ISO 22000 Standard
Short Description
Descripción: ISO 22000...
Description
INTERNATIONAL STANDARD
ISO 22000
First edition edition 2005-09-01
Food safety management systems ..:.Requirements for any organization in te food !ain Systemes de management de la sfJCurite des denrees alimentaires Exigences pour tout organisme appartenant a la chaine alimentaire
Reference Reference number ISO 22000:2005(E)
© ISO 2005
INTERNATIONAL STANDARD
ISO 22000
First edition edition 2005-09-01
Food safety management systems ..:.Requirements for any organization in te food !ain Systemes de management de la sfJCurite des denrees alimentaires Exigences pour tout organisme appartenant a la chaine alimentaire
Reference Reference number ISO 22000:2005(E)
© ISO 2005
ISO ""###:"##$%E&
'DF disclaimer !is "#F file ma$ contain embedded t$%efaces& In accordance 'it! dobes licensin* %olic$+ %olic$+ t!is file ma$ be %rinted or ,ie'ed but s!all not be edited unless t!e t$%efaces '!ic! are embedded are licensed to and installed on t!e com%uter %erformin* t!e editin*& In do'nloadin* do'nloadin* t!is file+ %arties acce%t t!erein t!e res%onsibilit$ of not infrin*in* dobes licensin* %olic$& %olic$& !e ISO entral Secretariat acce%ts no liabilit$ in t!is area&
dobe is a trademar. trademar. of dobe S$stems Incor%orated& Incor%orated& #etails of t!e soft'are %roducts used to create t!is "#F file can be found in t!e /eneral Info relati,e to t!e file t!e "#F-creation %arameters 'ere o%timied for %rintin*& E,er$ care !as been ta.en to ensure t!at t!e file is suitable for use b$ ISO member bodies& In t!e unli.el$ e,ent t!at a %roblem relatin* to it is found+ %lease inform t!e entral Secretariat at t!e address *i,en belo'&
© ISO 2005 ll ri*!ts reser,ed& nless nless ot!er'ise s%ecified+ s%ecified+ no %art of t!is %ublication %ublication ma$ be re%roduced or utilied utilied in an$ form or b$ an$ means+ electronic electronic or mec!anical+ includin* %!otoco%$in* %!otoco%$in* and microfilm+ 'it!out %ermission in 'ritin* from eit!er ISO at t!e address belo' or ISOs member bod$ in t!e countr$ of t!e re3uester& ISO co%$ri*!t office ase %ostale 54 -1211 -1211 /ene,a 20 el& 6 7122 8790111 Fa 6 71228790978 E-mail co%$ri*!tiso&or* co%$ri*!tiso&or* ;eb '''&iso&or* "ublis!ed in S'iterland
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< ISO 2005 - ll ri*!ts reser,ed
ISO :l0;:0;==t:)
(ontents
"a*e
1
Sco%e &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&& &&&&&&& &&&&&&&&&&&&& &&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&& &&&& &&&&&&& &&&& &&& &1
2
>ormati,e refe rences &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&& &&&&&&&&&&&&&& &&&&&&& &&&&&&&&&&&&& &&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&& &&&& &&&&&&& &&&& &&& &1
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erms an d defi n itions &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&& &&&&&&&&&&&&& &&&&&& &&&&&&&&&& &&& &&&&&&&&&&&&&& &&&&&&& &&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&& &&&&&&&&&&2 &&&&2
7
Food safet$ mana*ement mana*ement s$stem &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&& &&&&&&&&&&& &&&&&& &&&&&&&&&&&& &&&&&&&&&&&&& &&&&&&&&&&&& &&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&& &&&&&&&&&7 &&&7
7&1 /ene ral re3u
i
rements
&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&7
7&2 #ocumentation re3 ui rements &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&: &&&&&&&&&&&&5 5 @ana*ement res%onsibi lit$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&5 5&1 @ana*ement commitment &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&5 5&2 Food safet$ %ol ic$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&4 5&? Food safet$ mana*ement s$stem %lannin* &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&4 5&7 Res%onsi bil it$ and aut!orit$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&4 5&5 Food safet$ team leader &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&4 5&4 ommu n ication &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&8 5&8 Emer*enc$ %re%aredness and res%onse &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&A 5&A @ana*ement re,ie' &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&A 4 Resou rce mana*ement &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&A 4&1 "ro,ision of resources &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&A 4&2 uman resources &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&B &&&&&&&&&&&&&&&&&&&&&&9 4&? I nfrastructu re &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&9 4&7 ;or. en,i ronment &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&9 8 "lannin* and realiation of safe %roducts &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&9 8&1 /ene ral &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&: &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&9 8&2 "rere3 uisite %ro* rammes (" R"s) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&10 8&? "reliminar$ ste%s to enable !aard anal$sis &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&11 8&7 aa rd anal$sis &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&1? 8&5 Establis!in* t!e o%erational %rere3uisite %ro*rammes ("R"s) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&17 8&4 Establ is!in* t!e " %lan &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&C&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&C&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 17 8&8 %datin* of %reliminar$ information and documents s%ecif$in* t!e "R"s and t!e " %i an &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&15 8&A Derification % lann i n* &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&14 8&9 raceabi lit$ s$stem &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&14 8&10 ontrol of nonconformit$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&: &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&14 A Dalidation+ Dalidation+ ,erification and im%ro,ement im%ro,ement of t!e food safet$ mana*ement mana*ement s$stem &&&&&&&&&&&& &&&&&&&&&&&&&&&&&&& &1A A&1 /en e ral &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&& &&&&&&&& &&& 1A A&2 Dalidatio Dalidation n of control measure measure combinations combinations &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&& &&&&&&& &&&&&&&&19 &19 A&? ontrol of mon itorin* and measurin* &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&19 A&7 Food safet$ mana*ement mana*ement s$stem ,erification &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&C&&&&&&&&&&&&&&&&&&&&&&&&&&& 19& A&5 Im%ro,ement Im%ro,ement &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&& &&&&&&&& &&&&&&&&&&&&& &&&&&&&&& 20
< ISO 2005 - ll ri*!ts reser,ed
Hi
ISO 22000:2005(E)
nne (informati, (informati,e) e) ross ross refere references nces bet'een bet'een ISO 22000:2005 22000:2005 and ISO ISO 9001:20 9001:2000 00 &&&&&&&& &&&&&&&&&&&&& &&&&&&&&& &&&&&&&&& &&&&&&&&&& &&&&&&&&&&&&22 &&&&&&&22 nne (informat (informati,e) i,e) ross ross references references bet'een bet'een " " and ISO ISO 22000:2 22000:2005 005 &&&&&& &&&&&&&&&&& &&&&&&&&& &&&&&&&&& &&&&&&&&&& &&&&&&&&&& &&&&&&&&&&&&&& &&&&&&&&&&&&&&&28 &&&&&&28 nne (inform (informati,e) ati,e) ode ode references references %ro,idin* %ro,idin* eam%les eam%les of control control measur measures+ es+ includin* includin* %rere3uisite %ro*rammes and *uidance for t!eir selection selecti on and use &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&2A &&&&&&&&&&&&&2A +
i blio*ra%!$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&? &&&&&&&&&?2 2
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ISO ""###:"##$%E&
Fore)ord ISO (t!e International Or*aniation for Standardiation) is a 'orld'ide federation of national standards bodies (ISO member bodies)& !e 'or. of %re%arin* International Standards is normall$ carried out t!rou*! ISO tec!nical committees& Eac! member bod$ interested in a subect for '!ic! a tec!nical committee !as been establis!ed !as t!e ri*!t to be re%resented on t!at committee& International or*aniations+ *o,ernmental and non-*o,ernmental+ in liaison 'it! ISO+ also ta.e %art in t!e 'or.& ISO collaborates closel$ 'it! t!e International Electrotec!nical ommission (lEe) on all matters of electrotec!nical standardiation& International Standards are drafted in accordance 'it! t!e rules *i,en in t!e ISOGIE #irecti,es+ "art 2& !e main tas. of tec!nical committees is to %re%are International Standards& #raft International Standards ado%ted b$ t!e tec!nical committees are circulated to t!e member bodies for ,otin*& "ublication as an International Standard re3uires a%%ro,al b$ at least 85 % of t!e member bodies castin* a ,ote& ttention is dra'n to t!e %ossibilit$ t!at some of t!e elements of t!is document ma$ be t!e subect of %atent ri*!ts& ISO s!all not be !eld res%onsible for identif$in* an$ or all suc! %atent ri*!ts& ISO 22000 'as %re%ared b$ ec!nical ommittee ISOG ?7+ Food products.
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ISO ""###:"##$%E&
Introdu!tion Food safet$ is related to t!e %resence of food-borne !aards in food at t!e %oint of consum%tion (inta.e b$ t!e consumer)& s t!e introduction of food safet$ !aards can occur at an$ sta*e of t!e food c!ain+ ade3uate control t!rou*!out t!e food c!ain is essential& !us+ food safet$ is ensured t!rou*! t!e combined efforts of all t!e %arties %artici%atin* in t!e food c!ain& Or*aniations 'it!in t!e food c!ain ran*e from feed %roducers and %rimar$ %roducers t!rou*! food manufacturers+ trans%ort and stora*e o%erators and subcontractors to retail and food ser,ice outlets (to*et!er 'it! inter-related or*aniations suc! as %roducers of e3ui%ment+ %ac.a*in* material+ cleanin* a*ents+ additi,es and in*redients)& Ser,ice %ro,iders are also included& !is International Standard s%ecifies t!e re3uirements for a food safet$ mana*ement s$stem t!at combines t!e follo'in* *enerall$ reco*nied .e$ elements to ensure food safet$ alon* t!e food c!ain+ u% to t!e %oint of final consum%tion: interacti,e communication s$stem mana*ement %rere3uisite %ro*rammes " %rinci%les& ommunication alon* t!e food c!ain is essential to ensure t!at all rele,ant food safet$ !aards are identified and ade3uatel$ controlled at eac! ste% 'it!in t!e food c!ain& !is im%lies communication bet'een or*aniations bot! u%stream and do'nstream in t!e food c!ain& ommunication 'it! customers and su%%liers about identified !aards and control measures 'ill assist in clarif$in* customer and su%%lier re3uirements (e&*& 'it! re*ard to t!e feasibilit$ and need for t!ese re3uirements and t!eir im%act on t!e end %roduct)& Reco*nition of t!e or*aniations role and %osition 'it!in t!e food c!ain is essential to ensure effecti,e interacti,e communication t!rou*!out t!e c!ain in order to deli,er safe food %roducts to t!e final consumer& n eam%le of t!e communication c!annels amon* interested %arties of t!e food c!ain is s!o'n in Fi*ure 1& !e most effecti,e food safet$ s$stems are establis!ed+ o%erated and u%dated 'it!in t!e frame'or. of a structured mana*ement s$stem and incor%orated into t!e o,erall mana*ement acti,ities of t!e or*aniation& !is %ro,ides maimum benefit for t!e or*aniation and interested %arties& !is International Standard !as been ali*ned 'it! ISO 9001 in order to en!ance t!e com%atibilit$ of t!e t'o standards& ross-references bet'een t!is International Standard and ISO 9001 are %ro,ided in nne & !is International Standard can be a%%lied inde%endentl$ of ot!er mana*ement s$stem standards& Its im%lementation can be ali*ned or inte*rated 'it! eistin* related mana*ement s$stem re3uirements+ '!ile or*aniations ma$ utilie eistin* mana*ement s$stem(s) to establis! a food safet$ mana*ement s$stem t!at com%lies 'it! t!e re3uirements of t!is International Standard& !is International Standard inte*rates t!e %rinci%les of t!e aard nal$sis and ritical ontrol "oint (") s$stem and a%%lication ste%s de,elo%ed b$ t!e ode limentarius ommission& $ means of auditable re3uirements+ it combines t!e " %lan 'it! %rere3uisite %ro*rammes ("R"s)& aard anal$sis is t!e .e$ to an effecti,e food safet$ mana*ement s$stem+ since conductin* a !aard anal$sis assists in or*aniin* t!e .no'led*e re3uired to establis! an effecti,e combination of control measures& !is International Standard re3uires t!at all !aards t!at ma$ be reasonabl$ e%ected to occur in t!e food c!ain+ includin* !aards t!at ma$ be associated 'it! t!e t$%e of %rocess and facilities used+ are identified and assessed& !us it %ro,ides t!e means fo determine and document '!$ certain identified !aards need to be controlled b$ a %articular or*aniation and '!$ ot!ers need not&
#urin* !aard anal$sis+ t!e or*aniation determines t!e strate*$ to be used to ensure !aard control b$ combinin* t!e "R"(s)+ o%erational "R"(s) and t!e " %lan&
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.
