质量管理系统–根本性和词汇量样本

IS09000:(E)

Qualitymanagementsystems-Fundamentalsandvocabulary

1Scope

ThisInternationalStandarddescribesfundamentalsofquali:ymanagementsystems,whichformthesubject

oftheISO9000family,anddefinesrelatedlerms.

ThisInternationalStandardisapplicabletothefollowing:

a)organizationsseekingadvantagethroughtheimplementationofaqualitymanagementsystem;

b)organizationsseekingconfidencefromtheirsuppliersthattheirproductrequirementswillbesatisfied;

c)usersoftheproducts;

d.thos.conccrnc.wit..inutua.undcrstandin.o.th.tcrminolog.usc.i.qualit.inanagcmcn.(c.g.suppliers,customers,

regulators);

anizatio.vvh.asses.th.qualit.nKnagemcn.syste.o.audi.i.fo.confonnit.wit.th.rcqui

rement.o.IS.900.(e.g.auditors,regulators,certification/registratio.bodies);

f)thoseinternalorexternaltotheorganizationwhogiveadviceortrainingonthequalitymanagement

systemappropriatetothatorganization;

g)developersofrelatedstandards.

2Fundamentalsofqualitymanagementsystems

2.1Rationaleforqualitymanagementsystems

Qualitymanagementsystemscanassistorganizationsinenhancingcustomersatisfaction.

Cduct.vvit.charactcristic.tha.satisf.thci.nccd.an.cxpcctations.Thcs.nccd.an.cxpcctation.ar.cx

duc.specification.an.collectiveI.referre.t.a.custoiTie.requirements.Custome.requirement.ma.b.speci

fie.contractualLanizatio.itself.I.eithe.case,

duct.Becaus.custome.need.an.expectation.ar.changing,

petitiv.pressure.an.technica.advances,

cesses.

Tanization.t.analys.custome.requirements,

duc.whic.i.acceptabl.t.th.customer,

vid.th.franievvor.fo.continua.iniprovenien.t.

ereste.parties.I.provide.confide

duct.tha.consistentl.fulfil.requirements.

2.2Requirementsofqualitynianageiiientsystemsandrequirementsforproducts

TheISO90()0familydistinguishesbetweenrequirementsforqualitymanagementsystemsandrequirements

forproducts.

Requirement.fo.qualit.managemen.system.an$pecific.i.IS.9001.Requircment.fo.qualit.managemen.syst

duc.categ

ory.IS.90().ducts.

Ranizatio.i.anticipatio.o.custome.requiremen

ts,o.b.regulation.Tcesse.ca.b.containe.in,

fo.example,technica.specifications,produc.standards,proces.standards,

contractua.agreement.an.regulator.requirements.

2.3Qualitymanagementsystemsapproach

Anapproachtodevelopingandimplementingaqualitymanagementsystemconsistsofseveralsteps

includingthefollowing:

a)determiningtheneedsandexpectationsofcustomersandinterestedparlies;

b)establishingthequalitypolicyandqualityobjectivesoftheorganization;

c)determiningtheprocessesandresponsibilitiesnecessarytoattainthequalityobjectives;

d)determiningandprovidingtheresources

e)establishingmethodstomeasuretheeffectivenessandefficiencyofeachprocess;

Dapplyingthesemeasurestodeterminetheeffectivenessandefficiencyofeachprocess;

g)determiningmeansofpreventingnonconformitiesandeliminatingtheircauses;

h)establishingandapplyingaprocessforcontinualimprovementofthequalitymanagementsystem.

Suchanapproachisalsoapplicabletomaintainingandimprovingandexistingqualitymanagementsystem.

A.ducts,

vide..basi.fb.continua.improvenient.Thi.ca.lea.t.increase.satisfactio.o.customer.an.othe.:ntereste.partie.

anization.

2.4Theprocessapproach

Anyactivity,orsetofactivities,thatusesresourcestotransforminputstooutputscanbeconsidered

asaprocess.

