9100:2016SeriesofStandards
FrequentlyAskedQuestions(FAQs)
IndevelopingthislistofFrequentlyAskedQuestions(FAQ's)forthe9100:2016Seriesrevisions,
inputhasbeenobtainedfromexpertsandusersofthestandardfromaroundtheworld.Thelistwill
bereviewedandupdatedonaregularbasistomaintainitsaccuracy,andtoincludenewquestions
whereappropriate.Itisintendedthatthislistwillalsoprovideagoodsourceofinformationfornew
usersofthestandards.
Questionsaboutthechange
1. WhyhasitbeendecidedtoissueanewversionofISO9001baselinetext?
BusinessneedsandexpectationshavechangedsignificantlysincethelastmajorrevisionofISO
9001intheyear2000.Examplesofthesechangesareevermoredemandingcustomers,the
emergenceofnewtechnologies,increasinglymorecomplexsupplychainsandamuchgreater
awarenessoftheneedforsustainabledevelopmentinitiatives.
2. Doesthe9100:2016Seriesstillapplytoallorganizations-big,small,differentsectorsand
differentitems–products,services?
Theconceptofthestandardhasnotchanged;it'sapplicabletoanytypeoforganization,
regardlessofthesize,typeoritscorebusiness.
3. Howhasthestructureofthestandardchanged?
Thestructurehasbeenchangedtoalignwiththecommon10clausehighlevelstructure
developedbyISOtoensuregreaterharmonizationamongitsmanydifferentmanagement
systemstandards.
Thenew10clausehighlevelstructurewillapplytoallISOmanagementsystemstandards,
whichisbuiltaroundthePDCA(Plan-Do-Check-Act)sequence.Thiswillmakeiteasierfor
organizationstoaddresstherequirementsofmorethanoneISOManagementSystemStandard
withinasingle,integratedsystem.
4. Whatarethemaindifferencesincontentbetweentheoldandnewversion?
• TheadoptionofthehighlevelstructureassetoutinAnnexSLofISODirectivesPart1
• Anexplicitrequirementforrisk-basedthinkingtosupportandimprovethe understanding
andapplicationoftheprocessapproach
• Fewerprescriptiverequirements
• Moreflexibilityregardingdocumentation
• Improvedapplicabilityforservices
• ArequirementtodefinetheboundariesoftheQMS
• Increasedemphasisonorganizationalcontext
• Increasedleadershiprequirements
9100:2016SeriesofStandards
FrequentlyAskedQuestions–July2017
• Greateremphasisonachievingdesiredprocessresultstoimprovecustomer satisfaction
5. Howhasdocumentationrequirementschanged?
Specificdocumentedproceduresarenolongermentioned;itistheresponsibilityofthe
organizationtomaintaindocumentedinformationtosupporttheoperationofitsprocessesand
retainthedocumentedinformationnecessarytohaveconfidencethattheprocessesarebeingcarried
outasplanned.Theextentofthedocumentationthatisneededwilldependonthebusiness
context.
6. Thestandarddoesnotmentionaqualitymanual,isitstillrequired?
Aqualitymanualisnolongerspecificallyrequired.Thenewstandardrequirestheorganization
tomaintaindocumentedinformationnecessaryfortheeffectivenessofthequalitymanagement
system(QMS).Therearemanywaystodothisandaqualitymanualisjustone.Ifitis
convenientandappropriateforanorganizationtocontinuetodescribeitsqualitymanagement
systeminaqualitymanualthenthatisperfectlyacceptable.The9100:2016standardadded
requirementsinclause4.4.2thatincludedthepreviousqualitymanualrequirementsinaddition
toincludingadditionalinformation.Ifyouhavestatutory/regulatoryorcustomerrequirements
tomaintainaqualitymanual,yourorganizationmustcomply.
7. Whyhasmanagementreviewbeenmovedtoperformanceevaluation?(9.3)
Thesequenceofthenewversionof9100:2016isbasedonthePlan,Do,Check,Actcycleandso,
inordertoevaluatequalitymanagementsystemperformance,itmakessenseformanagement
reviewtofollowthemeasurementofthesystemperformance.
8. ThetitleofmanagementrepresentativehasbeenremovedfromISO9001:2016andthen
addedin9100:2016.
TheISOintentwasthatitisuptotopmanagementtoensurethattherolesandresponsibilities
areassignedforreportingontheperformanceoftheQMS.Someorganizationsmightfindit
convenienttomaintaintheircurrentstructure,withasinglepersoncarryingoutthisrole.
