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.