1、Good is good, but better carries it.精益求精，善益求善。ISO9001-200828中英文29共33頁(yè)-ISO9001:2008EnglishChineseBilingualQualitymanagementsystemRequirement質(zhì)量管理體系要求Copyrightreserved,forreferencetoInterteksystemscertificationcustomersonlyISO9001:2008Introduction引言0.1General總則Theadoptionofaqualitymanagementsystemshoul

2、dbeastrategicdecisionofanorganization.Thedesignandimplementationofanorganizationsqualitymanagementsystemisinfluencedbya)itsorganizationalenvironment,changesinthatenvironment,andtherisksassociatedwiththatenvironment,b)itsvaryingneeds,c)itsparticularobjectives,d)theproductsitprovides,e)theprocessesite

3、mploys,f)itssizeandorganizationalstructure.采用質(zhì)量管理體系應(yīng)當(dāng)是組織的一項(xiàng)戰(zhàn)略性決策。一個(gè)組織質(zhì)量管理體系的設(shè)計(jì)和實(shí)施受下列因素的影響：a)組織的業(yè)務(wù)環(huán)境、該環(huán)境的變化或與該環(huán)境有關(guān)的風(fēng)險(xiǎn)，b)組織的不同需求，c)組織的特定目標(biāo)，d)所提供的產(chǎn)品，e)所采用的過(guò)程，f)組織的規(guī)模和組織結(jié)構(gòu)。ItisnottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation.統(tǒng)一質(zhì)量

4、管理體系的結(jié)構(gòu)或文件不是本標(biāo)準(zhǔn)的目的。ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproducts.Informationmarked“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.本標(biāo)準(zhǔn)所規(guī)定的質(zhì)量管理體系要求是對(duì)產(chǎn)品要求的補(bǔ)充?！白ⅰ笔菐椭斫?、澄清有關(guān)要求的參考性信息。ThisInternationalStandardcanbe

5、usedbyinternalandexternalparties,includingcertificationbodies,toassesstheorganizationsabilitytomeetcustomer,statutoryandregulatoryrequirementsapplicabletotheproduct,andtheorganizationsownrequirements.本標(biāo)準(zhǔn)能用于內(nèi)部和外部各方（包括認(rèn)證機(jī)構(gòu)）評(píng)定組織滿足顧客要求、適用的產(chǎn)品的法律法規(guī)要求和組織自身要求的能力。ThequalitymanagementprinciplesstatedinISO9000

6、andISO9004havebeentakenintoconsiderationduringthedevelopmentofthisInternationalStandard.本標(biāo)準(zhǔn)的制定已經(jīng)考慮了ISO9000和ISO9004中所闡明的質(zhì)量管理原則。0.2Processapproach過(guò)程方法ThisInternationalStandardpromotestheadoptionofaprocessapproachwhendeveloping,implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhanc

7、ecustomersatisfactionbymeetingcustomerrequirements.本標(biāo)準(zhǔn)鼓勵(lì)在建立、實(shí)施質(zhì)量管理體系以及改進(jìn)其有效性時(shí)采用過(guò)程方法，旨在通過(guò)滿足顧客要求，增強(qiáng)顧客滿意。Foranorganizationtofunctioneffectively,ithastodetermineandmanagenumerouslinkedactivities.Anactivityorsetofactivitiesusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbe

8、consideredasaprocess.Oftentheoutputfromoneprocessdirectlyformstheinputtothenext.為使組織有效運(yùn)行，需確定和管理眾多相互關(guān)聯(lián)的活動(dòng)。通過(guò)使用資源和實(shí)施管理，將輸入轉(zhuǎn)化為輸出的一項(xiàng)或一組活動(dòng)，可以視為一個(gè)過(guò)程。通常，一個(gè)過(guò)程的輸出可直接形成下一個(gè)過(guò)程的輸入。Theapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagemen

9、ttoproducethedesiredoutcome,canbereferredtoasthe“processapproach”.為了產(chǎn)生期望的結(jié)果，組織內(nèi)諸過(guò)程組成的系統(tǒng)的應(yīng)用，連同這些過(guò)程的識(shí)別和相互作用，以及對(duì)這些過(guò)程的管理，可稱之為“過(guò)程方法”。Anadvantageoftheprocessapproachistheongoingcontrolthatitprovidesoverthelinkagebetweentheindividualprocesseswithinthesystemofprocesses,aswellasovertheircombinationandinterac

