ISO9000培訓(xùn)資料

1、品質(zhì)管理ISO900值量管理醴系檄準(zhǔn)要素辭解ISO9001:2000QualitymanagementsystemsRequirements(Thirdedition2000-12-15)、合理的曾化2000版ISO9000襟準(zhǔn)聘其曾化懸以下五他I襟準(zhǔn)1. ISO9000：2000U量管理醴系-基本原理和jO吾，取代了ISO8402襟準(zhǔn)和ISO9000-1。2. ISO9001:2000U量管理醴系-要求，取代了94版的3dM量保證襟準(zhǔn)。3. ISO9004：2000U量管理醴系-棠娥改迤指南，取代垣行的ISO90041,-2,-3,-4襟準(zhǔn)。4. ISO19011U量和琪境寄核指南取代了垣行

2、的ISO10011（包才S3（0分襟準(zhǔn)）和ISO14010、ISO14011、ISO14012襟準(zhǔn)。5. ISO10012測量控制系統(tǒng)，取代？I行的ISO10012-1,-2襟瘁94版的ISO9001有20（0要素，垣改懸4（0部份，相互新B0系如下BI:ISO9001:2000ISO9001:19941.逾用輪HI11.1Bi定1.2ApplicationJ8用2.參考襟舉23jIt百吾及定莪34.品11管理系統(tǒng)4.1一般要求4.2.14.2文件要求4.2.24.2.1概述4.5.2+4.5.34.2.2品11手冊4.2.14.2.3文件的管制4.5.1+4.5.2+4.5.34.2.4品市

3、己金泉的管制J4.165.管理if任5.1管理承4.1+4.1.2.2+4.2.15.2以1S客懸中心4.3.25.3品U政策4.1.15.4祝1J5.4.1品U目襟4.1.1+4.2.15.4.2品11管理系統(tǒng)祝副4.2.35.5J1任、SM8、潢通5.5.1任典殿榷4.1.2.15.5.2管理代表4.1.2.35.5.3內(nèi)部潢通5.6管理寄查4.1.35.6.1概述4.1.35.6.2WSWA4.1.35.6.3雷查輸出4.1.36資源管理6.1資源的提供4.1.2.26.2人力資源6.2.1概述4.1.2.2+4.2.3+4.186.2.2培前1意和能力4.186.3資源結(jié)情4.1.2.

4、2+4.96.4工作琪境4.97ft品宣說7.1萬品a1的血4.2.3+4.9+4.10.17.2客戶相流程7.2.1萬品有信在需求的泱定4.3.2+4.4.47.2.2萬品有需求的塞查4.3.2+4.3.3+4.3.47.2.3客戶潢通4.3.27.37.3.1igt+>HW»J4.4.2+4.4.3+4.4.6+4.4.7+4.4.87.3.2段言十典俞入4.4.47.3.3IS言十典俞出4.4.57.3.4t+>H»WS4.4.67.3.5igt+>H»Mlt4.4.77.3.615言十典H彝吟4.4.87.3.7iS言十的管制典H彝建更4

5、.4.97.4冊7.4.1探H謾程4.6.1+4.6.27.4.2»IWft4.6.37.4.3探幡品的爆播4.6.4+4.10.2+4.10.3+4.10.47.5生筐及服矜作H7.5.1生崖奧服矜準(zhǔn)言午借管制4.9+4.10.3+4.15.6+4.197.5.2謾程的確B忍4.97.5.341別典追溯4.8+4.10.5+4.127.5.4客戶品4.77.5.5品的保存4.15.2+4.15.3+4.15.4+4.15.5+4.15.67.6量測典盛控像器的管制4.11.1+4.11.28量測、分析及改善8.1概括4.10+4.20.18.2量測典整:控8.2.1客戶滿意8.2.

