Standards Comparison

    ISO 37301

    Voluntary
    2021

    International standard for compliance management systems

    VS

    ISO 22000

    Voluntary
    2018

    International standard for food safety management systems.

    Quick Verdict

    ISO 37301 establishes certifiable compliance management systems for all industries, embedding risk-based integrity and whistleblowing. ISO 22000 delivers food safety management for food chain organizations via HACCP and PRPs. Companies adopt them for governance assurance, risk reduction, and market credibility.

    Compliance Management

    ISO 37301

    ISO 37301:2021 Compliance management systems – Requirements

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

    Key Features

    • First certifiable CMS standard replacing guidance-only ISO 19600
    • High-Level Structure for seamless IMS integration
    • Risk-based compliance obligations assessment and planning
    • Leadership commitment fostering integrity culture
    • Mandatory whistleblowing channels with anti-retaliation protections
    Food Safety

    ISO 22000

    ISO 22000:2018 Food safety management systems

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

    Key Features

    • High-Level Structure (HLS) for integrated management systems
    • Two nested PDCA cycles for governance and operations
    • Hazard analysis with CCPs and OPRPs categorization
    • Prerequisite programs (PRPs) for hygienic baseline
    • Interactive communication across food chain

    Detailed Analysis

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

    ISO 37301 Details

    What It Is

    ISO 37301:2021 is a certifiable international standard specifying requirements and guidance for Compliance Management Systems (CMS). It provides a systematic, risk-based approach applicable to all organization sizes and sectors, replacing guidance-only ISO 19600. Built on High-Level Structure (HLS) and PDCA cycle, it enables integration with standards like ISO 9001 and ISO 27001.

    Key Components

    • Leadership commitment, compliance policy, and culture
    • Risk assessment, objectives, and operational controls
    • Support: resources, competence, awareness, communication (including whistleblowing)
    • Performance evaluation: monitoring, audits, management reviews
    • Continual improvement via corrective actions Follows 10 HLS clauses with auditable 'shall' requirements; certification via accredited bodies like ANAB.

    Why Organizations Use It

    Drives regulatory compliance, reduces fines/reputational risks, enhances stakeholder trust. Supports ESG/SDGs, investor demands; provides third-party validation for competitive edge.

    Implementation Overview

    Phased: context analysis, obligation register, controls embedding, training, audits. Scalable for SMEs/enterprises; 3-year certification cycle with surveillance audits. Involves cultural change, tech platforms for registers/KPIs.

    ISO 22000 Details

    What It Is

    ISO 22000:2018 is the international standard for Food Safety Management Systems (FSMS). It provides a certifiable framework for organizations in the food chain to ensure safe products through systematic hazard control. The standard uses a risk-based approach with two nested **PDCA cyclesorganizational for governance and operational for HACCP principles.

    Key Components

    • 10 clauses aligned with ISO's High-Level Structure (HLS) for integration.
    • Core elements: PRPs, hazard analysis, CCPs/OPRPs, traceability, verification, internal audits.
    • Built on Codex HACCP principles, interactive communication, and continual improvement.
    • Voluntary certification via accredited bodies with staged audits.

    Why Organizations Use It

    • Meets regulatory/customer requirements, reduces recalls and risks.
    • Enhances market access, supplier qualification, and GFSI alignment (e.g., FSSC 22000).
    • Builds trust, integrates with ISO 9001/14001, improves efficiency.

    Implementation Overview

    • Phased: gap analysis, PRPs, hazard control plan, training, audits.
    • Applies to all food chain organizations; scalable by size.
    • Requires 3-month operation before certification audits.

    Key Differences

    Scope

    ISO 37301
    Compliance obligations, risks, culture across operations
    ISO 22000
    Food safety hazards, PRPs, HACCP in food chain

    Industry

    ISO 37301
    All sectors, all sizes, global applicability
    ISO 22000
    Food chain organizations, all sizes, global

    Nature

    ISO 37301
    Voluntary certifiable management system standard
    ISO 22000
    Voluntary certifiable FSMS standard

    Testing

    ISO 37301
    Internal audits, management reviews, certification audits
    ISO 22000
    Internal audits, verification, CCP/OPRP monitoring, certification

    Penalties

    ISO 37301
    Loss of certification, no direct legal penalties
    ISO 22000
    Loss of certification, no direct legal penalties

    Frequently Asked Questions

    Common questions about ISO 37301 and ISO 22000

    ISO 37301 FAQ

    ISO 22000 FAQ

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