Overview

The certifiable food safety management system standard for any organization in the food chain, combining the harmonized management system structure with HACCP principles and prerequisite programmes. Current edition is ISO 22000:2018 with Amendment 1:2024; a revision is at Draft International Standard stage.

ISO 22000:2018, Food safety management systems — Requirements for any organization in the food chain, is the second edition and cancels and replaces ISO 22000:2005. It applies to all organizations in the food chain regardless of size or complexity — primary producers, feed and food manufacturers, transport and storage operators, retail and food service, and producers of equipment, packaging, cleaning agents, ingredients and additives.

The 2018 edition adopted the harmonized structure used across ISO management system standards, so requirements sit in clauses covering context, leadership, planning, support, operation, performance evaluation and improvement. This makes it straightforward to integrate a food safety management system with ISO 9001 and to audit them together.

Its distinguishing feature is the explicit separation of two Plan-Do-Check-Act cycles, one nested inside the other. The outer cycle governs the management system as a whole. The inner cycle governs operations and covers the HACCP principles: conducting hazard analysis, determining critical control points, establishing validated critical limits, monitoring, correction and corrective action, verification, and documentation. Reading the standard through those two cycles is the key to understanding how its clauses fit together.

Hazard control under ISO 22000 is built on a layered structure. Prerequisite programmes (PRPs) provide the basic hygiene and environmental conditions — the ISO/TS 22002 series gives sector-specific PRP requirements for food manufacturing, catering, farming, feed production, packaging and other sectors. Operational PRPs and critical control points control the significant hazards identified by hazard analysis, with control measures validated before use and verified in operation. The standard also requires traceability, withdrawal and recall arrangements, and emergency preparedness and response.

Communication is treated as a control in itself. The standard requires interactive communication along the food chain — with suppliers, customers, regulators and other interested parties — because a hazard controlled at one step depends on what the previous and following steps do. Requirements for external and internal communication, and for information about products and processes flowing both ways, are explicit.

Amendment 1:2024 added climate action wording to the context and interested-parties clauses, consistent with the change applied to ISO management system standards generally.

Certification is available through accredited certification bodies, following the usual two-stage initial audit, surveillance during the certificate cycle and recertification. ISO 22000 also underpins FSSC 22000, a GFSI-recognised certification scheme that combines ISO 22000 with sector PRP requirements from the ISO/TS 22002 series and additional scheme requirements; many retailers and manufacturers require a GFSI-recognised scheme rather than ISO 22000 alone, so the choice between them is usually driven by customer requirements.

A revision of ISO 22000 is under way and has reached Draft International Standard stage. Until it is published, ISO 22000:2018 with Amendment 1:2024 remains the standard for certification, and transition arrangements will be set once the new edition appears.

Purpose

To specify requirements for a food safety management system so that an organization directly or indirectly involved in the food chain can plan, implement, operate, maintain and update a system providing products and services that are safe, and demonstrate conformity with applicable food safety requirements.

Key Benefits

• Provides a certifiable food safety framework applicable at every stage of the food chain
• Combines HACCP principles with a full management system rather than standing alone
• Uses the harmonized structure, so it integrates cleanly with ISO 9001
• Requires validated control measures and verification rather than assumed effectiveness
• Establishes traceability, withdrawal and recall capability
• Requires interactive communication with suppliers, customers and regulators
• Serves as the base standard for the GFSI-recognised FSSC 22000 scheme
• Supported by the ISO/TS 22002 series of sector-specific prerequisite programme requirements
• Recognised internationally, supporting export and multi-market supply

Key Requirements

• Determine the context of the organization and the needs and expectations of interested parties
• Define the scope of the food safety management system including products, processes and sites
• Demonstrate top management leadership, establish a food safety policy and assign roles including the food safety team leader
• Determine risks and opportunities, set food safety objectives and plan changes
• Provide resources, ensure competence and awareness, and manage external and internal communication
• Establish and maintain documented information, including an emergency preparedness and response process
• Establish prerequisite programmes appropriate to the sector and the organization
• Establish a traceability system covering incoming materials, processing and delivery
• Conduct hazard analysis: describe products and processes, identify hazards, assess them and select control measures
• Establish operational prerequisite programmes and the HACCP plan with critical control points and validated critical limits
• Validate control measures and combinations of control measures before implementation
• Implement monitoring and measurement of control measures and the associated calibration and verification
• Control nonconforming products and processes, including corrections, corrective actions, withdrawal and recall
• Verify the food safety management system and analyse the results of verification activities
• Conduct internal audits and management reviews at planned intervals
• Update the food safety management system and continually improve it
• Address climate change as a context issue in accordance with Amendment 1:2024

Who Needs This Standard?

Any organization directly or indirectly involved in the food chain — primary producers and growers, feed producers, food and beverage manufacturers, ingredient and additive suppliers, packaging manufacturers, storage and transport operators, retailers, caterers and food service businesses, and suppliers of equipment, cleaning and sanitation products. It is used by food safety and quality managers, HACCP teams, production and hygiene managers, and organizations facing customer or export requirements for certified food safety management.

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