6、2內(nèi)部稽核4.178.2.3流程的整:控典量測4.9+4.20.18.2.4品的量測典整:控4.10.2+4.10.3+4.10.4+4.10.5+4.208.3不合格品的管制4.13.1+4.13.28.4資料分析4.14.2+4.14.3+4.208.5改善8.5.1持改善之祝副4.1.38.5.2精正措施4.14.1+4.14.28.5.358防措施4.14.1+4.14.3、春司言吾的使用更加準(zhǔn)碓或符合黜的雪慣1用11量管理醴系”取代了II量保631系2用文件控制”取代了文件和資料控制”3用K客的irns”取代了K客提供的崖品4.供鷹由：桀包方-供方-is客”改懸：供方-wa-is客”

7、；5用最高管理者”取代有就行me的管理者”。、更方便地逾用于各槿崖品is型和規(guī)模的黜1 .以謾程模式代替20(0要素的模式。>20(0要素的形式建成四部分，道槿結(jié)情具有普遍的逾用性。但其并不強(qiáng)求黜更改其si量管理醴系的結(jié)情或其文件，以和本閾除襟準(zhǔn)的結(jié)橫保持一致，黜的si量管理醴系文件的規(guī)定鷹逾合于其特有的活勤方式。2 .強(qiáng)調(diào)根摞黜»的具醴情況is言十逾用的si量管理醴系。文件的要求有了敕大的寮活性，3 .襟準(zhǔn)要求必i(建立程序文件的共有6慮：文件控制言己金錄控制內(nèi)部寄核不合格品控制正措施55防措施b別一I®的黜要求的文件，主要指品謾程所需的文件。-DPola-Cnhe

8、ck- Act ” (PDCA) can be applied to all processes. PDCA can四、襟準(zhǔn)要求NOTEInaddition,themethodologyknownasbebrieflydescribedasfollows.品質(zhì)管理Plan:establishtheobjectivesandprocessesnecessarytodeliverresultsinaccordancewithcustomerrequirementsandtheorganization'spolicies.Do:implementtheprocesses.Check:moni

9、torandmeasureprocessesandproductagainstpolicies,objectivesandrequirementsfortheproductandreporttheresults.Act:takeactionstocontinuallyimproveprocessperformance.CUSTOMERCONTINUALIMPROVEMENTOFTHEQUALITYMANAGEMENTSYSTEMManagementresponsibilityMeasurement,analysisandimprovementResourcemanagementInputPro

10、ductrealizationProductsfacCUSTOMERLegend:.ValueaddingInformationFigure1Modelofaprocess-basedqualitymanagementsystemQualitymanagementsystemsRequirements1Scope1.1General獻(xiàn)ijThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization本閾除檄準(zhǔn)規(guī)定的量管理ft系要求:a)needstodemonstratei

11、tsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,and需其持提供符合客戶需求及遹用法規(guī)要求崖品的能力。b)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregu

12、latoryrequirements.目的在于通謾系統(tǒng)的有效作以逵到客戶的滿意，包括持改善系統(tǒng)的流程和碓保符合客戶滿及遹用法規(guī)的需求。NOTEInthisInternationalStandard,theterm“product"appliesonlytotheproductintendedfor,orrequiredby,acustomer.借注：在本閾除襟準(zhǔn)中,述II筐品指的是客戶言丁瞞或客戶需求的崖品。1.2Application鷹用AllrequirementsofthisInternationalStandardaregenericandareintendedtobeapp

13、licabletoallorganizations,regardlessoftype,sizeandproductprovided.本閾除檄準(zhǔn)規(guī)定的是一般和通用的要求,遹用于所有,不其型、規(guī)模和提供的品如何。Whereanyrequirement(s)ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.本閾除檄準(zhǔn)的要求曾因或品的特性因素而不遹用,可以考排除。Whereexclusionsaremade,claim

14、sofconformitytothisInternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganization'sability,orresponsibility,toprovideproductthatmeetscustomerandapplicableregulatoryrequirements.可以排除的修款僮限于修款7中的要求，并且僮可以排除不影提供符合客戶和遹用的法律要求的

15、崖品的能力和JT任的要求。否即就不能符合本閾除檄準(zhǔn)。2 Normativereference引用檄準(zhǔn)Thefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedo

16、nthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.下列相除檄準(zhǔn)所包含修文，通謾在本