10、tion.過(guò)程方法的一個(gè)優(yōu)點(diǎn)就是實(shí)現(xiàn)了對(duì)過(guò)程系統(tǒng)中單個(gè)過(guò)程之間的聯(lián)系以及過(guò)程的組合和相互作用進(jìn)行連續(xù)的控制。Whenusedwithinaqualitymanagementsystem,suchanapproachemphasizestheimportanceofa)understandingandmeetingrequirements,b)theneedtoconsiderprocessesintermsofaddedvalue,c)obtainingresultsofprocessperformanceandeffectiveness,andd)continualimprovementof

11、processesbasedonobjectivemeasurement.在質(zhì)量管理體系中應(yīng)用過(guò)程方法時(shí)，該方法強(qiáng)調(diào)以下方面的重要性：a)理解和滿足要求；b)需要從增值的角度考慮過(guò)程；c)獲得過(guò)程績(jī)效和有效性的結(jié)果；d)基于客觀的測(cè)量，持續(xù)改進(jìn)過(guò)程。Themodelofaprocess-basedqualitymanagementsystemshowninFigure1illustratestheprocesslinkagespresentedinClauses4to8.Thisillustrationshowsthatcustomersplayasignificantroleindefini

12、ngrequirementsasinputs.Monitoringofcustomersatisfactionrequirestheevaluationofinformationrelatingtocustomerperceptionastowhethertheorganizationhasmetthecustomerrequirements.ThemodelshowninFigure1coversalltherequirementsofthisInternationalStandard,butdoesnotshowprocessesatadetailedlevel.圖1所反映的以過(guò)程為基礎(chǔ)的

13、質(zhì)量管理體系模式展示了48章中所提出的過(guò)程聯(lián)系。該展示反映了在規(guī)定輸入要求時(shí)，顧客起著重要的作用。對(duì)顧客滿意的監(jiān)視要求對(duì)顧客關(guān)于組織是否已滿足其要求的感受的信息進(jìn)行評(píng)價(jià)。該模式雖覆蓋了本標(biāo)準(zhǔn)的所有要求，但卻未詳細(xì)地反映各過(guò)程。NOTEInaddition,themethodologyknownas“Plan-Do-Check-Act”(PDCA)canbeappliedtoallprocesses.PDCAcanbebrieflydescribedasfollows.Plan:establishtheobjectivesandprocessesnecessarytodeliverresults

14、inaccordancewithcustomerrequirementsandtheorganizationspolicies.Do:implementtheprocesses.Check:monitorandmeasureprocessesandproductagainstpolicies,objectivesandrequirementsfortheproductandreporttheresults.Act:takeactionstocontinuallyimproveprocessperformance.注：此外，稱之為“PDCA”的方法可適用于所有過(guò)程。PDCA模式可簡(jiǎn)述如下：P策劃

15、：根據(jù)顧客的要求和組織的方針，建立實(shí)現(xiàn)結(jié)果所必需的目標(biāo)和過(guò)程；D做：實(shí)施過(guò)程；C檢查：根據(jù)方針、目標(biāo)和產(chǎn)品要求，對(duì)過(guò)程和產(chǎn)品進(jìn)行監(jiān)視和測(cè)量，并報(bào)告結(jié)果；A處置：采取措施，以持續(xù)改進(jìn)過(guò)程績(jī)效。0.3RelationshipwithISO9004與ISO9004的關(guān)系ISO9001andISO9004arequalitymanagementsystemstandardswhichhavebeendesignedtocomplementeachother,butcanalsobeusedindependently.ISO9001和ISO9004都是質(zhì)量管理體系標(biāo)準(zhǔn)，這兩項(xiàng)標(biāo)準(zhǔn)相互補(bǔ)充，但也可單獨(dú)使用

16、。ISO9001specifiesrequirementsforaqualitymanagementsystemthatcanbeusedforinternalapplicationbyorganizations,orforcertification,orforcontractualpurposes.Itfocusesontheeffectivenessofthequalitymanagementsysteminmeetingcustomerrequirements.ISO9001規(guī)定了質(zhì)量管理體系要求，可供組織內(nèi)部使用，也可用于認(rèn)證或合同目的。ISO9001所關(guān)注的是質(zhì)量管理體系在滿足顧客要

