SIST EN ISO 22000:2018

SLOVENSKI STANDARD
01-september-2018
1DGRPHãþD
SIST EN ISO 22000:2005
SIST EN ISO 22000:2005/AC:2006
Sistemi vodenja varnosti živil - Zahteve za vsako organizacijo v prehranski verigi
(ISO 22000:2018)
Food safety management systems - Requirements for any organization in the food chain
(ISO 22000:2018)
Managementsysteme für die Lebensmittelsicherheit - Anforderungen an Organisationen
in der Lebensmittelkette (ISO 22000:2018)
Systèmes de management de la sécurité des denrées alimentaires - Exigences pour tout
organisme appartenant à la chaîne alimentaire (ISO 22000:2018)
Ta slovenski standard je istoveten z: EN ISO 22000:2018
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.

EN ISO 22000
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2018
EUROPÄISCHE NORM
ICS 03.100.70; 67.020 Supersedes EN ISO 22000:2005
English Version
Food safety management systems - Requirements for any
organization in the food chain (ISO 22000:2018)
Systèmes de management de la sécurité des denrées Managementsysteme für die Lebensmittelsicherheit -
alimentaires - Exigences pour tout organisme Anforderungen an Organisationen in der
appartenant à la chaîne alimentaire (ISO 22000:2018) Lebensmittelkette (ISO 22000:2018)
This European Standard was approved by CEN on 26 May 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22000:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 22000:2018) has been prepared by Technical Committee ISO/TC 34 "Food
products".
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2018, and conflicting national standards
shall be withdrawn at the latest by December 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 22000:2005.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 22000:2018 has been approved by CEN as EN ISO 22000:2018 without any modification.