Othersmighttakeadvantageoftheadditionalflexibilitytoconsiderotherstructuresdepending
ontheirorganizationalcontext.
9. Whyhasproductbeenchangedtoproductandservice?
9100:2009alreadymadeitclearthatthetermproductinthepreviousversionofthestandard
alsoincludesservice,sothereisnoimpactinpracticalterms.Thetermproductandserviceis
nowusedthroughoutthestandardtoreflectthefargreateruseofthestandardoutsideofthe
manufacturingsector,andtoemphasizeitsapplicabilityintheserviceindustries.
10. Whatisrisk-basedthinkingandwhyhasitbeenintroducedintothestandard?
Thephraserisk-basedthinkingisusedtodescribethewayinwhichtheISO9001:2015baseline
textaddressesthequestionofrisk.TheconceptofriskhasalwaysbeenimplicitintheISO9001
text,byrequiringtheorganizationtoplanitsprocessesandmanageitsbusinesstoavoid
undesirableresults.Organizationshavetypicallydonethisbyputtinggreateremphasison
planningandcontrollingprocessesthathavethebiggestimpactonthequalityoftheproducts
andservicestheyprovide.Thewayinwhichorganizationsmanageriskvariesdependingontheir
businesscontext(e.g.thecriticalityoftheproductsandservicesbeingprovided,complexityof
9100:2016SeriesofStandards
FrequentlyAskedQuestions–July2017
theprocesses,andthepotentialconsequencesoffailure).Useofthephraserisk-basedthinking
isintendedtomakeitclearthatwhileanawarenessofriskisimportant,formalriskmanagementmethodologiesandriskassessmentarenotnecessarilyappropriateforallbusiness
situationsandorganizations.Forfurtherinformationaboutrisk-basedthinking,see(link).(see
AnnexA)
Riskbasedthinkinghasmergedverywellwiththe9100:2009additionofriskmanagement,
whichwasproductfocusedandlimitedtotheProductRealizationclause,nowOperations.See
AnnexA.4foradditionalinformationonthedifferences
11. Whathasbeenchangedintermsofplanning?
9100:2016requirestheorganizationtoaddressrisksandopportunities,qualityobjectivesand
planningofchangesthroughouttheorganization.Asnewproducts,technologies,marketsand
businessopportunitiesarise,itistobeexpectedthatorganizationswillwanttotakefull
advantageoftheseopportunities.Thishastobedoneinacontrolledmanner,andbebalanced
againstthepotentialrisksinvolved,whichcouldleadtoundesirablesideeffects.
12. AreorganizationsstillallowedtoexcluderequirementsofISO9001?
9100:2016nolongerrefersto“exclusions”inrelationtotheapplicabilityofitsrequirementsto
theorganization’squalitymanagementsystem.However,anorganizationcandeterminethe
applicabilityofrequirements.Allrequirementsinthenewstandardareintendedtoapply.The
organizationcanonlydecidethatarequirementisnotapplicableifitsdecisionwillnotaffectits
abilityorresponsibilitytoensuretheconformityofproductsandservicesandtheenhancement
ofcustomersatisfaction.
13. Whatistheprocessapproachandisitstillapplicableto9100:2016?
Theprocessapproachisawayofobtainingadesiredresult,bymanagingactivitiesandrelated
resourcesasaprocess.Althoughtheclausestructureof9100:2016followsthePlan-Do-CheckActsequence,theprocessapproachisstilltheunderlyingconceptfortheQMS.Forfurther
guidance,pleaserefertotheSupportPackagemodule:GuidanceontheConceptandUseofthe
ProcessApproachformanagementsystems.
14. Whatarethebenefitsofthenewversionof9100:2016?
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Lessprescriptive,butwithgreaterfocusonachievingconformingproductsandservices
Moreuserfriendlyforserviceandknowledge-basedorganizations
Greaterleadershipengagement
Morestructuredplanningforsettingobjectives
Managementreviewisalignedtoorganizationalresults
Theopportunityformoreflexibledocumentedinformation
Addressesorganizationalrisksandopportunitiesinastructuredmanner
Addressessupplychainmanagementmoreeffectively
Opportunityforanintegratedmanagementsystemthataddressesotherelementssuch
asenvironment,health&safety,businesscontinuity,etc.
15. Whyistheresuchashorttransitionperiod?
IAQGdecidedtomatchtheISO9001:2015transitionperiodofSeptember2018soorganizations
couldavoidtwoseparatetransitioneffortsandaudits.
