oSIST prEN ISO 22000:2026

Food safety management systems — Requirements for any organization in the food chain (ISO/DIS 22000:2026)

This document specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain:
a)    to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use;
b)    to demonstrate compliance with applicable statutory and regulatory food safety requirements;
c)    to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them;
d)    to effectively communicate food safety issues to interested parties within the food chain;
e)    to ensure that the organization conforms to its stated food safety policy;
f)     to demonstrate conformity to relevant interested parties;
g)    to seek certification or registration of its FSMS by an external organization, or make a self-assessment or self-declaration of conformity to this document.
All requirements of this document are generic and are intended to be applicable to all organizations in the food chain, regardless of size and complexity. Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials.
This document allows any organization, including small and/or less developed organizations (e.g. a small farm, a small packer-distributor, a small retail or food service outlet) to implement externally-developed elements in their FSMS.
Internal and/or external resources can be used to meet the requirements of this document.

Managementsysteme für die Lebensmittelsicherheit - Anforderungen an Organisationen in der Lebensmittelkette (ISO/DIS 22000:2026)

Systèmes de management de la sécurité des denrées alimentaires — Exigences pour tout organisme appartenant à la chaîne alimentaire (ISO/DIS 22000:2026)

Le présent document spécifie les exigences relatives à un système de management de la sécurité des denrées alimentaires (SMSDA) pour permettre à un organisme directement ou indirectement impliqué dans la chaîne alimentaire, de:
a)    planifier, mettre en œuvre, exploiter, maintenir et actualiser un SMSDA fournissant des produits et services qui sont sûrs, conformément à leur utilisation prévue;
b)    démontrer sa conformité aux exigences légales et réglementaires applicables en matière de sécurité des denrées alimentaires;
c)    évaluer et apprécier les exigences en matière de sécurité des denrées alimentaires établies en accord avec le(s) client(s) et démontrer la conformité à celles-ci;
d)    communiquer efficacement sur les questions relatives à la sécurité des denrées alimentaires avec les parties intéressées de la chaîne alimentaire;
e)    garantir la conformité avec sa politique déclarée en matière de sécurité des denrées alimentaires;
f)     démontrer cette conformité auprès des parties intéressées;
g)    faire certifier ou enregistrer son SMSDA par un organisme externe, ou effectuer une auto-évaluation ou une auto-déclaration de conformité au présent document.
Toutes les exigences du présent document sont d'une portée générale et sont conçues pour s'appliquer à tous les organismes de la chaîne alimentaire, indépendamment de leur taille et de leur complexité. Les organismes directement ou indirectement impliqués incluent, entre autres, les producteurs d'aliments pour animaux producteurs de denrées alimentaires, les producteurs d'aliments pour animaux non producteurs de denrées alimentaires, les chasseurs/pêcheurs/cueilleurs, les agriculteurs, les producteurs d'ingrédients, les transformateurs de denrées alimentaires, les détaillants, les organismes fournissant des services de traiteur, de restauration, des services de nettoyage et de désinfection, des services de transport, d'entreposage et de distribution, et les fournisseurs d'équipements, de produits de nettoyage et de désinfection, de matériaux de conditionnement/emballage et d'autres matériaux en contact avec les denrées alimentaires.
Le présent document permet à tout organisme, y compris les organismes de petite taille et/ou peu développés (comme une petite ferme, un petit conditionneur-distributeur, un petit magasin de détail ou de service alimentaire), de mettre en œuvre des éléments élaborés en externe dans son SMSDA.
Des ressources internes et/ou externes peuvent être utilisées pour satisfaire aux exigences du présent document.

