ISO 22000: 2018 - The Context (Part 3)


With this post I conclude the analysis of the so-called “context” of the ISO 22000: 2018 standard, analysing the missing introductory and complementary elements of this standard.

Continuing with the clause of Introduction to the standard, subsection 0.3.3 Risk-based thinking is presented in a relatively more complex way, which is why it also contains three subsections:



In subsection General, the standard indicates that risk-based thinking is essential to achieve an effective FSMS. In this document, risk-based thinking is addressed at two levels, organizational and operational, which is consistent with the process-based approach described in subsection 0.3.2. Plan-Do-Check-Act Cycle (PVHA).


In subsection Organization risk management, the standard indicates that risk is the effect of uncertainty and any of the possible uncertainties can have positive or negative effects. In the context of the organization's risk management, a positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.


To comply with the requirements of this document, an organization plans and implements actions to address the organization's risks. Addressing risks lays the foundation for increasing the effectiveness of the food safety management system, achieving better results and preventing negative effects.


In subsection Hazard Analysis - Operational Processes states that the concept of risk-based thinking, which arises from HACCP principles at the operational level, is implicit in this document.


Subsequent steps in HACCP can be considered as the necessary measures to prevent or reduce hazards to acceptable levels to ensure that the food is safe at the time of consumption.


Decisions made in applying HACCP should be science-based, bias-free and documented. Documentation should include all key assumptions in the decision-making process.


One of the most important points in order to understand the requirements of this standard,  is to differentiate two terms that generally may cause confusion, which are the following: hazard and risk.


The same standard mentions that a food safety hazard is a biological, chemical, or physical agent in the food, including allergens and radiological substances, with the potential to cause an adverse effect on health. However, the same document clarifies that the term “hazard” should not be confused with the term “risk”, which, in the context of food safety, means a function of the probability of an adverse effect on the health (e.g., becoming diseased) and the severity of that effect (e.g., death, hospitalization) when exposed to a specified hazard. 


Therefore, the concept of “Hazard Analysis and Critical Control Points (HACCP)” refers to food contamination hazards and not the risks related to those hazards should be made clear.


Similarly, it is important to understand the concept of "risk-based thinking" in subsection 0.3.3 of the standard, it refers generally to the risks related to an FSMS.


0.4 Relationship with other management system standards


This document has been developed within the ISO High Level Structure (HLS). The goal of the HLS is to improve the alignment between ISO management system standards. This document enables an organization to use the process approach, coupled with the PHVA cycle and risk-based thinking, to align or integrate the FSMS approach with the requirements of other management systems and supporting standards.


This document is the central principle and frame of reference for the FSMS and establishes the specific requirements of the FSMS for the organizations throughout the food chain. Other guides related to food safety, specifications and / or specific requirements of the food sectors can be used in conjunction with this framework.


In addition, ISO has developed a family of associated documents, which includes documents for:


— prerequisite programs (ISO / TS 22002 series) for specific sectors of the food chain;


requirements for auditing and certification bodies;


—  traceability.


ISO also provides guidance documents for organizations on how to implement this document and related standards.


1 Scope


This first clause of the ISO 22000: 2018 standard, which is also informative, indicates that this document specifies the requirements for a food safety management system (FSMS) to be able to allow an organization that is directly or indirectly involved in the food chain:


All requirements in this document are generic and are intended to apply to all organizations in the food chain, regardless of size or complexity. Organizations that are directly or indirectly involved include, but are not limited to, food producers, animal food producers, plant and wildlife harvesters, farmers, ingredient producers, food manufacturers, retailers, and organizations that provide food services, catering services, cleaning and disinfection services, transportation, storage and distribution services, equipment suppliers, cleaning and disinfectants, packaging materials and other food contact materials.


This document enables any organization, including small and / or less developed (for example, a small farm, a small packer-distributor, a small retailer, or a food service sale) to implement externally developed elements in its FSMS.


Internal and / or external resources can be used to meet the requirements of this document.


Clause. 2 Normative references, indicates that no normative references are presented in this document.


Regarding Clause 3. Terms and definitions, 45 terms are identified and their corresponding definitions are established.


Regarding the Bibliography Clause, not numbered also, which is complementary information to the standard, the following documents are listed:


[1] ISO 9000: 2015, Quality management systems - Fundamentals and vocabulary

[2] ISO 9001: 2015, Quality management systems - Requirements

[3] ISO 19011, Guidelines for the audit of management systems

[4] ISO / TS 22002 (all parts), Prerequisite programs on food safety

[5] ISO / TS 22003, Food safety management systems - Requirements for bodies providing audit and certification of food safety management systems

[6] ISO 22005, Traceability in the food chain for human and animal nutrition - General principles and basic requirements for the design and implementation of the system

[7] ISO Guide 73: 2009, Risk management - Vocabulary

[8] CAC / GL 60-2006, Principles for Traceability / Product Tracing as a Tool Within a Food Inspection and Certification System

[9] CAC / GL 81-2013, Guidance for governments on prioritizing hazards in feed

[10] CAC / RCP 1-1969, General Principles of Food Hygiene

[11] Joint FAO / WHO Food Standards Program. Codex Alimentarius Commission: Procedural Manual. Twenty-fifth edition, 2016

[12] Codex Alimentarius. Available from:


Likewise, as supplementary information, two Annexes are presented at the end of the text of the standard:


- Annex A contains the cross references between the HACCP of the Codex Alimentarius Commission and this standard, and


- Annex B containing cross references between this standard and the ISO 22000: 2005 edition.



Ernesto Palomares Hilton