Standards Comparison

    ISO 9001

    Voluntary
    2015

    International standard for quality management systems

    VS

    ISO 45001

    Voluntary
    2018

    International standard for occupational health and safety management systems.

    Quick Verdict

    ISO 9001 ensures quality management for consistent products/services, enhancing customer satisfaction globally. ISO 45001 provides occupational health/safety systems to prevent injuries/illnesses. Companies adopt both for operational excellence, compliance, risk reduction, and competitive market access.

    Quality Management

    ISO 9001

    ISO 9001:2015 Quality management systems

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

    Key Features

    • Risk-based thinking embedded throughout all clauses
    • PDCA cycle drives continual process improvement
    • Seven quality management principles foundation
    • High-Level Structure enables multi-standard integration
    • Top management leadership and commitment required
    Occupational Health & Safety

    ISO 45001

    ISO 45001:2018 Occupational Health and Safety Management Systems

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

    Key Features

    • Top management leadership and accountability
    • Worker consultation and participation requirements
    • Hierarchy of controls for hazard elimination
    • Risk and opportunity-based planning
    • HLS alignment for integrated management systems

    Detailed Analysis

    A comprehensive look at the specific requirements, scope, and impact of each standard.

    ISO 9001 Details

    What It Is

    ISO 9001:2015 is the international certification standard for quality management systems (QMS). It provides a flexible, process-oriented framework applicable to any organization, emphasizing risk-based thinking and PDCA (Plan-Do-Check-Act) cycle for consistent customer satisfaction and continual improvement.

    Key Components

    • 10 clauses (4-10 auditable): context, leadership, planning, support, operation, performance evaluation, improvement.
    • Built on **seven quality principlescustomer focus, leadership, people engagement, process approach, improvement, evidence-based decisions, relationship management.
    • Voluntary third-party certification via accredited bodies, with surveillance audits.

    Why Organizations Use It

    • Enhances efficiency, reduces waste, boosts customer trust.
    • Meets market/contract demands; over 1M certifications worldwide.
    • Manages risks, including 2024 climate change considerations.
    • Improves reputation, competitiveness, stakeholder relationships.

    Implementation Overview

    • Gap analysis, process mapping, training, internal audits.
    • 6-12 months typical; scalable for all sizes/industries.
    • Certification involves Stage 1/2 audits, 3-year cycle.

    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, PDCA cycle approach aligned with ISO's High-Level Structure (HLS).

    Key Components

    • Clauses 4-10 cover context, leadership, planning, support, operation, performance evaluation, and improvement.
    • Emphasizes hierarchy of controls, worker participation, and top management accountability.
    • Built on Annex SL for integration with ISO 9001/14001; certification via accredited bodies.

    Why Organizations Use It

    • Reduces incidents, legal risks, and costs; enhances resilience and insurance savings.
    • Meets stakeholder expectations, boosts reputation, and supports ESG reporting.
    • Drives cultural change, talent retention, and competitive supply-chain advantages.

    Implementation Overview

    • Phased: gap analysis, policy/objectives, controls, audits, certification.
    • Scalable for all sizes/sectors; 6-12 months typical; requires training, audits.

    Key Differences

    Scope

    ISO 9001
    Quality management systems for products/services
    ISO 45001
    Occupational health/safety management systems

    Industry

    ISO 9001
    All industries, sizes, global applicability
    ISO 45001
    All industries, high-risk sectors emphasized, global

    Nature

    ISO 9001
    Voluntary certifiable standard
    ISO 45001
    Voluntary certifiable standard

    Testing

    ISO 9001
    Internal/external audits, certification every 3 years
    ISO 45001
    Internal/external audits, surveillance audits annually

    Penalties

    ISO 9001
    Loss of certification, market access issues
    ISO 45001
    Loss of certification, regulatory non-compliance risks

    Frequently Asked Questions

    Common questions about ISO 9001 and ISO 45001

    ISO 9001 FAQ

    ISO 45001 FAQ

    You Might also be Interested in These Articles...

    Run Maturity Assessments with GRADUM

    Transform your compliance journey with our AI-powered assessment platform

    Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.

    100+ Standards & Regulations
    AI-Powered Insights
    Collaborative Assessments
    Actionable Recommendations

    Check out these other Gradum.io Standards Comparison Pages