17、求方面的有效性。AtthetimeofpublicationofthisInternationalStandard,ISO9004isunderrevision.TherevisededitionofISO9004willprovideguidancetomanagementforachievingsustainedsuccessforanyorganizationinacomplex,demanding,andeverchanging,environment.ISO9004providesawiderfocusonqualitymanagementthanISO9001;itaddresse

18、stheneedsandexpectationsofallinterestedpartiesandtheirsatisfaction,bythesystematicandcontinualimprovementoftheorganizationsperformance.However,itisnotintendedforcertification,regulatoryorcontractualuse.與ISO9001相比，ISO9004對(duì)質(zhì)量管理體系更寬范圍的目標(biāo)提供了指南，除了有效性，該標(biāo)準(zhǔn)還特別關(guān)注持續(xù)改進(jìn)一個(gè)組織的總體績(jī)效與效率。對(duì)于最高管理者希望超越ISO9001要求，追求績(jī)效持續(xù)改進(jìn)

19、的那些組織，推薦ISO9004作為指南。然而，用于認(rèn)證或合同不是ISO9004的目的。Continualimprovementofthequalitymanagementsystem質(zhì)量管理體系的不斷改進(jìn)Customer顧客Customer客戶Requirements要求Satisfaction滿意ManagementResponsibility管理職責(zé)ResourceManagement資源管理Measurement,analysisandImprovement測(cè)量、分析和改進(jìn)ProductRealization產(chǎn)品實(shí)現(xiàn)Product產(chǎn)品Output輸出Input輸入0.4Compatibi

20、litywithothermanagementsystems與其他管理體系的相容性DuringthedevelopmentofthisInternationalStandard,dueconsiderationwasgiventotheprovisionsofISO14001:2004toenhancethecompatibilityofthetwostandardsforthebenefitoftheusercommunity.AnnexAshowsthecorrespondencebetweenISO9001:2008andISO14001:2004.為了使用者的便利，本標(biāo)準(zhǔn)在制定過(guò)程中適

21、當(dāng)考慮了ISO14001:2004標(biāo)準(zhǔn)的內(nèi)容，以增強(qiáng)兩個(gè)標(biāo)準(zhǔn)的相容性。附錄A表明了ISO9001:2008與ISO14001:2004之間的對(duì)應(yīng)關(guān)系。ThisInternationalStandarddoesnotincluderequirementsspecifictoothermanagementsystems,suchasthoseparticulartoenvironmentalmanagement,occupationalhealthandsafetymanagement,financialmanagementorriskmanagement.However,thisInternat

22、ionalStandardenablesanorganizationtoalignorintegrateitsownqualitymanagementsystemwithrelatedmanagementsystemrequirements.Itispossibleforanorganizationtoadaptitsexistingmanagementsystem(s)inordertoestablishaqualitymanagementsystemthatcomplieswiththerequirementsofthisInternationalStandard.本標(biāo)準(zhǔn)不包括針對(duì)其他管理

23、體系的特定要求，例如環(huán)境管理、職業(yè)健康與安全管理、財(cái)務(wù)管理或風(fēng)險(xiǎn)管理有關(guān)的特定要求。然而本標(biāo)準(zhǔn)使組織能夠?qū)⒆陨淼馁|(zhì)量管理體系與相關(guān)的管理體系要求結(jié)合或一體化。組織為了建立符合本標(biāo)準(zhǔn)要求的質(zhì)量管理體系，可能會(huì)改變現(xiàn)行的管理體系。.QualitymanagementsystemsRequirements質(zhì)量管理體系要求1Scope范圍1.1General總則ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization本標(biāo)準(zhǔn)為有下列需求的組織規(guī)定了質(zhì)量管理體系要求：a)need

24、stodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicablestatutoryandregulatoryrequirements,andb)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicables

25、tatutoryandregulatoryrequirements.a)需要證實(shí)其有能力穩(wěn)定地提供滿足顧客和適用的法律法規(guī)要求的產(chǎn)品；b)通過(guò)體系的有效應(yīng)用，包括體系持續(xù)改進(jìn)的過(guò)程以及保證符合顧客與適用的法律法規(guī)要求，旨在增強(qiáng)顧客滿意。NOTE1InthisInternationalStandard,theterm“product”onlyappliestoa)productintendedfor,orrequiredby,acustomer,b)anyintendedoutputresultingfromtheproductrealizationprocesses.注1：在本標(biāo)準(zhǔn)中，術(shù)語(yǔ)“產(chǎn)