INTERNATIONAL ISO
STANDARD 22000
Second edition
2018-06
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
Reference number
ISO 22000:2018(E)
©
ISO 2018
ISO 22000:2018(E)
© ISO 2018
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 22000:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 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 .10
5 Leadership .10
5.1 Leadership and commitment .10
5.2 Policy .10
5.2.1 Establishing the food safety policy .10
5.2.2 Communicating the food safety policy .10
5.3 Organizational roles, responsibilities and authorities.11
6 Planning .11
6.1 Actions to address risks and opportunities .11
6.2 Objectives of the food safety management system and planning to achieve them .12
6.3 Planning of changes .12
7 Support .13
7.1 Resources .13
7.1.1 General.13
7.1.2 People .13
7.1.3 Infrastructure .13
7.1.4 Work environment .13
7.1.5 Externally developed elements of the food safety management system.14
7.1.6 Control of externally provided processes, products or services .14
7.2 Competence .14
7.3 Awareness .14
7.4 Communication .15
7.4.1 General.15
7.4.2 External communication .15
7.4.3 Internal communication .15
7.5 Documented information .16
7.5.1 General.16
7.5.2 Creating and updating .16
7.5.3 Control of documented information .17
8 Operation .17
8.1 Operational planning and control .17
8.2 Prerequisite programmes (PRPs) .17
8.3 Traceability system .18
8.4 Emergency preparedness and response .19
8.4.1 General.19
8.4.2 Handling of emergencies and incidents .19
8.5 Hazard control .19
8.5.1 Preliminary steps to enable hazard analysis .19
8.5.2 Hazard analysis .21
8.5.3 Validation of control measure(s) and combinations of control measures .23
8.5.4 Hazard control plan (HACCP/OPRP plan) .24
8.6 Updating the information specifying the PRPs and the hazard control plan .25
ISO 22000:2018(E)
8.7 Control of monitoring and measuring .25
8.8 Verification related to PRPs and the hazard control plan .26
8.8.1 Verification .26
8.8.2 Analysis of results of verification activities .26
8.9 Control of product and process nonconformities .27
8.9.1 General.27
8.9.2 Corrections . .27
8.9.3 Corrective actions .27
8.9.4 Handling of potentially unsafe products .28
8.9.5 Withdrawal/recall .29
9 Performance evaluation .29
9.1 Monitoring, measurement, analysis and evaluation .29
9.1.1 General.29
9.1.2 Analysis and evaluation .29
9.2 Internal audit .30
9.3 Management review .31
9.3.1 General.31
9.3.2 Management review input .31
9.3.3 Management review output .31
10 Improvement .32
10.1 Nonconformity and corrective action .32
10.2 Continual improvement .32
10.3 Update of the food safety management system .32
Annex A (informative) Cross references between the CODEX HACCP and this document .33
Annex B (informative) Cross references between this document and ISO 22000:2005 .34
Bibliography .37
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ISO 22000:2018(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.
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.
This second edition cancels and replaces the first edition (ISO 22000:2005), which has been technically
revised through the adoption of a revised clause sequence. It also incorporates the Technical
Corrigendum ISO 22000:2005/Cor.1:2006.
The following annexes are included to provide the users of this document with further information:
— Annex A: cross references between the CODEX HACCP principles and this document;
— Annex B: cross reference between this document and ISO 22000:2005.
ISO 22000:2018(E)
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 and 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.
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.
“NOTES” provide guidance in understanding or clarifying the requirements in this document.
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 people;
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ISO 22000:2018(E)
— 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. 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.
ISO 22000:2018(E)
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 FSMS. 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
Risk is the effect of uncertainty, and any such uncertainty can have positive or negative effects. In the
context of organizational risk management, a positive deviation arising from a risk can provide an
opportunity, but not all positive effects of risk result in opportunities.
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, achieving improved results and preventing negative effects.
0.3.3.3 Hazard analysis — Operational processes
The concept of risk-based thinking based on the HACCP principles at the operational level is implicit in
this document.
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ISO 22000:2018(E)
The subsequent steps in HACCP can be considered as the necessary measures to prevent hazards or
reduce hazards to acceptable levels to ensure food is safe at the time of consumption (Clause 8).
Decisions taken in the application of HACCP should be based on science, free from bias and documented.
The documentation should include any key assumptions in the decision-making process.
0.4 Relationship with other management system standards
This document has been developed within the ISO high level structure (HLS). The objective of the
HLS 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 (ISO/TS 22002 series) for specific sectors of the food chain;
— requirements for auditing and certification bodies;
— traceability.
ISO also provides guidance documents for organizations on how to implement this document and
related standards. Information is available on the ISO website.
INTERNATIONAL STANDARD ISO 22000:2018(E)
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, 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.
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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
ISO 22000:2018(E)
3.1
acceptable level
level of a food safety hazard (3.22) not to be exceeded in the end product (3.15) provided by the
organization (3.31)
3.2
action criterion
measurable or observable specification for the monitoring (3.27) of an OPRP (3.30)
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 (3.36) 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.
Note 4 to entry: Relevant disciplines are, for example, food safety management, quality management or
environmental management.
3.4
competence
ability to apply knowledge and skills to achieve intended results
3.5
conformity
fulfilment of a requirement (3.38)
3.6
contamination
introduction or occurrence of a contaminant including a food safety hazard (3.22) in a product (3.37) or
processing environment
3.7
continual improvement
recurring activity to enhance performance (3.33)
3.8
control measure
action or activity that is essential to prevent a significant food safety hazard (3.22) or reduce it to an
acceptable level (3.1)
Note 1 to entry: See also significant food safety hazard (3.40).
Note 2 to entry: Control measure(s) is (are) identified by hazard analysis.
3.9
correction
action to eliminate a detected nonconformity (3.28)
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).
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ISO 22000:2018(E)
3.10
corrective action
action to eliminate the cause of a nonconformity (3.28) and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action includes cause analysis.
3.11
critical control point
CCP
step in the process (3.36) at which control measure(s) (3.8) is (are) applied to prevent or reduce a
significant food safety hazard (3.40) to an acceptable level, and defined critical limit(s) (3.12) and
measurement (3.26) enable the application of corrections (3.9)
3.12
critical limit
measurable value which separates acceptability from unacceptability
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 potentially unsafe products.
[SOURCE: CAC/RCP 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 (3.31) 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 (3.25), including related processes (3.36);
— 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 (3.37) that will undergo no further processing or transformation by the organization (3.31)
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
feed
single or multiple product(s), whether processed, semi-processed or raw, which is (are) intended to be
fed to food-producing animals
Note 1 to entry: Distinctions are made in this document between the terms food (3.18), feed (3.16) and animal
food (3.19):
— 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;
ISO 22000:2018(E)
— animal food is intended to be fed to non-food-producing animals, such as pets.
[SOURCE: CAC/GL 81-2013, modified — The word “materials” has been changed to “products” and
“directly” has been deleted.]
3.17
flow diagram
schematic and systematic presentation of the sequence and interactions of steps in the process
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 the terms food (3.18), feed (3.16) and animal
food (3.19):
— 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, such as pets.
[SOURCE: CAC/GL 81-2013, modified — The word “human” has been deleted.]
3.19
animal food
single or multiple product(s), whether processed, semi-processed or raw, which is (are) intended to be
fed to non-food-producing animals
Note 1 to entry: Distinctions are made in this document between the terms food (3.18), feed (3.16) and animal
food (3.19):
— 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, such as pets.
[SOURCE: CAC/GL 81-2013, modified — The word “materials” has been changed to “products”, “non”
has been added and “directly” has been deleted.]
3.20
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 (3.16) and animal food (3.19).
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.
3.21
food safety
assurance that food will not cause an adverse health effect for the consumer when it is prepared and/or
consumed in accordance with its intended use
Note 1 to entry: Food safety is related to the occurrence of food safety hazards (3.22) in end products (3.15) and
does not include other health aspects related to, for example, malnutrition.
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ISO 22000:2018(E)
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: CAC/RCP 1-1969, modified — The word “harm” has been changed to “adverse health effect”
and notes to entry have been added.]
3.22
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” (3.39) 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.
[SOURCE: CAC/RCP 1-1969, modified — The phrase “or condition of” has been deleted from the
definition and notes to entry have been added.]
3.23
interested party (preferred term)
stakeholder (admitted term)
person or organization (3.31) that can affect, be affected by, or perceive itself to be affected by a decision
or activity
3.24
lot
defined quantity of a product (3.37) 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.]
3.25
management system
set of interrelated or interacting elements of an organization (3.31) to establish policies (3.34) and
objectives (3.29) and processes (3.36) to achieve those objectives
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.
ISO 22000:2018(E)
Note 4 to entry: Relevant disciplines are, for example, a quality management system or an environmental
management system.
3.26
measurement
process (3.36) to determine a value
3.27
monitoring
determining the status of a system, a process (3.36) or an activity
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 (3.44), monitoring (3.27)
and verification (3.45):
— 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
...

SL OVEN SK I SIST EN ISO 22000

S T A NDA RD september 2018
Sistemi vodenja varnosti živil - Zahteve za katerokoli organizacijo v
prehranski verigi (ISO 22000:2018)

Food safety management systems – Requirements for any organization in the food
chain (ISO 22000:2018)
Systèmes de management de la sécurité des denrées alimentaires – Exigences
pour tout organisme appartenant à la chaîne alimentaire (ISO 22000:2018)

Managementsysteme für die Lebensmittelsicherheit – Anforderungen an

Organisationen in der Lebensmittelkette (ISO 22000:2018)

Referenčna oznaka
ICS 03.100.70; 67.020 SIST EN ISO 22000:2018 (sl, en)

Nadaljevanje na strani II in od 1 do 76

© 2021-04. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 22000 : 2018
NACIONALNI UVOD
Standard SIST EN ISO 22000 (sl), Sistemi vodenja varnosti živil – Zahteve za vsako organizacijo v
prehranski verigi (ISO 22000:2018), 2018, ima status slovenskega standarda in je enakovreden
evropskemu standardu EN ISO 22000 (en, de, fr), Food safety management systems – Requirements
for any organization in the food chain (ISO 22000:2018), 2018.

Ta standard nadomešča SIST EN ISO 22000:2005 in SIST EN ISO 22000:2005/AC:2006.

