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4.3

Determining the scope of the food safety management system

ClauseUnchanged titleRetrieved 2026-10-19Last updated: 2026-10-19

The requirement that applies today

The organization defines the boundary of the system and states where it applies. The statement has to name the products and services, the processes and the production sites inside the boundary, and it has to include every activity that can affect the safety of the end product. It is kept as controlled information.

ISO 22000:2018, 4.3 Determining the scope of the food safety management system; ISO/DIS 22000:2026, 4.3.

What the draft does

Unchanged title: The public contents keep 4.3 at the same number and title. No change to the requirement is shown in the public material.

Source: public contents and foreword at 4.3, retrieved 2026-10-19.

Why this clause matters

The scope decides what the auditor can look at and what the certificate covers. A narrow scope that leaves out a process which touches the product is a credibility problem, and a broad scope that claims sites the system does not control is a liability. The clause is short and the consequences are long.

Suggested evidence to discuss with your auditor

For 4.3, these are the artefacts we suggest discussing with your auditor. The standard publishes no evidence list, so this is our reading, not a requirement.

  • The current scope statement, approved and dated, matching the certificate
  • A site map or process map showing every location inside the boundary
  • A justification for any activity excluded, with the food safety reasoning

Where systems usually fall short

  • A scope written as a marketing sentence rather than a boundary
  • Contract manufacturing, storage or transport that affects the product left outside the scope without a reason

How to prepare

Compare the scope statement word for word with the certificate and with the site list in the context register. Any difference is a finding waiting to happen; fix the wording now rather than during a transition audit.

Dates

Applies todayISO 22000:2018 as amended in 2024, the edition published today; certificate treatment after a new edition depends on the transition arrangements
DraftISO/DIS 22000:2026, DIS ballot closed 2026-07-29
Planning date2027-09-12 (estimate, not an ISO date)

Cross-references

4.1, 4.2, 4.4, 8.1.1

Source

Clause 4.3. Current edition: ISO 22000:2018. Draft: ISO/DIS 22000:2026. Retrieved 2026-10-19. The full DIS text for 4.3 is sold by ISO and not held here; the sources page lists what is.

Not legal advice; does not certify; our words, not the standard's, and the planning date is an estimate.