Fanization.t.functio.effectively,

cesses.Often,

ces.wil.directi.forth.cess.Th.systemati.identificatio.an.fr.anagemen.o.th.

anizatio.an.particular!.cesse.i.refeire.t.a.tli.

“proces.approach."

Ten.o.thi.Internationa.Sanization.

Fcess-base.qualit.managemen.syste.describe.th.IS.9(X).famil.slandards.Thi.illustratio.sho

anization.Mereste.p

ereste.partie.a.t.th.exten.t.whic.thei.need.an.e

xpectation.hav.bee.met.Th.niode.show.i.Fcesse.a..detaile.level.

2.5Qualitypolicyandqualityobjectives

Qanization.Bot.determin.th.desi

anizatio.t.appl.it.resource.t.achiev.thes.results.Tvide..franiewo

r.fo.establishin.an.reviewin.qualit.objectives.Th.qualit.objective.nee.t.b.consisten.wit.th.qualit.polic.an.

niitnien.t.continua.iniprovenient,

an.thei.achievemen.need.t.l).measurable.Td

uc.quality,

ereste.parties.

5

----------►Value-addingactivities

———►kitormationflow

NOTEStatementsinparenthesesdonotapplytoISO9001.

Figure1-Modelofaprocess-basedqualitymanagementsystem

2.6Roleoftopmanagementwithinthequalitymanagementsystem

Throng,icadershi.an.actions,

(o.managemen.ca.creat.a.environmen.wher.peopl.ar.full.involve.an.i.whic..qualit.managemen.syste.ca.opeiat.

cffcctivcly.Th.qualit.managcmcn.principlc.(se.0.2.ca.b.use.b.to.managcincn.a.th.basi.o.it.role,

whic.i.a.follows:

a)toestablishandmaintainthequalitypolicyandqualityobjectivesoftheorganization;

b)topromotethequalitypolicyandqualityobjectivesthroughouttheorganizationtoincreaseawareness,

motivationandinvolvement;

c)toensurefocusoncustomerrequirementsthroughouttheorganization;

d)toensurethatappropriateprocessesareimplementedtoenablerequirementsofcustomersandother

interestedpartiestobefulfilledandqualityobjectivestobeachieved;

c)toensurethataneffectiveandefficientqualitymanagementsystemisestablished,implementedand

maintainedtoachievethesequalityobjectives;

f)toensuretheavailabilityofnecessaryresources;

g)toreviewthequalitymanagementsystemperiodically;

h)todecideonactionsregardingthequalitypolicyandqualityobjectives.

i)todecideonactionsforimprovementofthequalitymanagementsystem.

2.7Documentation

2.7.1Valueofdocumentation

a)Den.an.consistenc.o.action.It.us.contribute.fo.

b)achievementofconformitytocustomerrequirementsandqualityimprovement,

c)provisionofappropriatetraining.

d)repeatabilityandtraceability,

e)provisionoobjectiveevidence,and

f)evaluationoftheeffectivenessadcontinuingsuitabilityofthequalitymanagementsystem.

Generationofdocumentaticnshouldnotbeanendinitselfbutshouldbeavalue-addingactivity.

2.7.2Typesofdocumentusedinqualitymanagementsystems

Thefollowingtypesofdocumentareusedinqualitymanagementsystems:

a)documentsthatprovideconsistentinformation,bothinternallyandexternally,abouttheorganization's

qualitymanagementsystem；suchdocumentsarereferredtoasqualitymanuals;

b)documentsthatdescribehowthequalitymanagementsystemisappliedtoaspecificproduct,projector

contract：suchdocumentsarereferredtoasqualityplans;

c)documentsstalingrequirements；suchdocumentsarereferredtoasspecifications;

d)documentsstatingrecommendationsorsuggestions；suchdocumentsarereferredtoasguidelines;

e)documentsthatprovideinformationabouthowtoperformactivitiesandprocessesconsistently；such

documentscanincludedocumentedprocedures,workinstructionsanddrawings;

f)documentsthatprovideobjectiveevidenceofactivitiesperformedorresultsachieved：suchdocumentsare

referredtoasrecords.

