In the 2018 revision, organizations are required to analyze the results of Clauses 4.1 (Context of the organization), 4.2 (Interested parties), and Clause 6 (Planning). Based on these results, the FSMS must be appropriately maintained and updated, with relevant changes incorporated into management review.

For organizations that have implemented ISO 9001:2015, the change management process can generally be integrated. However, attention must be paid to the fact that ISO 22000 focuses specifically on FSMS-related changes.

 

    3-1. Top management must demonstrate commitment to the FSMS.
    3-2. Ensure alignment between food safety objectives and the organization’s strategic direction, provide resources for FSMS operation, and ensure staff understand their responsibilities.

The revised ISO 22000 emphasizes the role of top management in ensuring the successful implementation and continuous improvement of the FSMS through active involvement.

 

    4-1. Organizations must assess the capabilities and limitations of internal resources to effectively establish, update, and maintain the FSMS.
    4-2. Requirements have been expanded to include resources related to the work environment, including hardware, software, occupational safety factors, ergonomics, and employee health.
    4-3. PRPs (Prerequisite Programs) now include requirements for supplier evaluation, product information, consumer awareness, and applicability of the ISO/TS 22002 series.

 

    5-1. Additional requirements have been added regarding the scope of both internal and external communication.
    5-2. External communication has been strengthened. Organizations must identify responsible parties and establish mechanisms for gathering information, which must be included as inputs for management review.

 

   6-1. Additional requirements have been introduced for external providers.
   6-2. Organizations must establish criteria for the evaluation, selection, monitoring, and re-evaluation of external suppliers, as well as ensure effective communication. Supplier performance must be considered during management review.

For outsourced R&D, organizations must ensure that the information complies with the updated requirements, is reviewed by the food safety team, is applicable to existing facilities, processes, and products, is appropriately maintained and updated, and is supported by documented evidence.

 

   7-1. Enhanced traceability system requirements; organizations must verify and test the effectiveness of their traceability systems.
   7-2. Increased emphasis on raw material origins.
   7-3. Final product characteristics now include transportation, storage, and usage methods.
   7-4. Strengthened emergency preparedness requirements, including types of emergencies, legal requirements, communication, and response actions.

While traceability requirements may not pose a significant challenge under current national regulations, the revised standard outlines specific types of emergencies and requires documented procedures and records for both actual incidents and simulations.

 

   8-1. Enhanced process and environmental control with on-site verification requirements.
   8-2. Expanded guidance on HACCP, including defining monitoring limits and validating control measures.
   8-3. New terminology introduced: single control measures and combinations of control measures, with emphasis on validation.
   8-4. Software used for monitoring and measurement must be verified—either by the organization, the software provider, or a third party—before use.
   8-5. New requirements for validation plans.

 

   9-1. New sources of corrective actions added, including inspection reports and customer complaints.
   9-2. Stricter controls on nonconforming products: Products that exceed CCP (Critical Control Point) limits must not be released without proper evaluation.
   9-3. Corrective actions must consider the possibility of recurrence or similar nonconformities.

 

   10-1. Internal audits now include additional elements to verify whether the FSMS aligns with food safety policy and meets the organization’s FSMS objectives.
   10-2. Changes to the inputs required for management reviews.