ISO9001-2015-中英文對照版

PAGEPAGE10SecretariatofISO/TC176/SC2 Date: 3 2013TotheMembersofISO/TC176/SC2-QualityManagementandQualityAssurance/QualitySystemsISO/CD9001目錄Scope范圍Normativereferences規范性引用文件Termsanddefinitions術語和定義Contextoftheorganization組織的背景Understandingtheorganizationanditscontext理解組織及其背景Understandingtheneedsandexpectationsofinterestedparties理解相關方的需求和期望Determiningthescopeofthequalitymanagementsystem質量管理體系范圍的確定Qualitymanagementsystem質量管理體系Leadership領導作用Leadershipandcommitment領導作用和承諾Qualitypolicy質量方針Organizationalrolesresponsibilitiesandauthorities組織的作用、職責和權限Planning策劃Actionstoaddressrisksandopportunities風險和機遇的應對措施Qualityobjectivesandplanningtoachievethem質量目標及其實施的策劃Planningofchanges變更的策劃Support支持Resources資源Competence能力Awareness意識Communication溝通Documentedinformation形成文件的信息Operation運行Operationalplanningandcontrol運行的策劃和控制Determinationofmarketneedsandinteractionswithcustomers市場需求的確定和顧客溝通Operationalplanningprocess運行策劃過程Controlofexternalprovisionofgoodsandservices外部供應產品和服務的控制Developmentofgoodsandservices產品和服務開發Productionofgoodsandprovisionofservices產品生產和服務提供Releaseofgoodsandservices產品和服務放行Nonconforminggoodsandservices不合格產品和服務Performanceevaluation績效評價Monitoringmeasurementanalysisandevaluation監視、測量、分析和評價InternalAudit內部審核Managementreview管理評審Continualimprovement持續改進Nonconformityandcorrectiveaction不符合和糾正措施Improvement改進附錄AAnnexAQualitymanagementprinciples(Informative)質量管理原則文獻Scope范圍ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization本標準為有下列需求的組織規定了質量管理體系要求：a）needstodemonstrateitsabilitytoconsistentlyprovidegoodsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,and需要證實其具有穩定地提供滿足顧客要求和適用法律法規要求的產品和服務的能力；b）aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicablestatutoryandregulatoryrequirements系持續改進的過程，以及保證符合顧客和適用的法律法規要求，旨在增強顧客滿意。to在本標準一中，術語“產品”僅適用于：goodsandservicesintendedfororrequiredbyacustomerand預期提供給顧客或顧客所要求的商品和服務；anyintendedoutputresultingfromtheoperationalprocesses運行過程所產生的任何預期輸出。求可稱作為法定要求。Normativereferences規范性引用文件Thefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocumentincludinganyamendmentsapplies下列文件中的條款通過本標準的引用文件，其最新版本（包括任何修訂）適用于本標準。ISO9000:2015QualitymanagementsystemsFundamentalsandvocabularyGB/T19000-2015Termanddefinitions術語和定義Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000apply本標準GB/T19000中所確立的術語和定義。Contextoftheorganization組織的背景環境Understandingtheorganizationanditscontext理解組織及其背景環境Theorganizationshalldetermineexternalandinternalissuesthatarerelevanttoitspurposeanditsstrategicdirectionandthataffectitsabilitytoachievetheintendedoutcome(s)ofits質量管理體系實現預期結果的能力的事務。Theorganizationshallupdatesuchdeterminationswhenneeded需要時，組織應更新這些信息。Whendeterminingrelevantexternalandinternalissues,theorganizationshallconsiderthosearisingfrom:在確定這些相關的內部和外部事宜時，組織應考慮以下方面：changes ontheobjectivesoftheorganization可能對組織的目標造成影響的變更和趨勢；relationshipswithandperceptionsandvaluesofrelevantinterestedparties與相關方的關系，以及相關方的理念、價值觀；governanceissuesstrategicprioritiesinternalpoliciesandcommitmentsand優先、內部政策和承諾；resourceavailabilityandprioritiesandtechnologicalchange資源的獲得和優先供給、技術變更。