+ .
.
ro% %roducers
"roducers of %esticides+ fertiliers+ and ,eterinar$ dru*s
Feed %roducers
Food c!ain for t!e %roduction of in*redients and additi,es rans%ort and stora*e o%erators
"rimar$ food %roducers "roducers of e3ui%ment Food manufacturers
Secondar$ food manufacturers
"roducers of cleanin* and sanitiin* a*ents "roducers of %ac.a*in* materials Ser,ice %ro,iders
;!olesalers
Retailers+ food ser,ice o%erators and caterers
onsumers
>OE !e fi*ure does not s!o' t!e t$%e of interacti,e communications a lon* and across t!e food c!ain t!at b$-%ass immediate su%%liers and customers&
Figure , - Eam/e of !ommuni!ation )itin te food !ain ross-references bet'een t!e ode limentarius ommission " %rinci%les and a%%lication ste%s (see Reference 0,,1& and t!is International Standard are %ro,ided in nne & o facilitate t!e a%%lication of t!is International Standard+ it !as been de,elo%ed as an auditable standard& o'e,er+ indi,idual or*aniations are free to c!oose t!e necessar$ met!ods and a%%roac!es to fulfil t!e re3uirements of t!is International Standard& o assist indi,idual or*aniations 'it! t!e im%lementation of t!is International Standard+ *uidance on its use is %ro,ided in ISOIS 22007& !is International Standard is intended to address as%ects of food safet$ concerns onl$& !e same a%%roac! as %ro,ided b$ t!is International Standard can be used to or*anie and res%ond to ot!er food s%ecific as%ects (e&*& et!ical issues and consumer a'areness)& !is International Standard allo's an or*aniation (suc! as a small andGor less de,elo%ed or*aniation) to im%lement an eternall$ de,elo%ed combination of control measures& !e aim of t!is International Standard is to !armonie on a *lobal le,el t!e re3uirements for food safet$ mana*ement for businesses 'it!in t!e food c!ain& It is %articularl$ intended for a%%lication b$ or*aniations t!at see. a more focused+ co!erent and inte*rated food safet$ mana*ement s$stem t!an is normall$ re3uired b$ la'& It re3uires an or*aniation to meet an$ a%%licable food safet$ related statutor$ and re*ulator$ re3uirementsH t!rou*! its food safet$ mana*ement s$stem&
© ISO 2005 - ll ri*!ts reser,ed
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INTERNATIONAL STANDARD
ISO ""###:"##$%E&
Food safety management systems - Requirements 2for any organization in te food !ain
, S!oe !is International Standard s%ecifies re3uirements for a food safet$ mana*ement s$stem '!ere an or*aniation in t!e food c!ain needs to demonstrate its abilit$ to control food safet$ !aards in order to ensure t!at food is safe at t!e time of !uman consum%tion& It is a%%licable& to all or*aniations+ re*ardless of sie+ '!ic! are in,ol,ed in an$ as%ect of t!e food c!ain and 'ant to im%lement s$stems t!at consistentl$ %ro,ide safe %roducts& !e means of meetin* an$ re3uirements of t!is International Standard can be accom%lis!ed t!rou*! t!e use of internal andGor eternal resources& !is International Standard s%ecifies re3uirements to enable an or*aniation
e)
to %lan+ im%lement+ o%erate+ maintain and u%date a food safet$ mana*ement s$stem aimed at %ro,idin* %roducts t!at+ accordin* to t!eir intended use+ are safe for t!e consumer+
f)
to demonstrate com%liance 'it! a%%licable statutor$ and re*ulator$ food safet$ re3uirements+
*)
to e,aluate and assess customer re3uirements and demonstrate conformit$ 'it! t!ose mutuall$ a*reed customer re3uirements t!at relate to food safet$+ in order to en!ance customer satisfaction+
!)
to effecti,el$ communicate food safet$ issues to t!eir su%%liers+ customers and rele,ant interested %arties in t!e food c!ain+
i)
to ensure t!at t!e or*aniation conforms to its stated food safet$ %olic$+
) .)
to demonstrate suc! conformit$ to rele,ant interested %arties+ and to see. certification or re*istration of its food safet$ mana*ement s$stem b$ an eternal or*aniation+ or ma.e a self-assessment or self-declaration of conformit$ to t!is International Standard&
ll re3uirements of t!is International Standard are *eneric and are intended to be a%%licable to all or*aniations in t!e food c!ain re*ardless of sie and com%leit$& !is includes or*aniations directl$ or indirectl$ in,ol,ed in one or more ste%s of t!e food c!ain& Or*aniations t!at are directl$ in,ol,ed include+ but are not limited to+ feed %roducers+ !ar,esters+ farmers+ %roducers of in*redients+ food manufacturers+ retailers+ food ser,ices+ caterin* ser,ices+ or*aniations %ro,idin* cleanin* and sanitation ser,ices+ trans%ortation+ stora*e and distribution ser,ices& Ot!er or*aniations t!at are indirectl$ in,ol,ed include+ but are not limited to+ su%%liers of e3ui%ment+ cleanin* and sanitiin* a*ents+ %ac.a*in* material+ and ot!er food contact materials& !is International Standard allo's an or*aniation+ suc! as a small andGor less de,elo%ed or*aniation (e&*& a small farm+ a small %ac.er-distributor+ a small retail or food ser,ice outlet)+ to im%lement an eternall$ de,elo%ed combination of control measures& >OE /uidance on t!e a%%lication of t!is International Standard is *i,en in ISOITS 22!.
" Normati3e referen!es !e follo'in* referenced documents are indis%ensable for t!e a%%lication of t!is document& For dated references+ onl$ t!e edition cited a%%lies& For undated references+ t!e latest edition of t!e referenced document (includin* an$ amendments) a%%lies& ISO 9000:2000+ "uality management systems - Fundamentals and #oca$ulary
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ISO 22000:2005(E)
? erms and definitions For t!e %ur%oses of t!is document+ t!e terms and definitions *i, en in ISO 9000 and t!e follo'in* a%%l$& For t!e con,enience of t!e users of t!is International Standard+ some of t!e definitions in ISO 9000 are 3uoted 'it! added notes t!at are a%%licable onl$ to t!is s%ecial a%%lication& >OE erms are not defined '!ere t!e$ retain t!eir normal dictionar$ definition& ;!ere bold t$%e is used in a definition+ t!is indicates a cross-reference to anot!er term defined in t!is clause+ and t!e number reference for t!e term is *i,en in %arent!eses&
3.1 food safet$ conce%t t!at food 'ill not cause !arm to t!e consumer '!en it is %re%ared andGor eaten accordin* to its intended use
>OE 1 da%ted f rom Reference 11J& >OE 2 Food safet$ is related to t!e occurrence of food safet$ !aards (?&?) and does not include ot!er !uman !ealt! as%ects related to+ for eam%le+ m alnutrition& 3.2
food c!ain se3uence of t!e sta*es and o%erations in,ol,ed in t!e %roduction+ %rocessin*+ distribution+ stora*e and !andlin* of a food and its in*redients+ from %rimar$ %roduction to consum%tion >OE 1 !is includes t!e %roduction of feed for food-%roducin* animals and for animals intended for food %roduction& >OE 2 !e food c!ain also includes t!e %roduction of materials intended to come into contact 'it! food or ra' materials& 3.3
food safet$ !aard biolo*ical+ c!emical or %!$sical a*ent in food+ or condition of food+ 'it! t!e %otential to cause an ad,erse !ealt! effect
>OE 1 da%ted f rom Reference 11J& >OE 2 !e term B!aardB is not to be confused 'it! t!e term Bris.B '!ic!+ in t!e contet of food safet$+ means a function of t!e %robabilit$ of an ad,erse !ealt! effect (e&*& becomin* diseased) and t!e se,erit$ of t!at effect (deat!+ !os%italiation+ absence from 'or.+ etc&) '!en e%osed to a s%ecified !aard& Ris. is defined in ISOGlEe /uide 51 as t!e combination of t!e %robabilit$ of occurrence of !arm and t!e se,erit$ of t!at !arm& >OE ? Food safet$ !aards include aller*ens& >OE 7 In t!e contet of feed and feed in*redients+ rele,ant food safet$ !aards are t!ose t!at ma$ be %resent in andGor on feed and feed in*redients and t!at ma$ subse3uentl$ be transferred to food t!rou*! animal consum%tion of feed and ma$ t!us !a,e t!e %otential to cause an ad,erse !uman !ealt! effect& In t!e contet of o%erations ot!er t!an t!ose directl$ !andlin* feed and food (e&*& %roducers of %ac.a*in* materials+ cleanin* a*ents+ etc&)+ rele,ant food safet$ !aards are t!ose !aards t!at can be directl$ or indirectl$ transferred to food because of t!e intended use of t!e %ro,ided %roducts andGor ser,ices and t!us can !a,e t!e %otential to cause an ad,erse !uman !ealt! effect& 3.4
food safet$ %olic$ o,erall intentions and direction of an or*aniation related to food safet$ (?&1) as formall$ e%ressed b$ to% mana*ement
3.5
end %roduct %roduct t!at 'ill under*o no furt!er %rocessin* or transformation b$ t!e or*aniation >OE %roduct t!at under*oes furt!er %rocessin* or transformation b$ anot!er or*aniation is an e-nd %roduct in t!e contet of t!e first or*aniation and a ra' material or an in*redient in t!e contet of t!e second or*aniation&
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3.6 flo' dia*ram sc!ematic and s$stematic %resentation of t!e se3uence and interactions of ste%s 3.7
control measure (food safet$) action or acti,it$ t!at can be used to %re,ent or eliminate a food safet$ !aard (?&?) or reduce it to an acce%table le,el >OE da%ted from Reference 11J&
3.8 "R" %rere3uisite %ro*ramme (food safet$) basic conditions and acti,ities t!at are necessar$ to maintain a !$*ienic en,ironment t!rou*!out t!e food c!ain (?&2) suitable for t!e %roduction+ !andlin* and %ro,ision of safe end %roducts (?:5) and safe food for !uman consum%tion >OE !e "R"s needed de%end on t!e se*ment of t!e food c!ain in '!ic! t!e or*aniation o%erates and t!e t$%e of o r*aniation (see nne )& Eam%les of e3ui,alent terms are: /ood *ricultural "ractice (/")+ /ood Deterinarian "ractice (/D")+ /ood @anufacturin* "ractice (/@")+ /ood $*ienic "ractice (/")+ /ood "roduction "ractice (/"")+ /ood #istribution "ractice (/#") and /ood radin* "ractice (/")& 3.9
o%erational "R" o%erational %rere3uisite %ro*ramme "R" (?&A) identified b$ t!e !aard anal$sis as essential in order to control t!e li.eli!ood of introducin* food safet$ !aards (?&?) to andGor t!e contamination or %roliferation of food safet$ !aards in t!e %roduct(s) or in t!e %rocessin* en,ironment 3.10 " critical control %oint (food safet$) ste% at '!ic! control can be a%%lied and is essential to %re,ent or eliminate a food safet$ !aard (?&?) or reduce it to an acce%table le,el >OE da%ted from Reference 11J&
3.11 critical limit criterion '!ic! se%arates acce%tabilit$ from unacce%tabilit$ >OE 1 da%ted from Reference 11J& >OE 2 ritical limits are establis!ed to determine '!et!er a " (?&10) remains in control& If a critical limit is eceeded or ,iolated+ t!e %roducts affected are deemed to be %otentiall$ unsafe&
3.12 monitorin* conductin* a %lanned se3uence of obser,ations or measurements to assess '!et!er control measures (?&8) are o%eratin* as intended 3.13 correction action to eliminate a detected nonconformit$ ISO 9000:2000, definition ?&4&4J >OE 1 For t!e %ur%oses of t!is International Standard+ a correction relates to t!e !andlin* of %otentiall$ unsafe %roducts+ & and can t!erefore be made in conunction 'it! a correcti,e action (?&17)&
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>OE 2 correction ma$ be+ for eam%le+ re%rocessin*+ furt!er %rocessin*+ andGor elimination of t!e ad,erse conse3uences of t!e nonconformit$ (suc! as dis%osal for ot!er use or s%ecific labellin*)&
3.14 correcti,e action action to eliminate t!e cause of a detected nonconformit$ or ot!er undesirable situation >OE 1 !ere can be more t!an one cause for a nonconformit$& ISO 9000:2000+ definition ?&4&5J >OE 2 orrecti,e action includes cause anal$sis and is ta.en to %re,ent recurrence&
3.15 ,alidation (food safet$) obtainin* e,idence t!at t!e control measures (?&8) mana*ed b$ t!e " %lan and b$ t!e o%erational "R"s (?&9) are ca%able of bein* effecti,e >OE !is definition is based on Reference 11J and is more suitable for t!e field of food safet$ (?&1) t!an t!e definition *i,en in ISO 9000&
