ISO 22000:2018 is the international standard specifying requirements for a Food Safety Management System (FSMS). It enables organizations directly or indirectly involved in the food chain to establish, implement, maintain, update and continually improve a system capable of consistently providing products and services that are safe for their intended use, meeting statutory, regulatory and customer requirements, and effectively communicating food safety issues throughout the food chain.

ISO 22000 combines management system principles with interactive communication, prerequisite programmes (PRPs), and the HACCP principles and application steps developed by the Codex Alimentarius Commission. The 2018 edition operates through two interrelated PDCA cycles: one at the management system level and another at the operational food safety hazard control level. This approach enables an organization to address business risks affecting its FSMS while identifying, assessing and controlling relevant biological, chemical and physical food safety hazards, including allergens where applicable.

The standard applies to organizations of every size and complexity across the food chain, including animal feed production, farming, harvesting, primary processing, food manufacturing, ingredient and additive production, catering, retail, transportation, storage, distribution, cleaning services, and the production of equipment, packaging and food-contact materials. Small organizations may use externally developed elements, but remain responsible for ensuring that those elements are suitable and controlled within their FSMS.

At the time this article was updated, ISO 22000:2018, together with ISO 22000:2018/Amd 1:2024, remains the published edition used for certification audits. The 2024 amendment requires an organization to determine whether climate change is a relevant issue for the context of its FSMS and to consider related requirements of interested parties. ISO/DIS 22000 is being developed to replace the 2018 edition, but it remains a draft and is not yet a published International Standard.

Key technical elements of ISO 22000:2018 include:

• FSMS context, leadership and planning: Define the scope, interested parties, statutory, regulatory and customer requirements; establish policy, objectives, responsibilities, resources, and actions to address risks and opportunities at the system level.
• Communication throughout the food chain: Establish internal and external communication arrangements concerning raw materials, products, processes, hazards, control requirements, changes and situations that may affect food safety.
• Prerequisite programmes - PRPs: Establish basic hygienic conditions and activities appropriate to the sector, scale and operating environment to prevent or reduce contamination. ISO 22002-100:2025 and sector-specific parts of the ISO 22002 series can support PRP development but do not automatically constitute separate mandatory requirements for ISO 22000 certification.
• Traceability and emergency preparedness: Control lot identification and link raw materials, processes, finished products and distribution; prepare, test and update arrangements for incidents and product withdrawal or recall.
• Hazard analysis: Describe raw materials, products and intended use; establish and verify flow diagrams and process environments; identify hazards, determine acceptable levels, and assess likelihood and severity to select appropriate control measures.
• Validation and the hazard control plan: Validate that control measures or combinations of measures are capable of achieving the intended control; categorize and manage them as operational PRPs (OPRPs) or at critical control points (CCPs), using appropriate action criteria or critical limits, monitoring, corrections and records.
• Verification, evaluation and improvement: Perform calibration, sampling, testing and verification of PRPs and the hazard control plan; conduct internal audits and management reviews, address nonconformities, update preliminary information and continually improve the FSMS.