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FrequentlyAskedQuestions–July2017
Questionsrelatingtospecificclausesinthestandard
1. Whatismeantbythecontextoftheorganization?(4)
Thisisthecombinationofthoseinternalandexternalfactorsthataffectanorganization's
approachtothewayinwhichitprovidesproductsandservicesthataredeliveredtoits
customer.
Externalfactorscaninclude,forexample,cultural,social,political,legal,regulatory,
financial,technological,economic,andcompetitiveenvironment,attheinternational,
national,regionalorlocallevel.
Internalfactorstypicallyincludetheorganization’scorporateculture,governance,
organizationalstructure,technologies,informationsystems,anddecision-makingprocesses
(bothformalandinformal).
2. Whataretheneedsandexpectationsassociatedwithinterestedparties?(4.2)
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The organization w i l l n e e d to determine the interested parties that are
relevant to the quality management system and the requirements of those
interested parties,asoutlinedinclause4.2. Thisdoesnotextendpastthe
qualitymanagementsystemrequirementsandthescope ofthisInternational
Standard.
Asstatedinthescope,thisInternationalStandardisapplicablewhere an
organization needs to demonstrate its ability to consistently provide
products and services that meetcustomerandapplicablestatutoryand
regulatoryrequirements,andaimstoenhancecustomer satisfaction.
3. Whatismeantbyorganizationalknowledge?(7.1.6)
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Organizationalknowledgeisknowledgespecifictotheorganization;itisgainedby
experience.Itisinformationthatisusedandsharedtoachievetheorganization’s
objectives.Requirementsregardingorganizationalknowledgewereintroducedforthe
purposeofsafeguardingtheorganizationfromlossofknowledgeandencouragingthe
organizationtoacquirenewknowledgeasitsbusinesscontextchangesandsharethe
knowledgewithothers.
Implementationconsiderationsincludeactivitiestobenefitfromlessonslearned,e.g.,
database,communications,incorporationoflessonslearnedinprocessesandprocedures;
identificationofexpertsabletotransferknowledge;onjobtraining;tutorialsessions;
documentedinformationonhowtoperformtasks;competencymatrices;andsuccession
planningactivities.
4. WhatisexpectedforAwareness(7.3)?
Individualsshouldbeabletoexplaintheirrole(i.e.sales,engineering,procurement,
operator,repairtechnician)andhowtheycontributetoquality;qualitybasicssuchas
followinginstructions,reportingevents,maintainingrecords;andknowtheuseofthe
productsandpotentialimpactoffailures.
9100:2016SeriesofStandards
FrequentlyAskedQuestions–July2017
5. Documentsandrecordshavebeenreplacedbydocumentedinformation.Whatdoesthis
mean?(7.5)
Documentation,documentsandrecordsarenowcollectivelyreferredtoasdocumented
information.Wherethatdocumentedinformationmightbesubjecttochange(asinthe
caseofprocedures,workinstructions,etc),organizationsarerequiredtoMAINTAINthe
informationup-to-date;wheretheinformationisnotnormallysubjecttochange(for
examplerecords)theorganizationisrequiredtoRETAINthatinformation.
6. IsthereaguidancedocumentoranISOstandardthatIcanobtainthatdefinesaprocess
forRiskManagement(8.1.1)?
Yes.ThereareseveralgoodresourcesforRiskManagementwhicharelistedbelow:
• ISO31000RiskManagement
• IAQGSupplyChainManagementHandbookhasChapter11.2onRiskManagement
whichcanbeaccessedathttp://www.sae.org/iaqg/handbook/scmhtermsofuse.htm
• IAQG9134SupplyChainRiskManagement
• ISOGuide73RiskManagementVocabulary
• ISO17666SpaceSystems-RiskManagement
• ISO16085Systems-SoftwareEngineering-RiskManagement
• ProjectManagementInstitute
• RiskManagementGuideforDoDAcquisition
Therearenumerousriskmanagementresourcesand9100isnotprescriptiveinproviding
the“how”riskmanagementistobeperformed,onlythatcertainaspectsbeestablished,
implemented,andmaintainedasappropriate.RiskManagementforoperationalprocesses
isasubsetofRisk-basedThinking(6.1)whichtranscendstheentireQMS.See9100:2016
AnnexA.4foradditionalinformation.