17、檄準(zhǔn)中引用而橫成懸本檄準(zhǔn)的修文，由于引用的修文曾逐漸謾日寺、陛修正或改版，造成引用的閾除檄準(zhǔn)不再遹用。然而，使用本閾除檄準(zhǔn)的各方鷹探御使用下列相除檄準(zhǔn)之最新版本的可能性。IEC和ISO成it都持有垣行有效的閾除檄準(zhǔn)。ISO9000:2000,QualitymanagementsystemsFundamentalsandvocabulary.ISO9000:2000量管理ft系-基磁知和Tft言吾3 Termsanddefinitionsjfc言吾和定UForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninI

18、SO9000apply.出于本g|除檄準(zhǔn)的目的，使用的?。貉晕岷投ㄔ贗SO9000中給出。Thefollowingterms,usedinthiseditionofISO9001todescribethesupplychain,havebeenchangedtoreflectthevocabularycurrentlyused:在ISO9001:2000描述供鷹It所使用的Tft言吾被改建普遍使用的春司IS:Supplierorganizationcustomer供方客戶Thetermaorganization“replacesthetermasupplier“usedinISO9001:19

19、94,andreoethetunittowhichthisInternationalStandardapplies.Also,thetermasupplier"nowreplacesthetermasubcontractor品質(zhì)管理Tft言吾取代了ISO9001:1994版使用的Tft言吾彳共方，意思是遹用于本閾除檄準(zhǔn)的軍位。同檬用戊言吾供方取代了Tft言吾分供方。meanThroughoutthetextofthisInternationalStandard,wherevertheterm“product”occurs,itcanalso“service”.在整偃I檄準(zhǔn)中所使用的T

20、ft言吾崖品'在道里同檬包括服矜'。4 QualitymanagementsystemII量管理醴系4.1 Generalrequirements一般要求Theorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.建立、軌行并保持一偃I文件化的II量管理ft系，并持改迤其有效性使其典本

21、閾檄檄準(zhǔn)要求相一至。Theorganizationshalla) identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),熬別施量管理系統(tǒng)及鷹用于整偃所需的流程。b) determinethesequenceandinteractionoftheseprocesses,碓定道些流程之1嗔序及相互信司系。c) determinecriteriaandmethodsneededtoensurethatboththeoperationandc

22、ontroloftheseprocessesareeffective,碓定所需檄準(zhǔn)及方法,以碓保道些流程可逵成有效作it及管制。d) ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,提供有效的資源和以支持道些流程的行及管制。e) monitor,measureandanalysetheseprocesses,and整:控、測量及分析道些流程。f) implementactionsnecessarytoachieveplannedre

23、sultsandcontinualimprovementoftheseprocesses.軌行所需要的活勤,來逵成言十劃并持改迤道些流程。TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard.封道些流程迤行管理使其典本閾除檄準(zhǔn)的要求相一至。Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganiza

24、tionshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.攆曾影警到品符合要求的外部流程畤,保道些外部流程得到控制,并在量管理ft系中封道些流程迤行饕別。NOTEProcessesneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,

25、productrealizationandmeasurement.借注：在上面所述的量管理所需的流程包括管理活勤、資源提供、崖品JT垣及測量流程。4.2 Documentationrequirements文件需求4.2.1 General一般要求ThequalitymanagementsystemdocumentationshallincludeII量管理ft系文件鷹包括：a) documentedstatementsofaqualitypolicyandqualityobjectives,文件化的量方金十和量目檄。b) aqualitymanual,量手冊。c) documentedproc

26、eduresrequiredbythisInternationalStandard,本閾除檄準(zhǔn)要求的程序文件。d)documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,and需求的碓保流程得到有效的1T施和控制的文件。e)recordsrequiredbythisInternationalStandard(see4.2.4).本閾除襟準(zhǔn)要求的言已(M行修款4.2.4)NOTE1Wheretheterm“documentedprocedure”appearswi

27、thinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.借注1：要本閾除襟準(zhǔn)中出琨的7frti文件化程序是要求建立、形成文件、JT施程序并予以保持。NOTE2Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherdueto借注2：品管理ft系文件的范圉可能因以下原因在東且曾有差H:a) thesizeoforganizati