Sistemi vodenja varnosti živil - Zahteve za katerokoli organizacijo v prehranski verigi (ISO/DIS 22000:2026)

Ta dokument določa zahteve za sistem vodenja varnosti hrane (FSMS), ki omogoča organizaciji, ki je neposredno ali posredno vključena v prehransko verigo:
a)    načrtovati, izvajati, upravljati, vzdrževati in posodabljati FSMS, ki zagotavlja varne proizvode in storitve v skladu z njihovim predvidenim namenom;
b)    dokazati skladnost z veljavnimi zakonskimi in regulativnimi zahtevami glede varnosti hrane;
c)    oceniti in preveriti medsebojno dogovorjene zahteve kupcev glede varnosti hrane ter dokazati skladnost z njimi;
d)    učinkovito komunicirati vprašanja varnosti hrane z zainteresiranimi stranmi znotraj prehranske verige;
e)    zagotoviti, da organizacija izpolnjuje svojo navedeno politiko varnosti hrane;
f)     dokazati skladnost z relevantnimi zainteresiranimi stranmi;
g)    pridobiti certifikacijo ali registracijo svojega FSMS s strani zunanje organizacije ali opraviti samooceno ali samodeklaracijo skladnosti s tem dokumentom.
Vse zahteve tega dokumenta so splošne in so namenjene uporabi v vseh organizacijah v prehranski verigi, ne glede na velikost in kompleksnost. Organizacije, ki so neposredno ali posredno vključene, vključujejo, vendar niso omejene na, proizvajalce krme, proizvajalce hrane za živali, nabiralce divjih rastlin in živali, kmete, proizvajalce sestavin, proizvajalce hrane, trgovce na drobno in organizacije, ki zagotavljajo prehranske storitve, storitve cateringa, storitve čiščenja in sanacije, prevozne, skladiščne in distribucijske storitve, dobavitelje opreme, čistil in razkužil, embalažnih materialov in drugih materialov, ki prihajajo v stik s hrano.
Ta dokument omogoča kateri koli organizaciji, vključno z majhnimi in/ali manj razvitimi organizacijami (npr. majhna kmetija, majhen pakirno-distribucijski center, majhna trgovina na drobno ali prehranska storitev), da v svoj FSMS vključi zunanje razvite elemente.
Za izpolnjevanje zahtev tega dokumenta se lahko uporabijo notranji in/ali zunanji viri.

General Information

• Status: Not Published
• Public Enquiry End Date: 28-Jul-2026
• ICS: 03.100.70 - Management systems
• ICS: 67.020 - Processes in the food industry
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 15-May-2026
• Due Date: 02-Oct-2026
• Ref Project: prEN ISO 22000 - Food safety management systems — Requirements for any organization in the food chain

Relations

• Revises: SIST EN ISO 22000:2018 - Food safety management systems - Requirements for any organization in the food chain (ISO 22000:2018)
• Effective Date: 31-Jan-2024
• Revises: SIST EN ISO 22000:2018/A1:2024 - Food safety management systems - Requirements for any organization in the food chain - Amendment 1: Climate action changes (ISO 22000:2018/Amd 1:2024)
• Effective Date: 31-Jan-2024

Overview

oSIST prEN ISO 22000:2026: Food Safety Management Systems - Requirements for Any Organization in the Food Chain provides internationally recognized guidance for the development, implementation, and continual improvement of a food safety management system (FSMS). Published by CEN and developed in cooperation with ISO, this standard is relevant to any organization - regardless of size or sector - that is directly or indirectly involved in the food chain. This includes all stages, from primary producers and food manufacturers to retailers, food service providers, and associated organizations supplying equipment, packaging, logistics, and sanitation services.

The aim of oSIST prEN ISO 22000:2026 is to enable organizations to consistently provide safe products and services, meet customer needs, demonstrate legal and regulatory compliance, and effectively manage food safety hazards. The requirements are designed to be flexible, supporting a wide range of organizations throughout the global food industry.

Key Topics

• Food Safety Management System (FSMS): The standard outlines how to plan, implement, operate, maintain, and update a systematic approach to managing food safety.
• Statutory and Regulatory Compliance: Guidance to help organizations conform with applicable food safety laws and regulations.
• Customer Requirements: Procedures for evaluating, documenting, and demonstrating conformity with mutually agreed customer food safety requirements.
• Communication: Emphasis on effective internal and external communication regarding food safety issues throughout the food chain.
• Leadership and Food Safety Culture: Focus on leadership engagement, the establishment of a food safety policy, and the promotion of a robust food safety culture across the organization.
• Risk-Based Thinking: Incorporation of risk assessment at both organizational and operational levels, following the process and Plan-Do-Check-Act (PDCA) approach.
• Hazard Analysis and Critical Control Points (HACCP): Integration of HACCP principles and prerequisite programs (PRPs) to control significant food safety hazards.
• Food Defence and Food Fraud Prevention: Inclusion of new requirements aimed at preventing intentional product tampering and economically motivated food fraud.
• Continual Improvement and Corrective Actions: Systems for monitoring, measuring, evaluating, and improving food safety performance, including processes for complaint handling, internal audits, and management review.
• Documented Information: Structured approach for creating, updating, and controlling critical documentation required for effective FSMS operation.

