SIST EN ISO 22000:2018
(Main)Food safety management systems - Requirements for any organization in the food chain (ISO 22000:2018)
Food safety management systems - Requirements for any organization in the food chain (ISO 22000:2018)
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 selfassessment
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 externallydeveloped
elements in their FSMS.
Internal and/or external resources can be used to meet the requirements of this document.
Managementsysteme für die Lebensmittelsicherheit - Anforderungen an Organisationen in der Lebensmittelkette (ISO 22000:2018)
Dieses Dokument legt Anforderungen an ein Managementsystem für Lebensmittelsicherheit (FSMS) fest, um direkt oder indirekt an der Lebensmittelkette beteiligte Organisationen zu befähigen:
a) ein FSMS zu planen, zu verwirklichen, anzuwenden, aufrechtzuerhalten und zu aktualisieren, das Produkte und Dienstleistungen liefert, die bei bestimmungsgemäßer Verwendung sicher sind;
b) die Einhaltung der geltenden gesetzlichen und behördlichen Anforderungen an die Lebensmittel-sicherheit nachzuweisen;
c) mit dem Kunden vereinbarte Anforderungen an die Lebensmittelsicherheit zu prüfen und zu beurteilen und die Konformität mit diesen zu nachzuweisen;
d) interessierten Parteien in der Lebensmittelkette Themen der Lebensmittelsicherheit effektiv zu vermitteln;
e) die Konformität der Organisation mit ihrer niedergelegten Lebensmittelsicherheitspolitik sicherzustellen;
f) die Konformität gegenüber relevanten interessierten Parteien nachzuweisen;
g) die Zertifizierung oder Registrierung ihres FSMS durch eine externe Stelle anzustreben, eine Selbstbewertung vorzunehmen oder eine eigenverantwortliche Erklärung hinsichtlich der Konformität mit diesem Dokument abzugeben.
Sämtliche Anforderungen dieses Dokuments sind allgemeiner Natur und sollen für alle an der Lebensmittelkette mitwirkenden Organisationen gelten, und zwar ungeachtet ihrer Größe und ihrer Komplexität. Zu den direkt oder indirekt mitwirkenden Organisationen gehören unter anderem Futtermittelhersteller, Hersteller von Tiernahrung, auf Wildpflanzen und Wildtiere spezialisierte Ernte- bzw. Fangbetriebe, Agrar¬betriebe, Hersteller von Zutaten, Lebensmittelhersteller, Einzelhändler, Lebensmitteldienste, Catering-Dienstleister und in den Bereichen Reinigung, Desinfektion, Transport, Lagerung und Vertrieb tätige Unternehmen, Lieferanten von Geräten, Reinigungsmitteln und Desinfektionsmitteln, Verpackungs¬materialien und anderen Materialien mit Lebensmittelkontakt.
Dieses Dokument ermöglicht jeder Organisation, einschließlich kleiner und/oder weniger entwickelter Organisationen (z. B. einem landwirtschaftlichen Kleinbetrieb, einem kleinen Abfüll /Vertriebsunternehmen oder einem kleinen Einzelhandelsgeschäft oder Gastronomiebetrieb), extern entwickelte Elemente in ihr FSMS zu implemen¬tieren.
Die Übereinstimmung mit den Anforderungen dieses Dokuments kann durch die Verwendung interner und/oder externer Ressourcen erreicht werden.
Systèmes de management de la sécurité des denrées alimentaires - Exigences pour tout organisme appartenant à la chaîne alimentaire (ISO 22000:2018)
Le présent document spécifie les exigences relatives à un système de management de la sécurité des denrées alimentaires (SMSDA) pour permettre à un organisme directement ou indirectement impliqué dans la chaîne alimentaire, de:
a) planifier, mettre en œuvre, exploiter, maintenir et actualiser un SMSDA fournissant des produits et services qui sont sûrs, conformément à leur utilisation prévue;
b) démontrer sa conformité aux exigences légales et réglementaires applicables en matière de sécurité des denrées alimentaires;
c) évaluer et apprécier les exigences en matière de sécurité des denrées alimentaires établies en accord avec le(s) client(s) et démontrer la conformité à celles-ci;
d) communiquer efficacement sur les questions relatives à la sécurité des denrées alimentaires avec les parties intéressées de la chaîne alimentaire;
e) garantir la conformité avec sa politique déclarée en matière de sécurité des denrées alimentaires;
f) démontrer cette conformité auprès des parties intéressées;
g) faire certifier ou enregistrer son SMSDA par un organisme externe, ou effectuer une auto-évaluation ou une auto-déclaration de conformité au présent document.
