Iso 22003-1-2022

INTERNATIONAL ISO
STANDARD 22003-1
First edition
2022-06
Food safety —
Part 1:
Requirements for bodies providing
audit and certification of food safety
management systems
Sécurité des denrées alimentaires —
Partie 1: Exigences pour les organismes procédant à l'audit et à la
certification de systèmes de management de la sécurité des denrées
alimentaires
Reference number
ISO 22003-1:2022(E)
© ISO 2022
ISO 22003-1:2022(E)
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© ISO 2022
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ii © ISO 2022 – All rights reserved

ISO 22003-1:2022(E)
Contents Page
Foreword......................................................................................................................................................................................................................................... iv
Introduction..................................................................................................................................................................................................................................v
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references...................................................................................................................................................................................... 1
3 Terms and definitions..................................................................................................................................................................................... 2
4 Principles...................................................................................................................................................................................................................... 2
5 General requirements..................................................................................................................................................................................... 2
6 Structural requirements.............................................................................................................................................................................. 2
7 Resource requirements................................................................................................................................................................................. 2
7.1 Competence of personnel............................................................................................................................................................... 2
7.1.1 General considerations.................................................................................................................................................. 2
7.1.2 Determination of competence criteria............................................................................................................ 2
7.1.3 Evaluation processes....................................................................................................................................................... 3
7.1.4 Other considerations....................................................................................................................................................... 3
7.2 Personnel involved in the certification activities..................................................................................................... 3
7.3 Use of individual external auditors and external technical experts....................................................... 3
7.4 Personnel records................................................................................................................................................................................. 3
7.5 Outsourcing................................................................................................................................................................................................ 3
8 Information requirements......................................................................................................................................................................... 3
9 Process requirements..................................................................................................................................................................................... 4
9.1 Pre-certification activities............................................................................................................................................................ 4
9.1.1 Application................................................................................................................................................................................ 4
9.1.2 Application review............................................................................................................................................................. 4
9.1.3 Audit programme............................................................................................................................................................... 4
9.1.4 Determining audit time................................................................................................................................................. 4
9.1.5 Multi-site sampling............................................................................................................................................................ 5
9.1.6 Multiple management systems standards.................................................................................................... 7
9.2 Planning audit.......................................................................................................................................................................................... 7
9.3 Initial certification............................................................................................................................................................................... 7
9.4 Conducting audits................................................................................................................................................................................. 8
9.5 Certification decision......................................................................................................................................................................... 8
9.6 Maintaining certification............................................................................................................................................................... 8
9.7 Appeals........................................................................................................................................................................................................... 8
9.8 Complaints.................................................................................................................................................................................................. 8
9.9 Client records............................................................................................................................................................................................ 9
10 Management system requirements for certification bodies................................................................................. 9
Annex A (normative) Classification of food chain categories................................................................................................. 10
Annex B (normative) Minimum audit duration...................................................................................................................................... 14
Annex C (normative) Required food safety management system knowledge and skills to
determine competence................................................................................................................................................................................ 18
Annex D (informative) Guidance on generic certification functions.............................................................................. 22
Bibliography.............................................................................................................................................................................................................................. 26
© ISO 2022 – All rights reserved iii

ISO 22003-1:2022(E)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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, in collaboration with the ISO Committee on conformity assessment
(CASCO).
This first edition cancels and replaces ISO/TS 22003:2013, which has been technically revised
throughout.
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.
iv © ISO 2022 – All rights reserved

ISO 22003-1:2022(E)
Introduction
Certification of the food safety management system (FSMS) of an organization is one means of providing
assurance that the organization has implemented a system for the management of food safety in line
with its policy and the internationally accepted principles of food safety.
Requirements for an FSMS can originate from a number of sources. This document has been developed
to assist in the certification of FSMS that fulfil the requirements of ISO 22000. The contents of this
document can also be used to support certification of FSMS that are based on other sets of specified
FSMS requirements.
This document is intended for use, in combination with ISO/IEC 17021-1:2015, by bodies that carry out
audit and certification of FSMS. It provides generic requirements for such bodies, who are referred to
as “certification bodies”. This wording is not intended to be an obstacle to the use of this document by
bodies with other designations that undertake activities covered by the scope of this document. This
document is intended to be used by anybody involved in the assessment of FSMS.
Certification activities involve the audit of an organization’s FSMS. The form of attestation of conformity
of an organization’s FSMS to a specific FSMS standard (e.g. ISO 22000) or other specified requirements
is normally a certification document or a certificate.
It is for the organization seeking certification to develop its own management systems and, other
than where relevant legislative requirements specify to the contrary, it is for the organization to
decide how the various components of these will be arranged. The degree of integration between the
various management system components will vary from organization to organization. It is therefore
appropriate for certification bodies that operate in accordance with this document to take into account
the culture and practices of their clients with respect to the integration of their FSMS within the wider
organization.
This document was developed in conjunction with ISO 22003-2, which is used in combination with
ISO/IEC 17065.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
© ISO 2022 – All rights reserved v