Eanizatio.dctennine.th.exten.o.docuinentatio.require.a.th.niedi.t.b.used.Thi.depend.o.factor.suc.a.th.typ

.anization,cesses,ducts,

custome.requirements,th.applicabl.regulator.requireinents,th.demonstrate.abilit.o.personnel,

an.th.exten.t.whic.i.i.necessar.t.demonstrat.fulfillmen.o.qualit.managemen.syste.requirements

2.8Evaluatingqualitymanagementsystems

2.8.1Evaluatingprocesseswithinthequalitymanagementsystem

Whenevaluatingqualitymanagementsystems,therearefourbasicquestionsthatshouldbeaskedinrelation

toeveryprocessbeingevaluated.

a)Istheprocessidentifiedandappropriatelydefined?

b)Areresponsibilitiesassigned?

c)Aretheproceduresimplementedandmaintained?

d)Istheprocesseffectiveinachievingtherequiredresults?

Th.collectiv.answer.t.th.abov.question.ca.determin.th.resul.o.th.evaluation.Evaluatio.o..qualit.managernen.sys

te.ca.var.i.scop.an.encompas..rang.o.activities,suc.a.auditin.an.reviewin.th.qualit.managemen.system,

an.self-assessments.

2.8.2Auditingthequalitymanagementsystem

Audit.ar.use.t.detennin.th.exten.t.whic.th.qualit.managemen.syste.requirement.ar.fulfilled.Audi.finding.ar.use

.t.asses.th.effectivenes.o.th.qualit.managemen.syste.an.t.identif.opportunitie.fb.improvement.

First-partyauditsareconductedby,oronbehalfof,theorganizationitselfforinternalpurposesandcanform

thebasisforanorganization'sself-declarationofconformi:y.

Second-parlyauditsareconductedbycustomersoftheorganizationorbyotherpersonscnbehalfofthe

customer.

Tanizations.Sanizations,usuall.accredited,

provid.certificatio.o.rcgistratio.o.conformit.wit.rcquircnicnt.suc.a.thos.o.IS.9001.

ISO19011providesguidanceonauditing.

2.8.3Reviewingthequalitymanagementsystem

On.rol.o.to.managemen.i.t.carr.ou.regula.systemati.evaluation.o.th.suitability,

effectivenes.an.efficienc.o.th.qualit.managemen.syste.wit.respec.t.th.qualit.polic.an.qualit.objectives.Thi.revi

e.ca.includ.consideratio.o.th.en.t.adap.th.qualit.polic.an.objective.i.respons.t.changin.need.an.expectation.o.i

ntereste.parties.Th.revie.include.dcterminatio.o.th.nee.fo.actions.

Amongstothersourcesofinformation,auditreportsareusedfbrreviewofthequalitymanagementsystem.

2.8.4Self-assessment

A.organization'.anization'.activitie.an.result.ref

erence.agains.th.qualit.managemen.syste.o..niode.o.excellence.

Sanizatio.an.tli.degre.o.maturit.o.th.qualit.mana

gemen.system.Lanizatio.an.t.detennin.priorities.

2.9ContinualImprovement

Tbabilit.o.enhancin.th.satisfactio.o.c

ereste.parties.Action.fo.improvemen.includ.th.following:

a)analysingandevaluatingtheexistingsituationtoidentifyareasforimprovement;

b)establishingtheobjectivesforimprovement;

c)searchingforpossiblesolutionstoachievetheobjectives;

d)evaluatingthesesolutionsandmakingaselection;

e)implementingtheselectedsolution;

f)measuring,verifying,analyzingandevaluatingresultsoftheimplementationtodeterminethatthe

objectiveshavebeenmet;

g)formalizingchanges.