Applications

oSIST prEN ISO 22000:2026 can be applied across the entire food chain, including but not limited to:

• Primary Production: Farms, fisheries, and harvesters of wild plants and animals.
• Feed and Ingredient Production: Producers of animal feed and food ingredients.
• Food Manufacturing: Processors and manufacturers in all sectors of the food industry.
• Retail and Food Services: Grocery stores, wholesalers, catering services, restaurants, and e-commerce.
• Logistics and Support Services: Providers of transportation, warehousing, storage, and cleaning/sanitation.
• Suppliers: Providers of equipment, packaging, chemicals, cleaning agents, and other food contact materials.

The standard is relevant to organizations of all sizes, including small businesses and less-developed operations, and allows the use of both internal and external resources to fulfill FSMS requirements. It supports organizations seeking FSMS certification, registration by an external body, or those wishing to self-declare conformity.

Related Standards

Organizations implementing oSIST prEN ISO 22000:2026 may also benefit from referencing related international standards, such as:

• ISO 22002 Series: Prerequisite programmes for specific sectors of the food chain.
• ISO 22003: Requirements for bodies providing audit and certification of FSMS.
• ISO 22005: Traceability in the feed and food chain.
• Codex HACCP Principles: Internationally recognized hazard analysis and critical control point principles for food safety.
• ISO Harmonized Structure (HS): For integrated management systems across quality, environment, and food safety.

By aligning with oSIST prEN ISO 22000:2026, organizations demonstrate their commitment to robust food safety management, regulatory compliance, customer satisfaction, and the continual improvement of their food safety performance. This standard supports a proactive and preventive approach to food safety, enhancing trust and transparency throughout the global food chain.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2026
Sistemi vodenja varnosti živil - Zahteve za katerokoli organizacijo v prehranski
verigi (ISO/DIS 22000:2026)
Food safety management systems — Requirements for any organization in the food
chain (ISO/DIS 22000:2026)
Managementsysteme für die Lebensmittelsicherheit - Anforderungen an Organisationen
in der Lebensmittelkette (ISO/DIS 22000:2026)
Systèmes de management de la sécurité des denrées alimentaires — Exigences pour
tout organisme appartenant à la chaîne alimentaire (ISO/DIS 22000:2026)
Ta slovenski standard je istoveten z: prEN ISO 22000
ICS:
03.100.70 Sistemi vodenja Management systems
67.020 Procesi v živilski industriji Processes in the food
industry
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 22000
ISO/TC 34/SC 17
Food safety management systems —
Secretariat: DS
Requirements for any organization
Voting begins on:
in the food chain
2026-05-06
Systèmes de management de la sécurité des denrées
alimentaires — Exigences pour tout organisme appartenant à la
Voting terminates on:
chaîne alimentaire
2026-07-29
ICS: ISO ics
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 22000:2026(en)
ISO/DIS 22000:2026 (E)
ISO/TC 34/SC 17/WG 8 N 067
ISO/DIS 22000:2026(en)
Replaces N 066
Secretariat: DS
Food safety management systems — Requirements for any
organization in the food chain
Systèmes de management de la sécurité des denrées alimentaires— Exigences pour tout organisme appartenant à la
chaîne alimentaire
DIS stage
This document contains the modifications made at the WG 8 meeting (March 2026) before DIS
submission.
A version with tracked changes is circulated as document N 066.
Next step: This version of this draft will be sent to ISO/CS for the initiation of the DIS procedure. When
the ballot closes, the result and compiled comments will be submitted to the WG 8 experts for
discussion at the next meeting (November 2026, Buenos Aires).
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
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Contents
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization (BLUE text represents the HS) . 9
4.1 Understanding the organization and its context . 9
4.2 Understanding the needs and expectations of interested parties . 9
4.3 Determining the scope of the food safety management system . 9
4.4 Food safety management system . 9
5 Leadership . 9
5.1 Leadership and commitment . 9
5.2 Food safety policy . 10
5.3 Organizational roles, responsibilities and authorities . 10
5.4 Food safety culture . 10
6 Planning . 11
6.1 Actions to address risks and opportunities . 11
6.2 Food Safety management system objectives and planning to achieve them . 11
6.3 Planning of changes . 12
7 Support . 12
7.1 Resources . 12
7.1.1 General . 12
7.1.2 People . 12
7.1.3 Infrastructure . 12
7.1.4 Work environment . 12
7.1.5 Externally developed elements of the food safety management system . 13
7.1.6 Management of externally provided materials, products, processes and services . 13
7.2 Competence . 13
7.3 Awareness . 14
7.4 Communication . 14
7.4.1 General . 14
7.4.2 External communication . 14
7.4.3 Internal communication . 15
7.5 Documented information . 15
7.5.1 General . 15
7.5.2 Creating and updating documented information . 15
7.5.3 Control of documented information . 15
8 Operation . 16
8.1 Operational planning and control . 16
8.1.1 General . 16
8.1.2 Food defence . 16
8.1.3 Food fraud prevention . 17
8.2 Prerequisite programmes (PRPs) . 17
8.3 Traceability system. 18
8.4 Emergency preparedness and response . 18
8.4.1 General . 18
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8.4.2 Handling of emergencies and incidents . 18

