintaining, and improving effective Compliance Management Systems (CMS). It provides auditable requirements using a risk-based approach and Plan-Do-Check-Act (PDCA) cycle, applicable to all organization sizes and sectors, replacing guidance-only ISO 19600.

    Key Components

    • Core pillars: context analysis, leadership commitment, risk planning, support/resources, operations, performance evaluation, improvement.
    • Built on ISO High-Level Structure (HLS) for integration with ISO 9001, 14001, 27001.
    • Emphasizes whistleblowing, competence (ISO 37303), effectiveness measurement (ISO 37302).
    • Certification via accredited bodies like ANAB, with 3-year audit cycles.

    Why Organizations Use It

    • Demonstrates compliance to regulators, investors, partners; reduces risks/fines.
    • Builds ethical culture, enhances reputation, supports ESG/SDGs.
    • Provides competitive edge through third-party validation.

    Implementation Overview

    • Phased: gap analysis, policy design, training, audits, certification.
    • Scalable for SMEs to enterprises; global applicability.
    • Involves compliance registers, KPIs, continual improvement (176 words).

    Key Differences

    Scope

    ISO 45001
    Occupational health & safety management
    ISO 37301
    All compliance obligations & risks

    Industry

    ISO 45001
    All sectors, high-risk industries emphasized
    ISO 37301
    All sectors, regulated industries emphasized

    Nature

    ISO 45001
    Voluntary certifiable management standard
    ISO 37301
    Voluntary certifiable management standard

    Testing

    ISO 45001
    Internal audits, management reviews, certification
    ISO 37301
    Internal audits, management reviews, certification

    Penalties

    ISO 45001
    Loss of certification, no legal penalties
    ISO 37301
    Loss of certification, no legal penalties

    Frequently Asked Questions

    Common questions about ISO 45001 and ISO 37301

    ISO 45001 FAQ

    ISO 37301 FAQ

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