Result.ar.reviewed,a.necessary,t.determin.furthe.opportunitie.fo.improvement.I.thi.way,

improvemen.i..continua.activity.Fereste.parties,

audit.an.revie.o.th.qualit.nianagemen.syste.ca.als.b.use.t.identif.opportuiiitie.fo.improvement.

2.10Roleofstatisticaltechniques

Th.us.o.statistica.technique.ca.hel.i.understandin.variability,

blem.an.improv.effectivenes.an.efficiency.Thes.technique.als.facilitat.

bette.us.o.availabl.dat.t.assis.i.decisio.making.

Variabilit.ca.b.observe..(h.behaviou.an.outcom.o.rnan.activities,

eve.unde.condition.o.apparen.stability.Sc

esses,

duct.fro.marke.researc.t.custome.servic.a.fina.disposal.

Statistica.technique.ca.hel.t.measure,describe,analyse,interpre.an.mode.suc.variability»

eve.wit..relativel.limite.anicun.o.data.Svid..bette.understandin.o.th.natur

e,exten.an.cause.o.variabilily,blem.(ha.ina.resul.fro.suc.variability，

mot.continua.improvement.

GuidanceonstatisticaltechniquesinaqualitymanagementsystemisgiveninISO/TR10017.

2.11Qualitymanagementsystemsandothermanagementsystemfocuses

Tanization’.managemen.syste.tha.focuse.o.th.achievemen.o.resu

Its,i.relatio.t.th.qualit.objectives,t.satisf.th.needs,ereste.parties,

a.appropriate.Tanizatio.suc.a.thos.relate.i.growth,

funding,profitability,

(h.environmen.an.occupationa.healt.an.safety.Tanization'.managemen.syste.migh.b.ini

egrated,togethe.wit.th.qualit.managemen.system,

inL.mo.elements.Thi.ca.facilital.planning,allocatio.o.resources,

anization.Tanization

anization'.managemen.syste.requirements.Th.managemen.syste

.ca.als.b.auditc.agains.th.rcquircmcnt.o.lntcrnationa.Standard.suc.a.IS0900.an.IS.14(X)1:1996.Thcs.managc

bination.

2.12Relationshipbetweenqualitymanagementsystemsandexcellencemodels

Tli.approache.o.qualit.managemen.system.give.i.th.ISO900.anizationa.excellenc.nio

deLar.base.o.cornmo.principles.Bot.approache.

a)enableanorganizationtoidentifyitsstrengthsandweaknesses,

b)containprovisionforevaluationagainstgenericmodels,

c)provideabasisforcontinualimprovement,and

visio.fo.externa.recognition.

Th.differenc.betwee.th.approache.o.th.qualit.managemen.system.i.th.ISO900.famil.an.th.excellenc.mo

del.lie.i.thei.scop.o.application.Th.IS.90().vide.requirement.fo.qualiLmanagemen.s

ystem.an.guidanc.fo.performanc.improvement；

evaluatio.o.qualit.managemen.system.determine.fulfillmen.o.thos.requirements.Th.excellcnc.model.co

anizationa.performanc.an.thi.i.applicabl.t.al.activitie.a

anization.Aanizatio.t.

anizations.

3Termsanddefinitions

.ter.i..definitio.o.not.whic.Ldefiiie.elsewher.i.thi.claus.i.indicate.b.boldfac.followe.b.it.entr.iiumbe.i.pare

ntheses.Suc..bol(plet.definition.Fo.example:

product(3.4.2)isdefinedas“resultofaprocess(3.4.1)”；

processisdefinedas“setofinterrelatedorinteractingactivi:ieswhichtransformsinputsintooutputs.”

Iftheterm“process“isreplacedbyitsdefinition,asfollows:

productthenbecomes“resultofasetofinterrelatedorinteractingactivitieswhichtransformsinputsinto

outputs.

