ISO22000：2005與ISO22000：2018新舊版本對照分析表英文版

ISO22000GapAnalysis,,NewTekst,

"10July2018,version1",,Textchange,

,,Textdeletion,

Clause,2005,2018,NatureofChange

,,OverviewofMainChanges,

Introduction,,,

0.1General,Onegeneralsectionspecifyingapplicationandaimofthestandard,"BenefitsoftheFSMS,referencetoPDCAandclarificationinverbalforms(shall,should,may,can)havebeenincluded",AlignmenttoHLS

0.2FSMSPrinciples,Newsub-section,KeyelementsmovedfromtheIntroductionsection(2005)toaseparatesubsection.PrinciplescommontoISOManagementsystemstandardshavebeenincluded,AlignmenttoHLS

0.3ProcessApproach,Newsub-section,"Processapproach,PDCAcycleandrisk-basedthinking(includingrelationshipwithHACCP)explanationsincluded",AlignmenttoHLS

0.4RelationshipwithotherMSS,Newsub-section,IntroductiontotherelationshipwiththeHighLevelStructureanddocumentframework,AligmenttoHLS

FoodSafetyManagementSystems-Requirementsforanyorganizationinthefoodchain,,,

1Scope,Existingsection,"Generalrequirementsarethesame,butthewordinghadbeenchangedforclarificationoreliminationofredundantterms(e.g.suppliers&customersarenowallincludedunderinterestedparties)",Clarificationandimprovementofthetekst

2Normativereferences,ReferencetoISO9000:2000,Referencehasbeeneliminated,-

3Termsanddefinitions,Existingsection:Definitionshavebeenrevised,"ReferencetoISOandIECterminologydatabaseshasbeenincluded.Numberofdefinitionshasbeenincreasedfrom17to45.ThetermSignificantfoodsafetyhazardhasbeenincludedandlinkedtothedefinitionofcontrolmeasures.""Elimination""ofsignificantfoodsafetyhazardshasbeenremoved,leavingonlyreductionorprevention.DefinitionsofCCP'sandOPRP'shavebeenenhancedwithadditionalelementsandlinkedtosignificantfoodsafetyhazards.Clarificationbetweenvalidation,verificationandmonitoringincluded.Food,Feedandanimalfoodtermshavealsobeenincluded",Revision/improvementofthestandard

4.Contextoftheorganization(NewTitle),,,

4.1Understandingtheorganizationanditscontext,Newclause,"Requirementstodetermintetheexternalandinternalissuesrelevanttotheorganization'spurposeandabilitytoachieveintendedresults,havebeenincluded;aswellasthereviewandupdateoftheinformation",AlignmenttoHLS

4.2Understandingtheneedsandexppectationsofinterestedparties,Newclause,"Requirementstodeterminetheneedsandexpectationsofinterestedpartieshavebeenincluded,aswellasthereviewandupdateoftheinformation",AlignmenttoHLS

4.3DeterminingthescopeoftheFSMS,"Requirementsforscopedefintionalreadyincludedin4.1,howeverfurtherrequirementshavebeenadded","Theterm""services""hasbeenaddedtothescopedefinitionrequirement,aswellas""activities.....thatcanhaveaninfluenceonthefoodsafetyoftheendproductsoftheorganization"".Linktorequirementsdefinedin4.1and4.2hasbeenaddedwhendeterminingthescope.",AlignmenttoHLS

4.4FoodSafetyMgt.System,"Alreadyexistingin4.1butmoreextensivethaninthenewversion.""Theorganizationshallestablish,document,implementandmaintainaneffectivefoodsafetymanagement

systemandupdateitwhennecessaryinaccordancewiththerequirementsofthisInternationalStandard"".Controlofoutsourcedprocesseshasbeenmovedtoclause7.1","Generalrequirementsrelatedtothefoodsafetymanagementsystem,havebeenresumedinasinglegeneralclause.Theword""document""hasbeenremovedgivinganopendecisionhowtomanagetheFSMS.""Theorganizationshallestablish,implement,maintain,updateandcontinuallyimproveaFSMS,includingtheprocessesneededandtheirinteractions,inaccordancewiththerequirementsofthisdocument.",AlignmenttoHLS

Thewordd,,,

5.1Leadership&Commitmment,Partiallycoveredbyclause5.1&7.4.3,"Responsibilitesoftopmanagementhavebeenextended,includingdemonstrableleadershipandsupportingotherelevantmanagementroles",AlignmenttoHLS

5.2Policy,Partiallycoveredby5.2,"Theorganizationshallestablish,implement,maintain,updateandcontinuallyimproveaFSMS,includingtheprocessesneededandtheirinteractions,inaccordancewiththerequirementsofthisdocument.",AlignmenttoHLSandRevision/improvementofthestandard

"5.3Organizationalroles,responsibilities&authorities","Partiallycoveredby5.4,5.5and7.3.2","Responsibilitesandauthoritiesforrelevantrolesshallalsobe""understood"",notonlydefinedandcommunicated(newrequirement).

