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ISO 22000:2018

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ISO 22000:2018 – Food Safety Management System (FSMS)

1. Definition

ISO 22000:2018 is an international standard that specifies the requirements for a Food Safety Management System (FSMS).
It enables organizations involved in the food chain to ensure that food is safe for consumption, through the implementation of preventive controls, risk-based thinking, and continual improvement.

The standard integrates the principles of Hazard Analysis and Critical Control Points (HACCP) and the management system structure of ISO 9001:2015, forming a comprehensive and auditable system for managing food safety risks.

ISO 22000:2018 applies to all organizations — large or small — that are directly or indirectly involved in the food chain, including:

  • Food manufacturers and processors

  • Ingredient and packaging suppliers

  • Transport, storage, and distribution companies

  • Catering and food service providers

  • Producers of equipment, cleaning agents, and related materials

2. Purpose and Scope

The purpose of ISO 22000:2018 is to:

  • Establish a systematic framework for identifying, preventing, and controlling food safety hazards.

  • Integrate HACCP principles with management system practices to ensure safe food at all stages of the supply chain.

  • Enhance stakeholder confidence by demonstrating consistent control of food safety risks.

  • Facilitate compliance with statutory, regulatory, and customer requirements.

  • Foster a culture of continuous improvement and food safety awareness within the organization.

This standard covers the entire food supply chain, from primary production to consumption — the concept of “farm to fork.”

3. Relationship to Other Standards

ISO 22000:2018 belongs to the ISO 22000 family of food safety standards, which includes complementary guidelines such as:

  • ISO/TS 22002 series – Prerequisite programs (PRPs) for specific sectors, e.g. manufacturing, catering, packaging, transport.

  • ISO 22003:2022 – Requirements for bodies providing audit and certification.

  • ISO 22005:2007 – Traceability in the feed and food chain.

It is also harmonized with:

  • Codex Alimentarius HACCP principles

  • ISO 9001:2015 – Quality Management Systems

  • ISO 14001:2015 – Environmental Management Systems

  • ISO 45001:2018 – Occupational Health and Safety

This alignment enables organizations to integrate ISO 22000 into an Integrated Management System (IMS) for food safety, quality, and environmental control.

4. Key Principles of ISO 22000:2018

ISO 22000:2018 is based on seven key principles that guide an effective Food Safety Management System:

  1. Customer Focus and Responsibility – Commitment to producing safe food that meets customer and legal requirements.

  2. Leadership and Governance – Top management’s accountability for food safety policies and objectives.

  3. Risk-Based Thinking – Integration of operational risks (HACCP) and systemic risks (ISO management approach).

  4. Process Approach – Managing activities as interrelated processes to achieve consistent outcomes.

  5. Communication – Transparent internal and external communication across all levels of the food chain.

  6. Evidence-Based Decision Making – Using scientific data and verified information to make decisions.

  7. Continual Improvement – Ongoing enhancement of food safety performance through feedback and review.

5. Structure of ISO 22000:2018 (Annex SL Format)

The standard follows the High-Level Structure (HLS), which aligns it with other ISO management system standards:

  1. Scope

  2. Normative References

  3. Terms and Definitions

  4. Context of the Organization

  5. Leadership

  6. Planning

  7. Support

  8. Operation

  9. Performance Evaluation

  10. Improvement

6. Core Components of ISO 22000:2018

A. Context and Leadership

  • Determine internal and external issues affecting food safety.

  • Establish a Food Safety Policy and define responsibilities.

  • Ensure commitment from leadership to maintain the FSMS.

B. Planning

  • Identify risks and opportunities related to food safety objectives.

  • Define measurable objectives consistent with the organization’s mission.

C. Support

  • Manage resources, infrastructure, and human competence.

  • Ensure proper communication and documentation control.

D. Operation

This clause represents the core of the FSMS and includes:

  1. Prerequisite Programs (PRPs) – Basic hygiene and operational conditions (e.g., cleaning, pest control, personal hygiene).

  2. Hazard Analysis and Control – Implementation of HACCP principles:

    • Identify potential hazards.

    • Determine Critical Control Points (CCPs).

    • Establish monitoring and corrective actions.

  3. Traceability System – Maintain traceability from raw materials to finished products.

  4. Emergency Preparedness and Response – Manage food safety incidents effectively.

E. Performance Evaluation

  • Conduct internal audits and management reviews.

  • Analyze performance data, customer feedback, and incident reports.

F. Improvement

  • Implement corrective and preventive actions.

  • Drive continual improvement in food safety performance.

7. Benefits of Implementing ISO 22000:2018

A. For Organizations

  • Provides an internationally recognized framework for food safety management.

  • Reduces risks of contamination, recalls, and nonconformities.

  • Improves process efficiency and reduces waste.

  • Enhances credibility with regulators, suppliers, and customers.

  • Facilitates entry into global food markets requiring certification.

B. For Customers and Consumers

  • Ensures safe, reliable, and high-quality food products.

  • Increases confidence in the organization’s food safety commitment.

  • Contributes to better public health and consumer protection.

C. For Employees

  • Increases food safety awareness and accountability.

  • Encourages teamwork and continuous training.

  • Provides a clear structure for operational responsibilities.

8. Example of Implementation

A company implementing ISO 22000:2018 typically:

  1. Defines a Food Safety Policy approved by top management.

  2. Establishes and documents Prerequisite Programs (PRPs).

  3. Conducts a Hazard Analysis (HACCP study) to identify CCPs.

  4. Trains personnel on hygiene and critical control monitoring.

  5. Develops traceability and recall procedures.

  6. Conducts internal audits and management reviews.

  7. Continuously monitors performance and implements improvements.

9. Integration with HACCP and Risk Management

ISO 22000 incorporates both:

  • HACCP principles – to control food safety hazards at operational levels.

  • PDCA cycle (Plan-Do-Check-Act) – to ensure systematic management and continuous improvement.

This dual approach strengthens an organization’s ability to identify, prevent, and respond to food safety risks effectively.

10. Certification and Compliance

Certification to ISO 22000:2018:

  • Demonstrates compliance with international food safety regulations.

  • Enhances eligibility for GFSI (Global Food Safety Initiative) recognition.

  • Supports compliance with frameworks like FSSC 22000, which builds on ISO 22000 plus sector-specific PRPs.

11. Conclusion

ISO 22000:2018 establishes a comprehensive and internationally recognized system for managing food safety across the entire food supply chain.
It combines scientific hazard control (HACCP) with modern management system principles, ensuring that food is safe, compliant, and of high quality.

For any organization within the food chain, certification to ISO 22000:2018 is a clear demonstration of commitment to public health, regulatory compliance, and continuous improvement — enhancing trust, credibility, and market competitiveness.