Aconceptlimitedtoaspecialmeaninginaparticularcontextisindicatedbydesignatingthesubjectfieldin

anglebrackets,<>,beforethedefinition,forexample,technicalexpert<audit>(3.9.11).

3.1Termsrelatingtoquality

3.1.1

quality

degree(owhichasetofinherentcharacteristics(3.5.1)fulflsrequirements(3.1.2)

NOTE1Theterm“quality”canbeusedwithadjectivessuchaspoor,goodorexcellent.

NOTE2uInherent”,asopposedtouassigned”,meansexistinginsomething,especiallyasapermanent

characteristic.

3.1.2

requirement

needorexpectationthatisstated,generallyimpliedorobligatory

N0TE1uGenerallyimpliedmeansthatitiscustomorcommonpracticefortheorganization(3.3.1),its

customers(3.3.5)andotherinterestedparties(3.3.7),thattheneedorexpectationunderconsiderationis

implied:

NOTE..qualif,ie.ca.b.use.t.denot..specifi.typ.o.requiremenl，duc.requirement,

qualit.managemen.requirement,custome.requirement.

N0TE3Aspecifiedrequirementisonewhichisstated,forexample,inadocument(3.7.2).

N0TE4Requirementscanbegeneratedbydifferentinterestedparties.

3.1.3

grade

categoryorrankgiventodifferentqualityrequirements(3.1.2)forproducts(3.4.2)processes(3.4.1)or

systems(3.2.1)havingthesamefunctionaluse

EXAMPLEClassofairlineticketandcategoryofhotelinahotelguide.

NOTE4Requirementscanbegeneratedbydifferentinterestedparties.

3.1.4

customersatisfaction

customer'sperceptionofthedegreetowhichthecustomer'srequirements(3.1.2)havebeenfulfilled

NOTEICustomercomplaintsareacommonindicatoroflowcustomersatisfactionbuttheirabsencedoes

notnecessarilyimplyhighcustomersatisfaction.

N0TE2Evenwhencustomerrequirementshavebeenagreedwiththecustomerandfulfilled,thisdoesnot

necessarilyensurehighcustomersatisfaction.

3.1.5

capability

abilityofanorganization(3.3.1),system(3.2.1)orprocess(3.4.1)torealizeaproduct(3.4.2)thatwillfulfill

therequirements(3.1.2)forthatproduct

NOTEProcesscapabilitytermsinthefieldofstatisticsaredefinedinISO3534.2.

3.2Termsrelatingtomanagement

3.2.1

system

setofinterrelatedorinteractingelements

3.2.2

managementsystem

system(3.2.1)toestablishpolicyandobjectivesandtoachievethoseobjectives

NOTEAmanagementsystemofanorganization(3.3.1)canincludedifferentmanagementsystem,

suchasaqualitymanagementsystem(3.2.3),afinancialnianagenientsystemoranenvironmental

managementsystem.

3.2.3

qualitymanagementsystem

managementsystem(3.2.2)todirectandcontrolanorganization(3.3.1)withregardtoquality(3.1.1)

3.2.4

qualitypolicy

overallintentionsanddirectionofanorganization(3.3.1)relatedtoquality(3.1.1)asformallyexpressedby

topmanagement(3.2.7)

NOTEIGenerallythequalitypolicyisconsistentwiththeoverallpolicyoftheorganizationandprovidesa

frameworkfbrthesettingofqualityobjectives(3.2.5).

NOTE.Qualit.managemen.principle.presente.i.thi.Internationa.Standar.ca.for..basi.fo.th.establishmen.o..quali

t.policy.(Se.0.2.)

3.2.5

qualityobjective

somethingsought,oraimedfbr,relatedtoquality(3.1.1)

NOTE1Qualityobjectivesaregenerallybasedontheorganization'squalitypolicy(3.2.4).

NOTE2Qualityobjectivesaregenerallyspecifiedforrelevantfunctionsandlevelsintheorganization

(3.3.1).