Additionalrequirementshavebeenassignedtotopmanagement,relatedtotheassignationofspecificresponsibilitiesandauthoritieswithintheFSMS.",AlignmenttoHLS

6Planning(NewTitle),,,

6.1Actionstoaddressrisksandopportunites,Newclause,"Newrequirementsaddedrelatedtodeterminingrisksandopportunities,actionstoaddressthemandtheirplanning.ImportantNoteadded(6.1.1.)toclarifytheconceptofrisksandopportunitiesinthecontextofthestandard(eventsandtheirconsequencesrelatingtoperformance&effectivenessoftheFSMS)",AlignmenttoHLS

6.2ObjectivesoftheFSMSandplanningtoachievethem,Partiallycoveredby5.3,"Additionalspecificrequirementsforthedefinitonofobjectiveshavebeenincorporated(SMART),aswellasrequirementsrelatedtotheplanningtoachievethem.Newrequirement:Foodsafety,statutory,regulatoryandcustomerrequirementsshallbetakenintoaccountwhendefiningobjectives.",AlignmenttoHLS

6.3PlanningofChanges,Partiallycoveredby5.3,Thegeneralrequirementinclause5.3(V2005)hasbeenextendedtoincludeadditionalconsiderationswhenplanningandcarringoutchangeswithintheFSMS,AlignmenttoHLS

7Support(NewTitle),,,

7.1.1General,Partiallycoveredebyclause6.1,"Considerationofcapability&constraintsofexistingresourcesaswellastheneedforexternalresourcesinthedeterminationofresourcesneeded,hasbeenaddedasarequirement",Revision/improvementofthestandard

7.1.2People,"Partiallycoveredby6.2,6.2.2.","Separatedasasub-clauseunderresources,requirementsapplicabletoexternalexpertshavebeenincludedunderthissub-clause.Definitionofcompetencyintheagreement/contractswithexternalexpertshasbeenadded.",Revision/improvementofthestandard

7.1.3Infrastructure,Partiallycoveredbyclause6.3,Wordinghasbeenchangedslightlyandanoteadded,Revision/improvementofthestandard

7.1.4WorkEnviroment,Partiallycoveredbyclause6.4,"Wordinghasbeenchangedslightlyandanoteadded,inthenote,thesocialparthasbeenincluded",Revision/improvementofthestandard

7.1.5.ExternallydevelopedelementsoftheFSMS,Partiallycoveredby1,Specificrequirementsapplicabletoexternallydevelopedelementshavebeenintroducedunderthisclause,Revision/improvementofthestandard

"7.1.6Controlofexternallyprovidedprocesses,productsorservices",Partiallycoveredby4.1,"Version2005requiredthedefinitionanddocumentationofthecontrolofoutsourcedprocesses,howeverunderversion2018therequirementshavebeenextendedtoalsoprovidersofproductsandservices.Requirementshavealsobeenenhancedandmademorespecific.Requirementsforevaluation,selection,monitoringofperformance/reevauationofexternalprovidershavebeenaddedaswellasrequirementsforadequatecommunication.PerformanceofexternalprovidershasalsobeenaddedasaninputforManagementReview.",Revision/improvementofthestandard

7.2Competence,"Partiallycoveredbyclauses6.2.1,6.2.2,7.3.2.No,alltheinformationisinchapter6.2.2oftheiso22000-2005.","Foodsafetyteamcompetencehasbeenincludedunderthisclause,scopeofnecessarycompletenceincludesnowalsospecificallyexternalproviders.

Requirementforpersonnelresponsibleoftheoperationofthehazardcontrolplanhasbeenchangedfrom""trained""to""competent"".

Awarenessrequirementshavebeenmovedtoclause7.3.