NACIONALNI PREDGOVOR
Evropski standard EN ISO 22000:2018 je pripravil tehnični odbor Evropskega komiteja za
standardizacijo CEN/SS C01 Živila (Food products). Slovenski standard SIST EN ISO 22000:2018 je
prevod evropskega standarda EN ISO 22000:2018. V primeru spora glede besedila slovenskega
prevoda v tem standardu je odločilen izvirni evropski standard v enem izmed treh uradnih jezikov CEN.
Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC KŽP Kmetijski pridelki in živilski
proizvodi.
Odločitev za izdajo tega standarda je dne 11. julija 2018 sprejel SIST/TC KŽP Kmetijski pridelki in živilski
proizvodi.
ZVEZE S STANDARDI
Standard se ne sklicuje na druge standarde.
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 22000:2018

PREDHODNA IZDAJA
– standard SIST EN ISO 22000:2005 in SIST EN ISO 22000:2005/AC:2006

OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz "evropski standard", v SIST EN ISO
22000:2018 to pomeni "slovenski standard".

– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO 22000:2018 in je objavljen z dovoljenjem

Upravni center
CEN-CENELEC
Rue de la Science 23
B-1040 Bruselj
This national document is identical with EN ISO 22000:2018 and is published with the permission
of
CEN-CENELEC
Management Centre
Rue de la Science 23
B-1040 Brussels
II
EVROPSKI STANDARD     EN ISO 22000
EUROPEAN STANDARD
NORME EUROPÉENNE
junij 2018
EUROPÄISCHE NORM
ICS 03.100.70, 67.020 Nadomešča EN ISO 22000:2005

Slovenska izdaja
Sistemi vodenja varnosti živil – Zahteve za vsako organizacijo v
prehranski verigi (ISO 22000:2018)

Food safety management Systèmes de management de la Managementsysteme für die
systems – Requirements for any sécurité des denrées Lebensmittelsicherheit –
organization in the food chain alimentaires – Exigences pour Anforderungen an
(ISO 22000:2018) tout organisme appartenant à la Organisationen in der
chaîne alimentaire Lebensmittelkette
(ISO 22000:2018) (ISO 22000:2018)

Ta evropski standard je CEN sprejel dne 26. maja 2018.

Člani CEN morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je predpisano,
da mora biti ta evropski standard brez kakršnih koli sprememb sprejet kot nacionalni standard.
Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na voljo na
zahtevo pri Upravnem centru CEN-CENELEC ali članih CEN.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru
CEN-CENELEC, veljajo kot uradne izdaje.

Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve,
Luksemburga, Madžarske, Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije,
Nizozemske, Norveške, Poljske, Portugalske, Romunije, Srbije, Slovaške, Slovenije, Španije,
Švedske, Švice, Turčije in Združenega kraljestva.

CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung

Upravni center CEN-CENELEC: Rue de la Science 23, B-1040 Brussels

© 2018 CEN Lastnice avtorskih pravic so vse države članice CEN. Ref. oznaka EN ISO 22000:2018 E

SIST EN ISO 22000 : 2018
VSEBINA Stran CONTENTS Page
Evropski predgovor . 5 European foreword . 5
Predgovor . 6 Foreword . 6
Uvod  . 8 Introduction . 8
1 Področje uporabe . 15 1 Scope  . 15
2 Zveze s standardi . 16 2 Normative references . 16
3 Izrazi in definicije . 16 3 Terms and definitions . 16
4 Kontekst organizacije . 27 4 Context of the organization . 27
4.1 Razumevanje organizacije in 4.1 Understanding the organization and
njenega konteksta . 27 its context . 27
4.2 Razumevanje potreb in pričakovanj 4.2 Understanding the needs and
zainteresiranih strani . 27 expectations of interested parties . 27
4.3 Določanje obsega sistema vodenja 4.3 Determining the scope of the food
27 safety management system . 27
varnosti živil .
4.4 Sistem vodenja varnosti živil . 28 4.4 Food safety management system . 28
5 Voditeljstvo . 28 5 Leadership . 28
5.1 Voditeljstvo in zavezanost . 28 5.1 Leadership and commitment . 28
5.2 Politika . 29 5.2 Policy . 29
5.2.1 Vzpostavitev politike varnosti živil . 29 5.2.1 Establishing the food safety policy . 29
5.2.2 Komuniciranje o politiki varnosti 5.2.2 Communicating the food safety
živil  . 29 policy . 29
5.3 Organizacijske vloge, odgovornosti 5.3 Organizational roles, responsibilities
in pooblastila . 29 and authorities . 29
6 Planiranje . 30 6 Planning . 30
6.1 Ukrepi za obravnavanje tveganj in 6.1 Actions to address risks and
priložnosti . 30 opportunities . 30
6.2 Cilji sistema vodenja varnosti živil in 6.2 Objectives of the food safety
planiranje za njihovo doseganje . 31 management system and planning to
achieve them . 31
6.3 Planiranje sprememb . 32 6.3 Planning of changes . 32
7 Podpora . 32 7 Support . 32
7.1 Viri . 32 7.1 Resources . 32
7.1.1 Splošno . 32 7.1.1 General . 32
7.1.2 Ljudje . 32 7.1.2 People . 32
7.1.3 Infrastruktura . 32 7.1.3 Infrastructure . 32
7.1.4 Delovno okolje . 33 7.1.4 Work environment . 33
7.1.5 Elementi sistema vodenja varnosti 7.1.5 Externally developed elements of
živil, razviti z zunanjo pomočjo . 33 the food safety management system . 33
7.1.6 Obvladovanje procesov, izdelkov 7.1.6 Control of externally provided
in storitev zunanjih ponudnikov . 34 processes, products or services . 34

