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Module 1 of 8 · ISO 22000 · Clause 4

Context of the organisation

Before analysing a single hazard, ISO 22000 asks you to place the business within its food chain: what shapes it, who expects something from it and what it covers.

Content reviewed on

Internal and external issues (4.1)

The standard asks you to identify the factors that affect the system's ability to achieve safe products: food law, customer and retailer requirements, new technologies, changes in raw materials, the company's own culture or staff turnover on the production floor.

Since the 2024 amendment you must decide explicitly whether climate change is a relevant issue. In food it usually is: heatwaves strain the cold chain, drought affects water and crop quality, and changes in where raw materials come from bring new hazards.

Interested parties (4.2)

Customers, consumers, health authorities, suppliers, hauliers and, where applicable, the certification scheme owner. What is required is to identify which are relevant and which of their requirements affect food safety, and to review this when they change.

Scope of the system (4.3)

It must state the products or product categories, processes and production sites. It is documented information to be maintained, and it cannot leave out activities, processes or products that influence the safety of the end product: an external warehouse that repacks, for example, is either included or controlled as an externally provided process.

The system and its processes (4.4)

The food safety management system is established, implemented, maintained, updated and improved. That word in the middle — updated — is not rhetoric: clause 10.3 develops it, and it is one of the differences from ISO 9001.

What an auditor usually asks for

  • Analysis of internal and external issues, including the decision on climate change
  • Relevant interested parties with their food safety requirements
  • Scope with products, processes and sites, with no exclusions that affect the end product
  • Process map showing where PRPs, CCPs and OPRPs are applied

How to cover context in Kimobox

  1. 1Document the context analysis as a record with a review date and an owner, linked to management review.
  2. 2Enter the interested parties and their requirements in a versioned table.
  3. 3Draw the process map, marking the steps with hazard control measures.

If the scope says "all products" and the process map does not show the external repacking, the auditor will find it in the delivery notes.

How the process map is built in Kimobox

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

  1. ISO 22000:2018 — Food safety management systems. Requirements for any organization in the food chain ISO · 2018 ed. (2nd edition), published June 2018
  2. ISO 22000:2018/Amd 1:2024 — Climate action changes ISO · February 2024
  3. ISO/DIS 22000 — Draft revision of the standard (3rd edition) ISO · Under development
  4. ISO 22002-100:2025 — Prerequisite programmes on food safety. Part 100: requirements for the food, feed and packaging chain ISO · 29 July 2025
  5. ISO 22002-1:2025 — Prerequisite programmes on food safety. Part 1: food manufacturing ISO · 29 July 2025; replaces ISO/TS 22002-1:2009
  6. General Principles of Food Hygiene, CXC 1-1969 Codex Alimentarius (FAO/WHO) · 2020 revision
  7. Regulation (EC) No 852/2004 on the hygiene of foodstuffs EUR-Lex · 29 April 2004
  8. Regulation (EC) No 178/2002, Articles 18 and 19 (traceability and withdrawal) EUR-Lex · 28 January 2002
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