3.2.6

management

coordinatedactivitiestodirectandcontrolanorganization(3.3.1)

NOT.I.English,th.ten“management^ometime.refer.t.people,

anization.Whe.

“management.i.use.i.thi.sens.i.shoul.alway.b.use.wit.som.for.o.qualifie.t.avoi.confusio.wit.th.concep.

management.define^bove.Fo.example,“nianagemen.shall….i.deprecate.wherea.

wto.managemen.(3.2.7.shal.***.i.acceptable.

3.2.7

topmanagement

personorgroupofpeoplewhodirectandcontrolsanorganization(3.3.1)atthehighestlevel

3.2.8

qualitymanagement

coordinatedactivitiestodirectandcontrolanorganization(3.3.1)withregardtoquality(3.1.1)

NOTEDirectionandcontrolwithregardtoqualitygenerallyincludesestablishmentofthequalitypolicy

(3.2.4)andqualityobjectives(3.2.5),qualityplanning(3.2.9)qualitycontrol(3.2.10),qualityassurance

(3.2.11)andqualityimprovement(3.2.12).

3.2.9

qualityplanning

panofqualitymanagement(3.2.8)focusedonsettingqualityobjectives(3.2.5)andspecifyingnecessary

operationalprocesses(3.4.1)andrelatedresourcestofulfillthequalityobjectives

NOTEEstablishingqualityplans(3.7.5)canbepartofqualityplanning.

3.2.10

qualitycontrol

pariofqualitymanagement(3.2.8)focusedonfulfillingqualityrequirements(3.1.2)

3.2.11

qualityassurance

partofqualitymanagement(3.2.8)focusedonprovidingconfidencethatqualityrequirements(3.1.2)will

befulfilled

3.2.12

qualityimprovement

pailofqualitymanagement(3.2.8)focusedonincreasingtheabilitytofulfillqualityrequirements(3.1.2)

NOTETherequirementscanberelatedtoanyaspectsuchaseffectiveness(3.2.14),efficiency(3.2...15)or

traceability(3.5.4).

3.2.13

continualimprovement

recurringactivitytoincreasetheabilitytofulfillrequirements(3.1.2)

NOTETheprocess(3.4.1)ofestablishingobjectivesandfindingopportunitiesforimprovementisa

continualprocessthroughtheuseofauditfindings(3.9.5)andauditconclusions(3.9.6),analysisof

data,managementreviews(3.8.7)orothermeansandgenerallyleadstocorrectiveaction(3.6.5)or

preventiveaction(3.6.4).

3.2.14

effectiveness

extenttowhichplannedactivitiesarerealizedandplannedresultsachieved

3.2.15

efficiency

relationshipbetweentheresultachievedandtheresourcesused

3.3Termsrelatingtoorganization

3.3.1

organization

groupofpeopleandfacilitieswithanarrangementofresponsibilities,authoritiesandrelationships

EXAML.Company,corporation»firm,enterprise，institution,charity,soLtrader,association，

binatio.thereof.

NOTEIThearrangementisgenerallyorderly.

NOTE2Anorganizationcanbepublicorprivate.

NOT..Thi.definitio.i.vali.fo.th.purpose.o.qualit.managcmen.syste.(3.2.3.standards.Th.tcr.

worganization.i.define.differentl.i.ISO/IE.Guid.2.

3.3.2

organizationalstructure

arrangementofresponsibiliiies,authoritiesandrelationshipsbetweenpeople

NOTE1Thearrangementisgenerallyorderly.

NOTE2Aformalexpressionoftheorganizationalstructureisoftenprovidedinaqualitymanual(3.7.4)or

aqualityplan(3.7.5)fbraproject(3.4.3).

NOTE3Thescopeofanorganizationalstructurecaincluderelevantinterfacestoexternalorganizations

(3.3.1).