26、品”僅適用于a)預(yù)期提供給顧客或顧客所要求的產(chǎn)品，b)產(chǎn)品實(shí)現(xiàn)過(guò)程所產(chǎn)生的任何預(yù)期輸出。NOTE2Statutoryandregulatoryrequirementscanbeexpressedaslegalrequirements.注2：法律法規(guī)要求可稱作法定要求。1.2Application應(yīng)用AllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.本標(biāo)準(zhǔn)規(guī)定的所有要求是

27、通用的，旨在適用于各種類型、不同規(guī)模和提供不同產(chǎn)品的組織。Whereanyrequirement(s)ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.當(dāng)本標(biāo)準(zhǔn)的任何要求由于組織及其產(chǎn)品的特點(diǎn)不適用時(shí)，可以考慮對(duì)其進(jìn)行刪減。Whereexclusionsaremade,claimsofconformitytothisInternationalStandardarenotacceptableunlessthese

28、exclusionsarelimitedtorequirementswithinClause7,andsuchexclusionsdonotaffecttheorganizationsability,orresponsibility,toprovideproductthatmeetscustomerandapplicablestatutoryandregulatoryrequirements.如果進(jìn)行了刪減，而且這些刪減僅限于本標(biāo)準(zhǔn)第7章的要求，同時(shí)不影響組織提供滿足顧客和適用法律法規(guī)要求的產(chǎn)品的能力或責(zé)任,方可聲稱符合本標(biāo)準(zhǔn)。2Normativereferences規(guī)范性引用文件Thefol

29、lowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.下列文件中的條款通過(guò)本標(biāo)準(zhǔn)的引用而成為本標(biāo)準(zhǔn)的條款。凡是注日期的引用文件，其隨后所有的修改單（不包括勘誤的內(nèi)容）或修訂版均不適用于本標(biāo)準(zhǔn)，然而，鼓勵(lì)根據(jù)本標(biāo)準(zhǔn)達(dá)成協(xié)議的各方研究是

30、否可使用這些文件的最新版本。凡是不注日期的引用文件，其最新版本適用于本標(biāo)準(zhǔn)。ISO9000:2005,QualitymanagementsystemsFundamentalsandvocabularyISO9000:2005質(zhì)量管理體系基礎(chǔ)和術(shù)語(yǔ)3Termsanddefinitions術(shù)語(yǔ)和定義Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000apply.本標(biāo)準(zhǔn)采用ISO9000中所確立的術(shù)語(yǔ)和定義。ThroughoutthetextofthisInternationalStandard,whereverthete

31、rm“product”occurs,itcanalsomean“service”.本標(biāo)準(zhǔn)中所出現(xiàn)的術(shù)語(yǔ)“產(chǎn)品”，也可指“服務(wù)”。4Qualitymanagementsystem質(zhì)量管理體系4.1Generalrequirements總要求Theorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.組織

32、應(yīng)按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系，形成文件，加以實(shí)施和保持，并持續(xù)改進(jìn)其有效性。Theorganizationshalla)determinetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloft

33、heseprocessesareeffective,d)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,e)monitor,measurewhereapplicable,andanalysetheseprocesses,andf)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.組織應(yīng)：a)確定質(zhì)量管理體系所

34、需的過(guò)程及其在整個(gè)組織中的應(yīng)用（見(jiàn)1.2）；b)確定這些過(guò)程的順序和相互作用；c)確定為確保這些過(guò)程的有效運(yùn)作和控制所需的準(zhǔn)則和方法；d)確?？梢垣@得必要的資源和信息，以支持這些過(guò)程的運(yùn)作和監(jiān)視；e)監(jiān)視、測(cè)量(適用時(shí))和分析這些過(guò)程；f)實(shí)施必要的措施，以實(shí)現(xiàn)對(duì)這些過(guò)程所策劃的結(jié)果和對(duì)這些過(guò)程的持續(xù)改進(jìn)。TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard.組織應(yīng)按本標(biāo)準(zhǔn)的要求管理這些過(guò)程。Whereanorganizationchoose

