ISO9001标准最终发布版官网公开版本有部分删减Word格式.docx
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ISO9001标准最终发布版官网公开版本有部分删减Word格式.docx
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Conceptsandterminology.
Thisfourtheditioncancelsandreplacesthethirdedition(ISO
9000:
2005),whichhasbeentechnicallyrevised.
Introduction
ThisInternationalStandardprovidesthefundamentalconcepts,principlesandvocabularyforqualitymanagementsystems(QMS)andprovidesthefoundationforotherQMSstandards.ThisInternationalStandardisintendedtohelptheusertounderstandthefundamentalconcepts,principlesandvocabularyofqualitymanagement,inordertobeabletoeffectivelyandefficientlyimplementaQMSandrealizevaluefromotherQMSstandards.
ThisInternationalStandardproposesawell-definedQMS,basedonaframeworkthatintegratesestablishedfundamentalconcepts,principles,processesandresourcesrelatedtoquality,inordertohelporganizationsrealizetheirobjectives.Itisapplicabletoallorganizations,regardlessofsize,complexityorbusinessmodel.Itsaimistoincreaseanorganization’sawarenessofitsdutiesandcommitmentinfulfillingtheneedsandexpectationsofitscustomersandinterestedparties,andinachievingsatisfactionwithitsproductsandservices.
ThisInternationalStandardcontainssevenqualitymanagementprinciplessupportingthefundamentalconceptsdescribedin
2.2.In
2.3,foreachqualitymanagementprinciple,thereisa“statement”describingeachprinciple,a“rationale”explainingwhytheorganizationwouldaddresstheprinciple,“keybenefits”thatareattributedtotheprinciples,and“possibleactions”thatanorganizationcantakeinapplyingtheprinciple.
ThisInternationalStandardcontainsthetermsanddefinitionsthatapplytoallqualitymanagementandQMSstandardsdevelopedbyISO/TC
176,andothersector-specificQMSstandardsbasedonthosestandards,atthetimeofpublication.Thetermsanddefinitionsarearrangedinconceptualorder,withanalphabeticalindexprovidedattheendofthedocument.
Annex
A
includesasetofdiagramsoftheconceptsystemsthatformtheconceptordering.
NOTE
Guidanceonsomeadditionalfrequently-usedwordsintheQMSstandardsdevelopedbyISO/TC
176,andwhichhaveanidentifieddictionarymeaning,isprovidedinaglossaryavailableat:
http:
//www.iso.org/iso/03_terminology_used_in_iso_9000_family.pdf
1
Scope
ThisInternationalStandarddescribesthefundamentalconceptsandprinciplesofqualitymanagementwhichareuniversallyapplicabletothefollowing:
∙—
organizationsseekingsustainedsuccessthroughtheimplementationofaqualitymanagementsystem;
customersseekingconfidenceinanorganization’sabilitytoconsistentlyprovideproductsandservicesconformingtotheirrequirements;
organizationsseekingconfidenceintheirsupplychainthatproductandservicerequirementswillbemet;
organizationsandinterestedpartiesseekingtoimprovecommunicationthroughacommonunderstandingofthevocabularyusedinqualitymanagement;
organizationsperformingconformityassessmentsagainsttherequirementsofISO
9001;
providersoftraining,assessmentoradviceinqualitymanagement;
developersofrelatedstandards.
ThisInternationalStandardspecifiesthetermsanddefinitionsthatapplytoallqualitymanagementandqualitymanagementsystemstandardsdevelopedbyISO/TC
176.
Onlyinformativesectionsofstandardsarepubliclyavailable.Toviewthefullcontent,youwillneedtopurchasethestandardbyclickingonthe"
Buy"
button.
3
Termsanddefinitions
3.1
Termsrelatedtopersonorpeople
3.1.1
topmanagement
personorgroupofpeoplewhodirectsandcontrolsan
organization
(3.2.1)
atthehighestlevel
Note1toentry:
Topmanagementhasthepowertodelegateauthorityandprovideresourceswithintheorganization.