8.5 Hazard control . 18
8.5.1 Preliminary steps to enable hazard analysis . 18
8.5.2 Hazard analysis . 20
8.5.3 Validation of control measure(s) and combinations of control measures . 22
8.5.4 Hazard control plan (HACCP/OPRP plan) . 22
8.6 Updating the information specifying the PRP(s) and the hazard control plan . 23
8.7 Control of monitoring and measuring . 23
8.8 Verification related to PRP(s) and the hazard control plan . 24
8.8.1 Verification . 24
8.8.2 Analysis of results of verification activities . 24
8.9 Control of product and process nonconformities . 25
8.9.1 General . 25
8.9.2 Corrections . 25
8.9.3 Corrective actions . 25
8.9.4 Handling of unsafe products/potentially unsafe products . 26
8.9.5 Withdrawal/recall . 26
9 Performance evaluation . 27
9.1 Monitoring, measurement, analysis and evaluation . 27
9.1.1 General . 27
9.1.2 Analysis and evaluation . 27
9.2 Internal audit . 27
9.2.1 General . 27
9.2.2 Internal audit programme . 28
9.3 Management review . 28
10 Improvement . 29
10.1 Continual improvement . 29
10.2 Nonconformity and corrective action . 29
10.3 Complaints management . 29
10.4 Update of the food safety management system . 30
Annex A (informative) Cross references between the Codex HACCP and this document . 31
Annex B (informative) Selection and categorization of control measures for significant
food safety hazards (OPRP-CCP) . 33
B.1 General . 33
B.2 Selection and categorization of control measures . 33
Bibliography . 35