arisingfromlegal,technological,competitive,cultural,social,economicandnaturalenvironment,whetherinternational,national,regionalorlocal.外部的環境，可以考慮法律、技術、競爭、文化、社會、經濟和自然環境方面，不管是國際、國家、地區或本地。considerthoserelatedtoperceptionsvaluesandcultureoftheorganization.Understandingtheneedsandexpectationsofinterestedparties理解相關方的需求和期望Theorganizationshalldetermine組織應確定：theinterestedpartiesthatarerelevanttothequalitymanagementsystem,and與質量管理體系有關的相關方therequirementsoftheseinterestedparties相關方的要求Theorganizationshallupdatesuchdeterminationsinordertounderstandandanticipateneedsorexpectationsaffectingcustomerrequirementsandcustomersatisfaction組織應更新以上確定的結果，以便于理解和滿足影響顧客要求和顧客滿意度的需求和期望。Theorganizationshallconsiderthefollowingrelevantinterestedparties組織應考慮以下相關方：directcustomers直接顧客endusers最終使用者suppliers,distributors,retailersorothersinvolvedinthesupplychain供應鏈中的供方、分銷商、零售商及其他regulatorsand立法機構anyotherrelevantinterestedparties其他注：NoteAddressingcurrentandanticipatedfutureneedscanleadtotheidentificationofimprovementandinnovationopportunities應對當前的和預期的未來需求可導致改進和變革機會的識別。Determiningthescopeofthequalitymanagementsystem確定質量管理體系的范圍Theorganizationshalldeterminetheboundariesandapplicabilityofthequalitymanagementsystemtoestablishitsscope組織應界定質量管理體系的邊界和應用，以確定其范圍。Whendeterminingthisscope,theorganizationshallconsider應考慮：4.1,and4.1條款中提到的內部和外部事宜4.2條款的要求Thescopeshallbestatedintermsofgoodsandservicesthemainprocessestodeliverthemand質量管理體系的范圍應描述為組織所包含的產品、服務、主要過程和地點。Whenstatingthescope,theorganizationshalldocumentandjustifyanydecisionnottoapplyarequirementofthisInternationalStandardandtoexcludeitfromthescopeofthequalitymanagementsystem.Anysuchexclusionshallbelimitedtoclause7.1.4and8andshallnotaffecttheorganization’sabilityorresponsibilitytoassureconformityofgoodsandservicesandcustomersatisfaction,norcananexclusionbejustifiedonthebasisofadecisiontoarrangeforanexternalprovidertoperformafunctionorprocessoftheorganization.描述質量管理體系的過程外包不是正當的刪減理由。注：Anexternalprovidercanbeasupplierorasisterorganization(suchasaheadquartersoralternatesitelocation)thatisoutsideoftheorganization’squalitymanagementsystem.外部供應商可以是組織質量管理體系之外的供方或兄弟組織。Thescopeshallbeavailableasdocumentedinformation質量管理管理體系范圍應形成文件。Qualitymanagementsystem質量管理體系General總則Theorganizationshallestablish,implement,maintainandcontinuallyimproveaqualitymanagementsystem,includingtheprocessesneededandtheirinteractions,inaccordancewiththerequirementsofthisInternationalStandard.組織應按本標準的要求建立質量管理體系、過程及其相互作用，加以實施和保持，并持續改進。Processapproach過程方法Theorganizationshallapplyaprocessapproachtoitsqualitymanagementsystem.Theorganizationshall:組織應將過程方法應用于質量管理體系。