PublishedISO 9001:2026 published 16 Sept 2026 · 2015 certificates must transition by 30 Sept 2029What changed →
Internal Auditor course (ISO 19011:2026):free until 31 Oct · then $59 for three monthsStart free now →
← Back to Clause Explorer
4.3ISO 22000:2018

Setting the boundaries of your food-safety system

Plain-language summary

Be clear and honest about exactly which products, processes and sites your food-safety management system covers.

What the clause is really asking

A fuzzy scope is where unsafe product hides. This clause makes you define what is in and what is out - which product lines, which processes, which physical locations - so that everyone, including auditors and certifiers, knows what the system is responsible for. Anything you exclude must be genuinely outside your control of food safety.

What auditors look for

Auditors compare the written scope against what they see on the floor. If you make a product or run a process that affects food safety but it is not in scope, that is a finding. They are alert to convenient exclusions - an outsourced step or a second line quietly left out.

Typical evidence

Documented FSMS scope statement; site and process boundaries; justification for any exclusions; alignment with certificate scope

How to comply — recommendations

Write the scope in plain terms covering products, processes and sites, and make sure it matches your certificate and your reality. Do not exclude anything that genuinely touches food safety. Revisit the scope whenever you add a line, a product type or a site.

Common nonconformities

Scope narrower than actual operations; outsourced processes affecting safety omitted; scope not updated after a new product line

Related clauses

ISO 22000 4.4, 8.1; FSSC 22000 scope categories

Get the free HACCP Flow Diagram & Product Description Template

Free, instant download. We'll only email you the occasional practical quality update — no spam, unsubscribe anytime.

Qlause provides interpretive guidance only and is not a substitute for the standard. Refer to your licensed copy of the relevant standard for the authoritative text.

Certification & implementation

Working on a certification or system implementation project?

Implementing ISO 9001, moving to the 2026 edition, getting ready for a certification audit, or stuck on a clause that doesn't seem to fit your operation? Tell us where you are and where you're stuck. We'll look at it and suggest a practical next step, or connect you with people we trust who can help.

Email hello@qlause.app

No sales pitch, no obligation — we read every message.