INTERNATIONAL STANDARD ISO 22003-1:2022(E)
Food safety —
Part 1:
Requirements for bodies providing audit and certification
of food safety management systems
1 Scope
This document specifies the requirements for the audit and certification of a food safety management
system (FSMS) complying with the requirements given in ISO 22000 (or other specified FSMS
requirements). It also provides the necessary information and confidence to customers about the way
certification of their suppliers has been granted.
Certification of FSMS is a third-party conformity assessment activity (as described in
ISO/IEC 17000:2020, 4.3), and bodies performing this activity are third-party conformity assessment
bodies.
NOTE 1 In this document, the terms “product” and “service” are used separately (in contrast with the
definition of “product” given in ISO/IEC 17000).
NOTE 2 This document can be used as a criteria document for the accreditation or peer assessment of
certification bodies which seek to be recognized as being competent to certify that an FSMS complies with
ISO 22000 or other sets of specified FSMS requirements. It is also intended to be used as a criteria document
by regulatory authorities and industry consortia which engage in direct recognition of certification bodies
to certify that an FSMS complies with ISO 22000. Some of its requirements can also be useful to other parties
involved in the conformity assessment of such certification bodies, and in the conformity assessment of bodies
that undertake to certify the compliance of FSMS with criteria additional to, or other than, those in ISO 22000.
FSMS certification does not attest to the safety or fitness of the products of an organization within
the food chain. However, an FSMS requires an organization to meet all applicable food-safety-related
statutory and regulatory requirements through its management system.
NOTE 3 Certification of an FSMS according to ISO 22000 is a management system certification, not a product
certification.
Other FSMS users can use the concepts and requirements of this document provided that the
requirements are adapted as necessary.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
ISO/IEC 17021-1:2015, Conformity assessment — Requirements for bodies providing audit and certification
of management systems — Part 1: Requirements
ISO 22000, Food safety management systems — Requirements for any organization in the food chain
© ISO 2022 – All rights reserved 1

ISO 22003-1:2022(E)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO/IEC 17021-1,
ISO 22000 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://w ww.iso.org/obp
— IEC Electropedia: available at https://w ww.electropedia.org/
3.1
food safety management system
FSMS
set of interrelated or interacting elements of an organization to establish policies and objectives and
processes to achieve food safety management system objectives
Note 1 to entry: In this document, “food safety management system” replaces the term “management system”
used in ISO/IEC 17021-1.
3.2
hazard analysis and critical control points study
HACCP study
hazard analysis for a family of products/processes/services with similar hazards and similar processes
and technology (e.g. production, packaging, storage or implementation of services)
4 Principles
The principles of ISO/IEC 17021-1:2015, Clause 4, are the basis for the subsequent specific performance
and descriptive requirements in this document. This document does not set specific requirements
to address all issues related to audit and certification process. These principles should be applied as
guidance for the decisions that sometimes need to be made for unanticipated situations. Principles are
not requirements.
5 General requirements
ISO/IEC 17021-1:2015, Clause 5, shall be followed.
6 Structural requirements
7 Resource requirements
7.1 Competence of personnel
7.1.1 General considerations
ISO/IEC 17021-1:2015, 7.1.1, shall be followed.

The certification functions for which competence shall be identified are those given in Annex C.
7.1.2 Determination of competence criteria

Technical areas shall be defined using Annex A.
2 © ISO 2022 – All rights reserved

ISO 22003-1:2022(E)
The competence criteria, specifying required knowledge and skills, in Annex C shall apply.
NOTE 1 Annex D provides guidance to the certification body on many of the generic certification functions
identified in ISO/IEC 17021-1:2015, Annex A, for which competence criteria need to be determined for personnel
involved in the audit and certification of an FSMS.
NOTE 2 Qualification(s) and experience can be used as part of the criteria; however, competence is not
based on these alone, as it is important to ensure that a person can demonstrate the ability to apply the specific
knowledge and skills that one would expect a person to have after completing a qualification or having a certain
amount of industry experience.
7.1.3 Evaluation processes

The certification body shall evaluate, in particular, the individual’s knowledge relating to food safety,
including knowledge of specific prerequisite programmes (PRPs), food safety hazards and control
measures related to the categories within which the certification body personnel operate. These shall
have been identified for these categories under the requirements of 7.1.2.
Evaluators shall have knowledge of (one or more) evaluation methods (see ISO/IEC 17021-1:2015,
Annex B) and shall demonstrate the ability to apply them.
NOTE ISO/IEC 17021-1:2015, 7.1.3, requires the certification body to demonstrate the effectiveness of the
evaluation methods used to evaluate personnel against identified competence criteria.
7.1.4 Other considerations
7.2 Personnel involved in the certification activities

ISO/IEC 17021-1:2015, 7.2, shall be followed.
7.3 Use of individual external auditors and external technical experts

7.4 Personnel records

7.5 Outsourcing
8 Information requirements
8.1 ISO/IEC 17021-1:2015, Clause 8, shall be followed except where as amended in 8.2, 8.3 and 8.4.
8.2 The certification documents shall identify in detail the categories and subcategories in Table A.1
to which the FSMS applies.
8.3 A certification body shall not authorize the use of the FSMS certification mark on the product
nor the product packaging. In the context of this document, product packaging referred to in
ISO/IEC 17021-1:2015, 8.3, shall cover all product packaging, both primary packaging (which contains
the product) and any outer or secondary packaging.

ISO 22003-1:2022(E)
8.4 A certification body shall not permit the use of any statement on product packaging that the client
has a certified FSMS. This includes all product packaging, both primary packaging (which contains the
product) and any outer or secondary packaging.
9 Process requirements
9.1 Pre-certification activities
9.1.1 Application

The certification body shall require the applicant organization to provide the information concerning
products and processes relevant to determination of the audit duration, as per Annexes A and B.
9.1.2 Application review
9.1.2.1 ISO/IEC 17021-1:2015, 9.1.2, shall be followed.
9.1.2.2 The certification body shall use Annex A to define the relevant scope for the organization
applying for certification. The scope statement shall:
— identify the category(s) or subcategory(s) in scope of certification for each site or sites;
— briefly describe the main types of activities/processes for the products and/or services that are
audited by the certifying body.
9.1.2.3 The defined scope of certification shall not:
— be misleading;
— exclude activities, processes, products or services from the scope of certification when those
activities, processes, products or services can have an influence on the food safety of the end
products as defined by the legal responsibility of the organisations’ activities;
— include any promotional statements, brands or claims.
9.1.3 Audit programme
9.1.3.2 In addition, the certification body shall have a process for choosing the audit timing and season,
so that the audit team has the opportunity of auditing the organization operating on a representative
number of product lines and/or services covered by the scope of certification.
9.1.4 Determining audit time
9.1.4.2 The certification body shall have documented procedures for determining audit time, and for
each client, the certification body shall determine the time needed to plan and accomplish a complete
and effective audit of the client’s FSMS. In determining the audit duration, the certification body shall
use the methodology described in Annex B. The audit time determined by the certification body, and
the justification for the determination, shall be recorded including justification for any reductions or
additions.