3.16 ,erification confirmation+ t!rou*! t!e %ro,ision of obecti,e e,idence+ t!at s%ecified re3uirements !a,e been fulfilled ISO 9000:2000+ definition ?&A&7J
3.17 u%datin* immediate andGor %lanned acti,it$ to ensure a%%lication of t!e most recent information
7 Food safet$ mana*ement s$stem
4.1 /eneral re3uirements !e or*aniation s!all establis!+ document+ im%lement and maintain an effecti,e food safet$ mana*ement s$stem and u%date it '!en necessar$ in accordance 'it! t!e re3uirements of t!is International Standard& !e or*aniation s!all define t!e sco%e of t!e food safet$ mana*ement s$stem& !e sco%e s!all s%ecif$ t!e %roducts or %roduct cate*ories+ %rocesses and %roduction sites t!at are addressed b$ t!e food safet$ mana*ement s$stem&
!e or*aniation s!all
l)
ensure t!at food safet$ !aards t!at ma$ be reasonabl$ e%ected to occur in relation to %roducts 'it!in t!e sco%e of t!e s$stem are identified+ e,aluated and controlled in suc! a manner t!at t!e %roducts of t!e or*aniation do not+ directl$ or indirectl$+ !arm t!e consumer+
m) communicate a%%ro%riate information t!rou*!out t!e food c!ain re*ardin* safet$ issues related to its %roducts+ n)
communicate information concernin* de,elo%ment+ im%lementation and u%datin* of t!e food safet$ mana*ement s$stem t!rou*!out t!e or*aniation+ to t!e etent necessar$ to ensure t!e food safet$ re3uired b$ t!is International Standard+ and
o)
e,aluate %eriodicall$+ and u%date '!en necessar$+ t!e food safet$ mana*ement s$stem to ensure t!at t!e s$stem reflects t!e or*aniations acti,ities and incor%orates t!e most recent information on t!e food safet$ !aards subect to control&
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;!ere an or*aniation c!ooses to outsource an$ %rocess t!at ma$ affect end %roduct conformit$+ t!e or*aniation s!all ensure control o,er suc! %rocesses& ontrol of suc! outsourced %rocesses s!all be identified and documented 'it!in t!e food safet$ mana*ement s$stem&
4." Do!umentation requirements 4."., 5enera/ !e food safet$ mana*ement s$stem documentation s!all include
%) 3)
documented statements of a food safet$ %olic$ and related obecti,es (see 5&2)+
r)
documents needed b$ t!e or*aniation to ensure t!e effecti,e de,elo%ment+ im%lementation and u%datin* of t!e food safet$ mana*ement s$stem&
documented %rocedures and records re3uired b$ t!is International Standard+ and
4."." (ontro/ of do!uments #ocuments re3uired b$ t!e food safet$ mana*ement s$stem s!all be controlled& Records are a s%ecial t$%e of
document and s!all be controlled accordin* to t!e re3uirements *i,en in 4.2.3. !e controls s!all ensure t!at all %ro%osed c!an*es are re,ie'ed %rior to im%lementation to determine t!eir effects on food safet$ and t!eir im%act on t!e food safet$ mana*ement s$stem& documented %rocedure s!all be establis!ed to define t!e controls needed
s) t) u) ,)
to a%%ro,e documents for ade3uac$ %rior to issue+ to re,ie' and u%date documents as necessar$+ and re-a%%ro,e documents+ to ensure t!at c!an*es and t!e current re,ision status of documents are identified+ to ensure t!at rele,ant ,ersions of a%%licable documents are a,ailable at %oints of
use+ e) to ensure t!at documents remain le*ible and readil$ identifiable+ f) to ensure t!at rele,ant documents of eternal ori*in are identified and t!eir distribution controlled+ and
')
to %re,ent t!e unintended use of obsolete documents+ and to ensure t!at t!e$ are suitabl$ identified as suc! if t!e$ are retained for an$ %ur%ose&
4.".6 (ontro/ of re!ords Records s!all be establis!ed and maintained to %ro,ide e,idence of conformit$ to re3uirements and e,idence of t!e effecti,e o%eration of t!e food safet$ mana*ement s$stem& Records s!all remain le*ible+ readil$ identifiable and retrie,able& documented %rocedure s!all be establis!ed to define t!e controls needed for t!e identification+ stora*e+ %rotection+ retrie,al+ retention time and dis%osition of records&
$ 7anagement resonsi8i/ity $., 7anagement !ommitment o% mana*ement s!all %ro,ide e,idence of its commitment to t!e de,elo%ment and im%lementation of t!e food safet$ mana*ement s$stem and to continuall$ im%ro,in* its effecti,eness b$
)
s!o'in* food safet$ is su%%orted b$ t!e business obecti,es of t!e or*aniation+
$)
communicatin* to t!e or*aniation t!e im%ortance of meetin* t!e re3uirements of t!is International Standard+ an$ statutor$ and re*ulator$ re3uirements+ as 'ell as customer re3uirements relatin* to food safet$+
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) establis!in* t!e food safet$ %olic$+ conductin* mana*ement re,ie's+ and aa) bb)
ensurin* t!e a,ailabilit$ of resources&
$." Food safety o/i!y o% mana*ement s!all define+ document and communicate its food safet$ %olic$& o% mana*ement s!all ensure t!at t!e food safet$ %olic$
cc)
is a%%ro%riate to t!e role of t!e or*aniation in t!e food c!ain+
dd)
conforms 'it! bot! statutor$ and re*ulator$ re3uirements and 'it! mutuall$ a*reed food safet$ re3uirements of customers+
ee) ff)
is communicated+ im%lemented and maintained at all le,els of t!e or*aniation+
is re,ie'ed for continued suitabilit$ (see 5&A)+
**)
ade3uatel$ addresses communication (see 5&4)+ and
!!)
is su%%orted b$ measurable obecti,es&
$.6 Food safety management system /anning o% mana*ements!all ensure t!at
ii) )
%lannin* of t!e f ood safet$ mana*ement s$stem is carried out to meet re3uirements *i,en in 7&1 as 'ell as t!e obecti,es of t!e or*aniation t!at su%%ort food safet$+ and t!e inte*rit$ of t!e food safet$ mana*ement s$stem is maintained '!en c!an*es to t!e food safet$ mana*ement s$stem are %lanned and im%lemented&
$.4 Resonsi8i/ity and autority o% mana*ement s!all ensure t!at res%onsibilities and aut!orities are defined and communicated 'it!in t!e or*aniation to ensure t!e effecti,e o%eration and maintenance of t!e food safet$ mana*ement s$stem& ll %ersonnel s!all !a,e res%onsibilit$ to re%ort %roblems 'it! t!e food safet$ mana*ement s$stem to identified %erson(s)& #esi*nated %ersonnel s!all !a,e defined res%onsibilit$ and aut!orit$ to initiate and record actions&
$.$ Food safety team /eader o% mana*ement s!all a%%oint a food safet$ team leader '!o+ irres%ecti,e of ot!er res%onsibilities+ s!all !a,e t!e res%onsibilit$ and aut!orit$
..) ll)
to mana*e a food safet$ team (see 8&?&2) and or*anie its 'or.+
to ensure rele,ant trainin* and education of t!e food safet$ team members (see 4&2&1)+
mm)
to ensure t!at t!e food safet$ mana*ement s$stem is establis!ed+ im%lemented+ maintained and u%dated+
and
nn) to re%ort to t!e or*aniations to% mana*ement on t!e effecti,eness and suitabilit$ of t!e
food safet$
mana*ement s$stem& >OE !e res%onsibilit$ of t!e food safet$ team leader ma$ i nclude liaison 'it! eternal %arties on matters relatin* to t!e food safet$ mana*ement s$stem&
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$.9 (ommuni!ation $.9., Eterna/ !ommuni!ation +
o ensure t!at sufficient information on issues concernin* food safet$ is a,ailable t!rou*!out t!e food c!ain+ t!e or*aniation s!all establis!+ im%lement and maintain effecti,e arran*ements for communicatin* 'it!
oo)
su%%liers and contractors+
%%)
customers or consumers+ in %articular in relation to %roduct information (includin* instructions re*ardin* intended use+ s%ecific stora*e re3uirements and+ as a%%ro%riate+ s!elf life)+ en3uiries+ contracts or order!andlin* includin* amendments+ and customer feedbac. includin* customer com%laints+
33) rr)
statutor$ and re*ulator$ aut!orities+ and
ot!er or*aniations t!at !a,e an i m%act on+ or 'ill be affected b$+ t!e effecti,eness or u%datin* of t!e food safet$ mana*ement s$stem&
Suc! communication s!all %ro,ide information on food safet$ as%ects of t!e or*aniations %roducts t!at ma$ be rele,ant to ot!er or*aniations in t!e food c!ain& !is a%%lies es%eciall$ to .no'n food safet$ !aards t!at need to be controlled b$ ot!er or*aniations in t!e food c!ain& Records of communications s!all be maintained& Food safet$ re3uirements from statutor$ and re*ulator$ aut!orities and customers s!all be a,ailable& #esi*nated %ersonnel s!all !a,e defined res%onsibilit$ and aut!orit$ to communicate eternall$ an$ information concernin* food safet$& Information obtained t!rou*! eternal communication s!all be included as in%ut to s$stem u%datin* (see A&5&2) and mana*ement re,ie' (see 5&A&2)& $.9." Interna/ !ommuni!ation !e or*aniation s!all establis!+ im%lement and maintain effecti,e arran*ements for communicatin* 'it! %ersonnel on issues !a,in* an im%act on food safet$& In order to maintain t!e effecti,eness of t!e food safet$ mana*ement s$stem+ t!e or*aniation s!all ensure t!at t!e food safet$ team is informed in a timel$ manner of c!an*es+ includin* but not limited to t!e follo'in*:
ss)%roducts or ne' %roducts tt)
ra' materials+ in*redients and ser,ices
uu)
%roduction s$stems and e3ui%ment
,,)%roduction %remises+ location of e3ui%ment+ surroundin* en,ironment '')
cleanin* and sanitation %ro*rammes
)%ac.a*in*+ stora*e and distribution s$stems $$)
%ersonnel 3ualification le,els andGor allocation of res%onsibilities and
aut!oriations !) statutor$ and re*ulator$ re3uirements
).no'led*e re*ardin* food safet$ !aards and control measures aaa)
customer+ sector and ot!er re3uirements t!at t!e or*aniation
obser,es .) rele,ant en3uiries from eternal interested %arties I) com%laints indicatin* food safet$ !aards associated 'it! t!e %roduct m) ot!er conditions t!at !a,e an im%act on food safet$& !e food safet$ team s!all ensure t!at t!is information is included in t!e u%datin* of t!e food safet$ mana*ement s$stem (see A&5&2)& o% mana*ement s!all ensure t!at rele,ant information is included as in%ut to & t!e mana*ement re,ie' (see 5&A&2)&
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5&8 Emer*enc$ %re%aredness and res%onse o% mana*ement s!all establis!+ im%lement and maintain %rocedures to mana*e %otential emer*enc$ situations and accidents t!at can im%act food safet$ and '!ic! are rele,ant to t!e role of t!e or*aniation in t!e food c!ain&
5&A @ana*ement re,ie'
5&A&1 /eneral o% mana*ement s!all re,ie' t!e or*aniations food safet$ mana*ement s$stem at %lanned inter,als to ensure its continuin* suitabilit$+ ade3uac$ and effecti,eness& !is re,ie' s!all include assessin* o%%ortunities for im%ro,ement and t!e need for c!an*e to t!e food safet$ mana*ement s$stem+ includin* t!e food safet$ %olic$& Records of mana*ement re,ie's s!all be maintained (see 7&2&?) && 5&A&2 Re,ie' in%ut
!e in%ut to mana*ement re,ie' s!all include+ but is not limited to+ information on a) follo'-u% actions from %re,ious mana*ement re,ie's+ bbb) anal$sis of results of ,erification acti,ities (see A&7&?)+
ccc)
c!an*in* circumstances t!at can affect food safet$ (see 5&4&2)+
ddd)
emer*enc$ situations+ accidents (see 5&8) and 'it!dra'als (see 8&10&7)+
eee)
re,ie'in* results of s$stem-u%datin* acti,ities (see A&5&2)+
fff) re,ie' of communication acti,ities+ includin* customer feed-bac. (see 5&4&1)+ and ***)
eternal audits or ins%ections&
>OE !e term B'it!dra'alB includes recall&
!e data s!all be %resented in a manner t!at enables to% mana*ement to relate t!e information to stated obecti,es of t!e food safet$ mana*ement s$stem&
5&A&? Re,ie' out%ut !e out%ut from t!e mana*ement re,ie' s!all include decisions and actions related to
!!!) iii) )
assurance of food safet$ (see 7&1)+
im%ro,ement of t!e effecti,eness of t!e food safet$ mana*ement s$stem (see A&5)+ resource needs (see 4&1)+ and
...)
