SIST EN ISO 22000:2018

SLOVENSKI SIST EN ISO 22000


STANDARD september 2018













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)

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.

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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

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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

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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
varnosti živil . 27 safety management system . 27
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
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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
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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


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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.


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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.
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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.

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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.

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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
...

SLOVENSKI STANDARD
oSIST prEN ISO 22000:2017
01-junij-2017
Sistemi vodenja varnosti živil - Zahteve za vsako organizacijo v prehranski verigi
(ISO/DIS 22000:2017)
Food safety management systems - Requirements for any organization in the food chain
(ISO/DIS 22000:2017)
Managementsysteme für die Lebensmittelsicherheit - Anforderungen an Organisationen
in der Lebensmittelkette (ISO/DIS 22000:2017)
Systèmes de management de la sécurité des denrées alimentaires - Exigences pour tout
organisme appartenant à la chaîne alimentaire (ISO/DIS 22000:2017)
Ta slovenski standard je istoveten z: prEN ISO 22000
ICS:
03.100.70 Sistemi vodenja Management systems
67.020 Procesi v živilski industriji Processes in the food
industry
oSIST prEN ISO 22000:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 22000:2017

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oSIST prEN ISO 22000:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 22000
ISO/TC 34/SC 17 Secretariat: DS
Voting begins on: Voting terminates on:
2017-04-10 2017-07-03
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
ICS: 67.020; 03.100.70
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 22000:2017(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2017

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oSIST prEN ISO 22000:2017
ISO/DIS 22000:2017(E)
ISO/DIS 22000:2017(E)

Contents
Foreword . v
Introduction. vi
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  Context of the organization . 10
4.1  Understanding the organization and its context . 10
4.2  Understanding the needs and expectations of interested parties . 10
4.3  Determining the scope of the food safety management system . 10
4.4  Food safety management system . 10
5  Leadership . 11
5.1  Leadership and commitment . 11
5.2  Food safety policy . 11
5.2.1  Establishing the food safety policy . 11
5.2.2  Communicating the food safety policy . 12
5.3  Organizational roles, responsibilities and authorities . 12
6  Planning . 12
6.1  Actions to address risks and opportunities . 12
6.2  Objectives of the food safety management system and planning to achieve them . 13
6.3  Planning of changes . 14
7  Support . 14
7.1  Resources . 14
7.1.1  General . 14
7.1.2  People . 14
7.1.3  Infrastructure . 15
7.1.4  Work environment . 15
7.1.5  Externally developed elements of the food safety management system . 15
7.1.6  Control of externally provided processes, products or services . 15
7.2  Competence . 16
7.3  Awareness . 16
7.4  Communication . 16
7.4.1  General . 16
7.4.2  External communication . 17
7.4.3  Internal communication . 17
7.5  Documented information . 18
7.5.1  General . 18
7.5.2  Creating and updating . 18
COPYRIGHT PROTECTED DOCUMENT
7.5.3  Control of documented information . 19
© ISO 2017, Published in Switzerland 8  Operation . 19
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form 8.1  Operational planning and control . 19
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
8.2  PRPs . 19
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
8.3  Traceability . 21
the requester.
8.4  Emergency preparedness and response . 21
ISO copyright office
Ch. de Blandonnet 8 • CP 401 8.4.1  General . 21
CH-1214 Vernier, Geneva, Switzerland
8.4.2  Handling of emergencies and incidents . 21
Tel. +41 22 749 01 11
8.5  Hazard control . 22
Fax +41 22 749 09 47
8.5.1  Preliminary steps to enable hazard analysis . 22
copyright@iso.org
www.iso.org
8.5.2  Hazard analysis . 24
ii © ISO 2017 – All rights reserved © ISO 2017 – All rights reserved iii

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oSIST prEN ISO 22000:2017
ISO/DIS 22000:2017(E)
Contents
Foreword . v
Introduction. vi
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  Context of the organization . 10
4.1  Understanding the organization and its context . 10
4.2  Understanding the needs and expectations of interested parties . 10
4.3  Determining the scope of the food safety management system . 10
4.4  Food safety management system . 10
5  Leadership . 11
5.1  Leadership and commitment . 11
5.2  Food safety policy . 11
5.2.1  Establishing the food safety policy . 11
5.2.2  Communicating the food safety policy . 12
5.3  Organizational roles, responsibilities and authorities . 12
6  Planning . 12
6.1  Actions to address risks and opportunities . 12
6.2  Objectives of the food safety management system and planning to achieve them . 13
6.3  Planning of changes . 14
7  Support . 14
7.1  Resources . 14
7.1.1  General . 14
7.1.2  People . 14
7.1.3  Infrastructure . 15
7.1.4  Work environment . 15
7.1.5  Externally developed elements of the food safety management system . 15
7.1.6  Control of externally provided processes, products or services . 15
7.2  Competence . 16
7.3  Awareness . 16
7.4  Communication . 16
7.4.1  General . 16
7.4.2  External communication . 17
7.4.3  Internal communication . 17
7.5  Documented information . 18
7.5.1  General . 18
7.5.2  Creating and updating . 18
7.5.3  Control of documented information . 19
8  Operation . 19
8.1  Operational planning and control . 19
8.2  PRPs . 19
8.3  Traceability . 21
8.4  Emergency preparedness and response . 21
8.4.1  General . 21
8.4.2  Handling of emergencies and incidents . 21
8.5  Hazard control . 22
8.5.1  Preliminary steps to enable hazard analysis . 22
8.5.2  Hazard analysis . 24
© ISO 2017 – All rights reserved iii