ISO 22003-1:2022(E)
9.1.4.3 In determining and documenting audit time needed, the certification body shall determine:
a) the time for audit preparation;

b) the minimum duration for auditing for each site for on-site or remote auditing, as specified in
Clauses B.1, B.2 and B.3 and Table B.1;
c) the time for reporting and, if applicable, conducting post-audit activities;
d) where additional meetings are necessary (e.g. review meetings, coordination, audit team briefing),
an increase in audit time can be required;
e) where applicable and agreed, the time needed to ensure effective remote auditing or use of
information and communication technology (ICT).
9.1.5 Multi-site sampling

NOTE The whole of subclause 9.1.5 is intended to apply only to operations where activities present in the
scope statement are performed.
9.1.5.2 A multi-site organization is an organization having an identified central function at which

certain FSMS activities are planned, controlled or managed, and a network of sites at which such
activities are fully or partially carried out. Examples of possible multi-site organizations are:
— organizations operating with franchises;

— producer groups (for categories A and B);
— a manufacturing company with one or more production sites and a network of sales offices;
— service organizations with multiple sites offering a similar service;
— organizations with multiple branches.
Sampling of multi-site organizations shall cover all activities (see the criteria given in 9.1.5.3).
9.1.5.3 The certification body shall demonstrate that the sampling of sites does not undermine
effective auditing. When multi-site sampling is undertaken, the certification body shall justify and
document the rationale based on the following conditions:
a) sites are operating under one centrally controlled and administered FSMS;
b) sites subject to sampling are similar (food chain subcategory, geographical location, processes and
technologies, size and complexity, regulatory and statutory requirements, customer requirements,
food safety hazards and control measures);
c) the central function is part of the organization, clearly identified and not subcontracted to an
external organization;
d) all sites have a legal or contractual link with the central function;
e) the central function has organizational authority to define, establish and maintain the FSMS;
f) all sites are subject to the organization’s internal audit programme and have been audited;
g) audit findings at a site are considered indicative of the entire FSMS and corrective actions are
implemented accordingly;
h) the central function is responsible for ensuring that outcomes of performance evaluation and
customer complaints from all sites are collected and analysed;

ISO 22003-1:2022(E)
i) the organization’s FSMS is subject to central management review;

j) the central function has authority to initiate continual improvement of the FSMS.
NOTE The central function is where operational control and authority from the top management of the
organization is exerted over every site. There is no requirement for the central function to be located in a
single site.
9.1.5.4 The use of multi-site sampling is permitted for categories A and B. Sampling may be applied
to multi-site organizations, with the minimum sample size being the square root of the total number
of sites: √(x), rounded up to the next whole number. The square root sample shall be taken per risk
category based on production complexity of the sites (e.g. open field plant production, perennial plant
production, indoor production, open field livestock production, indoor livestock production).
The use of multi-site sampling is permitted for categories F and G, and only for re-heating-type facilities
(e.g. event catering, coffee shops, pubs) for category E and only for facilities with limited preparation or
cooking (e.g. re-heating, frying) (see Table A.1). For organizations with 20 sites or fewer, all sites shall
be audited. For organizations with more than 20 sites, the minimum number of sites to be sampled shall
be 20 plus the square root of the total number of other sites: y = 20 + √(x – 20), rounded up to the next
whole number. This applies to the initial certification, to surveillance and to recertification audits.
The use of multi-site sampling is not permitted for any other categories identified in Annex A.
9.1.5.5 Where multi-site sampling is permitted, the certification body shall ensure (e.g. via
contractual arrangements) that the organization has conducted an internal audit for each site within
one year prior to certification and when applicable the effectiveness of corrective actions shall be
available. Following certification, the annual internal audit shall cover all sites of the organization
included in the certification scope of the multi-site organization and ongoing effectiveness of corrective
actions shall be demonstrated.
9.1.5.6 Where multi-site sampling is permitted, the certification body shall define and utilize a
sampling programme to ensure an effective audit of the FSMS where the following conditions apply.
a) At least annually, an audit of the central function for the FSMS shall be performed by the certification
body prior to the sampled site audits.
b) At least annually, audits shall be performed by the certification body on the required number of
sampled sites.
c) Audit findings of the sampled sites shall be assessed to ascertain if these indicate an overall FSMS
deficiency and therefore can be applicable to some or all other sites.
d) Where audit findings of the sampled sites are considered indicative of the entire FSMS, corrective
actions shall be implemented accordingly.
e) For organizations with 20 sites or fewer, all sites shall be audited.
The certification body shall increase the size of sample or terminate the site sampling where the FSMS
subject to certification does not indicate the ability to achieve the intended results.
9.1.5.7 The sample shall be partly selective and partly random and shall result in a representative
range of different sites being selected, ensuring all processes covered by the scope of certification will
be audited.
At least 25 % of the sample shall be selected at random. The remainder shall be selected so that the
differences among the sites selected over the period of validity of the certification are as large as
possible.

