Standards Comparison

    ISO 9001

    Voluntary
    2015

    International standard for quality management systems

    VS

    FSSC 22000

    Voluntary
    2023

    GFSI-benchmarked certification scheme for food safety management systems.

    Quick Verdict

    ISO 9001 provides universal quality management for any industry, driving efficiency and customer satisfaction via PDCA. FSSC 22000 mandates food safety controls with HACCP and PRPs for food chains. Companies adopt ISO 9001 for broad excellence, FSSC 22000 for regulatory compliance and market access.

    Quality Management

    ISO 9001

    ISO 9001:2015 Quality management systems — Requirements

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

    Key Features

    • Process-based QMS framework with PDCA cycle
    • Risk-based thinking integrated throughout clauses
    • Seven quality management principles foundation
    • Leadership commitment and top management accountability
    • High-Level Structure for multi-standard integration
    Food Safety

    FSSC 22000

    Food Safety System Certification 22000

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

    Key Features

    • Combines ISO 22000, PRPs, and additional requirements
    • GFSI-benchmarked for global market access
    • Food chain categories from farm to packaging
    • Mandates food defense and fraud mitigation
    • Requires food safety culture objectives

    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 specifies requirements for organizations to consistently meet customer and regulatory needs through a process-based approach using the PDCA cycle and risk-based thinking.

    Key Components

    • 10 clauses (4-10 auditable): context, leadership, planning, support, operation, evaluation, improvement
    • Built on **7 quality principlescustomer focus, leadership, engagement of people, process approach, improvement, evidence-based decisions, relationship management
    • Annex SL High-Level Structure for integration; voluntary third-party certification with audits

    Why Organizations Use It

    • Enhances customer satisfaction, efficiency, risk management
    • Boosts market access, reputation; over 1M certifications worldwide
    • Drives cost savings, continual improvement, stakeholder trust

    Implementation Overview

    • Gap analysis, process mapping, training, internal audits, certification
    • Applicable to all sizes/sectors; 6-12 months typical; ongoing surveillance audits

    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 PDCA cycle with HACCP principles.

    Key Components

    • **Three pillarsISO 22000:2018 (clauses 4-10), sector-specific PRPs (e.g., ISO/TS 22002 series), FSSC Additional Requirements (e.g., food defense, fraud, allergens).
    • Over 100 requirements across management, operations, and verification.
    • Built on ISO harmonized structure; certification via licensed bodies per ISO 22003-1.

    Why Organizations Use It

    • Meets retailer mandates and enables global trade.
    • Reduces recalls, enhances supply-chain trust.
    • Drives risk management for defense/fraud; boosts reputation via public register.
    • Aligns with SDGs for sustainability.

    Implementation Overview

    • Phased: gap analysis, FSMS design, training, audits.
    • For food chain organizations worldwide; 6-12 months typical.
    • Requires Stage 1/2 audits, surveillance, recertification every 3 years.

    Key Differences

    Scope

    ISO 9001
    Quality management across all processes
    FSSC 22000
    Food safety management and PRPs

    Industry

    ISO 9001
    All industries, any organization size
    FSSC 22000
    Food chain sectors like manufacturing, packaging

    Nature

    ISO 9001
    Voluntary QMS certification standard
    FSSC 22000
    GFSI-benchmarked food safety certification scheme

    Testing

    ISO 9001
    Internal audits, management reviews, certification audits
    FSSC 22000
    HACCP validation, PRP verification, surveillance audits

    Penalties

    ISO 9001
    Loss of certification, market access issues
    FSSC 22000
    Certification suspension, supply chain exclusion

    Frequently Asked Questions

    Common questions about ISO 9001 and FSSC 22000

    ISO 9001 FAQ

    FSSC 22000 FAQ

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