Requirementsrelatedtopersonnelunderstandingofeffectivecommunicationhasbeenmovedtoclause7.4",AlignmenttoHLSandRevision/improvementofthestandard

7.3Awareness,"Partiallycoveredby6.2.2.No,alltheinformationisinchapter6.2.2oftheiso22000-2005.","Awarenessrequirementspreviouslymentionedinclause6.2.2e)havebeenmovedtoclause7.3andextendedwithspecificawarenessrelatedtothefoodsafetypolicy,objectives(relevanttotheirtasks),improvedsafetyperformanceandimplicationsofnon-conformingwiththeFSMSrequirements.",AlignmenttoHLS

7.4.1Communication-General,Partiallycoveredby6.2.2,Additionalrequirementsregardingthescopeoftheinternalandexternalcommunicationshavebeenadded.Understandingofeffectivecommunicationrequirementshavebeenincludedunderthisclause.,AlignmenttoHLS

7.4.2ExternalCommunication,Partiallycoveredby5.6.1,"Additionalrequirementshavebeenaddedinregardstotheexternalcommunicationrelatedtocustomers/consumers.

Theterm""suppliers""hasbeensubtitutedby""externalprovider"".

Theissuesthatneedtobecommunicatedarenowtobedefinedinapreviousstep(clause7.4.1)bytheorganization,thustheyarenotlongerrestrictedonlytoissuesconcerningfoodsafety,butallcommunicationrelevanttotheFSMS.",Revision/improvementofthestandard

7.4.3InternalCommunication,5.6.2Allexistingrequirementshavebeenmaintained,"""Personnelqualification""hasbeensubstitutedby""competencies""g).",Revision/improvementofthestandard

7.5.1DocumentedInformationGeneral,"Partiallycoveredby4.2.1,5.6.1,","Requirementfordocumentedinformationrequiredbystatutory,regulatoryauthoritiesandcustomershasbeenadded.

Documentedstatementsofthefoodsafetypolicyandobjectivesarenotlongermentionedseparatedlyunderthisclause,howevertherequirementsforthisdocumentsarestatedunder5.2.2.and6.2.1",AlignmenttoHLS

7.5.2CreatingandUpdating,Partiallycoveredby4.2.2,"Requirementmadeapplicabletoalltypesofdocumentedinformation(includingrecords).

Requirementsforidentification,descriptionandformat",AlignmenttoHLS

7.5.3Controlofdocumentedinformation,"Partiallycoveredby4.2.2,4.2.3",Scopeextendedforalltypesofdocumentedinformation,AlignmenttoHLS

8Operation(NewTitle),,,

8.1OperationalPlanningandControl,Partiallycoveredby7.1aandcoveredinthechapter8.3and8.5.2,"Therequirementsoriginallyincludedunder7.1wereextendedtotakeintoconsiderationtheimplementationofactionsdefinedtoaddressrisksandopportunities(6.1).

Responsibiityoftheorganizationtotakeundercontroltheplanned&unintendedchanges,aswellasoutsorucedprocesseshasbeenaddedinthisclause",AlignmenttoHLS

8.2Pre-Requisiteprograms,Partiallycoveredby7.2,"WordinghasbeenchangedslightlyandappropriatenessofthePRPlinkedtothecontextoftheorganization.

Referencetoconsider(""should"")theapplicableISO/TSdocumentinthedefinitionofPRPhasbeenadded.

Supplierapprovalandproductinformation/consumerawarenesshavebeenincludedinthelistofminimalPRPneededbytheorganization.

PRP'sDocumentedinformationshallnowalsospecifytheirselection,applicablemonitoringandverification.",Revision/improvementofthestandard

8.3Traceabilitysystem,Partiallycoveredby7.9,"Wordinghasbeenchanged,minimumrequirementswhenestablishingatraceabilitysystemhavebeenadded(includingreworking).

Requirementforverificationandtestingoftheeffectivenessofthetraceabilitysystemhasbeenadded.

Anotehasbeenaddedregardingthereconciliationofquantitiesofendproducts&ingredients.",Revision/improvementofthestandard

8.4Emergencypreparednessandresponse,Partiallycoveredby5.7,"Responsibilityisstillassignedtotopmanagement.Word""accidents""hasbeenchangedto""incidents"".

Arequirementfordocumentedinformationregardingthemanagementofthesesituationshasbeenincluded.Procedurestorespondtothesesituationsarestillrequired",Revision/improvementofthestandard

8.5.1Preliminarystepstoenablehazardanalysis,"Partiallycoveredby7.3

Descriptionofprocessstepsandcontrolmeasures(7.3.5.2)hasbeenreplacedbyDescriptionofprocessandprocessenvironment,andthescopeoftherequirementshasbeenextendedtoincludeadditionaldescriptionssuchas:layoutofpremisesandprocessingequipmentamongotherthings.Variationsfromexpectedseasonalchanges&shiftpatternsshallalsobeincluded.","RequirementsrelatedtothecompetenceoftheFoodSafetyTeamhavebeenrelocatedtoClause7.2Competence.