ISO 22003-1:2022(E)
The site selection shall consider, among others, the following aspects:
a) results of internal audits, management reviews or previous audits;
b) records of complaints, product withdrawals/recalls, and other relevant aspects of corrective
action;
c) variations in the site characteristics;
d) other relevant changes since the last audit.
9.1.5.8 If any site has a major nonconformity and satisfactory corrective action have not been
implemented in the agreed time frame, certification shall not be granted or maintained for the whole
multi-site organization pending satisfactory corrective action.
9.1.5.9 The certification body shall identify and include in the scope of certification the processes of
the FSMS implemented at each sampled site.
9.1.6 Multiple management systems standards
9.2 Planning audit

9.3 Initial certification
9.3.1 ISO/IEC 17021-1:2015, 9.3, shall be followed.
9.3.2 The objectives of stage 1 are to provide a focus for the planning of stage 2 of the initial audit by
gaining an understanding of the organization’s FSMS and the organization’s state of preparedness for
stage 2 by reviewing the extent to which:
a) the organization has identified PRPs that are appropriate to the business (e.g. regulatory, statutory,
customer and certification scheme requirements);
b) the FSMS includes adequate processes and methods for the identification and assessment of
the organization’s food safety hazards, and subsequent selection and categorization of control
measures (combinations);
c) the FSMS includes adequate processes and methods for the identification and implementation of
relevant food safety legislation;
d) the FSMS is designed to achieve the organization’s food safety policy;
e) the FSMS implementation programme justifies proceeding to stage 2;
f) the validation of control measures, verification of activities and improvement programmes conform
to the requirements of the FSMS standard;
g) the FSMS documents and arrangements are in place to communicate internally and with relevant
suppliers, customers and interested parties;
h) there is any additional documentation which needs to be reviewed and/or information which needs
to be obtained in advance.

ISO 22003-1:2022(E)
9.3.3 Where an organization has implemented externally developed elements of a FSMS, stage 1 shall
review the documentation included in the FSMS to determine if the combination of control measures:
— is suitable for the organization;

— was developed in conformity to the requirements of ISO 22000 or other sets of specified FSMS
requirements;
— is kept up to date.
9.3.4 The availability of relevant authorizations shall be checked when collecting the information
regarding the compliance to regulatory aspects.
9.3.5 For FSMS, stage 1 shall be carried out at the client’s premises in order to achieve the objectives
stated above. In exceptional circumstances or events, all or part of stage 1 can take place off-site or
remotely through the use of ICT and shall be fully justified. The evidence demonstrating that stage 1
objectives are fully achieved shall be provided.
NOTE 1 Exceptional circumstances or events can include a very remote location, a natural disaster, a
pandemic, a short seasonal production and other special situations.
NOTE 2 Any part of the FSMS that is audited during the stage 1 audit, and determined to be fully implemented,
effective and in conformity with requirements, does not necessarily need to be re-audited during stage 2. In this
case, the audit report includes these findings and clearly states that conformity has been established during the
stage 1 of the audit.
9.3.6 The interval between stage 1 and stage 2 shall not be longer than six months. Stage 1 shall be
repeated if a longer interval is needed.
9.3.7 ISO/IEC 17021-1:2015, 9.3.1.3 and 9.3.1.4, shall be followed.
9.4 Conducting audits

9.5 Certification decision

9.6 Maintaining certification
9.6.1 ISO/IEC 17021-1:2015, 9.6, shall be followed.
9.6.2 Where the certification body conducts unannounced audits as part of surveillance activities,
the certification body shall describe and make known in advance to the certified clients the conditions
under which such audits will be organized and conducted.
9.7 Appeals
9.8 Complaints

ISO 22003-1:2022(E)
9.9 Client records

10 Management system requirements for certification bodies


ISO 22003-1:2022(E)
Annex A
(normative)
Classification of food chain categories
The certification body shall use Table A.1 for the following purposes:
a) to define the subcategory (or category if no subcategory) within which it wishes to operate;
b) to identify the subcategories (or category if no subcategory) to which the client’s scope will be
audited or certified;
c) to assess the auditor and audit team competence given in Annex C within a particular subcategory
of Table A1;
d) to define the audit duration in accordance with Annex B;
e) to identify the appropriate PRPs, if applicable.
The scope of one specific client organization may cover more than one subcategory or category.
NOTE Relevant activities within the category H “services”: for operators in the food chain, there are many
different types of services that can be provided or called upon. Some of these services can fall outside the scope
of a certification that includes FSMS. If the organization/service is susceptible to introduce a food safety hazard
within the food chain, the service provider and its operator(s) can be considered within the scope.
Where a scheme owner has established their own rules for determination for categories/subcategories,
the outcome of the scheme rules shall apply provided that the scheme rules are not less than those
required in this annex as a common basis.
Table A.1 — Food chain categories

Clustera Category Subcategory Examples of included activities
Raising animals (other than fish and
aquaculture) used for meat production,
egg production, milk production or honey
Farming of
production.
animals for
AI
meat/milk/ Growing, keeping, trapping and hunting
eggs/honey (slaughtering at point of hunting).
Farming or
Primary handling of Associated temporary packing without
production A animals modification or processing of the product.
Raising fish and seafood used for meat
production.
Farming of fish Growing, trapping and fishing (slaughtering
AII
and seafood at point of capture).
Associated temporary packing without
modification or processing of the product.
a Clusters can be used for accreditation scope of accredited certification bodies, and for accreditation bodies witnessing
certification bodies.
NOTE “Perishable” can be considered as food of a type or condition such that it can spoil and must be preserved in a
temperature controlled environment.

ISO 22003-1:2022(E)
Table A.1 (continued)