7. Whataresomemethodstoimplementcounterfeitpartprevention(8.1.4)?
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Trainingintheawarenessandpreventionofcounterfeitparts
o Procurementpersonnelintrustedsourceselectionandrequirements
o Inspectionpersonnelforpreventionofcounterfeititems(visual/test)
o Designpersonnelinobsolescencemanagement
Obsolescencemonitoringofdesigndecisionsandpartsselectionstobeappropriatefor
servicelifeofproduct
Controlsforacquiringpartsfromoriginalmanufacturers,authorizeddistributors,or
otherapprovedsources
Assuringtraceabilityofpartsandcomponentstotheiroriginalmanufacturers:
o OriginalEquipmentManufacturer(OEM)or
o Authorizedmanufacturer(e.g.,incaseofPMA,directdeliveryauthorizations)
Verificationandtestmethodologiestodetectcounterfeitparts:
o Partsidentificationormarking
o Testsorchemicalanalysis
Counterfeitpartsreporting
o Monitoringreportingfromexternalsources(accesstodatabases,information
lettersfromOEMs)
9100:2016SeriesofStandards
FrequentlyAskedQuestions–July2017
Quarantineandreportingofinternalincidencesinappropriategovernmentand
industryreportingsystems
(determinetheresponsibilitiesintheescalationprocess,theprocesstofollowto
reporttoauthorities/customers)
Requirementregardingnonconformancecontrol:
o Segregateandcontrolsuspectedorknowncounterfeitproducts
o Ensuretheseproductsarenotre-introducedintothesupplychain
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8. WhyhasPurchasingchangedto‘Controlofexternallyprovidedprocesses,productsand
services’?(8.4)
Thischangereflectsthefactthatnotallproducts,servicesorprocessesthatanorganization
acquiresarenecessarilypurchasedinthetraditionalsense.Somemaybeacquiredfrom
otherpartsofacorporateentity,forexample,aspartofasharedpoolofresources,
productsdonatedbybenefactorsorservicesprovidedbyvolunteers.
9. Explainindetailtheintentofsection8.4.3m(aflowdownrequiringawarenessofsupplier
personnel).
Theintentofthisrequirementistoensureexternalproviderpersonnelunderstandtherole
theyplayinconformity,productsafety,andethicalbehavioraspartoffinalproductmeeting
requirements.Theintentoftheflowdowntoexternalprovidersoftheawareness
requirementistoensurethatthewholesupplychainhavethesameawarenessonthe
topicslisted
Theorganizationscananswerwith:
-ageneralrequirementtoalltheirexternalprovidersortokeyexternalproviders
(remindingthattheyareworkingfortypesofaerospaceproducts)
-specificrequirements(inPOsorinContracts)torelevantexternalprovidersremindingthat
theyaresupplyingproductshavingsafetyimpactsonthefinalproducts,
10. Whathashappenedtovalidationofprocessesorwhatusedtobecalledspecial
processes?(8.5)
ISO9001:2015chosetoremovethestandalonesub-clauseonspecialprocesses,this
requirementcontinues,andhasbeenincorporatedintothesub-clausefoncontrolof
productionandserviceprovision(Ref.8.5.1).Thiswasnotspecificordetailedenoughfor
Aviation,Space,andDefenseso9100:2016addeditasclause8.5.1.2,ValidationandControl
ofSpecialProcesses.
11. Whatismeantbypostdeliveryactivitiesandwhatistheextentofanorganization’s
responsibility?(8.5.5)
Thismeansthatbasedoncustomeragreementsorotherrequirements,theorganization
mayberesponsibleforprovidingsupportfortheirproductorserviceafterdelivery.This
couldinclude,forexample,technicalsupport,routinemaintenance,orinsomecasesrecall.
12. Whatisthedifferenceinthestandardbetweenimprovementandcontinual
improvement?(10)
9100:2016usedthetermcontinualimprovementtoemphasizethefactthatthisisan
ongoingactivity.However,itisimportanttorecognizethatthereareanumberofwaysin
whichanorganizationmayimprove.Smallstepcontinualimprovementisonlyoneofthese.
9100:2016SeriesofStandards
FrequentlyAskedQuestions–July2017
Othersmayincludebreakthroughimprovements,re-engineeringinitiativesorinnovation.
9100:2016thereforeusesthemoregeneraltermimprovement,ofwhichcontinual
improvementisonebutnottheonlycomponent.
ThisInternationalStandardisbasedonthequalitymanagementprinciplesdescribedinISO
9000.The descriptionsincludeastatementofeachprinciple,arationaleofwhythe
principleisimportantforthe organization,someexamplesofbenefitsassociatedwiththe
principleandexamplesoftypicalactionsto improvetheorganization’sperformancewhen
applyingtheprinciple.
9100:2016SeriesofStandards
FrequentlyAskedQuestions–July2017