3.3.3

infrastructure

〈organization〉systemoffacilities,equipmentandservicesneededfortheoperationofan

organization(3.3.1)

3.3.4

workenvironment

setofconditionsunderwhichworkisperformed

NOTEConditionsincludephysical,social,psychologicalandenvironmentalfactors(suchas

temperature,recognitionschemes,ergonomicsandatmosphericcomposition).

3.3.5

customer

organization(3.3.1)orperson(hatreceivesaproduct(3.4.2)

EXAMPLEConsumer,client,end-user,retailer,beneficiaryandpurchaser.

NOTEAcustomercanbeinternalorexternaltotheorganization.

3.3.6

supplier

organization(3.3.1)orpersonthatprovidesaproduct(3.4.2)

EXAMPLEProducer,distributor,retailerorvendorofaproduct,orproviderofaserviceorinformation.

NOTE1Asuppliercanbeinternalorexternaltotheorganization.

NOTE2Inacontractualsituationasupplierissometimescalled“contraclor.”

3.3.7

interestedparty

personorgrouphavinganinterestintheperformanceorsuccessofanorganization(3.3.1)

EXAMPL.Customer.(3.3.5),owners,anization,supplier.(3.3.6),bankers,unions,

partner.o.society.

NOTEAgroupcancompriseanorganization,apartthereof,ormorethanoneorganization.

3.4Termsrelatingtoprocessandproduct

process

setofinterrelatedorinteractingactivitieswhichtransformsinputsintooutputs

NOTE1Inputstoaprocessaregenerallyoutputsofotherprocesses.

NOTE2Processesinanorganization(3.3.1)aregenerallyplannedandcarriedoutundercontrolled

conditionstoaddvalue.

NOTE3Aprocesswheretheconformity(3.6.1)oftheresultingproduct(3.4.2)cannotbereadilyor

economicallyverifiedisfrequentlyreferredtoasa“specialprocess.

3.4.2

product

resultofaprocess(3.4.1)

NOTEITherearefourgenericproductcategories,asfollows:

-service.(e.g.transport);

-softwar.(gram,dictionary);

-hardwar.(e.g.engin.mechanica.part);

processe.material.(e.g.lubricant).

-Mpns.elenient.belongin.t.differen.generiproduc.categories.Wduc.i.the.calle.s

ervice,software,cesse.materia.depend.o.th.doniinan.element.Fduc.

automobile.consist.o.hardwar.(e.g.tyres),processe.material.(e.g.fuel,coolin.liquid),

softwar.(e.g.engin.contro.software.driver.manual).

an.servic.(e.g.operatin.explanation.give.b.th.salesman).

-NOT..Scrfac.bctwce.th.supplic.(3.3.6.an.cus

tome.(33.5.angible.Provisio.o..servic.ca.involve,fo.example,th.following:

-duc.(e.g.automobil.t.b.repaircd);

-duc.(e.g.th.incom.statemen.neede.t.prepar..ta.return);

-duc.(nnatio.i.th.contex.o.knowledg.transmission);

th.creatio.o.ambienc.fo.th.custome.(e.g.i.hotel.an.restaurants).

Softwareconsistsofinformationandisgenerallyintangibleandcanbeintheformofapproaches,

transactionsorprocedures(3.4.5)

Hardwar.i.generall.tangibl.an.it.amoun.i..countabl.characteristi.(3.5.1).Processe.material.ar.gcneralLtangibl.a

n.thei.amoun.i..continuou.chaiacteristic.Hardwar.an.piocesse.material.ofte.ar.refeiTe.t.a.goods.

NOTE3Qualityassurance(3.2.11)ismainlyfocusedonintendedproduct.

3.4.3

project

uniqueprocess(3.4.1),consistingofasetofcoordinatedandcontrolledactivitieswithstartandfinishdates,

undertakentoachieveanobjectiveconformingtospecificrequirements(3.1.2),includingtheconstraintsof

time,costandresources

NOTEIAnindividualprojectcanformpartofalargerprojectstructure.