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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of
(a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 17,
Management systems for food safety.
This third edition cancels and replaces the second edition (ISO 22000:2018) which has been technically
revised. It also incorporates ISO 22000:2018/Amd. 1.
The main changes are as follows:
— Addition of requirements for food safety culture, food defence, food fraud prevention, and handling
of complaints.
— New informative annex on the selection of control measures.
— Information on where to find guidance for food safety culture, food defence, food fraud prevention,
and continual improvement.
Any feedback or questions on this document should be directed to the user’s national standards body.
A complete listing of these bodies can be found at www.iso.org/members.html.
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Introduction
0.1 General
The adoption of a food safety management system (FSMS) is a strategic decision for an organization that
can help to improve its overall performance in food safety. The potential benefits to an organization of
implementing a FSMS based on this document are:
a) the ability to consistently provide safe foods, products and services that meet customer and
applicable statutory and regulatory requirements;
b) addressing risks associated with its objectives;
c) the ability to demonstrate conformity to specified FSMS requirements.
This document employs the process approach (see 0.3), which incorporates the Plan-Do-Check-Act
(PDCA) cycle (see 0.3.2) and risk-based thinking (see 0.3.3).
This process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and
its FSMS to deviate from the planned results, and to put in place controls to prevent or minimize adverse
effects.
0.2 FSMS principles
Food safety is related to the presence of food safety hazards at the time of consumption (intake by the
consumer). Food safety hazards can occur at any stage of the food chain. Therefore, adequate control
throughout the food chain is essential. Food safety is ensured through the combined efforts of all the
parties in the food chain. This document specifies the requirements for a FSMS that combines the
following generally recognized key elements:
— interactive communication;
— system management;
— prerequisite programmes;
— hazard analysis and critical control point (HACCP) principles.
In addition, this document is based on the principles that are common to ISO management system
standards. The management principles are:
— customer focus;
— leadership;
— engagement of personnel;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
0.3 Process approach
0.3.1 General
This document adopts a process approach when developing and implementing a FSMS and improving
its effectiveness to enhance production of safe products and services while meeting applicable
requirements. Understanding and managing interrelated processes as a system contributes to the
organization’s effectiveness and efficiency in achieving its intended results. The process approach
involves the systematic definition and management of processes, and their interactions, so as to achieve
the intended results in accordance with the food safety policy and strategic direction of the organization.
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Management of the processes and the system as a whole can be achieved using the PDCA cycle, with an

overall focus on risk-based thinking aimed at taking advantage of opportunities and preventing
undesirable results.
The recognition of the organization’s role and position within the food chain is essential to ensure
effective interactive communication throughout the food chain.
0.3.2 Plan-Do-Check-Act cycle
The PDCA cycle can be described briefly as follows:
Plan: establish the objectives of the system and its processes, provide the resources needed to deliver
the results, and identify and address risks and opportunities;
Do: implement what was planned;
Check: monitor and (where relevant) measure processes and the resulting products and services,
analyse and evaluate information and data from monitoring, measuring and verification
activities, and report the results;
Act: take actions to improve performance, as necessary.

In this document, and as illustrated in Figure 1, the process approach uses the concept of the PDCA cycle
at two levels. The first covers the overall frame of the FSMS (Clause 4 to Clause 7 and Clause 9 to
Clause 10). The other level (operational planning and control) covers the operational processes within
the food safety system as described in Clause 8. Communication between the two levels is therefore
essential.
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Figure 1 — Illustration of the Plan-Do-Check-Act cycle at the two levels
0.3.3 Risk-based thinking
0.3.3.1 General
Risk-based thinking is essential for achieving an effective and robust management system focused on
food safety. Risk is the effect of uncertainty, and any such uncertainty can have positive or negative
effects. In the context of risk management, a positive deviation arising from a risk can provide an
opportunity, but not all positive effects of risk result in opportunities.
In this document, risk-based thinking is addressed on two levels, organizational (see 0.3.3.2) and
operational (see 0.3.3.3), which is consistent with the process approach described in 0.3.2.
0.3.3.2 Organizational risk management
To conform to the requirements of this document, an organization plans and implements actions to
address organizational risks (Clause 6). Addressing risks establishes a basis for increasing the
effectiveness of the FSMS (including food safety culture), achieving improved results and preventing
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negative effects. This document highlights the importance of continual improvement by identifying and

