首页 ISO_TR-10013

ISO_TR-10013

举报
开通vip

ISO_TR-10013ReferencenumberISO/TR10013:2001(E)©ISO2001TECHNICALREPORTISO/TR10013Firstedition2001-07-15GuidelinesforqualitymanagementsystemdocumentationLignesdirectricespourledéveloppementdeladocumentationsurlessystèmesdemanagementdelaqualitéLicen...

ISO_TR-10013
ReferencenumberISO/TR10013:2001(E)©ISO2001TECHNICALREPORTISO/TR10013Firstedition2001-07-15GuidelinesforqualitymanagementsystemdocumentationLignesdirectricespourledéveloppementdeladocumentationsurlessystèmesdemanagementdelaqualitéLicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedISO/TR10013:2001(E)PDFdisclaimerThisPDFfilemaycontainembeddedtypefaces.InaccordancewithAdobe'slicensingpolicy,thisfilemaybeprintedorviewedbutshallnotbeeditedunlessthetypefaceswhichareembeddedarelicensedtoandinstalledonthecomputerperformingtheediting.Indownloadingthisfile,partiesacceptthereintheresponsibilityofnotinfringingAdobe'slicensingpolicy.TheISOCentralSecretariatacceptsnoliabilityinthisarea.AdobeisatrademarkofAdobeSystemsIncorporated.DetailsofthesoftwareproductsusedtocreatethisPDFfilecanbefoundintheGeneralInforelativetothefile;thePDF-creationparameterswereoptimizedforprinting.EverycarehasbeentakentoensurethatthefileissuitableforusebyISOmemberbodies.Intheunlikelyeventthataproblemrelatingtoitisfound,pleaseinformtheCentralSecretariatattheaddressgivenbelow.©ISO2001Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherISOattheaddressbeloworISO'smemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56�CH-1211Geneva20Tel.+41227490111Fax+41227490947E-mailcopyright@iso.chWebwww.iso.chPrintedinSwitzerlandii©ISO2001–AllrightsreservedLicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedISO/TR10013:2001(E)©ISO2001–AllrightsreservediiiContentsPageForeword.....................................................................................................................................................................ivIntroduction.................................................................................................................................................................v1Scope..............................................................................................................................................................12Normativereference......................................................................................................................................13Termsanddefinitions...................................................................................................................................14Qualitymanagementsystemdocumentation.............................................................................................24.1General............................................................................................................................................................24.2Purposesandbenefits..................................................................................................................................34.3Qualitypolicyanditsobjectives..................................................................................................................34.4Qualitymanual...............................................................................................................................................34.5Documentedprocedures..............................................................................................................................54.6Workinstructions..........................................................................................................................................64.7Forms..............................................................................................................................................................74.8Qualityplans..................................................................................................................................................74.9Specifications.................................................................................................................................................74.10Externaldocuments......................................................................................................................................74.11Records...........................................................................................................................................................85Processofpreparingqualitymanagementsystemdocumentation........................................................85.1Responsibilityforpreparation......................................................