General:MinimumrelevantinformationtobeconsideredwhenconductingtheHAhasbeenadded.

CharacteristicsRawMaterial:""Source(e.g.animal,mineralorvegetable)""hasbeenincludedinthelistofcharacteristicsofrawmaterialsandclarificationgiveninregardsto""placeoforigin"".

Characteristicsendproduct:wordingsuchasMethodsofdistributionanddeliveryhasbeenaddedinthelistofcharacteristicsoftheendproduct.

FlowDiagrams:InputsandOuputstobedetailedintheflowdiagramshavebeenextendedandtheon-sitevertificationrequirementsdescribedseparatedlyinasub-clause.

",Revision/improvementofthestandard

8.5.2Hazardanalysis,"Partiallycoveredby,7.4,","Hazardidentificacion&acceptablelevels:internalepidemiological/scientific/historicaldatashallalsobeusedasaninputintheidentificationofhazards,aswellasstatutory/regulatory/customerrequirements.ClarificationNoteshavebeenadded.Recommendationtoconsiderhazardsinsufficientdetailhasbeenadded.Requirementtousethepre-definedflowdiagramhasbeenadded(inalignmenttotheCodex).

HazardAssessment:Theword""elimination""offoodsafetyhazardshasbeenremoved.Requirementtoidentifysignificantfoodsafetyhazardshasbeenincluded.

Selectionofcontrolmeasures:Theword""elimination""offoodsafetyhazardshasbeenremovedandthewording""significantfoodsafetyhazards""hasbeenaddedtothescopeofapplicationofthissub-clause.AlsoclarificationoncontrolmeasurestobemanagedasOPRP(s)orasCCPs,(replacementofthewordsHACCPplan,CCPandOPRPtobemanagedviaaHazardControlPlan).Inputsforconductingtheassessment&categorizationofcontrolmeasureshavebeenextendedtoincludealsofeasibilityofestablishingmeasuringCriticallimitsandapplicabilityoftimelycorrections.Externalrequirementsthatcanimpactthechoiceandstrictnessofcontrolmeasuresshallbedocumented.",Revision/improvementofthestandard

8.5.3Validation,Partiallycoveredby8.2and7.6,"Wordinghasbeenchangedtoclarifythatvalidationappliestoboth:singlecontrolmeasuresandcombinationsofcontrolmeasures.

Requirementtomaintainthevalidationmethodologyandevidenceofcapabilityhasbeenadded.",Revision/improvementofthestandard

8.5.4HazardControlPlan,Partiallycoveredby7.5and7.6,"TheHACCPplanandOPRPdocumenthavebeencombinedinasingledocumentcalledHazardControlPlan.RequirementsforbothOPRPandCCP(monitoring,criticallimits/actioncriteria/corrections/correctiveactions)havebeencombinedunderthisclause(8.5.4)

""ActionCriteria""definitionhasbeenincludedasarequirementforOPRPaswellasspecificrequirementstodefinethem.

Theinputof""monitoringmethods""hasbeenaddedasanadditionaloptionnexttomonitoringdevices.

ForOPRP's,equivalentmethodsofverificationofreliablemeasurementsarenowpermittedinplacefromcalibrationmethods.

Requirementsforactionstobetakenarenotonlyapplicableforwhencriticallimitsarenotmetbutalsowhenactioncriteriaisnotmet.",Revision/improvementofthestandard

8.6UpdatingtheinformationspecifyingthePRPandHazardcontrolplan,Partiallycoveredby7.7,"ChangeinwordingtosubsituteHACCPPlan&OPRPforHazardControlPlan.

Additionalinformationhasbeenaddedintheoutputsoftheupdateprocess",Revision/improvementofthestandard

8.7Controlofmonitoringandmeasuring,Partiallycoveredby8.3,"Thescopeofapplicationof8.7hasbeenclarified:methodsandequipmentrelatedtoPRPandhazardcontrolplan.

Frequencyofcalibration/verificationhasbeenmodifiedto""specifiedintervalspriortouse"".