Growing or harvesting of plants (other than
Farming – grains and pulses): horticultural products
Handling of (fruits, vegetables, spices, mushrooms, etc.)
BI plants (other and hydrophytes for food.
than grains On farm storage of plants (other than grains
and pulses) and pulses), including horticultural
products and hydrophytes for food.
Growing and harvesting of grains and
Farming – pulses for food. Handling grains and
Farming or
Handling of pulses.
B handling of BII
grains and
plants On farm storage of grains and pulses for
pulses
food.
Activities on harvested plants that do not
transform the product from original whole
form, including horticultural products
Pre-process and hydrophytes for food. These include
BIII handling of cleaning, washing, rinsing, fluming, sort-
plant products ing, grading, trimming, bundling, cooling,
hydro-cooling, waxing, drenching, aeration
preparing for storage or processing, pack-
ing, repacking, staging, storing and loading.
Conversion of animal carcasses intended for
Animal – further processing including lairage, slaugh-
CO Primary ter, evisceration, bulk chilling, bulk freezing,
conversion bulk storage of animals and game gutting,
bulk freezing of fish and storage of game.
Processing and packaging including fish,
Processing of fish products, seafood, meat, eggs and dairy
perishable requiring chilled or frozen temperature
CI control.
animal
products Processing of pet food from animal products
only.
Processing and packaging including fruits
and fresh juices, vegetables, grains, nuts,
Processing food Food, ingredient Processing of pulses, frozen water-based products, plant-
for humans and C and pet food CII perishable plant- based meat and dairy substitutes.
animals processing based products
Processing pet food from plant products
only.
Processing and packaging including pizza,
Processing of lasagne, sandwiches, dumplings and ready-
perishable to-eat meals.
animal and Includes off-site catering kitchens.
CIII plant –
Products Includes products of industrial kitchens not
(mixed offered for immediate consumption.
products) Processing perishable pet food from mixed
products

ISO 22003-1:2022(E)

Processing and packaging of products
stored and sold at ambient temperature
Processing of including canned foods, biscuits, snacks,
CIV ambient stable oil, drinking water, beverages, pasta, flour,
products sugar and food-grade salt.
Processing ambient stable pet food.
Processing feed material intended for food
and non-food producing animals not kept in
households, e.g. meal from grain, oilseeds,
Feed and animal by-products of food production.
D
food processing Processing feed mixtures, with or without
additives, intended for food-producing
animals, e.g. premixes, medicated feed,
compound feeds.
Open exposed food activities such as
cooking, mixing and blending, preparation
of components and products for on-site
direct consumer consumption or take away.
Catering/food Catering/food Examples include restaurants, hotels, food
E
service service trucks, institutions, work places (school
or factory cafeteria), including retail with
on-site preparation (e.g. rotisserie chicken).
Includes reheating of food, event catering,
coffee shops and pubs.
Storage and provision of finished prod-
ucts to customers and consumers (retail
Retail/
FI outlets, shops, wholesalers). Includes minor
wholesale
Retail, transport Trading, retail processing activities, e.g. slicing, portioning,
and storage F and e-commerce reheating.
Buying and selling products on its own
Brokering/ account without physical handling or as an
FII
trading agent for others of any item that enters the
food chain.
Storage facilities and distribution vehicles
for perishable food and feed where
temperature integrity shall be
maintained.
Transport and Storage facilities and distribution vehicles
G for ambient stable food and feed.
storage services
Relabelling/repackaging excluding open
exposed product materials.
Storage facilities and distribution vehicles
for food packaging material.
Services provisioned related to the safe
Auxiliary production of food and feed including water
H Services
services supply, pest control, cleaning services and
waste disposal.

ISO 22003-1:2022(E)

Production of packaging material in contact
Production of with food, feed and animal food.
Packaging
I packaging
material May include packaging produced on-site for
material
use in processing.
Equipment for food, feed or packaging
processing, vending machines, kitchen
Auxiliary
J Equipment equipment, processing utensils, filters,
equipment
hygienic design of equipment and
facilities.
Production of food and feed processing aids,
Chemical and additives (e.g. flavourings, vitamins), gases
Bio/chemical K and minerals.
bio-chemical
Production of bio-cultures and enzymes.

ISO 22003-1:2022(E)
Annex B
(normative)
Minimum audit duration
B.1 Audit outcome requirements

Audit duration shall be justified to accomplish the following audit outcomes:
a) assesses effective implementation (identification and selection if allowed) of the management of
food safety hazards [this includes hazard analysis and critical control points (HACCP) and PRPs] as
defined by the scheme;
b) assesses effective management of the interrelated processes of the FSMS;
c) assesses system ability to meet applicable statutory and regulatory requirements;
d) assesses the organization’s use of an effective risk-based approach to products and processes and
management of change;
e) assesses whether the requirements of the scheme and of the organization, if any, are met;
f) verifies that the certification scope is appropriate to the activities of the organization and audit
sampling is representative.
B.2 Determining audit duration

In determining the audit duration, the certification body shall consider, among other things, the
following aspects:
a) the requirements of the relevant standards or schemes that may be included in, or in addition to,
audit duration;
b) the categories and subcategories given in Table A.1 (if the scope of the organization covers more
than one category, the audit duration calculation shall be taken from the highest recommended
basic audit duration);
c) the complexity of the client activities (e.g. number of product and process types, number of product
lines, number of people or type and variety of tasks affecting food safety, product development, in-
house laboratory testing, sanitation) and its FSMS;
d) the hazards associated with the products, processes and services of the organization;
e) the statutory and regulatory context;
f) any outsourcing of any activities included in the scope of certification;
g) the maturity and effectiveness of the FSMS, type of audit (e.g. initial, surveillance, unannounced,
follow-up) and the results of any prior audits;
h) the site size, infrastructure and number of sites, their geographical locations and seasonality;
i) the multi-site considerations;
j) whether audits are combined, joint or integrated;
k) the audit delivery method (e.g. ICT and the extent used);

ISO 22003-1:2022(E)
l) the level of centralized control of the FSMS;

m) the level of automation, closed production systems, use of technology, mechanization and labour
intensiveness;
n) any language or interpretation needs.
B.3 Calculation of minimum audit duration