7.2 Kompetentnost . 34
7.2 Competence . 34
7.3 Ozaveščenost . 35
7.3 Awareness . 35
7.4 Komunikacija . 35
7.4 Communication . 35
7.4.1 Splošno . 35
7.4.1 General . 35
7.4.2 Zunanja komunikacija . 35
7.4.2 External communication . 35
7.4.3 Notranja komunikacija . 36
7.4.3 Internal communication . 36
7.5 Dokumentirane informacije . 37
7.5 Documented information . 37
SIST EN ISO 22000 : 2018
7.5.1 Splošno . 37 7.5.1 General . 37
7.5.2 Ustvarjanje in posodabljanje . 37 7.5.2 Creating and updating . 37
7.5.3 Obvladovanje dokumentiranih 7.5.3 Control of documented information . 38
informacij . 38
8 Delovanje . 38 8 Operation . 38
8.1 Planiranje in obvladovanje 8.1 Operational planning and control . 38
delovanja . 38
8.2 Prerekvizitni programi (PRP) . 39 8.2 Prerequisite programmes (PRPs) . 39
8.3 Sistem sledljivosti . 40 8.3 Traceability system . 40
8.4 Pripravljenost in odziv v kriznih 8.4 Emergency preparedness and
situacijah . 40 response . 40
8.4.1 Splošno . 40 8.4.1 General . 40
8.4.2 Obravnavanje kriznih situacij in 8.4.2 Handling of emergencies and
incidentov . 41 incidents . 41
8.5 Obvladovanje dejavnikov tveganja . 41 8.5 Hazard control . 41
8.5.1 Predhodne stopnje, ki omogočajo 8.5.1 Preliminary steps to enable hazard
analizo dejavnikov tveganja . 41 analysis . 41
8.5.2 Analiza dejavnikov tveganja . 44 8.5.2 Hazard analysis . 44
8.5.3 Validacija kontrolnih ukrepov in 8.5.3 Validation of control measure(s)
kombinacij kontrolnih ukrepov . 47 and combinations of control measures . 47
8.5.4 Plan obvladovanja dejavnikov 8.5.4 Hazard control plan
tveganja (plan HACCP/OPRP) . 48 (HACCP/OPRP plan) . 48
8.6 Posodabljanje informacij, ki podrobno 8.6 Updating the information specifying
opisujejo prerekvizitne programe in plan the PRPs and the hazard control plan . 50
obvladovanja dejavnikov tveganja . 50
8.7 Obvladovanje nadzorovanja in 8.7 Control of monitoring and
merjenja . 50 measuring . 50
8.8 Overjanje, ki se nanaša na prerekvizitne 8.8 Verification related to PRPs and the
programe in plan obvladovanja dejavnikov hazard control plan . 51
tveganja . 51

8.8.1 Overjanje . 51 8.8.1 Verification . 51
8.8.2 Analiza rezultatov aktivnosti 8.8.2 Analysis of results of verification
overjanja . 52 activities . 52
8.9 Obvladovanje neskladnosti izdelkov 8.9 Control of product and process
in procesov . 52 nonconformities . 52
8.9.1 Splošno . 52 8.9.1 General . 52
8.9.2 Korekcije . 52 8.9.2 Corrections . 52
8.9.3 Korektivni ukrepi . 53 8.9.3 Corrective actions . 53
8.9.4 Ravnanje z izdelki, ki potencialno 8.9.4 Handling of potentially unsafe
niso varni . 54 products . 54
8.9.5 Umik/odpoklic . 55 8.9.5 Withdrawal/recall . 55
9 Vrednotenje izvedbe . 56 9 Performance evaluation . 56
9.1 Nadzorovanje, merjenje, analiza in 9.1 Monitoring, measurement, analysis
vrednotenje . 56 and evaluation . 56
9.1.1 Splošno . 56 9.1.1 General . 56
9.1.2 Analiza in vrednotenje . 57 9.1.2 Analysis and evaluation . 57
9.2 Notranja presoja . 57 9.2 Internal audit . 57
9.3 Vodstveni pregled . 58 9.3 Management review . 58
9.3.1 Splošno . 58 9.3.1 General . 58
SIST EN ISO 22000 : 2018
9.3.2 Vhodni podatki za vodstveni 9.3.2 Management review input. . 58
pregled . 58

9.3.3 Rezultat vodstvenega pregleda . 59
9.3.3 Management review output . 59
10 Izboljševanje  . 60
10 Improvement . 60
10.1 Neskladnost in korektivni ukrep  . 60
10.1 Nonconformity and corrective action . 60
10.2 Nenehno izboljševanje . 60
10.2 Continual improvement . 60
10.3 Posodobitev sistema vodenja
10.3 Update of the food safety
varnosti živil . 61
management system . 61
Dodatek A (informativni): Primerjava med
Annex A (informative) Cross references
CODEX HACCP in tem dokumentom . 62
between the CODEX HACCP and this
document . 63
Dodatek B (informativni): Primerjava med Annex B (informative) Cross references
tem dokumentom in ISO 22000:2005 . 66 between this document and ISO
22000:2005 . 67
Literatura . 76
Bibliography . 76