組織應：determinetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization;確定質量管理體系所需的過程及其在整個組織中的應用;determinetheinputsrequiredandtheoutputsexpectedfromeachprocess;確定每個過程所需的輸入和期望的輸出；determinethesequenceandinteractionoftheseprocesses;確定這些過程的順序和相互作用；determinetheriskstoconformityofgoodsandservicesandcustomersatisfactionifunintendedoutputsaredeliveredorprocessinteractionisineffective;確定產生非預期的輸出或過程失效對產品、服務和顧客滿意帶來的風險；determinecriteria,methods,measurements,andrelatedperformanceindicatorsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective確定所需的準則、方法、測量及相關的績效指標，以確保這些過程的有效運行和控制；determinetheresourcesandensuretheiravailability確定和提供資源；assignresponsibilitiesandauthoritiesforprocesses規定職責和權限；implementactionsnecessarytoachieveplannedresults實施所需的措施以實現策劃的結果；monitor,analyseandchange,ifneeded,theseprocessesensuringthattheycontinuetodeliver果；ensurecontinualimprovementoftheseprocesses.確保持續改進這些過程。Leadership領導作用Leadershipandcommitment領導作用與承諾Leadershipandcommitmentwithrespecttothequalitymanagementsystem針對質量管理體系的領導作用與承諾Topmanagementshalldemonstrateleadershipandcommitmentwithrespecttothequalitymanagementsystemby最高管理者應通過以下方面證實其對質量管理體系的領導作用與承諾：ensuringthatqualitypoliciesandqualityobjectivesareestablishedforthequalitymanagementsystemandarecompatiblewiththestrategicdirectionoftheorganization;確保質量方針和質量目標得到建立，并與組織的戰略方向保持一致；ensuringthequalitypolicyisunderstoodandfollowedwithintheorganization;確保質量方針在組織內得到理解和實施；ensuringtheintegrationofthequalitymanagementsystemrequirementsintotheorganization’sbusinessprocesses;確保質量管理體系要求納入組織的業務運作；promotingawarenessoftheprocessapproach;提高過程方法的意識；ensuringthattheresourcesneededforthequalitymanagementsystemareavailable;確保質量管理體系所需資源的獲得；communicatingtheimportanceofeffectivequalitymanagementandofconformingtothequalitymanagementsystemrequirementsandtherequirementsofgoodsandservices;傳達有效的質量管理以及滿足質量管理體系、產品和服務要求的重要性；ensuringthatthequalitymanagementsystemachievesitsintendedoutcomesoutputs;確保質量管理體系實現預期的輸出；engaging,directingandsupportingpersonstocontributetotheeffectivenessofthequalitymanagementsystem吸納、指導和支持員工參與對質量管理體系的有效性作出貢獻；promotingcontinualimprovementand innovationand增強持續改進和創新；supportingotherrelevantmanagementrolestodemonstratetheirleadershipasitappliestotheirareasofresponsibility.支持其他的管理者在其負責的領域證實其領導作用。Leadershipandcommitmentwithrespecttotheneedsandexpectationsofcustomers針對顧客需求和期望的領導作用與承諾Topmanagementshalldemonstrateleadershipandcommitmentwithrespecttocustomerfocusbyensuringthat諾：theriskswhichcanaffectconformityofgoodsandservicesandcustomersatisfactionareidentifiedandaddressed;可能影響產品和服務符合性、顧客滿意的風險得到識別和應對；customerrequirementsaredeterminedandmet;顧客要求得到確定和滿足；thefocusonconsistentlyprovidinggoodsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirementsismaintained;保持以穩定提供滿足顧客和相關法規要求的產品和服務為焦點；thefocusonenhancingcustomersatisfactionismaintained;保持以增強顧客滿意為焦點；注：Referenceto“business”inthisInternationalStandardshouldbeinterpretedbroadlytomeanthoseactivitiesthatarecoretothepurposesoftheorganization’sexistence.本標準中的“業務”可以廣泛地理解為對組織存在的目的很重要的活動。Qualitypolicy質量方針Topmanagementshallestablishaqualitypolicythat:最高管理者應制定質量方針，方針應：isappropriatetothepurposeoftheorganization;與組織的宗旨相適應；providesaframeworkforsettingqualityobjectives;提供制定質量目標的框架；includesacommitmenttosatisfyapplicablerequirementsand包括對滿足適用要求的承諾；includesacommitmenttocontinualimprovementofthequalitymanagementsystem.包括對持續改進質量管理體系的承諾。Thequalitypolicyshall:質量方針應：beavailableasdocumentedinformation;形成文件；becommunicatedwithintheorganization;在組織內得到溝通；beavailabletointerestedpartiesasappropriateand適用時，可為相關方所獲取；bereviewedforcontinuingsuitability.