re,isions of t!e or*aniations food safet$ %olic$ and related obecti,es (see 5&2)&
4 Resource mana*ement 4&1 "ro,ision of resources !e or*aniation s!all %ro,ide ade3uate resources for t!e establis!ment+ im%lementation+ maintenance and u%datin* of t!e food safet$ mana*ement s$stem&
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4&2 5uman resources
4&2&1 /eneral !e food safet$ team and t!e ot!er %ersonnel carr$in* out acti,ities !a,in* an im%act on food safet$ s!all be com%etent and s!all !a,e a%%ro%riate education+ trainin*+ s.ills and e%erience& ;!ere t!e assistance of eternal e%erts is re3uired for t!e de,elo%ment+ im%lementation+ o%eration or assessment of t!e food safet$ mana*ement s$stem+ records of a*reement or contracts definin* t!e res%onsibilit$ and aut!orit$ of eternal e%erts s!all be a,ailable&
4&2&2 om%etence+ a'areness and trainin* !e or*aniation s!all a) identif$ t!e necessar$ com%etencies for %ersonnel '!ose acti,ities !a,e an im%act on food safet$+ b) %ro,ide trainin* or ta.e ot!er action to ensure %ersonnel !a,e t!e necessar$ com%etencies+
lll)
ensure t!at %ersonnel res%onsible for monitorin*+ corrections and correcti,e actions of t!e food safet$ mana*ement s$stem are trained+
d) e,aluate t!e im%lementation and t!e effecti,eness of a)+ b) and c)+
mmm) ensure t!at t!e %ersonnel are a'are of t!e rele,ance and im%ortance of t!eir indi,idual acti,ities in contributin* to food safet$+
nnn)
ensure t!at t!e re3uirement for effecti,e communication (see 5&4) is understood b$ all %ersonnel '!ose acti,ities !a,e an im%act on food safet$+ and
*) maintain a%%ro%riate records of trainin* and actions described in b) and c)&
4&? Infrastructure !e or*aniation s!all %ro,ide t!e resources for t!e establis!ment and maintenance of t!e infrastructure needed to im%lement t!e re3uirements of t!is International Standard&
4&7 ;or. en,ironment !e or*aniation s!all %ro,ide t!e resources for t!e establis!ment+ mana*ement and maintenance of t!e 'or. en,ironment needed to im%lement t!e re3uirements of t!is International Standard&
8 "lannin* and realiation of safe %roducts
8&1 /eneral !e or*aniation s!all %lan and de,elo% t!e %rocesses needed for t!e realiation of safe %roducts& !e or*aniation s!all im%lement+ o%erate and ensure t!e effecti,eness of t!e %lanned acti,ities and an$ c!an*es to t!ose acti,ities& !is includes "R"(s) as 'ell as o%erational "R"(s) andGor t!e " %lan&
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ISO ""###:"##$%E&
." 'rerequisite rogrammes %'R's& ."., !e or*aniation s!all establis!+ im%lement and maintain "R"(s) to assist in controllin*
ooo)
t!e li.eli!ood of introducin* food safet$ !aards to t!e %roduct t!rou*! t!e 'or. en,ironmentB
%%%)
biolo*ical+ c!emical and %!$sical contamination of t!e %roduct(s)+ includin* cross contamination bet'een %roducts+ and
333)
food safet$ !aard le,els in t!e %roduct and %roduct %rocessin* en,ironment&
."." !e "R"(s) s!all
rrr) be a%%ro%riate to t!e or*aniational needs 'it! re*ard to food safet$+ sss)
be a%%ro%riate to t!e sie and t$%e of t!e o%eration and t!e nature of t!e %roducts bein* manufact=red andGor !andled+
ttt)
be im%lemented across t!e entire %roduction s$stem+ eit!er as %ro*rammes a%%licable in *eneral or as %ro*rammes a%%licable to a %articular %roduct or o%erational line+ and
uuu)
be a%%ro,ed b$ t!e food safet$ team&
!e or*aniation s!all identif$ statutor$ and re*ulator$ re3uirements related to t!e abo,e& ;!en selectin* andGor establis!in* "R"(s)+ t!e or*aniation s!all consider and utilie a%%ro%riate information e&*& statutor$ and re*ulator$ re3uirements+ customer re3uirements+ reco*nied *uidelines+ ode limentarius ommission (ode) %rinci%les and codes of %ractices+ national+ international or sector standardsJ& 7.2.3
>OE nne *i,es a list of rele,ant ode %ublications&
!e or*aniation s!all consider t!e follo'in* '!en establis!in* t!ese %ro*rammes:
,,,)
construction and la$-out of buildin*s and associated utilities
''')
la$-out of %remises+ includin* 'or.s%ace and em%lo$ee facilities
)
su%%lies of air+ 'ater+ ener*$ and ot!er utilities
$$$)
su%%ortin* ser,ices+ includin* 'aste and se'a*e dis%osal
)
t!e suitabilit$ of e3ui%ment and its accessibilit$ for cleanin*+ maintenance and %re,entati,e maintenance
aaaa)
mana*ement of %urc!ased materials (e&*& ra' materials+ in*redients+ c!emicals and %ac.a*in*)+ su%%lies (e&*& 'ater+ air+ steam and ice)+ dis%osals (e&*& 'aste and se'a*e) and !andlin* of %roducts (e&*& stora*e and trans%ortation)
bbbb)
measures for t!e %re,ention of cross contamination !) cleanin* and sanitiin*
cccc)
%est control
dddd)
%ersonnel !$*iene
eeee)
ot!er as%ects as a%%ro%riate&
Derification of "R"(s) s!all be %lanned (see 8&A) and "R"(s) s!all be modified as necessar$ (see 8&8)& Records of ,erifications and modifications s!all be maintained& #ocuments s!ould s%ecif$ !o' acti,ities included in t!e "R"(s) are mana*ed&
,#
© ISO 2005 - ll ri*!ts reser,ed
ISO 22000:2005(E)
8&? "reliminar$ ste%s to enable !aard anal$sis 8&?&1 /eneral +
ll rele,ant information needed to conduct t!e !aard anal$sis s!all be collected+ maintained+ u%dated and documented& Records s!all be maintained&
8&?&2 Food safet$ team food safet$ team s!all be a%%ointed& !e food safet$ team s!all !a,e a combination of multi-disci%linar$ .no'led*e and e%erience in de,elo%in* and im%lementin* t!e food safet$ mana*ement s$stem& !is includes+ but need not be limited to+ t!e or*aniations %roducts+ %rocesses+ e3ui%ment and food safet$ !aards 'it!in t!e sco%e of t!e &food safet$ mana*ement s$stem&
Records s!all be maintained t!at demonstrate t!at t!e food safet$ team !as t!e re3uired .no'led*e and e%erience (see 4&2&2)&
8&?&? "roduct c!aracteristics 8&?&?&1 Ra' materials+ in*redients and %roduct-contact materials ll ra' I)aterials+ in*redients and %roduct-contact materials s!all be described in documents to t!e etent needed to conduct t!e !aard anal$sis (see 8&7)+ includin* t!e follo'in*+ as a%%ro%riate:
ffff)
biolo*ical+ c!emical and %! $sical c!aracteristics
****)
com%osition of formulated in*redients+ includin* additi,es and %rocessin* aids
!!!!)
ori*in
iiii) met!od of %roduction e) %ac.a*in* and deli,er$ met!ods f) stora*e conditions and s!elf life
) %re%aration andGor !andlin* before use or %rocessin* ....)
food safet$-related acce%tance criteria or s%ecifications of %urc!ased materials and in*redients a%%ro%riate to t!eir intended uses&
!e or*aniation s!all identif$ statutor$ and re*ulator$ food safet$ re3uirements related to t!e abo,e& !e descri%tions s!all be .e%t u%-to-date includin*+ '!en re3uired+ in accordance 'it! 8&8& 8&?&?&2 !aracteristics of end %roducts !e c!aracteristics of end %roducts s!all be described in documents to t!e etent needed to conduct t!e !aard anal$sis (see 8&7)+ includin* information on t!e follo'in*+ as a%%ro%riate:
llll) %roduct name or similar identification mmmm)
com%osition
nnnn)
biolo*ical+ c!emical and %!$sical c!aracteristics rele,ant for food safet$
oooo)
intended s!elf life and stora*e conditions
%%%%)
%ac.a*in*
© ISO 2005 - ll ri*!ts reser,ed
, ,
ISO 22000:2005(E)
f) labellin* relatin* to food safet$ andGor instructions for !andlin*+ %re%aration and usa*e *) met!od(s) of distribution& !e or*aniation s!all identif$ statutor$ and re*ulator$ food safet$ re3uirements related to t!e abo,e& !e descri%tions s!all be .e%t u%-to-date i ncludin*+ '!en re3uired+ in accordance 'it! 8&8&
8&?&7 Intended use !e intended use+ t!e reasonabl$ e%ected !andlin* of t!e end %roduct+ and an$ unintended but reasonabl$ e%ected mis!andlin* and misuse of t!e end %roduct s!all be considered and s!all be described in documents to t!e etent needed to conduct t!e !aard anal$sis (see 8&7)& /rou%s of users and+ '!ere a%%ro%riate+ *rou%s of consumers s!all be identified for eac! %roduct+ and consumer *rou%s .no'n to be es%eciall$ ,ulnerable to s%ecific food safet$ !aards s!all be considered& !e descri%tions s!all be .e%t u%-to-date includin*+ '!en re3uired+ in accordance 'it! 8&8&
8&?&5 Flo' dia*rams+ %rocess ste%s and control measures
8&?&5&1 Flo' dia*rams Flo' dia*rams s!all be %re%ared for t!e %roducts or %rocess cate*ories co,ered b$ t!e food safet$ mana*ement s$stem& Flo' dia*rams s!all %ro,ide a basis for e,aluatin* t!e %ossible occurrence+ increase or introduction of food safet$ !aards& Flo' dia*rams s!all be clear+ accurate and sufficientl$ detailed& Flo' dia*rams s!all+ as a%%ro%riate+ include t!e follo'in*:
3333)
t!e se3uence and interaction of all ste%s in t!e o%eration
rrrr)
an$ outsourced %rocesses and subcontracted 'or.