SIST EN ISO 22000 : 2018
Evropski predgovor European foreword
Ta dokument (EN ISO 22000:2018) je pripravil This document (EN ISO 22000:2018) has been
tehnični odbor ISO/TC 34 "Živila". prepared by Technical Committee ISO/TC 34
"Food products"
Ta evropski standard mora dobiti status This European Standard shall be given the status
nacionalnega standarda bodisi z objavo of a national standard, either by publication of an
istovetnega besedila ali z razglasitvijo identical text or by endorsement, at the latest by
najpozneje do decembra 2018, nasprotujoče December 2018, and conflicting national
nacionalne standarde pa je treba razveljaviti standards shall be withdrawn at the latest by
najpozneje decembra 2018. December 2018.
Opozoriti je treba na možnost, da so nekateri Attention is drawn to the possibility that some of
elementi tega dokumenta lahko predmet the elements of this document may be the subject
patentnih pravic. CEN ne prevzema of patent rights. CEN shall not be held responsible
odgovornosti za identifikacijo nekaterih ali vseh for identifying any or all such patent rights.
takih patentnih pravic.
Ta dokument nadomešča EN ISO 22000:2005. This document supersedes EN ISO 22000:2005.
V skladu z notranjimi predpisi CEN-CENELEC According to the CEN-CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards organizations
nacionalne organizacije za standardizacijo of the following countries are bound to implement
naslednjih držav: Avstrije, Belgije, Bolgarije, this European Standard: Austria, Belgium,
Cipra, Češke republike, Danske, Estonije, Bulgaria, Croatia, Cyprus, Czech Republic,
Finske, Francije, Grčije, Hrvaške, Irske, Denmark, Estonia, Finland, Former Yugoslav
Islandije, Italije, Latvije, Litve, Luksemburga, Republic of Macedonia, France, Germany,
Madžarske, Malte, Nekdanje jugoslovanske Greece, Hungary, Iceland, Ireland, Italy, Latvia,
republike Makedonije, Nemčije, Nizozemske, Lithuania, Luxembourg, Malta, Netherlands,
Norveške, Poljske, Portugalske, Romunije, Norway, Poland, Portugal, Romania, Serbia,
Srbije, Slovaške, Slovenije, Španije, Švedske, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Švice, Turčije in Združenega kraljestva. Turkey and the United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo ISO 22000:2018 je CEN odobril kot  The text of ISO 22000:2018 has been approved
EN ISO 22000:2018 brez kakršnih koli by CEN as EN ISO 22000:2018 without any
sprememb. modification.
SIST EN ISO 22000 : 2018
Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for
(ISO) je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of
standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member bodies).
ponavadi pripravljajo tehnični odbori ISO. Vsak The work of preparing International Standards is
član, ki želi delovati na določenem področju, za normally carried out through ISO technical
katero je bil ustanovljen tehnični odbor, ima committees. Each member body interested in a
pravico biti zastopan v tem odboru. Pri delu subject for which a technical committee has been
sodelujejo tudi mednarodne vladne in nevladne established has the right to be represented on that
organizacije, povezane z ISO. V vseh zadevah, committee. International organizations,
ki so povezane s standardizacijo na področju governmental and non-governmental, in liaison
elektrotehnike, ISO tesno sodeluje z with ISO, also take part in the work. ISO
Mednarodno elektrotehniško komisijo (IEC). collaborates closely with the International
Electrotechnical Commission (IEC) on all matters
of electrotechnical standardization.
Postopki, uporabljeni pri razvoju tega The procedures used to develop this document
dokumenta, in predvideni postopki za njegovo and those intended for its further maintenance are
vzdrževanje so opisani v Direktivah ISO/IEC, described in the ISO/IEC Directives, Part 1. In
1. del. Posebna pozornost naj se nameni particular, the different approval criteria needed
različnim kriterijem odobritve, potrebnim za for the different types of ISO documents should
različne vrste dokumentov ISO. Ta dokument je be noted. This document was drafted in
bil pripravljen v skladu z uredniškimi pravili accordance with the editorial rules of the ISO/IEC
Direktiv ISO/IEC, 2. del (glej Directives, Part 2 (see www.iso.org/directives).
www.iso.org/directives).
Opozoriti je treba na možnost, da so lahko Attention is drawn to the possibility that some of
nekateri elementi tega dokumenta predmet the elements of this document may be the subject
patentnih pravic. ISO ne prevzema odgovornosti of patent rights. ISO shall not be held responsible
za identifikacijo katerihkoli ali vseh takih for identifying any or all such patent rights. Details
patentnih pravic. Podrobnosti o morebitnih of any patent rights identified during the
patentnih pravicah, identificiranih med pripravo development of the document will be in the
tega dokumenta, bodo navedene v uvodu in/ali Introduction and/or on the ISO list of patent
na seznamu patentnih izjav, ki jih je prejela declarations received (see www.iso.org/patents).
organizacija ISO (glej www.iso.org/patents).
Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is
dokumentu, so informacije za uporabnike in ne information given for the convenience of users
pomenijo podpore blagovni znamki. and does not constitute an endorsement.
Za razlago prostovoljne narave standardov, For an explanation of the voluntary nature of
pomena specifičnih pojmov in izrazov ISO, standards, the meaning of ISO specific terms and
povezanih z ugotavljanjem skladnosti, ter expressions related to conformity assessment, as
informacij o tem, kako ISO spoštuje načela well as information about ISO’s adherence to the
Svetovne trgovinske organizacije (WTO) v World Trade Organization (WTO) principles in the
Tehničnih ovirah pri trgovanju (TBT), glej spletno Technical Barriers to Trade (TBT) see
mesto www.iso.org/iso/foreword.html. www.iso.org/iso/foreword.html.
Ta dokument je pripravil tehnični odbor ISO/TC This document was prepared by Technical
34, Živila, pododbor SC 17, Sistemi vodenja za Committee ISO/TC 34, Food products,
varnost živil. Subcommittee SC 17, Management systems for
food safety.
Uporabnik naj vse povratne informacije ali Any feedback or questions on this document
vprašanja glede tega dokumenta posreduje should be directed to the user’s national
nacionalnemu organu za standarde v svoji standards body. A complete listing of these
državi. Celoten seznam teh organov je na voljo bodies can be found at
na spletnem mestu www.iso.org/members.html. www.iso.org/members.html.
SIST EN ISO 22000 : 2018
Ta druga izdaja razveljavlja in nadomešča prvo This second edition cancels and replaces the first
izdajo (ISO 22000:2005), ki je bila tehnično edition (ISO 22000:2005), which has been
revidirana s spremenjenim zaporedjem točk. technically revised through the adoption of a
Vključuje tudi tehnični popravek ISO revised clause sequence. It also incorporates the
22000:2005/Cor.1:2006. Technical Corrigendum ISO
22000:2005/Cor.1:2006.
Vključena sta naslednja dodatka, ki vsebujeta The following annexes are included to provide the
dodatne informacije za uporabnike tega users of this document with further information:
dokumenta:
a) dodatek A: primerjava med načeli CODEX a) Annex A: cross references between the
HACCP in tem dokumentom; CODEX HACCP principles and this
document;
b) dodatek B: primerjava med tem b) Annex B: cross reference between this
dokumentom in ISO 22000:2005. document and ISO 22000:2005.