utilizing opportunities.
The documentation of organizational risks includes key assumptions in the decision-making process.
0.3.3.3 Operational risk management
To ensure food safety, an organization plans and implements actions to address operational risks
(Clause 8) based on the international principles of Hazard Analysis Critical Control Points (HACCP),
Prerequisite Programmes, traceability, food defence and food fraud prevention. The objective of these
actions is to prevent or reduce food safety hazards to acceptable levels at the time of consumption.
Decisions taken in the application of food safety should be based on science, free from bias and
documented.
0.4 Relationship with other management system standards
This document has been developed within the ISO Harmonized Structure (HS). The objective of the HS
is to improve alignment between ISO management system standards. This document enables an
organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align
or integrate its FSMS approach with the requirements of other management systems and supporting
standards.
This document is the core principle and framework for FSMSs and sets out the specific FSMS
requirements for organizations throughout the food chain. Other guidance related to food safety,
specifications and/or requirements specific to food sectors can be used together with this framework.
In addition, ISO has developed a family of associated documents. These include documents for:
— prerequisite programmes (e.g. ISO 22002 series) for specific sectors of the food chain;
— requirements for auditing and certification bodies (ISO 22003 series);
— traceability (e.g. ISO 22005).
ISO also provides guidance documents for organizations on how to implement this document and
related standards. Information is available on the ISO website.
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Food safety management systems — Requirements for any
organization in the food chain
1 Scope
This document specifies requirements for a food safety management system (FSMS) to enable an
organization that is directly or indirectly involved in the food chain:
a) to plan, implement, maintain and update a FSMS providing products and services that are safe, in
accordance with their intended use;
b) to demonstrate compliance with applicable statutory and regulatory food safety requirements;
c) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate
conformity with them;
d) to effectively communicate food safety issues to interested parties;
e) to ensure that the organization conforms to its stated food safety policy;
f) to demonstrate conformity to relevant interested parties;
g) to seek certification or registration of its FSMS by an external organization, or make a self-assessment
or self-declaration of conformity to this document.
All requirements of this document are generic and are intended to be applicable to all organizations in
the food chain, regardless of size and complexity. Organizations that are directly or indirectly involved
include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and
animals, farmers, producers of ingredients, food manufacturers, brokering/trading,
retailers/wholesalers, e-commerce, and organizations providing food services, catering services,
cleaning and sanitation services, transportation, storage and distribution services, and suppliers of
equipment, service providers, chemical/biochemicals, cleaning and disinfectants, packaging materials,
and other food/product contact materials.
This document allows any organization, including small and/or less developed organizations (e.g. a
small farm, a small packer-distributor, a small retail or food service outlet) to implement externally-
developed elements in their FSMS.
Internal and external resources, or both, can be used to meet the requirements of this document.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/

3.1
acceptable level
level of hazard in a food at or below which the food is considered to be safe according to its intended
use
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3.2
action criterion
measurable or observable specification for the monitoring (3.29) of an OPRP (3.32)
Note 1 to entry: An action criterion is established to determine whether an OPRP remains in control and
distinguishes between what is acceptable (criterion met or achieved means the OPRP is operating as intended)
and unacceptable (criterion not met nor achieved means the OPRP is not operating as intended).
3.3
audit
systematic, independent and documented process (3.37) for obtaining audit evidence and evaluating it
objectively to determine the extent to which the audit criteria are fulfilled
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party),
and it can be a combined audit (combining two or more disciplines).
Note 2 to entry: An internal audit is conducted by the organization itself, or by an external party on its behalf.
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.
3.4
competence
ability to apply knowledge and skills to achieve intended results
3.5
conformity
fulfilment of a requirement (3.39)
3.6
contamination
introduction or occurrence of a contaminant including a food safety hazard (3.24) in a product (3.38) or
processing environment
3.7
continual improvement
recurring activity to enhance performance (3.34)
3.8
control measure
action or activity that is essential to prevent a significant food safety hazard (3.24) or reduce it to an
acceptable level (3.1)
Note 1 to entry: See also significant food safety hazard (3.24).
Note 2 to entry: Control measure(s) is (are) identified by hazard analysis and categorized as CCPs or OPRPs.
3.9
correction
action to eliminate a detected nonconformity (3.30)
Note 1 to entry: A correction includes the handling of potentially unsafe products and can therefore be made in
conjunction with a corrective action (3.10).
Note 2 to entry: A correction may be, for example, reprocessing, further processing and/or elimination of the
adverse consequences of the nonconformity (such as disposal for other use or specific labelling).
3.10
corrective action
action to eliminate the cause of a nonconformity (3.30) and to prevent recurrence
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Note 1 to entry: There can be more than one cause for a nonconformity.