B.3.1 General
FSMS audits shall meet the minimum audit duration calculation given in B.3.2 using the requirements
of Annexes A and B. FSMS schemes may design their own categories and audit duration calculations in
excess of Annex B. Certification bodies shall follow scheme categories and audit duration calculations
referenced in the requirements of Annexes A and B. The minimum audit duration includes stage 1 and
stage 2 of the initial certification.
When determining the number of employees involved in any aspect of food safety, it shall be expressed
as the number of full-time equivalent (FTE) employees. When an organization deploys workers in shifts
and the products and/or processes are similar, the FTE number will be calculated based on employees
on the main shift (including seasonal workers) plus non-production staff having an impact on food
safety.
In cases of unusually high repetitive shifts or process, a coherent and consistent reduction can be
applied on a company-to-company basis within the scope of certification. The determination and its
justification by the certification body shall be recorded.
Audit duration does not include time for audit planning, audit preparation, travel to and from site, audit
follow-up activities if there are nonconformities, or team member(s) not assigned as an auditor (i.e.
technical experts, translators, interpreters, observers and auditors-in-training, and report writers).
Where a scheme owner has established their own rules for determination for audit duration, the
outcome of the scheme rules shall apply provided that the scheme rules are not less than those required
in this annex as a common minimum.
B.3.2 Initial audit duration calculation

The minimum initial certification audit duration for FSMS certification audits shall be given as Ds,
expressed in days, which is calculated, considering Table B.1:
Ds = (T D + T H + T FTE)
where
Ds is the total audit duration;
TD is the basic site audit duration for (sub) category and scope of certification (includes one
HACCP study), in days;
TH is the number of audit days for additional HACCP studies;
T FTE is the number of audit days per number of FTE employees.

ISO 22003-1:2022(E)
Table B.1 — Variables for calculation of minimum audit duration

Basic site audit Number of audit days for
Category or
duration, in audit each additional HACCP Effective number FTE
subcategory
days study
TD TH T FTE
AI 1,0 0,25
AII 1,0 0,25
BI 1,0 0,25
BII 1,0 0,25
BIII 1,0 0,25
CO 2,0 0.50
CI 2,0 0,50 1 to 5 = 0
CII 2,0 0,50 6 to 49 = 0,5
CIII 2,0 0,50 50 to 99 = 1,0
CIV 2,0 0,50 100 to 199 = 1,5
D 1,0 0,50 200 to 499 = 2,0
E 1,5 0,50 500 to 999 = 2,5
FI 1,0 0,50 > 1 000 = 3
FII 1,0 0,5
G 1,5 0,25
H 1,5 0,25
I 1,5 0,50
J 1,5 0,50
K 2,0 0,5
If there are multiple categories or subcategories, use the category or subcategory with the highest
T D value to determine Ds. The combined parameters (HACCP study, FTE) for all the categories/
subcategories shall be used when calculating the audit duration.
When the scheme requirements encompass other interrelated elements [e.g. good agricultural practice
(GAP), agronomic] audited in conjunction with the FSMS, these shall be included in the minimum audit
duration.
The resulting audit duration using the factors in Clause B.2 and Table B.1 shall be justified and
documented.
A minimum 50 % of total audit duration shall be spent on auditing the operational food safety planning
and the implementation of PRPs and control measures.
NOTE 1 Operational food safety planning does not include activities related to FSMS development, training,
internal audit, management review and improvement.
In cases of a FSMS which is integrated with another relevant management system or food safety system
(FSS), a reduction in audit duration is possible. The combined audit duration shall be determined and
recorded as follows:
— calculate the audit duration for each scheme separately (including scheme restrictions and allowed
reductions);
— add the audit durations together;
— determine the degree of reduction considering a maximum of 20 % reduction can be made on the
combined duration. The reduction range based on integration is 0 % to 20 % determined by the
level of integration of overall business strategy, management reviews, approach to policy, objectives,
systems, processes, internal audits and effective corrective action to prevent reoccurrence.

ISO 22003-1:2022(E)
NOTE 2 “Relevant management system” means a quality or food safety system which covers the same
processes, products and services.
Deviations from Table B.1 can be justified and shall be recorded, determined by factors such as maturity
of the management system, prior knowledge of client processes and systems (e.g. already certified by
same certification body to different scheme), client preparedness (e.g. already certified by a relevant
third-party scheme) and a high level of automation.
B.3.3 Multi-site certification

The site audit duration of the central function shall be equal to or greater than Ds.
The site audit duration for each site audited shall be equal to or greater than half of Ds for that site.
B.3.4 Calculation of minimum surveillance and recertification audit duration

The minimum surveillance audit duration shall not be less than one third of the initial certification
audit duration, with a minimum of 1 audit day (0,5 audit day for categories A and B).
The minimum recertification audit duration shall not be less than two thirds of the initial certification
audit duration, with a minimum of 1 audit day (0,5 audit day for categories A and B).

ISO 22003-1:2022(E)
Annex C
(normative)
Required food safety management system knowledge and skills to

determine competence
C.1 General
Table C.1 specifies the knowledge and skills that a certification body shall define for specific certification
functions. “X” indicates that the certification body shall define the criteria and depth of knowledge and
skills.
Table C.1 — Table of knowledge and skills

Certification functions
Conducting the
application review
to determine the
Reviewing audit
Knowledge and skills audit team compe- Auditing and
reports and making
tence required, to leading the
certification
select the audit team audit team
decisions
members, and to
determine the audit
time
1. Ability to apply the application review require-
ments in this document, specific scheme rules and X
certification body procedures including:
— categorizing the organization into food
categories and subcategories, in accordance
with Annex A;
— determining the complexity of the

organization’s activities;
— multi-site sampling;
— calculating audit durationa .

2. Ability to identify and to determine factors
relevant to food chain categories (with reference to X X X
Table A.1) and to the organization, including:
— PRPs;
— food safety hazards;
— statutory and regulatory requirements;
— any specific seasonality factors related to the

organization and its food category or products;
— specific cultural and social customs related

to the categories and geographic areas to be
assessed;
— specific factors required to audit the FSMS,

food product, process or service.
a For the team leader, the ability to understand the principles of audit duration calculation in order to alert the certification body in
case of significant change.
b It is not expected that the certification decision function requires competence specific to the food chain category.

