Standards Comparison

    ISO 37301

    Voluntary
    2021

    International certifiable standard for compliance management systems

    VS

    FSSC 22000

    Voluntary
    2023

    GFSI-benchmarked certification scheme for food safety management.

    Quick Verdict

    ISO 37301 establishes certifiable compliance management systems for all industries, emphasizing risk-based obligations and culture. FSSC 22000 delivers GFSI-recognized food safety certification for food chains via ISO 22000, PRPs, and hazard controls. Organizations adopt them for governance assurance and market access.

    Compliance Management

    ISO 37301

    ISO 37301:2021 Compliance management systems – Requirements

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

    Key Features

    • Certifiable requirements standard for compliance management systems
    • High-Level Structure enables integration with other ISO standards
    • Risk-based planning identifies obligations and controls
    • Leadership commitment fosters compliance culture and tone from top
    • Mandatory confidential whistleblowing channels and protections
    Food Safety

    FSSC 22000

    Food Safety System Certification 22000

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

    Key Features

    • GFSI-benchmarked for global market recognition
    • Integrates ISO 22000 with sector PRPs
    • Mandates food defense and fraud mitigation
    • Additional requirements for allergens and culture
    • Public register ensures certification integrity

    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 titled Compliance management systems – Requirements with guidance for use. It provides auditable requirements for establishing, implementing, maintaining, and improving a compliance management system (CMS). Applicable to all organization sizes and sectors, it uses a risk-based, PDCA (Plan-Do-Check-Act) approach aligned with the ISO High-Level Structure (HLS).

    Key Components

    • Core clauses cover context, leadership, planning, support, operation, performance evaluation, and improvement.
    • Emphasizes leadership commitment, risk assessment, whistleblowing, competence, monitoring, audits, and continual improvement.
    • Built on HLS for integration with ISO 9001, 14001, 27001; supports companion standards like ISO 37302/37303.
    • Certification via accredited bodies like ANAB.

    Why Organizations Use It

    Drives regulatory compliance, reduces risks/fines, builds integrity culture, enhances stakeholder trust, and supports ESG/SDGs. Provides third-party validation for investors/partners, mitigates reputational harm.

    Implementation Overview

    Phased approach: gap analysis, obligation register, controls, training, audits. Scalable for SMEs/enterprises; 3-year certification cycle with surveillance audits. Focuses on cultural change and resource allocation.

    FSSC 22000 Details

    What It Is

    FSSC 22000 (Food Safety System Certification 22000) is a GFSI-benchmarked certification scheme for Food Safety Management Systems (FSMS). It applies across food chain categories like manufacturing, packaging, and logistics. The scheme uses a risk-based approach integrating ISO 22000:2018 PDCA cycle with HACCP principles.

    Key Components

    • **Three pillarsISO 22000:2018 (clauses 4-10), sector-specific PRPs (e.g., ISO/TS 22002 series), and FSSC Additional Requirements (e.g., food defense, fraud, allergens).
    • Covers governance, operations, verification; no fixed control count but clause-mapped requirements.
    • Built on ISO harmonized structure; certification via licensed bodies per ISO 22003-1:2022.

    Why Organizations Use It

    • Meets retailer/buyer mandates for GFSI recognition.
    • Reduces recalls, enhances supply-chain trust via public register.
    • Drives risk management, sustainability (SDGs), and market access.
    • Builds reputation through independent audits.

    Implementation Overview

    • Phased: gap analysis, FSMS design, training, audits.
    • Applies to all sizes in food sectors globally.
    • Requires Stage 1/2 certification audits, surveillance/recertification.

    Key Differences

    Scope

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

    Industry

    ISO 37301
    All sectors, sizes, global applicability
    FSSC 22000
    Food chain categories (manufacturing, packaging, logistics)

    Nature

    ISO 37301
    Voluntary certifiable CMS standard
    FSSC 22000
    GFSI-benchmarked FSMS certification scheme

    Testing

    ISO 37301
    Internal audits, management reviews, certification audits
    FSSC 22000
    Stage 1/2 audits, surveillance, PRP/CCP verification

    Penalties

    ISO 37301
    Loss of certification, no legal penalties
    FSSC 22000
    Certification suspension, market access loss

    Frequently Asked Questions

    Common questions about ISO 37301 and FSSC 22000

    ISO 37301 FAQ

    FSSC 22000 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