28、onandtypeofactivities,的規(guī)模和I®型。b) thecomplexityofprocessesandtheirinteractions,and流程的彳復(fù)余隹程度和相互作用。c) thecompetenceofpersonnel.人Jt的能力。NOTE3Thedocumentationcanbeinanyformortypeofmedium.借注3：文件化的程序和文件可存在任何形式的媒醴。4.2.2 Qualitymanual量手冊Theorganizationshallestablishandmaintainaqualitymanualthatincludes就建

29、立并保持偃111量手冊，包含以下內(nèi)容：a) thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see1.2) ,II量管理ft系的范圉,包括辭區(qū)田內(nèi)容及任何排除情況和原因。b) thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,and量管理ft系建立的文件化程序或其援引。c) adescriptionoftheinteractionbetweenthepro

30、cessesofthequalitymanagementsystem.描述量管理ft系各流程的相互作用信司系。4.2.3 Controlofdocuments文件控制Documentsrequiredbythequalitymanagementsystemshallbecontrolled.Recordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.II量管理ft系所需的文件鷹富是受控的，言己金錄是一槿特殊的文件，鷹照修款4.2.4的要求迤行控制,Adocumentedpr

31、ocedureshallbeestablishedtodefinethecontrolsneeded建立一偃I文件化程序碓定a) toapprovedocumentsforadequacypriortoissue,彝行前批準(zhǔn)其遹富性。b) toreviewandupdateasnecessaryandre-approvedocuments,迤行必要的塞核和更新，并重新貍得批準(zhǔn)。c) toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,碓保封文件修言丁及修言丁狀熊迤行檄Od) toensurethatrel

32、evantversionsofapplicabledocumentsareavailableatpointsofuse,在需要使用文件的埸合,碓保得到相鷹文件的有效版本。e) toensurethatdocumentsremainlegibleandreadilyidentifiable,碓保文件保持清楚易H,可供別并可追溯。f) toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,and碓保外來文件已作檄,并控制其樊放。g) topreventtheunintendeduseofob

33、soletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose.防止作座文件的非期使用,如需保留以借它用,即鷹作出遹富的檄言哉。4.2.4 ControlofrecordsII量言己金錄的控制Recordsshallbeestablishedandmaintainedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Recordsshallrem

34、ainlegible,readilyidentifiableandretrievable.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofrecords.it量言己金錄鷹被建立和保持以me明it量管理tt系得到有效的行并符合本a除檄準(zhǔn)的要求。it量音己金錄鷹保持清楚易并易于掩取。鷹建立程序文件以檄言哉、吩存、追溯和保量言己金錄，并規(guī)定保存期限和慮理方法。5 Ma

35、nagementresponsibility管理!«5.1 Managementcommitment管理承Topmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessby最高管理)1鷹提供以下tBt,以示品II管理系統(tǒng)的樊展典施并迤行有效的改善的承a) communicatingtotheorganizationtheimportanceofmeeti

36、ngcustomeraswellasstatutoryandregulatoryrequirements,向逵符合客戶及規(guī)章/法令的重要性。b) establishingthequalitypolicy,建立量方金十c) ensuringthatqualityobjectivesareestablished,碓保量目檄被建立。d) conductingmanagementreviews,and軌行管理看平塞。e) ensuringtheavailabilityofresources.碓保資源得以取用。5.2 Customerfocus客戶醇向Topmanagementshallensureth

37、atcustomerrequirementsaredeterminedandaremetwiththeaimofenhancingcustomersatisfaction(see7.2.1and8.2.1).最高管理卜皆眉鷹碓保客戶的需求得已碓定,并醇化懸以琪客戶滿意的要求.(M7.2.1和8.2.1)5.3 QualitypolicyK量方金十Topmanagementshallensurethatthequalitypolicy最高管理)1鷹碓保量方金十：a) isappropriatetothepurposeoftheorganization,輿的目的相;aw；b) includesac