在持續適宜性方面得到評審。QulityngeetPncilscnesdstebisorteqltypoic.方針的基礎。Organizationalrolesresponsibilitiesandauthorities組織的作用、職責和權限Topmanagementshallensurethattheresponsibilitiesandauthoritiesforrelevantrolesareassignedandcommunicatedwithintheorganization.最高管理者應確保組織內相關的職責、權限得到規定和溝通。Topmanagementshallbeaccountablefortheeffectivenessofthequalitymanagementsystemandshallassigntheresponsibilityandauthorityfor:最高管理者應對質量管理體系的有效性負責，并規定職責和權限以便：ensuringthatthequalitymanagementsystemconformstotherequirementsofthisInternationalStandardand,確保質量管理體系符合本標準的要求；ensuringthattheprocessesinteractandaredeliveringtheirintendedoutputs;確保過程相互作用并產生期望的結果；reportingontheperformanceofthequalitymanagementsystemtotopmanagementandanyneedforimprovementand向最高管理者報告質量管理體系的績效和任何改進的需求；ensuringthepromotionofawarenessofcustomerrequirementsthroughouttheorganization.確保在整個組織內提高滿足顧客要求的意識。Planning策劃Actionstoaddressrisksandopportunities風險和機遇的應對措施Whenplanningforthequalitymanagementsystem,theorganizationshallconsidertheissuesreferredtoin4.1andtherequirementsreferredtoin4.2anddeterminetherisksandto4.14.2的要求，確定需應對的風險和機遇，以便：assurethequalitymanagementsystemcanachieveitsintendedoutcome(s);確保質量管理體系實現期望的結果；assurethattheorganizationcanconsistentlyachieveconformityofgoodsandservicesandcustomersatisfaction;確保組織能穩定地實現產品、服務符合要求和顧客滿意；preventorreduce,undesiredeffectsand預防或減少非預期的影響；achievecontinualimprovement.實現持續改進。Theorganizationshallplan:組織應策劃：actionstoaddresstheserisksandopportunitiesand風險和機遇的應對措施；howto如何integrateandimplementtheactionsintoitsqualitymanagementsystemprocessessee4.4),在質量管理體系過程中納入和應用這些措施（4.4）evaluatetheeffectivenessoftheseactions.評價這些措施的有效性Anyactionstakentoaddressrisksandopportunitiesshallbeproportionatetothepotentialeffectsonconformityofgoodsandservicesandcustomersatisfaction.采取的任何風險和機遇的應對措施都應與其對產品、服務的符合性和顧客滿意的潛在影響相適應。ptinsodssiscnncldeorpleiskodne,isktitinorskcetce可選的風險應對措施包括風險規避、風險降低、風險接受等。Qualityobjectivesandplanningtoachievethem質量目標及其實施的策劃Theorganizationshallestablishqualityobjectivesatrelevantfunctions,levelsandprocesses.Thequalityobjectivesshall:組織應在相關職能、層次、過程上建立質量目標。質量目標應：beconsistentwiththequalitypolicy;與質量方針保持一致berelevanttoconformityofgoodsandservicesandcustomersatisfaction;與產品、服務的bemeasurable(ifpracticable);可測量（可行時）takeintoaccountapplicablerequirements,考慮適用的要求bemonitored,得到監測becommunicatedand得到溝通beupdatedasappropriate.適當時進行更新Theorganizationshallretaindocumentedinformationonthequalityobjectives.組織應將質量目標形成文件。Whenplanninghowtoachieveitsqualityobjectives,theorganizationshalldetermine:在策劃目標的實現時，組織應確定：whatwillbedone;做什么；hatousilbequde見whowillberesponsible;責任人；whenitwillbecompleted,and完成的時間表；howtheresultswillbeevaluated.結果如何評價。Planningofchanges變更的策劃Theorganizationshalldeterminetheneedsandopportunitiesforchangetomaintainandimprovetheperformanceofthequalitymanagementsystem.保持和改進質量管理體系績效。Theorganizationshallundertakechangeinaplannedandsystematicmanner,identifyingrisksandopportunitiesandreviewingthepotentialconsequencesofchange.行變更，識別風險和機遇，并評價變更的潛在后果。