35、stooutsourceanyprocessthataffectsproductconformitytorequirements,theorganizationshallensurecontroloversuchprocesses.Thetypeandextentofcontroltobeappliedtotheseoutsourcedprocessesshallbedefinedwithinthequalitymanagementsystem.針對(duì)組織所選擇的任何影響產(chǎn)品符合要求的外包過(guò)程，組織應(yīng)確保對(duì)其實(shí)施控制。對(duì)此類外包過(guò)程控制的類型和程度應(yīng)在質(zhì)量管理體系中加以規(guī)定。NOTE1Proce

36、ssesneededforthequalitymanagementsystemreferredtoaboveincludeprocessesformanagementactivities,provisionofresources,productrealization,measurement,analysisandimprovement.注1：上述質(zhì)量管理體系所需的過(guò)程包括與管理活動(dòng)、資源提供、產(chǎn)品實(shí)現(xiàn)和測(cè)量、分析和改進(jìn)有關(guān)的過(guò)程。NOTE2An“outsourcedprocess”isaprocessthattheorganizationneedsforitsqualitymanagement

37、systemandwhichtheorganizationchoosestohaveperformedbyanexternalparty.注2：外包過(guò)程是經(jīng)組織識(shí)別為質(zhì)量管理體系所需的，但選擇由組織的外部方實(shí)施的過(guò)程。NOTE3Ensuringcontroloveroutsourcedprocessesdoesnotabsolvetheorganizationoftheresponsibilityofconformitytoallcustomer,statutoryandregulatoryrequirements.Thetypeandextentofcontroltobeappliedtot

38、heoutsourcedprocesscanbeinfluencedbyfactorssuchasa)thepotentialimpactoftheoutsourcedprocessontheorganizationscapabilitytoprovideproductthatconformstorequirements,b)thedegreetowhichthecontrolfortheprocessisshared,c)thecapabilityofachievingthenecessarycontrolthroughtheapplicationof7.4.注3：確保對(duì)外包過(guò)程的控制并不免

39、除組織滿足顧客和法律法規(guī)要求的責(zé)任。對(duì)外包過(guò)程控制的類型和程度可受下列因素影響：a)外包過(guò)程對(duì)組織提供滿足要求的產(chǎn)品的能力的潛在影響；b)對(duì)外包過(guò)程控制的分擔(dān)程度；c)通過(guò)應(yīng)用7.4條款實(shí)現(xiàn)所需控制的能力。4.2Documentationrequirements文件要求4.2.1General總則Thequalitymanagementsystemdocumentationshallincludea)documentedstatementsofaqualitypolicyandqualityobjectives,b)aqualitymanual,c)documentedproceduresan

40、drecordsrequiredbythisInternationalStandard,andd)documents,includingrecords,determinedbytheorganizationtobenecessarytoensuretheeffectiveplanning,operationandcontrolofitsprocesses.質(zhì)量管理體系文件應(yīng)包括：a)形成文件的質(zhì)量方針和質(zhì)量目標(biāo)；b)質(zhì)量手冊(cè)；c)本標(biāo)準(zhǔn)所要求的形成文件的程序和記錄；d)組織確定的為確保其過(guò)程有效策劃、運(yùn)作和控制所需的文件，包括記錄。NOTE1Wheretheterm“documentedpro

41、cedure”appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.Asingledocumentmayaddresstherequirementsforoneormoreprocedures.Arequirementforadocumentedproceduremaybecoveredbymorethanonedocument.注1：本標(biāo)準(zhǔn)出現(xiàn)“形成文件的程序”之處，即要求建立該程序，形成文件，并加以實(shí)施和保持。一個(gè)文件

42、可包括一個(gè)或多個(gè)程序的要求。一個(gè)形成文件的程序的要求可以被包含在多個(gè)文件中。NOTE2Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherduetoa)thesizeoforganizationandtypeofactivities,b)thecomplexityofprocessesandtheirinteractions,andc)thecompetenceofpersonnel.注2：不同組織的質(zhì)量管理體系文件的多少與詳略程度取決于：a)組織的規(guī)模和活動(dòng)的類型；b)過(guò)