................................................................85.2Methodofpreparationofqualitymanagementsystemdocumentation..................................................85.3Useofreferences...........................................................................................................................................96Processofapproval,issueandcontrolofqualitymanagementsystemdocuments............................96.1Reviewandapproval.....................................................................................................................................96.2Distribution.....................................................................................................................................................96.3Incorporationofchanges..............................................................................................................................96.4Issueandchangecontrol.............................................................................................................................96.5Uncontrolledcopies....................................................................................................................................10AnnexATypicalqualitymanagementsystemdocumentationhierarchy..........................................................11AnnexBExampleofstructuredtextworkinstructions........................................................................................12Bibliography..............................................................................................................................................................14LicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedISO/TR10013:2001(E)iv©ISO2001–AllrightsreservedForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhomatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3.ThemaintaskoftechnicalcommitteesistoprepareInternationalStandards.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.Inexceptionalcircumstances,whenatechnicalcommitteehascollecteddataofadifferentkindfromthatwhichisnormallypublishedasanInternationalStandard(“stateoftheart”,forexample),itmaydecidebyasimplemajorityvoteofitsparticipatingmemberstopublishaTechnicalReport.ATechnicalReportisentirelyinformativeinnatureanddoesnothavetoberevieweduntilthedataitprovidesareconsideredtobenolongervalidoruseful.AttentionisdrawntothepossibilitythatsomeoftheelementsofthisTechnicalReportmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ISO/TR10013waspreparedbyTechnicalCommitteeISO/TC176,Qualitymanagementandqualityassurance,SubcommitteeSC3,Supportingtechnologies.ThisfirsteditionofISO/TR10013cancelsandreplacesISO10013:1995,Guidelinesfordevelopingqualitymanuals.LicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedISO/TR10013:2001(E)©ISO2001–AllrightsreservedvIntroductionTheISO9000familyofInternationalStandardsrequiresthequalitymanagementsystemofanorganizationtobedocumented.ThisTechnicalReportpromotestheadoptionoftheprocessapproachwhendevelopingandimplementingthequalitymanagementsystemandimprovingitseffectiveness.Foranorganizationtofunctioneffectively,ithastoidentifyandmanagenumerouslinkedactivities.Anactivityusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbeconsideredasaprocess.Oftentheoutputfromoneoftheprocessesdirectlyformstheinputtothenext.Theapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagement,canbereferredtoasthe'processapproach'.Anadvantageoftheprocessapproachistheongoingcontrolthatitprovidesoverthelinkagebetweentheindividualprocesseswithinthesystemofprocesses,aswellasovertheircombinationandinteraction.Anorganizationhasflexibilityinthewayitchoosestodocumentitsqualitymanagementsystem.Eachindividualorganizationshoulddevelopthatamountofdocumentationneededtodemonstratetheeffectiveplanning,operation,controlandcontinualimprovementofitsqualitymanagementsystemanditsprocesses.Qualitymanagementsystemdocumentationmayrelatetoanorganization’stotalactivitiesortoaselectedpartofthoseactivities;forexample,specifiedrequirementsdependinguponthenatureofproducts,processes,contractualrequirements,governingregulationsortheorganizationitself.Itisimportantthattherequirementsandcontentofthequalitymanagementsystemdocumentationaddressthequalitystandardstheyintendtosatisfy.TheguidelinesgiveninthisTechnicalReportareintendedtoassistanorganizationwithdocumentingitsqualitymanagementsystem.Theyarenotintendedtobeusedasrequirementsforcontractual,regulatoryorcertification/registrationpurposes.Oneaspectofaqualitymanagementsystemisqualityplanning.Qualityplanningdocumentsmayincludemanagerialandoperationalplanning,preparingtheapplicationofthequalitymanagementsystemincludingorganizingandscheduling,andtheapproachbywhichqualityobjectivesaretobeachieved.LicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedLicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedTECHNICALREPORTISO/TR10013:2001(E)©ISO2001–Allrightsreserved1Guidelinesforqualitymanagementsystemdocumentation1ScopeThisTechnicalReportprovidesguidelinesforthedevelopmentandmaintenanceofthedocumentationnecessarytoensureaneffectivequalitymanagementsystem,tailoredtothespecificneedsoftheorganization.Theuseoftheseguidelineswillaidinestablishingadocumentedsystemasrequiredbytheapplicablequalitymanagementsystemstandard.ThisTechnicalReportmaybeusedtodocumentmanagementsystemsotherthanthatoftheISO9000family,forexampleenvironmentalmanagementsystemsandsafetymanagementsystems.NOTEWhenaprocedureisdocumented,theterm“writtenprocedure”or“documentedprocedure”isfrequentlyused.2NormativereferenceThefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisTechnicalReport.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisTechnicalReportareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferedtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.ISO9000:2000,Qualitymanagementsystems—Fundamentalsandvocabulary3TermsanddefinitionsForthepurposesofthisTechnicalReport,thetermsanddefinitionsgiveninISO9000andthefollowingapply.Anorganization'squalitymanagementsystemmayusedifferentterminologyforthedefinedtypesofdocumentation.3.1workinstructionsdetaileddescriptionsofhowtoperformandrecordtasksNOTE1Workinstructionsmaybedocumentedornot.NOTE2WorkInstructionsmaybe,forexample,detailedwrittendescriptions,flowcharts,templates,models,technicalnotesincorporatedintodrawings,specifications,equipmentinstructionmanuals,pictures,videos,checklists,orcombinationsthereof.Workinstructionsshoulddescribeanymaterials,equipmentanddocumentationtobeused.Whenrelevant,workinstructionsincludeacceptancecriteria.3.2formdocumentusedtorecorddatarequiredbythequalitymanagementsystemNOTEAformbecomesarecordwhendataareentered.LicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedISO/TR10013:2001(E)2©ISO2001–Allrightsreserved4Qualitymanagementsystemdocumentation4.1GeneralThearrangementofqualitymanagementsystemdocumentationtypicallyfollowseithertheprocessesoftheorganizationorthestructureoftheapplicablequalitystandard,oracombinationofboth.Anyotherarrangementthatsatisfiestheorganization’sneedsmayalsobeused.Thestructureofthedocumentationusedinthequalitymanagementsystemmaybedescribedasahierarchy.Thisstructurefacilitatesthedistribution,maintenanceandunderstandingofthedocumentation.AnnexAillustratesatypicalhierarchyofqualitymanagementsystemdocumentation.Thedevelopmentofahierarchydependsonthecircumstancesoftheorganization.Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherduetoa)thesizeoftheorganizationandtypeofactivities,b)thecomplexityofprocessesandtheirinteractions,andc)thecompetenceofpersonnel.Thequalitymanagementsystemdocumentationmayincludedefinitions.Thevocabularyusedshouldbeinaccordancewithstandarddefinitionsandterms,whicharereferencedinISO9000oringeneraldictionaryusage.Thequalitymanagementsystemdocumentationusuallyincludesthefollowing:a)qualitypolicyanditsobjectives;b)qualitymanual;c)documentedprocedures;d)workinstructions;e)forms;f)qualityplans;g)specifications;h)externaldocuments;i)records.Qualitymanagementsystemdocumentationmaybeinanytypeofmedia,suchashardcopyorelectronicmedia.NOTESomeadvantagesofusingelectronicmediaarethefollowing:a)appropriatepersonnelhaveaccesstothesameup-to-dateinformationatalltimes;b)accessandchangesareeasilymadeandcontrolled;c)distributionisimmediateandeasilycontrolledwiththeoptionofprintinghardcopies;d)thereisaccesstodocumentsfromremotelocations;e)withdrawalofobsoletedocumentsissimpleandeffective.LicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedISO/TR10013:2001(E)©ISO2001–Allrightsreserved34.2PurposesandbenefitsThepurposesandbenefitsofhavingqualitymanagementsystemdocumentationforanorganizationinclude,butarenotlimitedto,thefollowing:a)describingthequalitymanagementsystemoftheorganization;b)providinginformationforcross-functionalgroupssothattheymaybetterunderstandinterrelationships;c)communicatingtoemployeesmanagement’scommitmenttoquality;d)helpingemployeestounderstandtheirrolewithintheorganization,thusgivingthemanincreasedsenseofpurposeandimportanceoftheirwork;e)providingmutualunderstandingbetweenemployeesandmanagement;f)providingabasisforexpectationsofworkperformance;g)statinghowthingsaretobedoneinordertoachievespecifiedrequirements;h)providingobjectiveevidencethatspecifiedrequirementshavebeenachieved;i)providingaclear,efficientframeworkofoperation;j)providingabasisfortrainingnewemployeesandperiodicre-trainingofcurrentemployees;k)providingabasisfororderandbalancewithintheorganization;l)providingconsistencyinoperationsbasedondocumentedprocesses;m)providingabasisforcontinualimprovement;n)providingcustomerconfidencebasedondocumentedsystems;o)demonstratingtointerestedpartiesthecapabilitieswithintheorganization;p)providingaclearframeworkofrequirementsforsuppliers;q)providingabasisforauditingthequalitymanagementsystem;r)providingabasisforevaluatingtheeffectivenessandcontinuingsuitabilityofthequalitymanagementsystem.4.3QualitypolicyanditsobjectivesThequalitypolicyanditsobjectivesshouldbedocumentedandmaybeanindependentdocumentorbeincludedinthequalitymanual.4.4Qualitymanual4.4.1ContentsAqualitymanualisuniquetoeachorganization.ThisTechnicalReportallowsforflexibilityindefiningthestructure,format,content,ormethodofpresentationfordocumentingthequalitymanagementsystemforalltypesoforganizations.Asmallorganizationmayfinditappropriatetoincludethedescriptionofitsentirequalitymanagementsystemwithinasinglemanual,includingallthedocumentedproceduresrequiredbyISO9001.Large,multinationalLicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedISO/TR10013:2001(E)4©ISO2001–Allrightsreservedorganizationsmayneedseveralmanualsattheglobal,nationalorregionallevel,andamorecomplexhierarchyofdocumentation.Thequalitymanualshouldincludethescopeofthequalitymanagementsystem,thedetailsofandjustificationforanyexclusion,thedocumentedproceduresorreferencetothem,andadescriptionoftheprocessesofthequalitymanagementsystemandtheirinteractions.Informationabouttheorganization,suchasname,locationandmeansofcommunication,shouldbeincludedinthequalitymanual.Additionalinformationsuchasitslineofbusiness,abriefdescriptionofitsbackground,historyandsizemayalsobeincluded.Aqualitymanualshouldcontaintheelementsdescribedin4.4.2to4.4.9,butnotnecessarilyinthesameorder.4.4.2TitleandscopeThetitleand/orscopeofthequalitymanualshoulddefinetheorganizationtowhichthemanualapplies.Themanualshouldmakereferencetothespecificqualitymanagementsystemstandardonwhichthequalitymanagementsystemisbased.4.4.3TableofcontentsThetableofcontentsofthequalitymanualshouldlistthenumberandtitleofeachsectionanditslocation.4.4.4Review,approvalandrevisionEvidenceofthereview,approval,revisionstatusanddateofthequalitymanualshouldbeclearlyindicatedinthemanual.Wherepracticable,thenatureofthechangeshouldbeidentifiedinthedocumentortheappropriateattachments.4.4.5QualitypolicyandobjectivesWheretheorganizationelectstoincludethequalitypolicyinthequalitymanual,thequalitymanualmayincludeastatementofthequalitypolicyandtheobjectivesforquality.Theactualqualitygoalstomeettheseobjectivesmaybespecifiedinanotherpartofthequalitymanagementsystemdocumentationasdeterminedbytheorganization.Thequalitypolicyshouldincludeacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem.Objectivesaretypicallyderivedfromtheorganization’squalitypolicyandaretobeachieved.Whentheobjectivesarequantifiedtheybecomegoalsandaremeasurable.4.4.6Organization,responsibilityandauthorityThequalitymanualshouldprovideadescriptionofthestructureoftheorganization.Responsibility,authorityandinterrelationmaybeindicatedbysuchmeansasorganizationcharts,flowchartsand/orjobdescriptions.Thesemaybeincludedorreferencedinthequalitymanual.4.4.7ReferencesThequalitymanualshouldcontainalistofdocumentsreferredtobutnotincludedinthemanual.4.4.8QualitymanagementsystemdescriptionThequalitymanualshouldprovideadescriptionofthequalitymanagementsystemanditsimplementationintheorganization.Descriptionsoftheprocessesandtheirinteractionsshouldbeincludedinthequalitymanual.Documentedproceduresorreferencestothemshouldbeincludedinthequalitymanual.LicensedtoPROXSEELLC/CAHYONONUGROHOISOStoreorder#:849562/Downloaded:2007-09-22Singleuserlicenceonly,copyingandnetworkingprohibitedISO/TR10013:2001(E)©ISO2001–Allrightsreserved5Theorganizationshoulddocumentitsspecificqualitymanagementsystemfollowingthesequenceoftheprocessfloworthestructureoftheselectedstandardoranysequencingappropriatetotheorganization.Cross-referencingbetweentheselectedstandardandthequalitymanualmaybeuseful.Thequalitymanualshouldreflectthemethodsusedbytheorganizationtosatisfyitspolicyandobjectives.4.4.9AppendicesAppendic
本文档为【ISO_TR-10013】,请使用软件OFFICE或WPS软件打开。作品中的文字与图均可以修改和编辑, 图片更改请在作品中右键图片并更换,文字修改请直接点击文字进行修改,也可以新增和删除文档中的内容。
该文档来自用户分享,如有侵权行为请发邮件ishare@vip.sina.com联系网站客服,我们会及时删除。
[版权声明] 本站所有资料为用户分享产生,若发现您的权利被侵害,请联系客服邮件isharekefu@iask.cn,我们尽快处理。
本作品所展示的图片、画像、字体、音乐的版权可能需版权方额外授权,请谨慎使用。
网站提供的党政主题相关内容(国旗、国徽、党徽..)目的在于配合国家政策宣传,仅限个人学习分享使用,禁止用于任何广告和商用目的。
下载需要: 免费 已有0 人下载
最新资料
资料动态
专题动态
is_342245
暂无简介~
格式:pdf
大小:131KB
软件:PDF阅读器
页数:22
分类:企业经营
上传时间:2017-07-18
浏览量:153