ssss)
'!ere ra' materials+ in*redients and intermediate %roducts enter t!e flo'
d) '!ere re'or.in* and rec$clin* ta.e %lace e) '!ere end %roducts+ intermediate %roducts+ b$-%roducts and 'aste are released or remo,ed& In accordance 'it! 8&A+ t!e f ood safet$ team s!all ,erif$ t!e accurac$ of t!e flo' dia*rams b$ on-site c!ec.in*& Derified flo' dia*rams s!all be maintained as records&
8&?&5&2 #escri%tion of %rocess ste%s and control measures !e eistin* control measures+ %rocess %arameters andGor t!e ri*orousness 'it! '!ic! t!e$ are a%%lied+ or %rocedures t!at ma$ influence food safet$+ s!all be described to t!e etent needed to conduct t!e !aard anal$sis (see 8&7)& Eternal re3uirements (e&*& from re*ulator$ aut!orities or customers) t!at ma$ im%act t!e c!oice and t!e ri*orousness of t!e control measures s!all also be described& !e descri%tions s!all be u%dated in accordance 'it! 8&8&
12
< ISO 2005 - ll ri*!ts reser,ed
ISO ""###:"##$%E&
.4 ;azard ana/ysis .4., 5enera/ !e food safet$ team s!all conduct a !aard anal$sis to determine '!ic! !aards need to be controlled+ t!e de*ree of control re3uired to ensure food safet$+ and '!ic! combination of control measures is re3uired&
.4." ;azard identifi!ation and determination of a!!eta8/e /e3e/s .4."., ll food safet$ !aards t!at are reasonabl$ e%ected to occur in relation to t!e t$%e of %roduct+ t$%e of %rocess and actual %rocessin* facilities s!all be identified and recorded& !e identification s!all be based on&
tttt)
t!e %reliminar$ information and data collected accordin* to 8&?+
uuuu)
e%erience+
,,,,)
eternal information includin*+ to t!e etent %ossible+ e%idemiolo*ical and ot!er !istorical data+ and
'''')
information from t!e food c!ain on food safet$ !aards t!at ma$ be of rele,ance for t!e safet$ of t!e end %roducts+ intermediate %roducts and t!e food at consum%tion&
!e ste%(s) (from ra' materials+ %rocessin* and distribution) at '!ic! eac! food safet$ !aard ma$ be introduced s!all be indicated& .4."." ;!en identif$in* t!e !aards+ consideration s!all be *i,en to
)
t!e ste%s %recedin* and follo'in* t!e s%ecified o%eration+
$$$$)
t!e %rocess e3ui%ment+ utilitiesGser,ices and surroundin*s+ and
)
t!e %recedin* and follo'in* lin.s in t!e food c!ain&
.4.".6 For eac! of t!e food safet$ !aards identified+ t!e acce%table le,el of t!e food safet$ !aard in t!e end %roduct s!all be determined '!ene,er %ossible& !e determined le,el s!all ta.e into account establis!ed statutor$ and re*ulator$ re3uirements+ customer food safet$ re3uirements+ t!e intended use b$ t!e customer and ot!er rele,ant data& !e ustification for+ and t!e result of+ t!e determination s!all be recorded&
.4.6 ;azard assessment !aard assessment s!all be conducted to determine+ for eac! food safet$ !aard identified (see 8&7&2)+ '!et!er its elimination or reduction to acce%table le,els is essential to t!e %roduction of a safe food+ and '!et!er its control is needed to enable t!e defined acce%table le,els to be met& Eac! food safet$ !aard s!all be e,aluated accordin* to t!e %ossible se,erit$ of ad,erse !ealt! effects and t!e li.eli!ood of t!eir occurrence& !e met!odolo*$ used s!all be described+ and t!e results of t!e food safet$ !aard assessment s!all be recorded& .4.4 Se/e!tion and assessment of !ontro/ measures ased on t!e !aard assessment of 8&7&?+ an a%%ro%riate combination of control measures s!all be selected '!ic! is ca%able of %re,entin*+ eliminatin* or reducin* t!ese food safet$ !aards to defined acce%table le,els& In t!is selection+ eac! of t!e control measures as described in 8&?&5&2 s!all be re,ie'ed 'it! res%ect to its effecti,eness a*ainst t!e identified food safet$ !aards& !e control measures selected s!all be cate*oried as to '!et!er t!e$ need t4 be mana*ed t!rou*! o%erational "R"(s) or b$ t!e " %lan&
< ISO 2005 - ll ri*!ts reser,ed
, 6
ISO ""###:"##$*E&
!e selection and cate*oriation s!all be carried out usin* a lo*ical a%%roac! t!at includes assessments 'it! re*ard to t!e follo'in*:
aaaaa) bbbbb)
its effect on identified food safet$ !aards relati,e to t!e strictness a%%lied its feasibilit$ for monitorin* (e&*& abilit$ to be monitored in a timel$ manner to enable immediate&
corrections)
ccccc) its %lace 'it!in t!e s$stem relati,e to ot!er control measures t!e li.eli!ood of failure in t!e functionin* of a control measure or si*nificant %rocessin* ,ariabilit$ ddddd) eeeee) t!e se,erit$ of t!e conse3uence(s) in t!e case of failure in its functionin* fffff)
'!et!er t!e control measure is s%ecificall$ establis!ed and a%%lied to eliminate or si*nificantl$ reduce t!e le,el of !aard(s)
*****)
s$ner*istic effects (i&e& interaction t!at occurs bet'een t'o or more measures resultin* in t!eir combined effect bein* !i*!er t!an t!e sum of t!eir indi,idual effects)& ontrol measures cate*oried as belon*in* to t!e " %lan s!all be im%lemented in accordance 'it! 8&4& Ot!er control measures s!all be im%lemented as o%erational "R"s accordin* to 8&5& !e met!odolo*$ and %arameters used for t!is cate*oriation s!all be described in documents+ and t!e results of t!e assessment s!all be recorded&
.$ Esta8/ising te oerationa/ rerequisite rogrammes %'R's& !e o%erational "R"s s!all be documented and s!all include t!e f ollo'in* information for eac! %ro*ramme:
!!!!!) food safet$ !aard(s) to be controlled b$ t!e %ro*ramme (see 8&7&7) iiiii) control measure(s) (see 8&7&7) ) monitorin* %rocedures t!at demonstrate t!at t!e o%erational "R"s are im%lemented .....) corrections and correcti,e actions to be ta.en if monitorin* s!o's t!at t!e o%erational "R"s are not in control (see 8&10&1 and 8&10&2+ res%ecti,el$) res%onsibilities and aut!orities lllll) record(s) of monitorin*& mmmmm)
.9 Esta8/ising te ;A((' /an .9., ;A((' /an !e " %lan s!all be documented and s!all include t!e follo'in* i nformation for eac! identified critical control %oint ("):
nnnnn) food safet$ !aard(s) to be controlled at t!e " (see 8&7&7) ooooo) control measure(s) (see 8&7&7) criticallimit(s) (see 8&4&?) %%%%%) 33333) monitorin* %rocedure(s) (see 8&4&7) rrrrr) corrections and correcti,e action(s) to be ta.en if critical l imits are eceeded (see 8&4&5) sssss) res%onsibilities and aut!orities ttttt) record(s) of monitorin*& .9." Identifi!ation of !riti!a/ !ontro/ oints %(('s& For eac! !aard t!at is to be controlled b$ t!e " %lan+ "(s) s!all be identifiedfor t!e !ontro/ measures identified (see 8&7&7)&
, 4
© ISO 2005 - ll ri*!ts reser,ed
ISO 22000:2005(E)
8&4&? #etermination of critical limits for critical control %oints ritical limits s!all be determined for t!e monitorin* establis!ed for eac! "& ritical limits s!all be establis!ed to ensure t!at t!e identified acce%table le,el of t!e food safet$ !aard in t!e end %roduct (see 8&7&2) is not eceeded& ritical limits s!all be measurable& !e rationale for t!e c!osen critical limits s!all be documented& ritical limits based on subecti,e data (suc! as ,isual ins%ection of %roduct+ %rocess+ !andlin*+ etc&) s!all be su%%orted b$ instructions or s%ecifications andGor education and trainin*&
8&4&7 S$stem for t!e monitorin* of critical control %oints monitorin* s$stem s!all be establis!ed for eac! " to demonstrate t!at t!e " is in control& !e s$stem s!all include all sc!eduled measurements or obser,ations relati,e to t!e criticallimit(s)& !e monitorin* s$stem s!all consist of rele,ant %rocedures+ instructions and records t!at co,er t!e follo'in*: a) measurements or obser,ations t!at %ro,ide results 'it!in an ade3uate time frame b)
monitorin* de,ices used
c)
a%%licable calibration met!ods (see A&?)
d)
monitorin* fre3uenc$
e)
res%onsibilit$ and aut!orit$ related to monitorin* and e,aluation of monitorin* results
f)
record re3uirements and met!ods&
!e monitorin* met!ods and fre3uenc$ s!all be ca%able of determinin* '!en t!e critical limits !a,e been eceeded in time for t!e %roduct to be isolated before it is used or consumed& 8&4&5 ctions '!en monitorin* results eceed critical limits "lanned corrections and correcti,e actions to be ta.en '!en critical limits are eceeded s!all be s%ecified in t!e " %lan& !e actions s!all ensure t!at t!e cause of nonconformit$ is identified+ t!at t!e %arameter(s) controlled at t!e " is (are) brou*!t bac. under control+ and t!at recurrence is %re,ented (see 8&10&2)& #ocumented %rocedures s!all be establis!ed and maintained for t!e a%%ro%riate !andlin* of %otentiall$ unsafe %roducts to ensure t!at t!e$ are not released until t!e$ !a,e been e,aluated (see 8&10&?)&
8&8 %datin* of %reliminar$ information and documents s%ecif$in* t!e "R"s and t!e " %lan
Follo'in* t!e establis!ment of o%erational "R"(s) (see 8&5) andGor t!e " %lan (see 8&4)+ t!e or*aniation s!all u%date t!e follo'in* information+ if necessar$: %roduct c!aracteristics (see 8&?&?) uuuuu) ,,,,,) intended use (see 8&?&7) ''''') flo' dia*rams (see 8&?&5&1) ) %rocess ste%s (see 8&?&5&2) $$$$$) control measures (see 8&?&5&2)& If necessar$+ t!e " %lan (see 8&4&1) and t!e %rocedures and instructions s%ecif$in* t!e "R"(s) (see 8&2) s!all be amended&
© ISO 2005 - ll ri*!ts reser,ed
1 5
ISO ""###:"##$%E&
.< =erifi!ation /anning Derification %lannin* s!all define t!e %ur%ose+ met!ods+ fre3uencies and res%onsibilities for t!e ,erification acti,ities& !e ,erification acti,ities s!all confirm t!at
) t!e "R"(s) are im%lemented (see 8&2)+ aaaaaa) in%ut to t!e !aard anal$sis (see 8&?) is continuall$ u%dated+ bbbbbb)
t!e o%erational "R"(s) (see 8&5) and t!e elements 'it!in t!e " %lan (see 8&4&1) are im%lemented and effecti,e+
cccccc) dddddd)
!aard le,els are 'it!in identified acce%table le,els (see 8&7&2)+ and ot!er %rocedures re3uired b$ t!e or*aniation are im%lemented and effecti,e&
!e out%ut of t!is %lannin* s!all be in a form suitable for t!e or*aniations met!od of o%erations& Derification results s!all be recorded and s!all be communicated to t!e food safet$ team& Derification results s!all be %ro,ided to enable t!e anal$sis of t!e results of t!e ,erification acti,ities (see A&7&?)& If s$stem ,erification is based on testin* of end %roduct sam%les+ and '!ere suc! test sam%les s!o' nonconformit$ 'it! t!e acce%table le,el of t!e food safet$ !aard (see 8&7&2)+ t!e affected lots of %roduct s!all be !andled as %otentiall$ unsafe in accordance 'it! 8&10&?&
.> Tra!ea8i/ity system !e or*aniation s!all establis! and a%%l$ a traceabilit$ s$stem t!at enables t!e identification of %roduct lots and t!eir relation to batc!es of ra' materials+ %rocessin* and deli,er$ records& !e traceabilit$ s$stem s!all be able to identif$ incomin* material from t!e immediate su%%liers and t!e initial distribution route of t!e end %roduct& raceabilit$ records s!all be maintained for a defined %eriod for s$stem assessment to enable t!e !andlin* of %otentiall$ unsafe %roducts and in t!e e,ent of %roduct 'it!dra'al& Records s!all be in accordance 'it! statutor$ and re*ulator$ re3uirements and customer re3uirements and ma$+ for eam%le+ be based on t!e end %roduct lot identification&
.,# (ontro/ of non!onformity :.,#., (orre!tions !e or*aniation s!all ensure t!at '!en critical limits for "(s) are eceeded (see 8&4&5)+ or t!ere is a loss of control of o%erational "R"(s)+ t!e %roducts affected are i dentified and controlled 'it! re*ardto t!eir use and release&
documented %rocedure s!all be establis!ed and maintained definin*
eeeeee)
t!e identification and assessment of affected end %roducts to determine t!eir %ro%er !andlin* (see
8&10&?)+ and b) a re,ie' of t!e corrections carried out& "roducts manufactured under conditions '!ere critical limits !a,e been eceeded are %otentiall$ unsafe %roducts and s!all be !andled in accordance 'it! 8&10&?& "roducts manufactured under conditions '!ere o%erational "R"(s) !a,e not been conformed 'it! s!all be e,aluated 'it! res%ect to t!e cause(s) of t!e nonconformit$ and to t!e conse3uences t!ereof in terms of food safet$ and s!all+ '!ere necessar$+ be !andled in accordance 'it! 8&10&?& !e e,aluation s!all be recorded&
16
© ISO 2005 - ll ri*!ts reser,ed
ISO ""###:"##$%E&
ll corrections s!all be a%%ro,ed b$ t!e res%onsible %erson(s)+ and s!all be recorded to*et!er 'it! information on t!e nature of t!e nonconformit$+ its cause(s) and conse3uence(s)+ includin* information needed for traceabilit$ %ur%oses related to t!e nonconformin* lots&
.,#." (orre!ti3e a!tions #ata deri,ed from t!e monitorin* of o%erational "R"s and "s s!all be e,aluated b$ desi*nated %erson(s) 'it! sufficient .no'led*e (see 4&2) and aut!orit$ (see 5&7) to initiate correcti,e actions& orrecti,e actions s!all be initiated '!en critical limits are eceeded (see 8&4&5) or '!en t!ere is a lac. of conformit$ 'it! o%erational "R"(s)& !e or*aniation s!all establis! and maintain documented %rocedures t!at s%ecif$ a%%ro%riate actions to identif$ and eliminate t!e cause of detected nonconformities+ to %re,ent recurrence+ and to brin* t!e %rocess or s$stem bac. into control after nonconformit$ is encountered& !ese actions include &
ffffff)
re,ie'in* nonconformities (includin* customer com%laints)+
******)
re,ie'in* trends in monitorin* results t!at ma$ indicate de,elo%ment to'ards loss of control+
!!!!!!)