38、ommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem,包括符合檄準(zhǔn)的要求及持改迤的承oc) providesaframeworkforestablishingandreviewingqualityobjectives,篇目檄的建立及看平富提供框架。d) iscommunicatedandunderstoodwithintheorganization,and在內(nèi)各部行潢通,并使各部力都能理解e) isreviewedforcontinuingsuitab

39、ility.封K量方金十的持用性迤行押寄。5.4 Planning策劃5.4.1 Qualityobjectives量目檄Topmanagementshallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproductsee7.1a,areestablishedatrelevantfunctionsandlevelswithintheorganization.Thequalityobjectivesshallbemeasurableandconsistentwiththequalitypolicy.最高

40、管理)1鷹碓保在的各級相信司殿能部力都建立量目檄,量目檄鷹可被測量,并輿量方金十及持改迤的承相一至。量目檄鷹包含符合品要求所需之內(nèi)容。5.4.2 QualitymanagementsystemplanningII量管理ft系策劃Topmanagementshallensurethat最高管理唇5鷹碓保：a) theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1,aswellasthequalityobjectives,andII量管理ft系策劃的軌行要符合品II目檄及修

41、文4.1的要求。b) theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.常量管理ft系在規(guī)劃和軌行上有改建畤，要雉持量管理ft系的完整性。5.5 Responsibility,authorityandcommunication、本霍力典潢通5.5.1 Responsibilityandauthority典本瞿力Topmanagementshallensurethatresponsibilitiesandauthor

42、itiesaredefinedandcommunicatedwithintheorganization.最高管理)1鷹碓保工的HIT和本瞿力被碓定并在內(nèi)迤行俾逵。5.5.2 Managementrepresentative管理者代表Topmanagementshallappointamemberofmanagementwho,irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritythatincludes最高管理者鷹指定一名管理者,不受其他殿矜、JT任影警,鷹具有以下JT任及本瞿力：a) ensuringth

43、atprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained,碓保建立、施和雉持K量管理if系所需的程序。b) reportingtotopmanagementontheperformanceofthequalitymanagementsystemandanyneedforimprovement,and向最高管理)1幸艮告II量管理ft系的軌行成效及改善需求。c) ensuringthepromotionofawarenessofcustomerrequirementsthrougho

44、uttheorganization.碓保全人客戶需求的充分知悉。NOTETheresponsibilityofamanagementrepresentativecanincludeliaisonwithexternalpartiesonmattersrelatingtothequalitymanagementsystem.借注：管理者代表的!»逮包括輿II量管理ft系有信司的外部耳粉格。5.5.3 Internalcommunication內(nèi)部潢通Topmanagementshallensurethatappropriatecommunicationprocessesareestab

45、lishedwithintheorganizationandthatcommunicationtakesplaceregardingtheeffectivenessofthequalitymanagementsystem.最高管理)1鷹碓保在建立遹富的潢通流程，碓保品管理系統(tǒng)的有效。5.6 Managementreview管理看瘠平5.6.1 GeneraleiijTopmanagementshallreviewtheorganization'squalitymanagementsystem,atplannedintervals,toensureitscontinuingsuitabi

46、lity,adequacyandeffectiveness.Thisreviewshallincludeassessingopportunitiesforimprovementandtheneedforchangestothequalitymanagementsystem,includingthequalitypolicyandqualityobjectives.最高管理鷹每隔規(guī)定日寺,塞核品II管理ft系,碓保II量管理ft系的持遹用性、正碓、有效。tKii平富包括看平估II量管理ft系的改迤械曾及改迤需要,包括II量方金十和II量目檄的看平富。Recordsfrommanagementre

47、viewsshallbemaintained(see4.2.4).管理看瘠平的言己金錄鷹被保存。(H4.2.4)5.6.2 Reviewinput管理看平塞輸入Theinputtomanagementreviewshallincludeinformationon管理看平塞輸入鷹包括：品質(zhì)管理品質(zhì)管理a) resultsofaudits,塞核的結(jié)果b) customerfeedback,客戶的反ifc) processperformanceandproductconformity,謾程的軌行及品的符合性。d) statusofpreventiveandcorrectiveactions,S(防及