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oSIST prEN ISO 22000:2017
ISO/DIS 22000:2017(E)
8.5.3  Validation of control measure(s) and combination(s) of control measure(s) . 26
8.5.4  Hazard control plan (HACCP/OPRP plan) . 26
8.6  Updating the information specifying the PRPs and the hazard control plan . 28
8.7  Control of monitoring and measuring . 28
8.8  Verification related to PRPs and the hazard control plan . 29
8.8.1  Verification . 29
8.8.2  Analysis of results of verification activities . 29
8.9  Control of product and process nonconformities . 30
8.9.1  General . 30
8.9.2  Corrective actions . 30
8.9.3  Corrections . 30
8.9.4  Handling of potentially unsafe products . 31
8.9.5  Withdrawal/Recall . 32
9  Performance evaluation of the food safety management system . 32
9.1  Monitoring, measurement, analysis and evaluation . 32
9.1.1  General . 32
9.1.2  Analysis and evaluation . 33
9.2  Internal audit . 33
9.3  Management review . 34
9.3.1  General . 34
9.3.2  Management review input . 34
9.3.3  Management review output . 35
10  Improvement . 35
10.1  Nonconformity and corrective action . 35
10.2  Updating the food safety management system . 36
10.3  Continual improvement . 36
Annex A (informative) Cross references between the CODEX HACCP and ISO 22000:XXXX . 37
Annex B (informative) Comparison of ISO/DIS 22000 versus ISO 22000:22005 . 38
Bibliography . 41

iv © ISO 2017 – All rights reserved

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oSIST prEN ISO 22000:2017
ISO/DIS 22000:2017(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 on 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 the following URL:
www.iso.org/iso/foreword.html.
The committee responsible for this document is Technical Committee ISO/TC 34, Food products,
Subcommittee SC 17, Management system for food safety.
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.
The following Annexes are included to provide the users of this document further information:
‐ Annex A Cross references between the CODEX HACCP principles and this document;
‐ Annex B Comparison of clauses between this draft standard (ISO/DIS 22000:2017) and the – at
present – existing version (ISO 22000:2005).


© ISO 2017 – All rights reserved v

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oSIST prEN ISO 22000:2017
ISO/DIS 22000:2017(E)
Introduction
0.1 General
The adoption of a food safety management system 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 food safety management system based on this document are:
a) the ability to consistently provide safe foods and relevant 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 food safety management system
requirements.
This document employs the process approach (see 0.3), which incorporates the Plan‐Do‐Check‐Act
(PDCA) (0.3.2) cycle and risk‐based thinking (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 food safety management system 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.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated
requirement.
0.2 Food safety management system principles
Food safety is related to the presence of food safety hazards at the time of consumption (intake by the
consumer). As the introduction of food safety hazards can occur at any stage of the food chain, adequate
control throughout the food chain is essential. Thus, food safety is ensured through the combined
efforts of all the parties in the food chain. This document specifies the requirements for a food safety
management system that combines the following generally recognized key elements:
‐ interactive communication;
‐ system management;
‐ prerequisite programmes;
‐ hazard analysis and critical control points (HACCP) principles.
vi © ISO 2017 – All rights reserved

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oSIST prEN ISO 22000:2017
ISO/DIS 22000:2017(E)
In addition, this document is based on the principles that are common to all other ISO management
system standards. The management principles are:
‐ customer focus;
‐ leadership;
‐ engagement of people;
‐ process approach;
‐ improvement;
‐ evidence‐based decision making;
‐ relationship management.
0.3 Process approach
0.3.1 General
This document promotes the adoption of a process approach when developing and implementing a food
safety management system and improving its effectiveness in order to enhance production of safe
products and services and meet 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 and 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
against policies, objectives, requirements and planned 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 embraces two PDCA cycles. One
cycle covers the over
...