N0TE2Insomeprojectstheobjectivesarerefinedandtheproductcharacteristics(3.5.1)defined

progressivelyastheprojectproceeds.

NOTE3Theoutcomeofaprojectmaybeoneorseveralunitsofproduct(3.4.2).

NOTE4AdaptedfromISO10(X)6:1997.

3.4.4

designanddevelopment

setofprocesses(3.4.1)thattransformsrequirements(3.1.2)intospecifiedcharacteristics(35.1)orintothe

specification(3.7.3)ofaproduct(3.4.2),process(3.4.1)orsystem(3.2.1)

NOTE1Theterms“design"and"development“arcsometimesusedsynonymouslyandsometimesusedto

definedifferentstagesoftheoveralldesignanddevelopmentprocess.

NOT...qualifie.ca.b.applie.t.indicat.th.natur.o.wha.i.bein.designe.an.develope.(duc.desig.an.developme

ces.desig.an.development).

3.4.5

procedure

specifiedwaytocarryoutanactivityoraprocess(3.4.1)

N0TE1Procedurescanbedocumentedornot.

NOTE.Wcedur.i.documented,th.ter."cedure.o.

cedure.i.frequentl.used.Th.documen.(3.7.2.cedur.ca.b.calle..

“procedur.document”.

3.5Termsrelatingtocharacteristics

3.5.1

characteristic

distinguishingfeature

NOTE1Acharacteristiccabeinherentorassigned.

NOTE2Acharacteristiccanbequalitativeorquantitative.

-NOTE3Therearevariousclassesofcharacteristic,suchasthefollowing:

-physica.(e.g.mechanical,electrical,chemica.o.biologica.characteristics)；

-sensor.(e.g.relate.t.smell,touch,taste,sight,hearing);

-behaviora.(e.g.courtesy.honesty,veracity);

-tempora.(e.g.punctuality,reliability,availability);

ergonomi.(e.g.physiologica.characteristic,o.relate.t.huma.satety);

functiona.(e.g.maximu.spee.o.a.aircraft).

3.5.2

qualitycharacteristic

inherentcharacteristic(3.5.1)ofaproduct(3.4.2),process(3.4.1)orsystem(3.2.1)relatedtoa

requirement(3.1.2).

NOTE1Inherentmeansexistinginsomething,especiallyasapermanentcharacteristic.

NOT...duct,proces.o.syste.(duct,

duct>proces.o.system.

3.5.3

dependability

collectivetermusedtodescribetheavailabilityperformanceanditsinfluencingfactors:reliability

performance,maintainabilityperformanceandmaintenancesupportperformance

NOTEDependabilityisusedonlyforgeneraldescriptionsinnon-quantitativeterms.

(IEC60050-191:19901.

3.5.4

traceability

abilitytotracethehistory,applicationorlocationofthatwhichisunderconsideration

NOTE1Whenconsideringproduct(3.4.2)traceabilitycanrelateto

-theoriginofmaterialsandparts,

-theprocessinghistory,and

-thedistributionandlocationoftheproductafterdelivery.

NOTE2InthefieldofmetrologythedefinitioninVIM:1993,6.10,istheaccepteddefinition.

3.6Termsrelatingtoconformity

3.6.1

conformity

fulfillmentofarequirement(3.1.2)

NOTE1ThisdefinitionisconsistentwithISO/IECGuide2butdiffersfromitinphrasingtofitintotheISO

9000concepts.

NOTE2Theterm“conformance“issynonymousbutdeprecate

3.6.2

nonconformity

non-fulfillmentofarequirement(3.1.2)

3.6.3

defect

non-fulfillmentofarequirement(3.1.2)relatedtoanintendedorspecifieduse

NOT..Th.distinctio.betwee.th.concept.defec.an.nonconformit.(3.6.2.i.importan.a.i.ha.lega.conno