determinin* t!e cause(s) of nonconformities+
iiiiii)
e,aluatin* t!e need for action to ensure t!at nonconformities do not
recur+ e) determinin* and im%lementin* t!e actions needed+ f) recordin* t!e results of correcti,e actions ta.en+ and *) re,ie'in* correcti,e actions ta.en to ensure t!at t!e $ are effecti,e& orrecti,e actions s!all be recorded&
.,#.6 ;and/ing of otentia//y unsafe rodu!ts
.,#.6., 5enera/ !e or*aniation s!all !andle nonconformin* %roducts b$ ta.in* action(s) to %re,ent t!e nonconformin* %roduct from enterin* t!e food c!ain unless it is %ossible to ensure t!at
)
t!e food safet$ !aard(s) of concern !as(,e) been reduced to t!e defined acce%table le,els+
......)
t!e food safet$ !aard(s) of concern 'ill be reduced to identified acce%table le,els (see 8&7&2) %rior to enterin* into t!e food c!ain+ or
llllll)
t!e %roduct still meets t!e defined acce%table le,el(s) of t!e food safet$ !aard(s) of concern des%ite t!e nonconformit$&
ll lots of %roduct t!at ma$ !a,e been affected b$ a nonconformin* situation s!all be !eld under control of t!e or*aniation until t!e$ !a,e been e,aluated& If %roducts t!at !a,e left t!e control of t!e or*aniation are subse3uentl$ determined to be unsafe+ t!e or*aniation s!all notif$ rele,ant interested %arties and initiate a 'it!dra'al (see 8&10&7)& >OE !e term B'it!dra'alB includes recall&
!e controls and related res%onses and aut!oriation for dealin* 'it! %otentiall$ un-safe %roducts s!all be & documented&
< ISO 2005 - ll ri*!ts reser,ed
1 7
ISO ""###:"##$%E&
.,#.6." E3a/uation for re/ease Eac! lot of %roduct affected b$ t!e nonconformit$ s!all onl$ be released as safe '!en an$ of t!e follo 'in* conditions a%%l$:
mmmmmm)
e,idence ot!er t!an t!e monitorin* s$stem demonstrates t!at t!e control measures !a,e been
effecti,e
nnnnnn)
e,idence s!o's t!at t!e combined effect of t!e control measures for t!at %articular %roduct com%lies 'it! t!e %erformance intended (i&e& identified acce%table le,els as identified in accordance 'it! 8&7&2)
oooooo)
t!e results of sam%lin*+ anal$sis andGor ot!er ,erification acti,ities demonstrate t!at t!e affected lot of %roduct com%lies 'it! t!e identified acce%table le,els for t!e food safet$ !aard(s) concerned& .,#.6.6 Disosition of non!onforming rodu!ts Follo'in* e,aluation+ if t!e lot of %roduct is not acce%table for release it s!all be !andled b$ one of t!e follo'in* acti,ities:
%%%%%%)
re%rocessin* or furt!er %rocessin* 'it!in or outside t!e or*aniation to ensure t!at t!e food safet$ !aard is eliminated or reduced to acce%table le,els
333333)
destruction andGor dis%osal as 'aste&
.,#.4 ?itdra)a/s o enable and f acilitate t!e com%lete and timel$ 'it!dra'al of lots of end %roducts '!ic! !a,e been identified as unsafe
rrrrrr)
to% mana*ement s!all a%%oint %ersonnel !a,in* t!e aut!orit$ to initiate a 'it!dra'al and %ersonnel res%onsible for eecutin* t!e 'it!dra'al+ and
ssssss)
t!e or*aniation s!all establis! and maintain a documented %rocedure for
tttttt)
notification to rele,ant interested %arties (e&*& statutor$ and re*ulator$ aut!orities+ customers andGor consumers)+
uuuuuu)
!andlin* of 'it!dra'n %roducts as 'ell as affected lots of t!e %roducts still in stoc.+ and
,,,,,,)
t!e se3uence of actions to be ta.en&
;it!dra'n %roducts s!all be secured or !eld under su%er,ision until t!e$ are destro$ed+ used for %ur%oses ot!er t!an ori*inall$ intended+ determined to be safe for t!e same (or ot!er) intended use+ or re%rocessed in a manner to ensure t!e$ become safe& !e cause+ etent and result of a 'it!dra'al s!all be recorded and re%orted to to% mana*ement as in%ut to t!e mana*ement re,ie' (see 5&A&2)& !e or*aniation s!all ,erif$ and record t!e effecti,eness of t!e 'it!dra'al %ro*ramme t!rou*! t!e use of a%%ro%riate tec!ni3ues (e&*& moc. 'it!dra'al or %ractice 'it!dra'al)&
< =a/idation@ 3erifi!ation and imro3ement of te food safety management system OE ISO 9001 addresses continual im%ro,ement of t!e effecti,eness of 3ualit$ mana*ement s$stems& ISO 9007 %ro,ides *uidance on continual im%ro,ement of t!e effecti,eness and efficienc$ of 3ualit$ mana*emenf s$stems be$ond '!at is addressed in ISO 9001&
"#
© ISO 2005 - ll ri*!ts reser,ed
ISO ""###:"##$%E&
ISO 22000:2005(E) ISO 22000:2005
ISO 9001 :2000
Introduction
0 01
uts GR" 5?-200?+ ode of $*ienic "ractice For Fres! Fruits and De*etables
(.,.: 7eat and meat rodu!ts GR" 71-199?+ ode for nte-mortem and "ost-mortem I ns%ection of Slau*!ter nimals and for ntemortem and "ost-mortem Nud*ement of Slau*!ter nimals and @eat GR" ?2-19A?+ ode of "ractice for t!e "roduction+ Stora*e and om%osition of @ec!anicall$ Se%arated @eat and "oultr$ for Furt!er "rocessin* GR" 29-19A?+ Re,& 1 (199?)+ ode of $*ienic "ractice for /ame GR" ?0-19A?+ ode of $*ienic "ractice for t!e "rocessin* of Fro* Le*s GR" 11-1984+ Re,& 1 (199?)+ ode of $*ienic "ractice for Fres! @eat GR" 1?-1984+ Re,& 1 (19A5)+ ode of $*ienic "ractice for "rocessed @eat and "oultr$ "roducts GR" 17-1984+ ode of $*ienic "ractice f or "oultr$ "rocessin* G/L 52-200?+ /eneral "rinci%les of @eat $*iene ode of $*ienic "ractice for @eat2)
(.,.< 7i/C and mi/C rodu!ts GR" 58-2007+ ode of $*ienic "ractice for @il. and @il. "roducts Re,ision of t!e /uidelines for t!e Establis!ment of a Re*ulator$ "ro*ramme for t!e ontrol of Deterinar$ #ru* Residues in Foods "re,ention and ontrol of #ru* Residues in @il. and @il. "roducts (includin* mil. and mil. %roducts)2)
(.,.> Egg and egg rodu!ts GR" 15-1984+ ode of $*ienic "ractice for E** "roducts (amended 198A+ 19A5) Re,ision of t!e ode of $*ienic "ractice for E** "roducts2)
< ISO 2005 - ll ri*!ts reser,ed
" >
ISO ""###:"##$%E&
(.,.,# Fis and fisery rodu!ts GR" ?8-19A9+ ode of "ractice for e%!alo%ods GR" ?5-19A5+ ode of "ractice for Froen attered andGor readed Fis!er$ %roducts GR" 2A-19A?+ ode of "ractice f or rabs GR" 27-1989+ ode of "ractice for Lobsters GR" 25-1989+ ode of "ractice for Smo.ed Fis! GR" 24-1989+ ode of "ractice for Salted Fis! GR" 18-198A+ ode of "ractice for S!rim%s or "ra'ns GR" 1A-198A+ ode of $*ienic "ractice f or @olluscan S!ellfis!