Toutes les exigences du présent document sont d'une portée générale et sont conçues pour s'appliquer à tous les organismes de la chaîne alimentaire, indépendamment de leur taille et de leur complexité. Les organismes directement ou indirectement impliqués incluent, entre autres, les producteurs d'aliments pour animaux producteurs de denrées alimentaires, les producteurs d'aliments pour animaux non producteurs de denrées alimentaires, les chasseurs/pêcheurs/cueilleurs, les agriculteurs, les producteurs d'ingrédients, les transformateurs de denrées alimentaires, les détaillants, les organismes fournissant des services de traiteur, de restauration, des services de nettoyage et de désinfection, des services de transport, d'entreposage et de distribution, et les fournisseurs d'équipements, de produits de nettoyage et de désinfection, de matériaux de conditionnement/emballage et d'autres matériaux en contact avec les denrées alimentaires.
Le présent document permet à tout organisme, y compris les organismes de petite taille et/ou peu développés (comme une petite ferme, un petit conditionneur-distributeur, un petit magasin de détail ou de service alimentaire), de mettre en œuvre des éléments élaborés en externe dans son SMSDA.
Des ressources internes et/ou externes peuvent être utilisées pour satisfaire aux exigences du présent document.
Sistemi vodenja varnosti živil - Zahteve za katerokoli organizacijo v prehranski verigi (ISO 22000:2018)
Ta dokument določa zahteve za sistem vodenja varnosti živil (FSMS) z namenom, da se organizaciji, ki je neposredno ali posredno vključena v prehransko verigo, omogoči:
a) načrtovanje, izvajanje, vodenje, vzdrževanje in posodabljanje sistema vodenja varnosti živil, s katerim se zagotovijo izdelki in storitve, ki so glede na namen uporabe varni;
b) prikazovanje skladnosti z ustreznimi zakonskimi in regulativnimi zahtevami za varnost živil;
c) vrednotenje in ocenjevanje medsebojno usklajenih zahtev kupcev glede varnosti živil ter prikazovanje skladnost z njimi;
d) uspešna predstavitev vidikov varnosti živil vključenim zainteresiranim strankam v prehranski verigi;
e) zagotavljanje, da organizacija usklajuje določeno politiko zagotavljanja varnih živil;
f) prikazovanje usklajenosti zadevnim zainteresiranim strankam;
g) pridobitev certifikacije ali registracije lastnega sistema vodenja varnosti živil pri zunanji organizaciji ali izvedba samoocenjevanja ali samodeklariranja skladnosti s tem dokumentom.
Vse zahteve tega dokumenta so splošne ter so namenjene vsem organizacijam v prehranski verigi ne glede na velikost in kompleksnost. Organizacije, ki so neposredno ali posredno vključene, brez omejitev vključujejo proizvajalce krme, proizvajalce hrane za živali, nabiralce divjih rastlin in lovce divjadi, kmete, proizvajalce sestavin, proizvajalce živil, prodajalce ter organizacije, ki zagotavljajo prehranske storitve, storitve gostinstva (»catering«), storitve čiščenja in sanitacije, storitve transporta, skladiščenja in distribucije ter dobavitelje opreme za čiščenje in sredstev za razkuževanje, embalaže in drugih materialov, namenjenih za stik z živili.
Ta dokument omogoča vsem organizacijam, tudi majhnim in/ali manj razvitim organizacijam (npr. malim kmetijam, distributerjem, trgovcem ali strežbi), da v svojem sistemu vodenja varnosti živil uvedejo elemente, razvite z zunanjo pomočjo.
Zahteve iz tega dokumenta je mogoče izpolniti z notranjimi in/ali zunanjimi sredstvi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2018
Nadomešča:
SIST EN ISO 22000:2005
SIST EN ISO 22000:2005/AC:2006
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)
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
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 comb
...
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
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
...
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 .
...
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