peiiceuietsoncntolofchgseincuddincluse.8條規定。Support支持Resources資源General總則Theorganizationshalldetermineandprovidetheresourcesneededfortheestablishment,implementation,maintenanceandcontinualimprovementofthequalitymanagementsystem.組織應確定、提供為建立、實施、保持和改進質量管理體系所需的資源。Theorganizationshallconsider組織應考慮：whatareexistinginternalresourcescapabilitiesandlimitationsand現有的資源、能力、局限whichgoodsandservicesaretobesourcedexternally.外包的產品和服務Infrastructure基礎設施Theorganizationshalldetermine,provideandmaintaintheinfrastructurenecessaryforitsoperationsandtoassureconformityofgoodsandservicesandcustomersatisfaction.組織應確定、提供和維護其運行和確保產品、服務符合性和顧客滿意所需的基礎設施。注：Note Infrastructurecaninclude:基礎設施可包括：buildingsandassociatedutilities;建筑物和相關的設施equipmentincludinghardwareandsoftware,and設備（包括硬件和軟件）transportationcommunicationandinformationsystems.運輸、通訊和信息系統Processenvironment過程環境Theorganizationshalldetermine,provideandmaintaintheprocessenvironmentnecessaryforitsoperationsandtoassureconformityofgoodsandservicesandcustomersatisfaction.組織應確定、提供和維護其運行和確保產品、服務符合性和顧客滿意所需的過程環境。注：Processenvironmentcanincludephysical,social,psychologicalandenvironmentalfactors(suchastemperature,recognitionschemesergonomicsandatmosphericcomposition).過程環境可包括物理的、社會的、心理的和環境的因素（例如：溫度、承認方式、人因工效、大氣成分Monitoringandmeasuringdevices監視和測量設備Theorganizationshalldetermine,provideandmaintainthemonitoringandmeasuringdevicesneededtoverifyconformitytoproductrequirementsandshallensurethatthedevicesarefit監視和測量設備滿足使用要求。Theorganizationshallretainappropriatedocumentedinformationasevidenceoffitnessforpurposeofmonitoringandmeasuringdevices.量設備滿足使用要求的證據。assurveys.監視和測量設備可包括測量設備和評價方法（例如：調查問卷orboth,atspecifiedintervals,orpriortouse,againstmeasurementstandardstraceabletointernationalornationalmeasurementstandards.對備進行校準和（或）檢定。Knowledge知識Theorganizationshalldeterminetheknowledgenecessaryfortheoperationofthequalitymanagementsystemanditsprocessesandtoassureconformityofgoodsandservicesandcustomersatisfaction.Thisknowledgeshallbemaintained,protectedandmadeavailableasnecessary.組織應確定質量管理體系運行、過程、確保產品和服務符合性及顧客滿意所需的知識。這些知識應得到保持、保護、需要時便于獲取。Whereaddressingchangingneedsandtrendstheorganizationshalltakeintoaccountitscurrentknowledgebaseanddeterminehowtoacquireoraccessthenecessaryadditionalknowledge.(Seealso6.3)在應對變化的需求和趨勢時，組織應考慮現有的知識基礎，確定（6.3）Competence能力Theorganizationshall:組織應：determinethenecessarycompetenceofperson(s)doingworkunderitscontrolthataffectsitsqualityperformance,and確定在組織控制下從事影響質量績效工作的人員所必要的能力；ensurethatthesepersonsarecompetentonthebasisofappropriateeducation,training,orexperience;基于適當的教育、培訓和經驗，確保這些人員是勝任的；whereapplicable,takeactionstoacquirethenecessarycompetence,andevaluatetheoftheactionstakenand適用時，采取措施以獲取必要的能力，并評價這些措施的有效性；retainappropriatedocumentedinformationasevidenceofcompetence保持形成文件的信息，以提供能力的證據。注：Applicableactionsmayinclude,forexample:theprovisionoftrainingto,thementoringof,orthere-assignmentofcurrentlyemployedpersonsorthehiringorcontractingofcompetentpersons.適當的措施可包括，例如提供培訓、輔導、重新分配任務、招聘勝任的人員等。