GR" 52-200?+ ode of "ractice for Fis! and Fis!er$ "roducts ode of "ractice for Fis! and Fis!er$ "roducts (a3uaculture)2)
(.,.,, ?aters GR" ??-19A5+ ode of $*ienic "ractice for t!e ollection+ "rocessin* and @ar.etin* of >atural @ineral ;aters GR" 7A-2001+ ode of $*ienic "ractice f or ottledG"ac.a*ed #rin.in* ;aters (Ot!er t!an >atural @ineral ;aters)
(.,.," Transortation GR" 78-2001+ ode of $*ienic "ractice for t!e rans%ort of Food in ul. and Semi-%ac.ed Food GR" ?4-19A8 (Re,& 1-1999)+ ode of "ractice for t!e Stora*e and rans%ort of Edible Oils and Fats in ul. GR" 77-1995+ ode of "ractice f or "ac.a*in* and rans%ort of ro%ical Fres! Fruit and De*etables
(.,.,6 Retai/ GR" 7?-1998 (Re,& 1-2001)+ ode of $*ienic "ractice for t!e "re%aration and Sale of Street Foods (Re*ional ode - Latin merica and t!e aribbean) GR" ?9-199?+ ode of $*ienic "ractice for "recoo.ed and oo.ed Foods in @ass aterin* G/L 22-1998 (Re,& 1-1999)+ /uidelines for t!e #esi*n of ontrol @easures for Street-Dended Foods in frica
(." Food safety azard se!ifi! !odes and guide/ines ,& GR" ?A-199?+ ode of "ractice for ontrol of t!e se of Deterinar$ #ru*s GR" 50-200?+ ode of "ractice for t!e "re,ention of "atulin ontamination in %%le Nuice and %%le Nuice In*redients in Ot!er e,era*es GR" 51-200?+ ode of "ractice for t!e "re,ention of @$cotoin ontamination in e-reals+ inludin* nnees on Oc!ratoin + earalenone+ Fumonisin and ricot!ecenes
30
© ISO 2005 - ll ri*!ts reser,ed
ISO ""###:"##$*E&
GR" 55-2007+ ode of "ractice for t!e "re,ention and Reduction of flatoin ontamination in "eanuts GR" 54-2007+ ode of "ractice for t!e "re,ention and Reduction of Lead ontamination in Foods /uidelines for t!e ontrol of *isteria monocytogenes in Foods2) ode of "ractice for t!e "re,ention and Reduction of Inor*anic in ontamination in anned Foods2) ode of "ractice to @inimie and ontain ntimicrobial Resistance2) ode of "ractice for t!e "re,ention and Reduction of flatoin ontamination in reenuts2)
(.6 (ontro/ measure-se!ifi! !odes and guide/ines ,& GR" 19-1989 (Re,& 1-19A?)+ ode of "ractice for t!e O%eration of Irradiation Facilities =ed for t!e reatment of Foods GR" 70-199?+ ode of $*ienic "ractice f or se%ticall$ "rocessed and "ac.a*ed Lo'-acid Foods GR" 79-2001+ ode of "ractice for Source #irected @easures to Reduce ontamination of Food 'it! !emicals G/L 1?-1991+ /uidelines for t!e "reser,ation of Ra' @il. b$ se of t!e Lacto%eroidase S$stem GS> 104-19A? (Re,& 1-200?)+ /eneral Standard for Irradiated Foods
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6,
ISO ""###:"##$%E&
Bi8/iogray
1J
ISO 9001 :2000+ "uality management systems - +e,uirements
2J
ISO 9007:2000+ "uality management systems - uidelines for performance impro#ements
?J
ISO 10012:200?+ easurement management systems - +e,uirements for measurement processes and measuring e,uipment
7J
ISO 17159:2002+ Safety of machinery - /ygiene re,uirements for the design of machinery
5J
ISO 15141 :2001+ uidelines on the application of ISO 01)2 for the food and drin industry
4J
ISO 19011 :2002+ uidelines for ,uality and(or en#ironmental management systems auditing
8J
ISOIS 22007:-4), Food safety management systems - uidance on the application of
ISO 22)23 AJ
ISO 22005:-5), Tracea$ility in the feed and food chain - eneral principles and guidance for system design and de#elopment
9J
ISOGlE/ /uide 51 :1999+ Safety aspects - uidelines for their inclusion in standards
eneral re,uirements 10J ISOGlE/ /uide 42:1994+ certification(registration of ,uality systems
for
$odies
operating
assessment
and
4115 Codex 'limentarius Food /ygiene 6asic Texts. Food and *ricultural Or*aniation of t!e nited >ations+ ;orld ealt! Or*aniation+ Rome+ 2001 12J Reference 'ebsites: !tt%:GG'''&iso&or* !tt%:GG'''&codealimentarius&net
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32
© ISO 2005 - ll ri*!ts reser,ed
TE(;NI(AL S'E(IFI(ATION
ISODTS ""##4
First edition 2005-11-15
Food safety management systems 5uidan!e on te a/i!ation of ISO ""###:"##$ Systemes de management de la securite des denrees alimentaires 7gnes directrices relati#es a I8application de I8IS 22)23
=-~-=-
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=--~-=-=-
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Reference number & ISOrS 22007:2005(E)
< 1A02005
ISOITS ""##4:"##$%E&
PDF disclaimer
!is "#F file m a$ contain embedded t$%efaces& In accordance 'it! dobes licensin* %olic$+ t!is file ma$ be %rinted or ,ie'ed but s!all not be edited unless t!e t$%efaces '!ic! are embedded are licensed to and installed on t!e com%uter %erformin* t!e editin*& In do'nloadin* t!is file+ %arties acce%t t!erein t!e res%onsibilit$ of not infrin*in* dobes licensin* %olic$& !e ISO entral Secretariat acce%ts no liabilit$ in t!is area&
dobe is a trademar. of dobe S$stems Incor%orated& #etails of t!e soft'are %roducts used to create t!is "#F file can be found in t!e /eneral Info relati,e to t!e file t!e "#F-creation %arameters 'ere o%timied for %rintin*& E,er$ care !as been ta.en to ensure t!at t!e file is suitable for use b$ ISO member bodies& In t!e unli.el$ e,ent t!at a %roblem relatin* to it is found+ %lease inform t!e entral Secretariat at t!e address *i,en belo'&
© ISO 2005 ll ri*!ts reser,ed& nless ot!er'ise s%ecified+ no %art of t!is %ublication ma$ be re%roduced or utilied in an$ form or b$ an$ means+ electronic or mec!anical+ includin* %!otoco%$in* and microfilm+ 'it!out %ermission in 'ritin* from eit!er ISO at t!e address belo' or ISO s member bod$ in t!e countr$ of t!e re3uester& ISO co%$ri*!t office ase %ostale 54 -1211 /ene,a 20 el& 6 71228 790111 Fa + 71228790978 E-mail co%$ri*!tiso&or* ;eb '''&iso&or* "ublis!ed in S'iterland
i i
< ISO 2005 - ll ri*!ts reser,ed
ISOGS 22007:2005QE)
(ontents
"a*e
1
Sco%e &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& && &&&&&&&&&&&&&&&&&&&&&&& &&&&&1
2
>ormati,e references &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&& & = &&&&&&&&&&&&&&&&&&&&&&& &&&&&1
?
erms and defi n itions &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&& &&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&& &&&&&1
7
/uidance on t!e use of ISO 22000:2005+ lause 7: Food safet$ mana*ement s$stem &&&&&&&&&&&&&&&&&& &&1
7&1 /eneral re3u irements &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&1 7&2 #ocumentatio n re3u i rements &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&1 5 /uidance on t!e use of ISO 22000:2005+ lause 5: @ana*ement res%onsibilit$ &&&&&&&&&&&&&&&&&&&&: &&&&&&&&&&&&2 5&1 @ana*ement commitment &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&2 5&2 Food safet$ %ol ic$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&2 5&? Food safet$ mana*ement s$stem %lannin* &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&2 5&7 Res%onsibi I it$ and aut!orit$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&2 5&5 Food safet$ team leader &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&2 5&4 ommu n ication &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&? 5&8 Emer*enc$ %re%aredness and res%onse &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&? 5&A @ana* ement re,ie' &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&? 4 /uidance on t!e use of ISO 22000:2005+ lause 4: Resource mana*ement &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&? 4&1 "ro,is ion of resou rces &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&? 4&2 uman resources &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&7 4&? I nfrastructu re &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&7 4&7 ;or. en,i ronment &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&7 8 /uidance on t!e use of ISO 22000:2005+ lause 8: "lannin* and realiation of safe %roducts && 7 8&1 /ene ral &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&& &&&&&&& 7 8&2 "rere3uis ite %ro* rammes &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&& 5 8&? "reliminar$ ste%s to enable !aard anal$sis &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&4 8&7 aard anal$sis &&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&& 4 8&5 Establis!in* t!e o%erational %rere3uisite %ro*rammes &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&A 8&4 Establis! i n* t!e " %lan &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&A 8&8 %datin* of %reliminar$ information and documents s%ecif$in* t!e "R"s and t!e " %ia n &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&10 8&A Derifi cation %lan n in* &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&10 8&9 raceabi lit$ s$stem &&&&&&&&&&&&&&&&&&&&&&&&&&: &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&10 8&10 ontrol of nonconformit$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&10 A /uidance on t!e use of ISO 22000:2005+ lause A: Dalidation+ ,erification and im%ro,ement of t!e food safet$ mana*ement s$stem &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&10 A&1 /eneral &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&10 A&2 Dalidation of control measure combinations &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&11 A&? ontrol of monitorin* and measurin* &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&11 A&7 Food safet$ mana*ement s$stem ,erification &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&11 A&5 Im%ro,ement &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&+ &&&&&&&&&&+ &&&&&&&&&&&&&&&&12H 8
i blio* ra%!$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&1?
< ISO 2005 - ll ri*!ts reser,ed
ii i
ISOITS ""##4:"##$%E&
Fore)ord ISO (t!e International Or*aniation for Standardiation) is a 'orld'ide federation of national standards bodies (ISO member bodies)& !e 'or. of %re%arin* International Standards is normall$ carried out t!rou*! ISO tec!nical committees& Eac! member bod$ interested in a subect for '!ic! a tec!nical committee !as been establis!ed !as t!e ri*!t to be re%resented on t!at committee& International or*aniations+ *o,ernmental and non-*o,ernmental+ in liaison 'it! ISO+ also ta.e %art in t!e 'or.& ISO collaborates closel$ 'it! t!e International Electrotec!nical ommission (IE) on all matters of electrotec!nical standardiation& International Standards are drafted in accordance 'it! t!e rules *i,en in t!e ISOIIE #irecti,es+ "art 2& !e main tas. of tec!nical committees is to %re%are International Standards& #raft International Standards ado%ted b$ t!e tec!nical committees are circulated to t!e member bodies for ,otin*& "ublication as an International Standard re3uires a%%ro,al b$ at least 85 % of t!e member bodies castin* a ,ote& In ot!er circumstances+ %articularl$ '!en t!ere is an ur*ent mar.et re3uirement for suc! documents+ a tec!nical committee ma$ decide to %ublis! ot!er t$%es of normati,e document: an ISO "ublicl$ ,ailable S%ecification (ISOG"S) re%resents an a*reement bet'een tec!nical e%erts in an ISO 'or.in* *rou% and is acce%ted for %ublication if it is a%%ro,ed b$ more t!an 50 % of t!e members of t!e %arent committee castin* a ,ote an ISO ec!nical S%ecification (ISOIS) re%resents an a*reement bet'een t!e members ofa tec!nical committee and is acce%ted for %ublication if it is a%%ro,ed b$ 2G? of t!e members of t!e committee castin* a ,ote& n ISOG"S or ISOIS is re,ie'ed after t!ree $ears in order to decide '!et!er it 'ill be confirmed for a furt!er t!ree $ears+ re,ised to become an International Standard+ or 'it!dra'n& If t!e ISOG"S or ISOIS is confirmed+ it is re,ie'ed a*ain after a furt!er t!ree $ears+ at '!ic! time it must eit!er be transformed into an International Standard or be 'it!dra'n& ttention is dra'n to t!e %ossibilit$ t!at some of t!e elements of t!is document ma$ be t!e subect of %atent ri*!ts& ISO s!all not be !eld res%onsible for identif$in* an$ or all suc! %atent ri*!ts& ISOGS 22007 'as %re%ared b$ ec!nical ommittee ISOI ?7+ Food products.