43、程及其相互作用的復(fù)雜程度；c)人員的能力。NOTE3Thedocumentationcanbeinanyformortypeofmedium.注3文件可采用任何形式或類型的媒體。4.2.2Qualitymanual質(zhì)量手冊(cè)Theorganizationshallestablishandmaintainaqualitymanualthatincludesa)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see1.2),b)thedocumentedprocedures

44、establishedforthequalitymanagementsystem,orreferencetothem,andc)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.組織應(yīng)編制和保持質(zhì)量手冊(cè)，質(zhì)量手冊(cè)包括：a)質(zhì)量管理體系的范圍，包括任何刪減的細(xì)節(jié)與理由（見(jiàn)1.2）；b)為質(zhì)量管理體系建立的形成文件的程序或?qū)ζ湟?；c)質(zhì)量管理體系過(guò)程之間的相互作用的表述。4.2.3Controlofdocuments文件控制Documentsrequiredbythequalitymanagem

45、entsystemshallbecontrolled.Recordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.質(zhì)量管理體系所要求的文件應(yīng)予以控制。記錄是一種特殊類型的文件，應(yīng)依據(jù)4.2.4的要求進(jìn)行控制。Adocumentedprocedureshallbeestablishedtodefinethecontrolsneeded應(yīng)編制形成文件的程序，以規(guī)定以下方面所需的控制：a)toapprovedocumentsforadequacypriortoissue,b)to

46、reviewandupdateasnecessaryandre-approvedocuments,c)toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,d)toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse,e)toensurethatdocumentsremainlegibleandreadilyidentifiable,f)toensurethatdocumentsofexternalorigindet

47、erminedbytheorganizationtobenecessaryfortheplanningandoperationofthequalitymanagementsystemareidentifiedandtheirdistributioncontrolled,andg)topreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose.a)文件發(fā)布前得到批準(zhǔn)，以確保文件是充分與適宜的；為文件的充分性與適宜性，在文件發(fā)布前進(jìn)行批

48、準(zhǔn)。b)必要時(shí)對(duì)文件進(jìn)行評(píng)審與更新，并再次批準(zhǔn)；c)確保文件的更改和現(xiàn)行修訂狀態(tài)得到識(shí)別；d)確保在使用處可獲得有關(guān)版本的適用文件；e)確保文件保持清晰、易于識(shí)別；f)確保組織所確定的策劃和運(yùn)行質(zhì)量管理體系所需的外來(lái)文件得到識(shí)別，并控制其分發(fā)；g)防止作廢文件的非預(yù)期使用，若因任何原因而保留作廢文件時(shí)，對(duì)這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí)。4.2.4Controlofrecords記錄的控制Recordsestablishedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagement

49、systemshallbecontrolled.為符合要求和質(zhì)量管理體系有效運(yùn)行提供證據(jù)而建立的記錄，應(yīng)予以控制。Theorganizationshallestablishadocumentedproceduretodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentionanddispositionofrecords.組織應(yīng)編制形成文件的程序，以規(guī)定記錄的標(biāo)識(shí)、貯存、保護(hù)、檢索、保存和處置所需的控制。Recordsshallremainlegible,readilyidentifiabl

50、eandretrievable.記錄應(yīng)保持清晰、易于識(shí)別和檢索。5Managementresponsibility管理職責(zé)5.1Managementcommitment管理承諾Topmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessbya)communicatingtotheorganizationtheimportanceofmeetingcustomer

51、aswellasstatutoryandregulatoryrequirements,b)establishingthequalitypolicy,c)ensuringthatqualityobjectivesareestablished,d)conductingmanagementreviews,ande)ensuringtheavailabilityofresources.最高管理者應(yīng)通過(guò)以下活動(dòng)，對(duì)其建立、實(shí)施質(zhì)量管理體系并持續(xù)改進(jìn)其有效性的承諾提供證據(jù)：a)向組織傳達(dá)滿足顧客和法律法規(guī)要求的重要性；b)制定質(zhì)量方針；c)確保質(zhì)量目標(biāo)的制定；d)進(jìn)行管理評(píng)審；e)確保資源的獲得。5.2C