Awareness意識Personsdoingworkundertheorganization’scontrolshallbeawareof在組織控制下工作的人員應意識到：thequalitypolicy;質量方針relevantqualityobjectives相關的質量目標theircontributiontotheeffectivenessofthequalitymanagementsystem,includingthebenefitsofimprovedqualityperformance,and質量績效的益處theimplicationsofnotconformingwiththequalitymanagementsystemrequirements.偏離質量管理體系要求的后果Communication溝通Theorganizationshalldeterminetheneedforinternalandexternalcommunicationsrelevanttothequalitymanagementsystemincluding:組織應確定與質量管理體系相關的內部和外部溝通的需求，包括：onwhatitwillcommunicate;溝通的內容whentocommunicate,and溝通的時機withwhomtocommunicate.溝通的對象Documentedinformation形成文件的信息General總則Theorganization’squalitymanagementsystemshallinclude組織的質量管理體系應包括：requiredbythisInternationalStandard;本標準所要求的文件信息documentedinformationdeterminedbytheorganizationasbeingnecessaryfortheeffectivenessofthequalitymanagementsystem;組織確定的為確保質量管理體系有效運行所需的形成文件的信息注：Theextentofdocumentedinformationforaqualitymanagementsystemcandifferfromoneorganizationtoanotherdueto不同組織的質量管理體系文件的多少與詳略程度可以不同，取決于：thesizeoforganizationanditstypeofactivitiesprocessesproductsgoodsandservices;組織的規模、活動類型、過程、產品和服務；thecomplexityofprocessesandtheirinteractionsand過程及其相互作用的復雜程度；thecompetenceofpersons人員的能力。Creatingandupdating編制和更新Whencreatingandupdatingdocumentedinformationtheorganizationshallensureappropriate在編制和更新文件時，組織應確保適當的：a）identificationanddescription(e.g.atitle,date,author,orreferencenumber);標識和說明（例如：標題、日期、作者、索引編號等）format(e.g.language,softwareversion,graphics)andmedia(e.g.paper,electronic);格式（例如：語言、軟件版本、圖示）和媒介（例如：紙質、電子格式）reviewandapprovalforsuitabilityandadequacy.評審和批準以確保適宜性和充分性ControlofdocumentedInformation文件控制DocumentedinformationrequiredbythequalitymanagementsystemandbythisInternationalStandardshallbecontrolledtoensure:質量管理體系和本標準所要求的形成文件的信息應進行控制，以確保：itisavailableandsuitableforuse,whereandwhenitisneeded,and需要文件的場所能獲得適用的文件itisadequatelyprotected(e.g.fromlossofconfidentiality,improperuse,orlossofintegrity).文件得到充分保護，如防止泄密、誤用、缺損。Forthecontrolofdocumentedinformation,theorganizationshalladdressthefollowingactivitiesasapplicable適用時，組織應以下文件控制活動：distributionaccessretrievalanduse,分發、訪問、回收、使用；storageandpreservationincludingpreservationoflegibility;存放、保護，包括保持清晰；controlofchangese.gversioncontrol),and更改的控制（如：版本控制retentionanddisposition.保留和處置。Documentedinformationofexternalorigindeterminedbytheorganizationtobenecessaryfortheplanningandoperationofthequalitymanagementsystemshallbeidentifiedasappropriate,andcontrolled組織所確定的策劃和運行質量管理體系所需的外來文件應確保得到識別和控制。注：Accessimpliesadecisionregardingthepermissiontoviewthedocumentedinformationonly,orthepermissionandauthoritytoviewandchangethedocumentedinformationetc.“訪問”指僅得到查閱文件的許可，或授權查閱和修改文件。Operation運行Operationalplanningandcontrol運行策劃和控制Theorganizationshallplan,implementandcontroltheprocessesneededtomeetrequirementsandtoimplementtheactionsdeterminedin6.1by6.1條確定的措施所需的過程，包括：establishingcriteriafortheprocesses建立過程準則；implementingcontroloftheprocessesinaccordancewiththecriteria,and按準則要求實施過程控制；keepingdocumentedinformationtotheextentnecessarytohaveconfidencethattheprocesseshavebeencarriedoutasplanned.保持充分的文件信息，以確信過程按策劃的要求實施。