Note 2 to entry: Corrective action includes root cause analysis.
3.11
critical control point
CCP
control measure(s) (3.8) that is (are) applied with defined critical limit(s) (3.12) and monitoring (3.29)
to enable timely application of correction (3.9)
Note 1 to entry: See Annex B for selection and categorization of control measures.
3.12
critical limit
measurable value which separates acceptability from unacceptability for a CCP
Note 1 to entry: Critical limits are established to determine whether a CCP (3.11) remains in control. If a critical
limit is exceeded or not met, the products affected are to be handled as unsafe products.
[SOURCE: CXC 1-1969, modified — The definition has been modified and Note 1 to entry has been
added.]
3.13
documented information
information required to be controlled and maintained by an organization (3.33) and the medium on
which it is contained
Note 1 to entry: Documented information can be in any format and media, and from any source.
Note 2 to entry: Documented information can refer to:
— the management system (3.27), including related processes (3.37);
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).
3.14
effectiveness
extent to which planned activities are realized and planned results achieved
3.15
end product
product (3.38) that will undergo no further processing or transformation by the organization (3.33)
Note 1 to entry: A product that undergoes further processing or transformation by another organization is an end
product in the context of the first organization and a raw material or an ingredient in the context of the second
organization.
3.16
externally developed element
aspect, component or part of a food safety management system provided by an external party
Note 1 to entry: Any element of a FSMS can be sourced externally (e.g. training, withdrawal/recall, traceability
system, hazard analysis, PRP, hazard control plan, etc.).
Note 2 to entry: Sources for externally developed elements can include industry associations, universities,
governments and other relevant sources of knowledge.
3.17
flow diagram
schematic and systematic presentation of the sequence and interactions of steps in the process (3.37)
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3.18
food
substance (ingredient), whether processed, semi-processed or raw, which is intended for consumption,
and includes drink, chewing gum and any substance which has been used in the manufacture,
preparation or treatment of “food” but does not include cosmetics or tobacco or substances
(ingredients) used only as drugs
Note 1 to entry: Distinctions are made in this document between food, feed and animal food:
— food is intended for consumption by humans and animals, and includes feed and animal food;
— feed is intended to be fed to food-producing animals;
— animal food is intended to be fed to non-food-producing animals.
[SOURCE: CXC 81-2013, modified — The word “human” has been deleted.]
3.19
food chain
sequence of the stages in the production, processing, distribution, storage and handling of a food (3.18)
and its ingredients, from primary production to consumption
Note 1 to entry: This includes the production of feed and animal food.
Note 2 to entry: The food chain also includes the production of materials intended to come into contact with food
or raw materials.
Note 3 to entry: The food chain also includes service providers.
3.20
food defence
process of protecting food and other materials in the food chain from intentional harm resulting in
potentially unsafe products
3.21
food fraud
intentional misrepresentation or adulteration of food and other materials in the food chain for economic
gain and at times may result in potentially unsafe products
Note 1 to entry: Examples of food fraud include substitution, concealment, mislabelling, grey market
production/diversion, unapproved enhancements/additives, counterfeiting, dilution, etc.
3.22
food safety
assurance that food will not cause an adverse health effect for the consumer when it is prepared and/or
consumed according to its intended use
Note 1 to entry: Food safety is related to the occurrence of food safety hazards (3.24) in end products (3.15) and
does not include other health aspects related to, for example, malnutrition.
Note 2 to entry: It is not to be confused with the availability of, and access to, food (“food security”).
Note 3 to entry: This includes feed and animal food.
[SOURCE: CXC 1-1969, modified — The word “harm” has been changed to “adverse health effect” and
notes to entry have been added.]
3.23
food safety culture
shared values, beliefs, and social norms that affect mindset and behaviour toward food safety in, across
and throughout an organization (3.33)
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3.24
food safety hazard
biological, chemical or physical agent in food (3.18) with the potential to cause an adverse health effect
Note 1 to entry: The term “hazard” is not to be confused with the term “risk” (3.40) which, in the context of food
safety, means a function of the probability of an adverse health effect (e.g. becoming diseased) and the severity of
that effect (e.g. death, hospitalization) when exposed to a specified hazard.
Note 2 to entry: Food safety hazards include allergens and radiological substances.
Note 3 to entry: In the context of feed and feed ingredients, relevant food safety hazards are those that can be
present in and/or on feed and feed ingredients and that can through animal consumption of feed be transferred to
food and can thus have the potential to cause an adverse health effect for the animal or the human consumer. In
the context of operations other than those directly handling feed and food (e.g. producers of packaging materials,
disinfectants), relevant food safety hazards are those hazards that can be directly or indirectly transferred to food
when used as intended (see 8.5.1.4).
Note 4 to entry: In the context of animal food, relevant food safety hazards are those that are hazardous to the
animal species for which the food is intended.
3.25
interested party (preferred term)
person or organization (3.33) that can affect, be affected by, or perceive itself to be affected by a decision
or activity
3.26
lot
defined quantity of a product (3.38) produced and/or processed and/or packaged essentially under the
same conditions
Note 1 to entry: The lot is determined by parameters established beforehand by the organization and may be
described by other terms, e.g. batch.
Note 2 to entry: The lot may be reduced to a single unit of product.
[SOURCE: Codex STAN 1, modified — Reference to “and/or processed and/or packaged” has been
included in the definition and notes to entry have been added.]
3.27
management system
set of interrelated or interacting elements of an organization (3.33) to establish policies (3.35) and
objectives (3.31) and processes (3.37) to achieve those objectives (3.31)
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The system elements include the organization's structure, roles and responsibilities, planning and
operation.
Note 3 to entry: The scope of a management system may include the whole of the organization, specific and
identified functions of the organization, specific and identified sections of the organization, or one or more
functions across a group of organizations.
Note 4 to entry: Relevant disciplines are, for example, a quality management system or an environmental
management system.
3.28
measurement
process (3.37) to determine a value
3.29
monitoring
determining the status of a system, a process (3.37) or an activity
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Note 1 to entry: To determine the status, there may be a need to check, supervise or critically observe.