Note2toentry:
Ifthescopeofthe
managementsystem
(3.5.3)
coversonlypartofanorganization,thentopmanagementreferstothosewhodirectandcontrolthatpartoftheorganization.
Note3toentry:
ThisconstitutesoneofthecommontermsandcoredefinitionsforISOmanagementsystemstandardsgiveninAnnex
SLoftheConsolidatedISO
SupplementtotheISO/IEC
1.
3.1.2
qualitymanagementsystemconsultant
personwhoassiststhe
on
qualitymanagementsystemrealization
(3.4.3),givingadviceor
information
(3.8.2)
Thequalitymanagementsystemconsultantcanalsoassistinrealizingpartsofa
qualitymanagementsystem
(3.5.4).
ISO
10019:
2005
providesguidanceonhowtodistinguishacompetentqualitymanagementsystemconsultantfromonewhoisnotcompetent.
[SOURCE:
ISO
2005,3.2,modified]
3.1.3
involvement
takingpartinanactivity,eventorsituation
3.1.4
engagement
involvement
(3.1.3)
in,andcontributionto,activitiestoachieveshared
objectives
(3.7.1)
3.1.5
configurationauthority
configurationcontrolboard
dispositioningauthority
personoragroupofpersonswithassignedresponsibilityandauthoritytomakedecisionsonthe
configuration
(3.10.6)
Relevant
interestedparties
(3.2.3)
withinandoutsidethe
shouldberepresentedontheconfigurationauthority.
10007:
2003,3.8,modified]
3.1.6
disputeresolver
<
customersatisfaction>
individualpersonassignedbya
DRP-provider
(3.2.7)
toassistthepartiesinresolvinga
dispute
(3.9.6)
EXAMPLE:
Staff,volunteer,
contract
(3.4.7)
personnel.
10003:
2007,3.7,modified]
3.2
Termsrelatedtoorganization
3.2.1
organization
personorgroupofpeoplethathasitsownfunctionswithresponsibilities,authoritiesandrelationshipstoachieveits
Theconceptoforganizationincludes,butisnotlimitedto,sole-trader,company,corporation,firm,enterprise,authority,partnership,
association
(3.2.8),charityorinstitution,orpartorcombinationthereof,whetherincorporatedornot,publicorprivate.
1.TheoriginaldefinitionhasbeenmodifiedbymodifyingNote1toentry.
3.2.2
contextoftheorganization
combinationofinternalandexternalissuesthatcanhaveaneffectonan
organization’s
approachtodevelopingandachievingitsobjectives
Theorganization’sobjectivescanberelatedtoits
products
(3.7.6)
and
services
(3.7.7),investmentsandbehaviourtowardsits
(3.2.3).
Theconceptofcontextoftheorganizationisequallyapplicabletonot-for-profitorpublicserviceorganizationsasitistothoseseekingprofits.
InEnglish,thisconceptisoftenreferredtobyothertermssuchas“businessenvironment”,“organizationalenvironment”or“ecosystemofanorganization”.
Note4toentry:
Understandingthe
infrastructure
(3.5.2)
canhelptodefinethecontextoftheorganization.
3.2.3
interestedparty
stakeholder
personor
thatcanaffect,beaffectedby,orperceiveitselftobeaffectedbyadecisionoractivity
Customers
(3.2.4),owners,peopleinanorganization,
providers
(3.2.5),bankers,regulators,unions,partnersorsocietythatcanincludecompetitorsoropposingpressuregroups.
1.TheoriginaldefinitionhasbeenmodifiedbyaddingtheExample.
3.2.4
customer
thatcouldordoesreceivea
product
ora
service
(3.7.7)
thatisintendedfororrequiredbythispersonororganization
Consumer,client,end-user,retailer,receiverofproductorservicefromaninte
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