RequirementsforvalidationofsoftwareusedinmonitoringandmeasuringwithintheFSMShavebeenadded,includingdocumentedinformationinvalidationactivities.updatesandmanagementofchangesofthesoftware.",Revision/improvementofthestandard

8.8VerificationrelatedtoPRPandthehazardcontrolplan,"Partiallycoveredby7.8,8.4.2","Theactivitiestobecoveredbytheverificationactivitieshavebeenextended:effectivenessofPRP'shasbeenaddedandhazardcontrolplanhasbeenincludedinplaceofHACCPplan/oprp.Requirementforimpartialityofpersonconductingtheverificationhasbeenadded(notthesamepersonthatperformsthemonitoring).

Applicationofcorrectiveactionshasbeenincludedincasepotentiallyunsafeproductisdetectedviatheverifcationactivities",Revision/improvementofthestandard

8.9Controlofproductandprocessnonconformities,Partiallycoveredby7.10,"Corrections/CorrectiveActions:ActionstoreviewtheNCidentifiedbyregulatoryinspectionsreports&consumercomplaintshavebeenadded.Theterm""actioncriteria""hasbeendefinedasatriggerofcorrections/CA.

Thewording""evaluatingtheneedforactiontoensurethatnonconformitiesdonotrecur""hasbeenreplacedby""determining&implementingactionstoensure..."".

Handlingofpotentiallyunsafeproducts:Wordingslightlychanged.Requirementclarifiedforevaluatingeachlotofaffectedproduct.RequirementaddedfornotreleasingproductaffectedbyfailuretomeetcriticallimitsataCCP,leavingtheevaluationforreleaseonlyapplicabletoproductsthatfailtocomplywiththeauditcriterionofanOPRP.Requirementaddedtoretainasdocumentedinformationtheresultsoftheevaluationofrelease.

AnadditionalpotentialdispositionofNCproducthasbeenadded(redirectedforotheruse)&requirementtoretaindocumentedinformation.

Withdrawal/recall:Separationbewteenwithdrawalandrecallhasbeenmade,applicabilityforrequirementsunder8.9.5isforbothprocesses",Revision/improvementofthestandard

9.PerformanceEvaluation(newtitle),,,

"9.1Monitoring,measuring,analysisandevaluation","Partiallycoveredby8.4.2,8.4.4+newsubclause","General:Newrequirementsintroducedrelatedtotheorganizationresponsibilitytodeteminethemeasuring&monitoringprocesseshavingasgoaltheevaluationoftheperformance&effectivenessoftheFSMS.

",AlignmenttoHLS

9.2InternalAudits,Partiallycoveredby8.4.1,"Inputsforgeneratingtheauditprogramhavebeenextended:changesintheFSMS&resultsofmonitoringandmeasurementshallbetakenintoaccounttodeveloptheauditprogram.

RequirementaddedtoensurethattheresultsoftheauditarereportedtotheFSTeam&relevantmanagement.

RequirementaddedrelatedtodeterminingiftheFSMSmeetstheintentofthefoodsafetypolicy&objectivesaspartoftheinternalauditprocess.",AlignmenttoHLSandRevision/improvementofthestandard

9.3ManagementReview,"Partiallycoveredby5.2,5.8","Mgt.Reviewinputs:Thestructureandnumberofinputsforthemanagementreviewhavebeenammended.Additionalinputshavebeenincludedandanumberofinputsgroupedunderageneralinputof""informationontheperformance&effectivenessoftheFSMS"".

Mgt.ReviewOutputshavealsobeenammendedtoincludespecificactions/decisionsrelatedtocontinualimprovementopportunitiesandtheneedforupdates&changesintheFSMS",AlignmenttoHLSandRevision/improvementofthestandard

10.Improvement,,,

10.1Nonconformityandcorrectiveaction,New,"NewclausespecifyingrequirementstodealwithNonConformitieswithintheorganization,includingtherequirementtodetermineifsimilarnonconformitiescouldpotentiallyoccur(preventiveactions)",AlignmenttoHLS

10.2ContinualImprovement,"Partiallycoveredby8.1,8.5.1","RequirementextendedtoincludetheimprovementofthesuitabilityandadequacyoftheFSMS,besidestheeffectiveness.

Wordingofinputschangesduetotheinclusionofnewtitlesoftheclauses(e.g.analysisofresutsofverificationactivities)",AlignmenttoHLSandRevision/improvementofthestandard

10.3UpdateoftheFSMS,8.5.2,Wordingchangesslightlyaccordingtonewterms&titles.,Revision/improvementofthestandard

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