48、余U正措施的狀憨。e) follow-upactionsfrompreviousmanagementreviews,上一次管理看平富的跟K情況。f) changesthatcouldaffectthequalitymanagementsystem,and可能影警量管理ft系的改迤og) recommendationsforimprovement.改善建H5.6.3 Reviewoutput春平塞輸出Theoutputfromthemanagementreviewshallincludeanydecisionsandactionsrelatedto管理看平富輸出鷹包括輿以下有信司的決定及措施：a

49、) improvementoftheeffectivenessofthequalitymanagementsystemanditsprocesses,II量管理ft系及其流程的有效性改迤。b) improvementofproductrelatedtocustomerrequirements,and典客戶需求有信司的品改善。c) resourceneeds.資源需求6 Resourcemanagement資源管理6.1 Provisionofresources資源的提供Theorganizationshalldetermineandprovidetheresourcesneeded碓定和提供所

50、需資源a) toimplementandmaintainthequalitymanagementsystemandcontinuallyimproveitseffectiveness,and軌行輿雉持品管理ft系并持改迤其有效性。b) toenhancecustomersatisfactionbymeetingcustomerrequirements.通謾符合客戶要求提高客戶滿意度。6.2 Humanresources人力資源6.2.1 GeneraleiijPersonnelperformingworkaffectingproductqualityshallbecompetentontheb

51、asisofappropriateeducation,training,skillsandexperience.軌行典品量有信司工作的人it,鷹有遹富的教育、HIM、技Tft和6.2.2 Competence,awarenessandtraining培就I意和能力Theorganizationshalla) determinethenecessarycompetenceforpersonnelperformingworkaffectingproductquality,別人在優(yōu)事影警II量的活勤中封能力的需求。b) providetrainingortakeotheractionstosatis

52、fytheseneeds,提供培就I或其他方式以滿足道些需求。c) evaluatetheeffectivenessoftheactionstaken,春平估所遭攆的行勤的效果。d) ensurethatitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives,and碓保其工能意言哉到他例活勤的iPi性和重要性以及他例封逵到品目檄的貢)1。e) maintainappropriaterecordsofeduc

53、ation,training,skillsandexperience(see4.2.4).保存有信司教育、培前I、技jft和的言己金黑6.3 Infrastructure資源結(jié)情Theorganizationshalldetermine,provideandmaintaintheinfrastructureneededtoachieveconformitytoproductrequirements.Infrastructureincludes,asapplicable、提供、保持逵成品合格所需的資源結(jié)橫,資源結(jié)橫包括：a) buildings,workspaceandassociateduti

54、lities,建筑、工作埸地和相信施。b) processequipment(bothhardwareandsoftware),and流程,包括硬ft及軟11。c) supportingservices(suchastransportorcommunication).支援服矜如、潢通。6.4 Workenvironment工作璟境Theorganizationshalldetermineandmanagetheworkenvironmentneededtoachieveconformitytoproductrequirements.定和管理逵到品合格要求所需的工作璟境。7 Productrea

55、lization品的H現(xiàn)7.1 Planningofproductrealization品H現(xiàn)的規(guī)劃Theorganizationshallplananddeveloptheprocessesneededforproductrealization.Planningofproductrealizationshallbeconsistentwiththerequirementsoftheotherprocessesofthequalitymanagementsystem(see4.1).品質(zhì)管理品質(zhì)管理建立和IT施品所需的言十劃和樊展程序。品的言十劃?jì)椵汭I量管理ft系的其它流程的要求相一至。In

56、planningproductrealization,theorganizationshalldeterminethefollowing,asappropriate:在言十劃品日寺的決定如下各項(xiàng):a) qualityobjectivesandrequirementsfortheproduct;品的量目檄和需求。b) theneedtoestablishprocesses,documents,andprovideresourcesspecifictotheproduct;建立品所需的流程、文件及提供資源。c) requiredverification,validation,monitoring,inspectionandtestactivitiesspecifictotheproductandthecriteriaforproductacceptance;金十封品及品允收修件決定所需之各瞬嗑e、eB、整:控、檢查及測之活勤。d) recordsn