Theorganizationshallcontrolplannedchangesandreviewtheconsequencesofunintendedchangestakingactiontomitigateanyadverseeffectsasnecessary.組織應控制計劃的變更，評價非預期的變更的后果，必要時采取措施減輕任何不良影響。Theorganizationshallensurethatoutsourcedprocessesaretheoperationofafunctionorprocessoftheorganizationbyanexternalprovideriscontrolled(see8.4).組織應確保由外部供（見注：Operationofafunctionorprocessoftheorganizationbyanexternalproviderisoftenreferredtoasoutsourcing..組織的某項職能或過程由外部供方實施通常稱作為外包。Determinationofmarketneedsandinteractionswithcustomers市場需求的確定和顧客溝通General總則Theorganizationshallimplementaprocessforinteractingwithcustomerstodeterminetheirrequirementsrelatingtogoodsandservices.產品和服務的要求。“existingorpotentialcustomer“顧客”指當前的或潛在的顧客；requirementsforgoodsandservices(see4.2).組織可與其他相關方溝通以確定對產品和服務的附加要求（見Determinationofrequirementsrelatedtothegoodsandservices與產品和服務有關要求的確定Theorganizationshalldetermineasapplicable適用時，組織應確定：a)requirementsspecifiedbythecustomerincludingtherequirementsfordeliveryandpost-deliveryactivities;顧客規定的要求，包括對交付及交付后活動的要求；b）requirementsnotstatedbythecustomerbutnecessaryforspecifiedorintendeduse,whereknown,顧客雖然沒有明示，但規定的用途或已知的預期用途所必需的要求；c）statutoryandregulatoryrequirementsapplicabletothegoodsandservices,and適用于產品和服務的法律法規要求；d）anyadditionalrequirementsconsiderednecessarybytheorganization組織認為必要的任何附加要求。注：Additionalrequirementscanincludethosearisingfromrelevantinterestedparties附加要求可包含由有關的相關方提出的要求。Reviewofrequirementsrelatedtothegoodsandservices與產品和服務有關的要求評審Theorganizationshallreviewtherequirementsrelatedtothegoodsandservices.Thisreviewshallbeconductedpriortotheorganization'scommitmenttosupplygoodsandservicestothecustomer(e.g.submissionoftenders,acceptanceofcontractsororders,acceptanceofchangestocontractsorordersandshallensurethat（書、接受合同或訂單及接受合同或訂單的更改）之前進行，并應確保：a）goodsandservicesrequirementsaredefinedandagreed,產品和服務要求已得到規定并達成一致；b）contractororderrequirementsdifferingfromthosepreviouslyexpressedareresolvedand與以前表述不一致的合同或訂單的要求已予解決；c）theorganizationisabletomeetthedefinedrequirements組織有能力滿足規定的要求。Documentedinformationdescribingtheresultsofthereviewshallbemaintained.評審結果的信息應形成文件。Wherethecustomerdoesnotprovidedocumentedstatementoftheirrequirements,thecustomerrequirementsshallbeconfirmedbytheorganizationbeforeacceptance.若顧客沒有提供形成文件的要求，組織在接受顧客要求前應對顧客要求進行確認。Whererequirementsforgoodsandservicesarechanged,theorganizationshallensurethatrelevantdocumentedinformationisamendedandthatrelevantpersonnelaremadeawareofthechangedrequirements若產品和服務要求發生變更，組織應確保相關文件信息得到修改，并確保相關人員知道已變更的要求。注：Insomesituationsaformalreviewisimpracticalforeachorder.Insteadthereviewcancoverotherrelevantinformationavailabletothecustomer.在某些情況下，對每一個訂單進行正式的評審可能是不實際的，作為替代方法，可對提供給顧客的有關的產品信息進行評審。Customercommunication顧客溝通Theorganizationshalldetermineandimplementplannedarrangementsforcommunicatingwithcustomersinrelationto:組織應對以下有關方面確定并實施與顧客溝通的安排：agoodsandservicesinformation;產品和服務信息；問詢、合同或訂單的處理，包括對其修改；c）customerfeedback,includingcustomercomplaints(see9.1);顧客反饋，包括顧客抱怨（見9.1）;d）thehandlingofcustomerpropertyifapplicable,and適用時，對顧客財產的處理；ethespecificrequirementsforcontingencyactionswhererelevant.