ISO 22003-1:2022(E)
Table C.1 (continued)

Conducting the
application review
to determine the
Reviewing audit
reports and making
certification
decisions
members, and to
determine the audit
time
3. Ability to identify the auditor competencies
required for categories and subcategories in
X X X
accordance with Table A.1 and certification body
procedures.
4. Ability to apply generic audit principles, practices
and techniques, as specified in this document,
X X
sufficient to conduct certification audits and to
evaluate internal audit processes.
5. Ability to conduct and manage an audit to achieve
the audit objectives within the agreed time frame.
For the team leader, the ability to facilitate meetings X
for the effective exchange of information and the
ability to make assignments or re-assignments
where necessary.
6. Knowledge of the terminology, practices and
processes common to an/the organization’s
business sector sufficient to understand the X X
sector’s expectations in the context of the
standard/scheme or other normative documents.
7. Knowledge of general organization types, size,
governance, structure and workplace practices,
X X
information and data systems, documentation
systems and information technology.
8. Knowledge of the role and impact of the leader-
ship of the organization and the ability to evaluate
whether the top management of the organization
X
under audit is demonstrating commitment to the
FSMS, providing adequate resources and achieving
its intended outcomes.
9. Ability to apply normative documents being
specified for certification sufficient to determine
if its scope and audit duration is appropriate and X X
that the scheme/standard has been effectively
implemented and conforms to requirements.
10. Knowledge related to the types of products
or processes of a client sufficient to understand
how such an organization can operate, and how
X X
the organization can apply the requirements of
the standard/scheme or other relevant normative
documents.

ISO 22003-1:2022(E)

Conducting the
application review
to determine the
Reviewing audit
reports and making
certification
decisions
members, and to
determine the audit
time
11. Ability to identifyb:
— biological hazards;
— chemical hazards;
— physical hazards;
— allergens; X X
— food safety labelling requirements;
— food safety regulations that are relevant to the

food chain category (see Annex A) and their
recognized control mechanisms.
Ability to evaluate the organization’s capacity to
identify and meet applicable (country of
production/country of destination) food safety
regulation and labelling requirements.
12. Ability to apply the principles of food safety,
HACCP, hazard assessment and hazard analysis in
the food chain (sub)categoryb. X X
Ability to apply scheme requirements including, but
not limited to:
— outsourced processes;
— food defence;
— food fraud.
13. Ability to apply food chain (sub)category
X
practices and vocabulary in relation to:
— food chain relationships;
— best practice with respect to PRPs and control

measures;
— common food chain processes;
— production technologies and processing terms;
— common equipment;
— facility design;
— packaging types and attributes;
— microbiological terms and names;

— chemical terms and names;
— good laboratory practices;
— local terminology.

ISO 22003-1:2022(E)

Conducting the
application review
to determine the
Reviewing audit
reports and making
certification
decisions
members, and to
determine the audit
time
14. Understanding the organization and its
responsibilities for external communicationb.
Understanding the organizational structures,
X X
cultures and communication methodologies.
Ability to assess whether the organization is
meeting required communication objectives.
15. Ability to evaluate audit reports, corrective
action documentation and other information X
needed to make a certification decision.
16. Ability to communicate effectively to fulfil their
function within the certification process.
For audit team members, ability to communicate X X X
effectively with persons at any level of an
organization, including top management, using
appropriate terms, expressions and speech.
17. Ability to read and write to fulfil their function
within the certification process.
For audit team members, ability to read and write X X X
with sufficient speed, accuracy and comprehension
to record, take notes, and effectively communicate
audit findings and conclusions.
18. Ability to present audit findings and conclusions
to be easily understood.
For presenting in a public forum (e.g. closing X
meeting) audit findings, conclusions, and
recommendations appropriate to the audience.
19. Ability to interview to obtain information
relevant to their function within the certification
process. Ability to interview by asking open-ended, X
well formulated questions and listening to
understand and evaluate the answers.

ISO 22003-1:2022(E)
Annex D
(informative)
Guidance on generic certification functions
D.1 General
This annex provides useful guidance to the certification body on many of the generic certification
functions identified in ISO/IEC 17021-1:2015, Annex A, for which competence criteria for personnel
involved in audit and certification of an FSMS should be determined.
D.2 Application review

— Determine if the proposed certification (contract) fits within scope of the certification body’s scope
of operations (e.g. accreditation, regulatory authorization).
— Determine if there are specific issues to be considered (issues specific to locality, industry, legislation,
organization, etc.)
— Determine if there are multi-site issues.
— Determine if there are seasonality issues.
— Calculate the audit duration or duration of combined or integrated audit durations.
— Create a certification agreement/contract.
— Finalize a certification agreement/contract with client.
D.3 Selection of audit teams

— Determine resource needs (e.g. competencies, number of auditors based on audit duration and
number of categories, technical experts, interpreters).
— Determine if competent resources (e.g. auditors, technical experts) are available.
— Review resource (e.g. auditor) selection for impartiality.
D.4 Planning audit activities

— Verify the scope of the audit.
— Review the history of facility to be audited.
— Confirm resource needs.
— Confirm travel plans.
— Develop or confirm the audit strategy and methodology.
— Assign audit team roles, responsibilities and activities.
— Develop the audit plan, including the sampling plan.
— Review audit logistics.

ISO 22003-1:2022(E)
— Consider the results of any previous audits and corrective actions.

— Consider any regulatory requirements.
— Plan audit team meetings.
D.5 Auditing
D.5.1 Conduct document review
— Obtain programme documentation.
— Review documentation against requirements.
— Verify the organization’s management system.
— Determine if the organization’s documents meet requirements or identify nonconformities.
— Establish investigative lines for the stage 2 audit.
— Confirm readiness for the stage 2 audit.
D.5.2 Conduct opening meeting

— Confirm the certification scope.
— Review the audit criteria/methodology and explain the outcome (e.g. audit as sampling, process
approach).
— Establish communication channels.
— Identify guides/escorts.
— Confirm the reporting method.
— Identify food safety and security requirements.
— Confirm the audit plan.
— Reaffirm the time of the closing meeting.
— Complete the meeting records.
D.5.3 Collecting and verifying information

— Verify the process flow chart.
— Assess the effectiveness of the implementation of control measures and processes.
— Verify the effectiveness of corrective actions of previous nonconformities/deficiencies.
— Perform the process approach audit.
D.5.4 Preparation for closing meeting

— Hold an audit team preparatory meeting (if required).
— Analyse audit findings and compare them with requirements.
— Confirm the completion of the audit plan.
— Categorize, review and finalize any nonconformities and opportunities for improvement, and relate
them to the process and the system.