SIST EN ISO 22000 : 2018
Uvod Introduction
0.1 Splošno
0.1 General
Privzem sistema vodenja varnosti živil (FSMS) je The adoption of a food safety management
strateška odločitev organizacije, ki ji lahko system (FSMS) is a strategic decision for an
pomaga izboljšati celotno izvajanje na področju organization that can help to improve its overall
varnosti živil. Koristi, ki jih ima lahko organizacija performance in food safety. The potential
od izvajanja sistema vodenja varnosti živil na benefits to an organization of implementing a
podlagi tega dokumenta, so: FSMS based on this document are:
a) zmožnost, da dosledno zagotavlja varna a) the ability to consistently provide safe

živila, izdelke in storitve, ki izpolnjujejo foods and products and services that meet
zahteve odjemalcev ter veljavne zakonske customer and applicable statutory and
in regulativne zahteve; regulatory requirements;
b) obravnavanje tveganj, povezanih s cilji; b) addressing risks associated with its
objectives;
c) zmožnost, da dokaže skladnost s c) the ability to demonstrate conformity to
specificiranimi zahtevami sistema vodenja specified FSMS requirements.
varnosti živil.
V tem dokumentu je uporabljen procesni pristop This document employs the process approach
(glej 0.3), ki vključuje cikel "planiraj-izvedi- (see 0.3), which incorporates the Plan-Do-
preveri-ukrepaj" (PDCA) (glej 0.3.2) in Check-Act (PDCA) cycle (see 0.3.2) and risk-
razmišljanje na podlagi tveganja (glej 0.3.3). based thinking (see 0.3.3).
Ta procesni pristop pomaga organizaciji This process approach enables an organization
načrtovati njene procese in njihovo interakcijo. to plan its processes and their interactions.
Cikel PDCA pomaga organizaciji zagotavljati, da The PDCA cycle enables an organization to
svoje procese podpre z ustreznimi viri in jih vodi ensure that its processes are adequately
ter opredeli priložnosti za izboljšanje in ustrezno resourced and managed, and that opportunities
ukrepa. for improvement are determined and acted on.
Razmišljanje na podlagi tveganja pomaga Risk-based thinking enables an organization to
organizaciji opredeliti dejavnike, ki bi lahko determine the factors that could cause its
povzročili odstopanje njenih procesov in sistema processes and its FSMS to deviate from the
vodenja varnosti živil od planiranih rezultatov, ter planned results, and to put in place controls to
sprejeti ukrepe za preprečevanje ali prevent or minimize adverse effects.
zmanjševanje škodljivih učinkov.
V tem dokumentu so uporabljene naslednje In this document, the following verbal forms are
glagolske oblike: used:
– "treba je" ali "mora" označuje zahtevo; – "shall" indicates a requirement;
– "naj" označuje priporočilo; – "should" indicates a recommendation;
– "sme" označuje dovoljenje; – "may" indicates a permission;
– "lahko" označuje možnost ali sposobnost. – "can" indicates a possibility or a capability.
"OPOMBE" podajajo usmeritve za razumevanje ali "NOTES" provide guidance in understanding or

pojasnjevanje zahtev v tem dokumentu. clarifying the requirements in this document.

SIST EN ISO 22000 : 2018
0.2 Načela sistemov vodenja varnosti živil 0.2 FSMS principles
(FSMS)
Varnost živil je povezana s prisotnostjo Food safety is related to the presence of food
dejavnikov tveganja v času, ko uporabnik to safety hazards at the time of consumption
živilo zaužije. Dejavniki tveganja se lahko (intake by the consumer). Food safety hazards
pojavijo na vsaki stopnji prehranske verige, zato can occur at any stage of the food chain.
je slednjo treba v celoti ustrezno nadzirati. Therefore, adequate control throughout the food
Varnost živil je zagotovljena, če so povezana chain is essential. Food safety is ensured
prizadevanja vseh strani v prehranski verigi. Ta through the combined efforts of all the parties in
dokument navaja zahteve za sistem vodenja the food chain. This document specifies the
varnosti živil s povezovanjem naslednjih splošno requirements for a FSMS that combines the
znanih ključnih elementov: following generally recognized key elements:
– vmesne povezave, – interactive communication;
– vodenje sistema, – system management;
– prerekvizitni programi, – prerequisite programmes;
– načela analize dejavnikov tveganja in – hazard analysis and critical control point
kritičnih kontrolnih točk (HACCP). (HACCP) principles.
Poleg tega ta dokument temelji na načelih, ki so In addition, this document is based on the
skupna standardom ISO za sisteme vodenja. principles that are common to ISO management
Načela vodenja so: system standards. The management principles
are:
– osredotočenost na odjemalce, – customer focus;
– voditeljstvo, – leadership;
– angažiranost zaposlenih, – engagement of people;
– procesni pristop, – process approach;
– izboljševanje, – improvement;
– odločanje na podlagi dejstev, – evidence-based decision making;
– upravljanje odnosov. – relationship management.
0.3 Procesni pristop  0.3 Process approach
0.3.1 Splošno 0.3.1 General
S tem dokumentom je sprejet procesni pristop k This document adopts a process approach when
razvijanju in izvajanju sistema vodenja varnosti developing and implementing a FSMS and
živil ter izboljševanju njegove uspešnosti, da bi improving its effectiveness to enhance
se z izpolnjevanjem veljavnih zahtev izboljšala production of safe products and services while
proizvodnja varnih izdelkov in storitev. meeting applicable requirements.
Razumevanje in vodenje medsebojno povezanih Understanding and managing interrelated
procesov kot sistema prispevata k uspešnosti in processes as a system contributes to the
učinkovitosti organizacije pri doseganju organization’s effectiveness and efficiency in
predvidenih rezultatov. Procesni pristop achieving its intended results. The process
vključuje sistematično določitev in vodenje approach involves the systematic definition and
procesov ter njihovih interakcij, da se dosežejo management of processes, and their
predvideni rezultati v skladu s politiko varnosti interactions, so as to achieve the intended
živil in strateško usmeritvijo organizacije. results in accordance with the food safety policy
Vodenje procesov in sistema kot celote je and strategic direction of the organization.
SIST EN ISO 22000 : 2018
mogoče doseči z uporabo cikla PDCA s popolno Management of the processes and the system
osredotočenostjo na razmišljanje na podlagi as a whole can be achieved using the PDCA
tveganja, ki je usmerjeno v izkoriščanje cycle, with an overall focus on risk-based
priložnosti in preprečevanje neželenih thinking aimed at taking advantage of
rezultatov. opportunities and preventing undesirable
results.
Nujno je tudi prepoznavanje vloge in položaja The recognition of the organization’s role and
organizacije v prehranski verigi, saj lahko position within the food chain is essential to
omogoči uspešno medsebojno komuniciranje v ensure effective interactive communication
celotni verigi. throughout the food chain.
0.3.2 Cikel planiraj-izvedi-preveri-ukrepaj 0.3.2 Plan-Do-Check-Act cycle
Cikel PDCA je mogoče na kratko opisati takole: The PDCA cycle can be described briefly as
follows:
Planiraj: vzpostavi cilje sistema in njegove Plan: establish the objectives of the system
procese, zagotovi vire, potrebne za and its processes, provide the
doseganje rezultatov, ter resources needed to deliver the
identificiraj in obravnavaj tveganja results, and identify and address risks
in priložnosti. and opportunities;
Izvedi: izvedi, kar je planirano. Do: implement what was planned;
Preveri: nadzoruj in (kjer je primerno) meri Check: monitor and (where relevant) measure
procese ter nastale izdelke in processes and the resulting products
storitve, analiziraj in ovrednoti and services, analyse and evaluate
informacije ter podatke, pridobljene information and data from monitoring,
z nadzorovanjem, merjenjem in measuring and verification activities,
overjanjem, ter poročaj o rezultatih. and report the results;
Ukrepaj: po potrebi ukrepaj, da se izvajanje Act: take actions to improve performance,
izboljša. as necessary.
V tem dokumentu (kot je prikazano na sliki 1) In this document, and as illustrated in Figure 1,
procesni pristop uporablja cikel PDCA na dveh the process approach uses the concept of the
ravneh. Prva raven zajema celoten okvir sistema PDCA cycle at two levels. The first covers the
vodenja varnosti živil (točke 4 do 7 in 9 do 10). overall frame of the FSMS (Clause 4 to Clause 7
Druga raven (planiranje in obvladovanje and Clause 9 to Clause 10). The other level
delovanja) zajema delovne procese v sistemu (operational planning and control) covers the
vodenja varnosti živil, kot je opisano v točki 8. operational processes within the food safety
Povezava med obema ravnema je zato bistvena. system as described in Clause 8.
Communication between the two levels is
therefore essential.
SIST EN ISO 22000 : 2018
Slika 1: Prikaz cikla planiraj-izvedi-preveri-ukrepaj na dveh ravneh