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© ISO 2005 - ll ri*!ts reser,ed
ISO/TS ""##4:"##$%E&
Introdu!tion #., 5enera/ !e ado%tion of a food safet$ mana*ement s$stem b$ an or*aniation in,ol,ed in t!e food c!ain is a useful tool for ensurin* com%liance 'it! re3uirements s%ecified b$ la'+ statute+ re*ulation andGor customers& !e desi*n and im%lementation of an or*aniations food safet$ mana*ement s$stem are influenced b$ ,ar$i!* factors+ in %articular food safet$ !aards+ t!e %roducts %ro,ided+ t!e %rocesses em%lo$ed and t!e sie and structure of t!e or*aniation& !is ec!nical S%ecification *i,es *uidance on t!e use of ISO 22000+ '!ic! is based on t!e %rinci%les of " as described b$ t!e ode limentarius ommission 7J and is desi*ned to be a%%lied to*et!er 'it! rele,ant standards %ublis!ed b$ t!at or*aniation&
#." Food !ain and ro!ess aroa! ISO 22000 %romotes t!e ado%tion of a food c!ain a%%roac! '!en de,elo%in*+ im%lementin* and im%ro,in* t!e effecti,eness and efficienc$ of a food safet$ mana*ement s$stem& In t!is re*ard+ in ISO 22000 t!e or*aniation is re3uired to consider t!e effects of t!e food c!ain %rior to and subse3uent to its o%erations '!en de,elo%in* and im%lementin* t!e food safet$ mana*ement s$stem& For an or*aniation to function effecti,el$ and efficientl$+ it !as to identif$ and mana*e numerous lin.ed acti,ities& n acti,it$ usin* resources+ and mana*ed in order to enable t!e transformation of in%uts into out%uts+ is considered as a %rocess& Often t!e out%ut from one %rocess directl$ forms t!e in%ut to t!e net& !e a%%lication of a s$stem of %rocesses 'it!in an or*aniation+ to*et!er 'it! t!e i dentification of interactions and t!e mana*ement of t!ese %rocesses can be referred to as t!e B%rocess a%%roac!&B n ad,anta*e of t!e %rocess a%%roac! is t!e on*oin* control t!at it %ro,ides o,er t!e lin.a*e bet'een t!e indi,idual %rocesses 'it!in t!e s$stem of %rocesses+ as 'ell as t!eir combination and interaction& ;!en used 'it!in a f ood safet$ mana*ement s$stem+ suc! an a%%roac! em%!asies t!e im%ortance of
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understandin* and fulfillin* t!e re3uirements+ t!e need to consider %rocesses in terms of food safet$ and traceabilit$+ obtainin* results of %rocess %erformance and effecti,eness+ and continual im%ro,ement of %rocesses based on obecti,e measurement&
Interested %arties %la$ a si*nificant role in definin* re3uirements as in%uts& @onitorin* t!e satisfaction of interested %arties re3uires e,aluation of information relatin* to t!eir %erce%tion of '!et!er t!e or*aniation !as met t!eir re3uirements or not&
© ISO 2005 - ll ri*!ts reser,ed
,
ISOIS 22007:2005QE)
!e model of a %rocess-based food safet$ mana*ement s$stem s!o'n in Fi*ure 1 illustrates t!e %rocess lin.a*es %resented in lauses 7 to A of ISO 22000:2005& !e model s!o'n in Fi*ure 1 does not s!o' t!e %rocesses at a detailed le,el&
@onitorin* correcti,e actions
Derification
Im%ro,ement
Im%lementation
"lannin* and
realiation of safe %roducts
"reliminar$ ste%s to enable !aard anal$sis
Establis!in* aard anal$sis
.. -----
Dalidation of control measures
" %lan Establis!in* o%erational "R"s
Fi*ure 1 - once%t of continuous im%ro,ement
0&? Relations!i% 'it! ISO 9001 ISO 22000 !as been desi*ned to 'or. in !armon$ 'it! ISO 9001 and its su%%ortin* standards& ISO 9001 %ro,ides re3uirements for a 3ualit$ mana*ement s$stem t!at can be used for internal a%%lication b$ or*aniations+ or for certification+ or for contractual %ur%oses& It focuses on t!e effecti,eness of t!e 3ualit$ mana*ement s$stem in meetin* customer re3uirements& ISO 22000 %ro,ides t!e essential elements of a food safet$ mana*ement s$stem for similar %ur%oses& 0&7 om%atibilit$ 'it! ot!er mana*ement s$stems !is ec!nical S%ecification does not include *uidance s%ecific to ot!er mana*ement s$stems+ suc! as t!ose %articular to en,ironmental mana*ement+ occu%ational !ealt! and safet$ mana*ement+ financial mana*ement+ or ris. mana*ement& o'e,er+ ISO 22000 enables an or*aniation to ali*n or inte*rate its o'n food safet$ mana*ement s$stem 'it! related mana*ement s$stems& It is %ossible for an or*aniation to ada%t its eistin* mana*ement s$stem(s) in order to establis! a food safet$ mana*ement s$stem t!at follo's t!e re3uirements of ISO 22000&
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© ISO 2005 - ll ri*!ts reser,ed
TE(;NI(AL S'E(IFI(ATION
ISOITS ""##4:"##$%E&
Food safety management systems - 5uidan!e on te a/i!ation of ISO ""###:"##$
, S!oe !is ec!nical S%ecification %ro,ides *eneric *uidance t!at can be a%%lied in t!e use of ISO 22000& >OE ;!ere a subclause of ISO 22000 is not mentioned+ *uidance is not *i,en&
" Normati3e referen!es !e follo'in* referenced documents are indis%ensable for t!e a%%lication of t!is document& For dated references+ onl$ t!e edition cited a%%lies& For undated references+ t!e latest edition of t!e referenced document (includin* an$ amendments) a%%lies& ISO 22000:2005+ Food safety management s$stems - +e,uirements for any organi9ation in the food chain
6 Terms and definitions For t!e %ur%oses of t!is document+ t!e terms and definitions *i,en in ISO 22000 a%%l$&
4 5uidan!e on te use of ISO ""###:"##$@ (/ause 4: Food safety management system
4., 5enera/ requirements Eternal com%etences ma$ be used b$ t!e or*aniation to de,elo% and im%lement a food safet$ mana*ement s$stem accordin* to ISO 22000 %ro,ided t!at it is ensured t!at suc! outsourced %rocesses !a,e been de,elo%ed and are im%lemented+ monitored+ maintained and u%dated in com%liance 'it! t!e re3uirements of ISO 22000&
@oreo,er+ ISO 22000 allo's an$ or*aniation+ in %articular a small andGor less de,elo%ed or*aniation+ to im%lement an eternall$ de,elo%ed and establis!ed combination of %rere3uisite %ro*ramme(s) "R"(s)J+ o%erational "R"(s) and aard nal$sis and ritical ontrol "oint (") %lans %ro,ided t!at it can be demonstrated t!at
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t!is combination !as been de,elo%ed in com%liance 'it! t!e re3uirements of ISO 22000 s%ecified for t!e !aard anal$sis+ "R"(s) and " %lan+
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s%ecific measures !a,e been underta.en to ada%t t!e eternall$ de,elo%ed combination to t!e or*aniation+ and
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t!is combination !as been im%lemented and is o%erated in accordance 'it! t!e ot!er re3uirements of ISO 22000&
4." Do!umentation requirements !e or*aniation s!ould use documents of eternal ori*in rele,ant for food safet$ in its ,arious acti,ities+ for eam%le in meetin* statutor$+ re*ulator$ and customer re3uirements& In some- situations+ electronic documentation ma$ be re3uired to com%l$ 'it! re*ulator$ re3uirements&
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ISOITS ""##4:"##$%E&
!e t$%e and etent of documentation 'ill %robabl$ differ from one or*aniation to anot!er due to t!e sie and com%leit$ of t!e acti,it$ and t!e com%etence of %ersonnel+ as 'ell as t!e etent of t!e use of eternall$ de,elo%ed combinations of "R"s+ o%erational "R"s and " %lans& eternall$ de,elo%ed combinations of "R"s+ o%erational "R"s and " %lans are used+ t!eir suitabilit$ s!ould be documented and t!is documentation s!ould be a %art of t!e food safet$ mana*ement s$stem& If
;!ere ISO 22000 refers to a documented %rocedure or statement+ t!is s!ould be inter%reted to mean t!at t!e %rocedure or statement is establis!ed+ documented+ im%lemented+ re,ie'ed and maintained b$ t!e or*aniation as %art of t!e food safet$ mana*ement s$stem& #ocuments t!at usuall$ form %art of t!e s$stem include %roduct s%ecifications+ " %lans+ o%erational "R"s and "R"s and ot!er re3uired o%eratin* %rocedures+ includin* contracts for an$ outsourced %rocesses (e&*& %est control+ %roduct testin*)& !e documents used b$ t!e or*aniation s!ould be a,ailable '!en and '!ere re3uired and ma$ be in an$ ,alid format (e&*& %a%er+ electronic or %icture)&
critical acti,it$ for an$ or*aniation is t!e retention of a%%ro%riate records for s%ecified %eriods and under controlled conditions& !e or*aniation s!ould base its decision on record retention '!en it !as considered t!e intended use of its %roducts and t!e e%ected s!elf-life alon* t!e food c!ain&
$ 5uidan!e on te use of ISO ""###:"##$@ (/ause $: 7anagement resonsi8i/ity $., 7anagement !ommitment !e met!od '!ereb$ t!e or*aniation %ro,ides e,idence of to% mana*ement commitment to t!e food safet$ mana*ement s$stem includes t!e settin* of a'areness and leaders!i% initiati,es lin.ed to t!e de,elo%ment and im%lementation of t!e s$stem&
$." Food safety o/i!y !e food safet$ %olic$ is t!e basis of an$ or*aniations food safet$ mana*ement s$stem& @easurable obecti,es and tar*ets are defined in t!is %olic$& @easurable acti,ities ma$ include identification and im%lementation of acti,ities to im%ro,e an$ as%ect of t!e s$stem (e&*& reduce t!e number of recallsG'it!dra'als+ decrease t!e occurrence of forei*n bodies)& Obecti,es s!ould be s%ecific+ measurable+ ac!ie,able+ rele,ant and time-framed&
$.6 Food safety management system /anning >o *uidance is *i,en&
$.4 Resonsi8i/ity and autority >o *uidance is *i,en&
$.$ Food safety team /eader !e food safet$ team leader is central to t!e food safet$ mana*ement s$stem of an$ or*aniation and s!ould be a member of t!e or*aniation and+s!ould understand its food safet$ issues& ;!ere t!e food safet$ team leader !as ot!er res%onsibilities 'it!in t!e or*aniation+ t!ese s!ould not conflict 'it! food safet$ res%onsibilities& !e res%onsibilit$ of t!e food safet$ team leader ma$ include liaison 'it! eternal %arties on matters relatin* to t!e food safet$ mana*ement s$stem& It is recommended t!at t!e food safet$ team leader !a,e a basic .no'led*e of !$*iene mana*ement and
a%%lication of t!e " %rinci%les&
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< ISO 2005 - ll ri*!ts reser,ed
$.9 (ommuni!ation !e %ur%ose of an$ communication is to ensure t!at t!e necessar$ interactions occur& ISO 22000 re3uires t!at bot! eternal and internal communication ta.es %lace as %art of t!e food safet$ mana*ement s$stem& Eternal communication aims to ec!an*e information in order to ensure t!at an$ rele,ant !aard is controlled at one ste% t!rou*! t!e food c!ain b$ interaction+ for eam%le+
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u% and do'n t!e food c!ain+ for food safet$ !aard(s) t!at ma$ not or cannot be controlled b$ t!e or*aniation and '!ic! conse3uentl$ need(s) to be controlled at ot!er ste%s in t!e food c!ain+
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'it! customers as t!e basis for mutual acce%tance of t!e le,el of food safet$ re3uired (b$ t!e customer)+ and
c) 'it! statutor$ and re*ulator$ aut!orities and ot!er or*aniations& Eternal communication is t!e met!od '!ereb$ t!e or*aniation and t!e eternal or*aniation a*ree b$ contract or ot!er means u%on t!e le,el of food safet$ re3uired and on t!e ca%abilit$ of deli,erin* to t!e a*reed re3uirements& !annels of communication 'it! statutor$ and re*ulator$ aut!orities and ot!er or*aniations s!ould be establis!ed as a basis for %ro,idin* %ublic acce%tance of t!e le,el of food safet$ and for ensurin* t!e reliabilit$ of t!e or*aniation& rainin* of desi*nated %ersonnel in communication s.ills ma$ be an im%ortant as%ect as 'ell& !e internal communication s$stem of t!e or*aniation s!ould ensure t!at sufficient and rele,ant information and data are a,ailable to all %ersonnel in,ol,ed in t!e ,arious o%erations and %rocedures& !e food safet$ team leader !as a maor role in t!e area of t!e internal communication of food safet$ issues 'it!in t!e or*aniation& ommunication to %ersonnel 'it!in in t!e or*aniation s!ould be carried out in a clear and timel$ manner on t!e de,elo%ment and launc! of ne' %roducts+ as 'ell as intended c!an*es in ra' materials and in*redients+ %roduction s$stems and %rocesses andGor customers and customer re3uirements& In %articular+ attention s!ould be *i,en to t!e communication of c!an*es in statutor$ and re*ulator$ re3uirements+ ne' or emer*in* food safet$ !aards+ and t!e met!od of control of t!ese ne ' !aards& n$ member of t!e or*aniation seein* somet!in* '!ic! ma$ !a,e an im%act on food safet$ s!ould .no' !o' to re%ort t!is e,ent&
$. Emergen!y rearedness and resonse !e or*aniation s!ould be a 'are of %otential emer*enc$ situations '!ic! ma$ include+ for eam%le+ fire+ floodin*+ bioterrorism and sabota*e+ ener*$ failure+ ,e!icle accidents and contamination of t!e en,ironment&
$.< 7anagement re3ie) !e mana*ement re,ie's %ro,ide mana*ement 'it! an o%%ortunit$ to assess t!e %erformance of t!e or*aniation in meetin* t!e obecti,es 'it! res%ect to its food safet$ %olic$ and t!e o,erall effecti,eness of t!e food safet$ mana*ement s$stem&
9 5uidan!e on te use of ISO ""###:"##$@ (/ause 9: Resour!e management 9., 'ro3ision of resou r!es >o *uidance is *i,en&
< ISO 2005 - ll ri*!ts reser,ed
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