ISO 22003-1:2022(E)
— Prepare the preliminary audit report.
D.5.5 Conduct closing meeting

— Present and review the audit findings (nonconformities and/or opportunities for improvement).
— Confirm the objectives of the audit have been met.
— Provide positive feedback.
— Explain the next steps (e.g. appeals, post-audit processes, certification decision-making timeline).
— Obtain written acknowledgement of nonconformities.
— Complete the meeting records.
D.5.6 Audit reporting

— Describe the findings against the certification standard’s requirements (e.g. nonconformities,
opportunities for improvement).
— Incorporate comments of competence and conformity.
— Describe the final audit conclusions.
— Judge the effectiveness of corrective actions (when required).
— Finalize the audit report.
D.5.7 Conducting post-audit activities

— Deliver the audit report.
— Communicate any information regarding nonconformity resolution timing.
— Report any unusual circumstances that occurred during the audit.
— Review corrective actions for appropriateness.
— Determine requirements for the verification of corrective actions.
— Verify the effectiveness of implementation of corrective actions.
— Report any necessary adjustment of the audit programme, as appropriate.
D.6 Certification decision

— Review the report and other relevant information necessary to make a decision regarding
certification.
— Interact with the audit team regarding audit findings (if required).
— Resolve problems with the audit team regarding the audit undertaken (if required).
— Determine if the evidence available supports the issuing of certification.
— Document the decision.
— Provide feedback to the audit team (if required).

ISO 22003-1:2022(E)
D.7 Develop professional competence

D.7.1 Identify development needs
— Auditing.
— Technical.
— Management systems.
— Skills.
D.7.2 Expand competence

— Participate in professional development activities.
— Participate in certification body or other auditor calibration activities.
— Undertake self-study or training activities.

ISO 22003-1:2022(E)
Bibliography
[1] ISO 9000, Quality management systems — Fundamentals and vocabulary

[2] ISO 9001, Quality management systems — Requirements
[3] ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in
organizations
[4] ISO 14001, Environmental management systems — Requirements with guidance for use
[5] ISO 19011, Guidelines for auditing management systems
[6] ISO/TS 22002 (all parts), Prerequisite programmes on food safety
[7] ISO 22003-2, Food safety — Part 2: Requirements for bodies providing evaluation and certification
of products, processes and services, including an audit of the food safety system
[8] ISO/IEC 17024, Conformity assessment — General requirements for bodies operating certification
of persons
[9] ISO/IEC 17030, Conformity assessment — General requirements for third-party marks of conformity
[10] ISO/IEC 17065, Conformity assessment — Requirements for bodies certifying products, processes
and services
[11] Codex Alimentarius. General Principles of Food Hygiene, CXC 1-1969. Adopted in 1969. Amended
in 1999. Revised in 1997, 2003, 2020. Editorial corrections in 2011
[12] Codex Alimentarius. Food Hygiene Basic Texts. Food and Agricultural Organization of the United
Nations, World Health Organization, Rome, Fourth Edition, 2009

ISO 22003-1:2022(E)
ICS 03.120.20; 67.020

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3 Terms and definitions

7.1 Competence of personnel

7.1.1 General considerations

ISO/IEC 17021-1:2015, 7.1.1, shall be followed.

7.1.2 Determination of competence criteria

ISO/IEC 17021-1:2015, 7.1.2, shall be followed.

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7.1.3 Evaluation processes

ISO/IEC 17021-1:2015, 7.1.3, shall be followed.

7.1.4 Other considerations

ISO/IEC 17021-1:2015, 7.1.4, shall be followed.

7.2 Personnel involved in the certification activities

7.3 Use of individual external auditors and external technical experts

7.4 Personnel records

© ISO 2022 – All rights reserved ﻿ 3

9.1 Pre-certification activities

ISO/IEC 17021-1:2015, 9.1.1, shall be followed.

9.1.2 Application review

9.1.2.1 ISO/IEC 17021-1:2015, 9.1.2, shall be followed.

9.1.2.3 The defined scope of certification shall not:

9.1.3 Audit programme

9.1.3.1 ISO/IEC 17021-1:2015, 9.1.3, shall be followed.

9.1.4 Determining audit time

9.1.4.1 ISO/IEC 17021-1:2015, 9.1.4, shall be followed.

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a) the time for audit preparation;

9.1.5 Multi-site sampling

9.1.5.1 ISO/IEC 17021-1:2015, 9.1.5, shall be followed.

9.1.5.2 A multi-site organization is an organization having an identified central function at which

— organizations operating with franchises;

© ISO 2022 – All rights reserved ﻿ 5

i) the organization’s FSMS is subject to central management review;

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9.1.6 Multiple management systems standards

ISO/IEC 17021-1:2015, 9.1.6, shall be followed.

9.2 Planning audit

9.3 Initial certification

9.3.1 ISO/IEC 17021-1:2015, 9.3, shall be followed.

© ISO 2022 – All rights reserved ﻿ 7

— is suitable for the organization;

9.3.7 ISO/IEC 17021-1:2015, 9.3.1.3 and 9.3.1.4, shall be followed.

9.4 Conducting audits

9.5 Certification decision

9.6 Maintaining certification

9.6.1 ISO/IEC 17021-1:2015, 9.6, shall be followed.

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9.9 Client records

10 Management system requirements for certification bodies

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Classification of food chain categories

Table A.1 — Food chain categories

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