SIST EN ISO 22000 : 2018
Figure 1 — Illustration of the Plan-Do-Check-Act cycle at the two levels

0.3.3 Razmišljanje na podlagi tveganja  0.3.3 Risk-based thinking
0.3.3.1 Splošno 0.3.3.1 General
Razmišljanje na podlagi tveganja je bistveno za Risk-based thinking is essential for achieving an
doseganje uspešnega sistema vodenja varnosti effective FSMS. In this document, risk-based
živil. V tem dokumentu je razmišljanje na podlagi thinking is addressed on two levels,
tveganja obravnavano na dveh ravneh: organizational (see 0.3.3.2) and operational (see
organizacijski ravni (glej 0.3.3.2) in ravni 0.3.3.3), which is consistent with the process
delovanja (glej 0.3.3.3), kar je skladno s approach described in 0.3.2.
procesnim pristopom v 0.3.2.
0.3.3.2 Obvladovanje organizacijskega 0.3.3.2 Organizational risk management
tveganja
Tveganje je posledica negotovosti in vsaka Risk is the effect of uncertainty, and any such
takšna negotovnost ima lahko pozitivne ali uncertainty can have positive or negative effects.
negativne učinke. V okviru obvladovanja In the context of organizational risk
organizacijskega tveganja lahko pozitivno management, a positive deviation arising from a
odstopanje, ki izhaja iz tveganja, predstavlja risk can provide an opportunity, but not all
priložnost, vendar nimajo vsi pozitivni učinki positive effects of risk result in opportunities.
tveganja za posledico priložnosti.
SIST EN ISO 22000 : 2018
Organizacija planira in izvaja ukrepe za To conform to the requirements of this
obravnavanje organizacijskih tveganj, da document, an organization plans and
zagotovi izpolnjevanje zahtev tega dokumenta implements actions to address organizational
(točka 6). Obravnavanje tveganj vzpostavlja risks (Clause 6). Addressing risks establishes a
podlago za povečanje uspešnosti sistema basis for increasing the effectiveness of the
vodenja varnosti živil, doseganje boljših FSMS, achieving improved results and
rezultatov in preprečevanje negativnih vplivov. preventing negative effects.
0.3.3.3 Analiza dejavnikov tveganja – Delovni 0.3.3.3 Hazard analysis — Operational
procesi processes
Koncept razmišljanja na podlagi tveganja, ki The concept of risk-based thinking based on the
temelji na načelih HACCP na ravni delovanja, je HACCP principles at the operational level is
vključen v ta dokument. implicit in this document.
Nadaljnje korake v planu HACCP je mogoče The subsequent steps in HACCP can be
obravnavati kot ukrepe, ki so potrebni za considered as the necessary measures to
preprečevanje ali zmanjševanje dejavnikov prevent hazards or reduce hazards to
tveganja na sprejemljive ravni, da se zagotovi acceptable levels to ensure food is safe at the
varnost živila v času njegovega zaužitja (točka time of consumption (Clause 8).
8).
Odločitve, sprejete med uporabo plana HACCP, Decisions taken in the application of HACCP
naj temeljijo na znanstvenih izsledkih ter naj should be based on science, free from bias and
bodo nepristranske in dokumentirane. documented. The documentation should include
Dokumentacija naj vključuje vse ključne any key assumptions in the decision-making
predpostavke v procesu odločanja. process.
0.4 Povezava z drugimi standardi sistema 0.4 Relationship with other management
vodenja system standards
Ta dokument je bil pripravljen znotraj strukture This document has been developed within the
ISO na visoki ravni (HLS). Cilj HLS je izboljšati ISO high level structure (HLS). The objective of
usklajenost med standardi ISO za sistem the HLS is to improve alignment between ISO
vodenja. Ta dokument omogoča organizaciji, da management system standards. This document
z uporabo procesnega pristopa skupaj s ciklom enables an organization to use the process
PDCA in razmišljanjem na podlagi tveganja approach, coupled with the PDCA cycle and risk-
uskladi ali združi svoj pristop v sistemu vodenja based thinking, to align or integrate its FSMS
varnosti živil (FSMS) z zahtevami drugih approach with the requirements of other
sistemov vodenja in spremnih standardov. management systems and supporting
standards.
Ta dokument je glavno načelo in okvir za sistem This document is the core principle and
vodenja varnosti živil ter določa specifične framework for FSMSs and sets out the specific
zahteve sistema vodenja varnosti živil za FSMS requirements for organizations
organizacije v celotni prehranski verigi. Skupaj s throughout the food chain. Other guidance
tem okvirom se lahko uporabljajo tudi drugi related to food safety, specifications and/or
napotki v zvezi z varnostjo živil, specifikacije requirements specific to food sectors can be
in/ali zahteve, specifične za živilski sektor. used together with this framework.
Organizacija ISO je poleg tega pripravila še In addition, ISO has developed a family of
skupino s tem povezanih dokumentov. To associated documents. These include
vključuje dokumente za: documents for:
– prerekvizitne programe (skupina – prerequisite programmes (ISO/TS 22002
dokumentov ISO/TS 22002) za specifične series) for specific sectors of the food chain;
sektorje v prehranski verigi;
– zahteve za organe, ki izvajajo presojanje in – requirements for auditing and certification
certificiranje; bodies;
– sledljivost. – traceability.
SIST EN ISO 22000 : 2018
Organizacija ISO zagotavlja organizacijam tudi ISO also provides guidance documents for
dokumente z usmeritvami za uvedbo tega organizations on how to implement this
dokumenta in s tem povezanih standardov. document and related standards. Information is
Informacije so na voljo na spletni strani ISO. available on the ISO website.