52、ustomerfocus以顧客為關(guān)注焦點(diǎn)Topmanagementshallensurethatcustomerrequirementsaredeterminedandaremetwiththeaimofenhancingcustomersatisfaction(see7.2.1and8.2.1).最高管理者應(yīng)以增強(qiáng)顧客滿意為目的，確保顧客的要求得到確定并予以滿足（見(jiàn)7.2.1和8.2.1）。5.3Qualitypolicy質(zhì)量方針Topmanagementshallensurethatthequalitypolicya)isappropriatetothepurposeoftheorgani

53、zation,b)includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem,c)providesaframeworkforestablishingandreviewingqualityobjectives,d)iscommunicatedandunderstoodwithintheorganization,ande)isreviewedforcontinuingsuitability.最高管理者應(yīng)確保質(zhì)量方針：a)與組織的宗旨相適應(yīng)；b

54、)包括對(duì)滿足要求和持續(xù)改進(jìn)質(zhì)量管理體系有效性的承諾；c)提供制定和評(píng)審質(zhì)量目標(biāo)的框架；d)在組織內(nèi)得到溝通和理解；e)在持續(xù)適宜性方面得到評(píng)審。5.4Planning策劃5.4.1Qualityobjectives質(zhì)量目標(biāo)Topmanagementshallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproductsee7.1a),areestablishedatrelevantfunctionsandlevelswithintheorganization.Thequalityobjectivessh

55、allbemeasurableandconsistentwiththequalitypolicy.最高管理者應(yīng)確保在組織的相關(guān)職能和層次上建立質(zhì)量目標(biāo)，質(zhì)量目標(biāo)包括滿足產(chǎn)品要求所需的內(nèi)容（見(jiàn)7.1a）。質(zhì)量目標(biāo)應(yīng)是可測(cè)量的，并與質(zhì)量方針保持一致。5.4.2Qualitymanagementsystemplanning質(zhì)量管理體系策劃Topmanagementshallensurethata)theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1,aswellasthequ

56、alityobjectives,andb)theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.最高管理者應(yīng)確保：a)對(duì)質(zhì)量管理體系進(jìn)行策劃，以滿足質(zhì)量目標(biāo)以及4.1的要求。b)在對(duì)質(zhì)量管理體系的變更進(jìn)行策劃和實(shí)施時(shí)，保持質(zhì)量管理體系的完整性。5.5Responsibility,authorityandcommunication職責(zé)、權(quán)限和溝通5.5.1Responsibilityandauthority職責(zé)和權(quán)限To

57、pmanagementshallensurethatresponsibilitiesandauthoritiesaredefinedandcommunicatedwithintheorganization.最高管理者應(yīng)確保組織內(nèi)的職責(zé)、權(quán)限得到規(guī)定和溝通。5.5.2Managementrepresentative管理者代表Topmanagementshallappointamemberoftheorganizationsmanagementwho,irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritytha

58、tincludesa)ensuringthatprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained,b)reportingtotopmanagementontheperformanceofthequalitymanagementsystemandanyneedforimprovement,andc)ensuringthepromotionofawarenessofcustomerrequirementsthroughouttheorganization.最高管理者應(yīng)指定一名本組織的

59、管理者，無(wú)論該成員在其他方面的職責(zé)如何，應(yīng)具有以下方面的職責(zé)和權(quán)限：a)確保質(zhì)量管理體系所需的過(guò)程得到建立、實(shí)施和保持；b)向最高管理者報(bào)告質(zhì)量管理體系的業(yè)績(jī)和任何改進(jìn)的需求；c)確保在整個(gè)組織內(nèi)提高滿足顧客要求的意識(shí)。NOTETheresponsibilityofamanagementrepresentativecanincludeliaisonwithexternalpartiesonmattersrelatingtothequalitymanagementsystem.注：管理者代表的職責(zé)可包括與質(zhì)量管理體系有關(guān)事宜的外部聯(lián)絡(luò)。5.5.3Internalcommunication內(nèi)部溝通

60、Topmanagementshallensurethatappropriatecommunicationprocessesareestablishedwithintheorganizationandthatcommunicationtakesplaceregardingtheeffectivenessofthequalitymanagementsystem.最高管理者應(yīng)確保在組織內(nèi)建立適當(dāng)?shù)臏贤ㄟ^(guò)程，并確保對(duì)質(zhì)量管理體系的有效性進(jìn)行溝通5.6Managementreview管理評(píng)審5.6.1General總則Topmanagementshallreviewtheorganizationsqua