Note 2 to entry: In the context of food safety, monitoring is conducting a planned sequence of observations or
measurements to assess whether a process is operating as intended.
Note 3 to entry: Distinctions are made in this document between the terms validation (3.45), monitoring (3.29)
and verification (3.46):
— validation is applied prior to an activity and provides information about the capability to deliver intended
results;
— monitoring is applied during an activity and provides information for action within a specified time frame;
— verification is applied after an activity and provides information for confirmation of conformity.
3.30
nonconformity
non-fulfilment of a requirement (3.39)
3.31
objective
result to be achieved
Note 1 to entry: An objective can be strategic, tactical, or operational.
Note 2 to entry: Objectives can relate to different disciplines (such as financial, health and safety, and
environmental goals) and can apply at different levels (such as strategic, organization-wide, project, product and
process (3.37)).
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an operational
criterion, as a FSMS objective, or by the use of other words with similar meaning (e.g. aim, goal, or target).
Note 4 to entry: In the context of FSMS, objectives are set by the organization, consistent with the food safety policy,
to achieve specific results.
3.32
operational prerequisite programme
OPRP
control measure(s) (3.8) that is (are) applied, with defined action criterion (3.2) and monitoring (3.29)
that enables effective control of the process and/or the product
Note 1 to entry: OPRPs are control measures which after selection and categorization are not determined to be
CCPs.
Note 2 to entry: See Annex B for selection and categorization of control measures.
3.33
organization
person or group of people that has its own functions with responsibilities, authorities and relationships
to achieve its objectives (3.31)
Note 1 to entry: The concept of organization includes, but is not limited to sole-trader, company, corporation, firm,
enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or
not, public or private.
Note 2 to entry: If the organization is part of a larger entity, the term “organization” refers only to the part of the
larger entity that is within the scope of the management system (3.27).
3.34
performance
measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to the management of activities, processes (3.37), products (3.38)
(including services), systems or organizations (3.33).
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3.35
policy
intentions and direction of an organization (3.33) as formally expressed by its top management (3.42)
3.36
prerequisite programme
PRP
basic conditions and activities that are necessary within the organization (3.33) and throughout the food
chain (3.19) to maintain food safety (3.22)
Note 1 to entry: The PRP(s) needed depend on the segment of the food chain (3.19) in which the organization
(3.33) operates and the type of organization. They include good agricultural practice (GAP), good veterinary
practice (GVP), good manufacturing practice (GMP), good hygiene practice (GHP), good production practice (GPP),
good distribution practice (GDP) and good trading practice (GTP).
3.37
process
set of interrelated or interacting activities which transforms inputs to outputs
Note 1 to entry: Whether
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