SIST EN ISO 22000 : 2018
Sistemi vodenja varnosti živil – Food safety management systems —
Zahteve za vsako organizacijo v Requirements for any organization in
prehranski verigi the food chain
1 Področje uporabe 1 Scope
Ta dokument določa zahteve za sistem vodenja This document specifies requirements for a food
varnosti živil (FSMS), ki organizaciji, ki je safety management system (FSMS) to enable
neposredno ali posredno vključena v prehransko an organization that is directly or indirectly
verigo, omogočajo:
involved in the food chain:
a) planirati, izvajati, voditi, vzdrževati in a) to plan, implement, operate, maintain and
posodabljati sistem vodenja varnosti živil, s update a FSMS providing products and
katerim zagotavlja, da so izdelki in storitve services that are safe, in accordance with
varni glede na predvideno uporabo;
their intended use;
b) prikazati skladnost z ustreznimi zakonskimi b) to demonstrate compliance with applicable
in regulativnimi zahtevami glede varnosti statutory and regulatory food safety
živil; requirements;
c) vrednotiti in oceniti medsebojno usklajene c) to evaluate and assess mutually agreed
zahteve odjemalcev glede varnosti živil ter customer food safety requirements and to
prikazati skladnost z njimi;
demonstrate conformity with them;
d) uspešno povezati vidike varnosti živil d) to effectively communicate food safety
zainteresiranih strani, vključenih v issues to interested parties within the food
prehransko verigo; chain;
e) zagotavljati, da organizacija usklajuje e) to ensure that the organization conforms to
določeno politiko varnosti živil; its stated food safety policy;
f) prikazati usklajenost relevantnim f) to demonstrate conformity to relevant
zainteresiranim stranem; interested parties;

g) pridobiti certifikacijo ali registracijo svojega g) to seek certification or registration of its
sistema vodenja varnosti živil pri zunanji FSMS by an external organization, or
organizaciji ali izvesti samoocenjevanje ali make a selfassessment or self-declaration
samodeklariranje skladnosti s tem of conformity to this document.
dokumentom.
Vse zahteve tega dokumenta so splošne in so All requirements of this document are generic
namenjene vsem organizacijam v prehranski and are intended to be applicable to all
verigi ne glede na velikost in kompleksnost. organizations in the food chain, regardless of
Organizacije, ki so neposredno ali posredno size and complexity. Organizations that are
vključene, med drugim vključujejo proizvajalce directly or indirectly involved include, but are not
krme, proizvajalce hrane za živali, nabiralce limited to, feed producers, animal food
divjih rastlin in lovce divjadi, kmete, proizvajalce producers, harvesters of wild plants and
sestavin, proizvajalce živil, trgovce ter animals, farmers, producers of ingredients, food
organizacije, ki zagotavljajo oskrbo z živili, manufacturers, retailers, and organizations
gostinske storitve (strežbo hrane), storitve providing food services, catering services,
čiščenja in sanitacije, prevoz, skladiščenje in cleaning and sanitation services, transportation,
distribucijo, ter dobavitelje opreme za čiščenje in storage and distribution services, suppliers of
sredstev za razkuževanje, embalaže in drugih equipment, cleaning and disinfectants,
materialov, ki pridejo v stik z živili. packaging materials and other food contact
materials.
Ta dokument omogoča vsem organizacijam, tudi This document allows any organization,
majhnim in/ali manj razvitim organizacijam (npr. including small and/or less developed
SIST EN ISO 22000 : 2018
malim kmetijam, distributerjem, trgovcem ali organizations (e.g. a small farm, a small packer-
strežbi), da v svoj sistem vodenja varnosti živil distributor, a small retail or food service outlet) to
uvedejo elemente, razvite z zunanjo pomočjo. implement externally-developed elements in
their FSMS.
Zahteve iz tega dokumenta je mogoče izpolniti z Internal and/or external resources can be used
notranjimi in/ali zunanjimi viri. to meet t
...