求。Operationalplanningprocess運行策劃過程Inpreparingfortherealizationofgoodsandservices,theorganizationshallimplementaprocesstodeterminethefollowing,asappropriate為產品和服務實現作準備，組織應實施過程以確定以下內容，適用時包括：a）requirementsforthegoodsandservicestakingintoconsiderationrelevantqualityobjectives;產品和服務的要求，并考慮相關的質量目標；b）actionstoidentifyandaddressrisksrelatedtoachievingconformityofgoodsandservicestorequirements;識別和應對與實現產品和服務滿足要求所涉及的風險相關的措施；c）theresourcesthatwillberequiredarisingfromtherequirementsforthegoodsandservices針對產品和服務確定資源的需求；d）thecriteriafortheacceptanceofgoodsandservices產品和服務的接收準則e）requiredverification,validation,monitoring,measurement,inspectionandtestactivitiesspecifictothegoodsandservices產品和服務所要求的驗證、確認、監視、檢驗和試驗活動；f）howtheperformancedatawillbeestablishedandcommunicated;and績效數據的形成和溝通；g）requirementsfortraceability,preservation,goodsandservicesdeliveryandpostdeliveryactivities可追溯性、產品防護、產品和服務交付及交付后活動的要求。Theoutputofthisplanningprocessshallbeinaformsuitablefortheorganization'soperations.策劃的輸出形式應便于組織的運作。managementsystem(includingtherealizationofgoodsandservicesprocesses)andtheresourcestobeappliedtoaspecificgoodandservice,projectorcontractcanbereferredtoasaqualityplan.對應用于特定產品、項目或合同的質量管理體系的過程（包括產品和服務實現過程）和資源作出規定的文件可稱之為質量計劃。8.5tothedevelopmentofprocessesfortheandservices.8.5的要求應用于產品和服務實現過程的開發。Controlofexternalprovisionofgoodsandservices供應的產品和服務的控制General總則Theorganizationshallensurethatexternallyprovidedgoodsandservicesconformtospecifiedrequirements組織應確保外部提供的產品和服務滿足規定的要求。注：Wheretheorganizationhasarrangedforanexternalprovidertoperformafunctionorprocessoftheorganizationitisassumedthiswillresultintheprovisionofgoods,servicesorbothgoodsandservices.當組織安排由外部供方實施其職能和過程時，這就意味由外部提供產品和（或）服務。Typeandextentofcontrolofexternalprovision外部供應的控制類型和程度Thetypeandextentofcontrolappliedtotheexternalprovidersandtheexternally-providedprocessesgoodsandservicesshallbedependentupon對外部供方及其供應的過程、產品和服務的控制類型和程度取決于：therisksidentifiedandthepotentialimpacts,識別的風險及其潛在影響thedegreetowhichthecontrolofanexternallyprovidedprocessissharedbetweentheorganizationandtheproviderand組織與外部供方對外部供應過程控制的分擔程度thecapabilityofpotential controls潛在的控制能力Theorganizationshallestablishandapplycriteriafortheevaluation,selection,andre-evaluationofexternalprovidersbasedontheirabilitytoprovide,goodsandservicesinaccordancewiththe組織應根據外部供方按組織的要求提供產品的能力，建立和實施對外部供方的評價、選擇和重新評價的準則。Documentedinformationdescribingtheresultsofevaluationsshallbemaintained.評價結果的信息應形成文件。Documentedinformationforexternalproviders提供外部供方的文件信息Documentedinformationshallbeprovidedtotheexternalproviderdescribing,whereappropriate:適用時，提供給外部供方的形成文件信息應闡述：thegoodsandservicestobeprovidedortheprocesstobeperformed,供應的產品和服務，以及實施的過程；therequirementsforapprovalorreleaseofgoodsandservices,procedures,processesorequipment,產品、服務、程序、過程和設備的放行或批準要求；therequirementsforcompetenceofpersonnel,includingnecessaryqualification,人員能力的要求，包含必要的資格；thequalitymanagementsystemrequirements,質量管理體系的要求；thecontrolandmonitoringoftheexternalprovider’sperformancetobeappliedbytheorganization;組織對外部供方業績的控制和監視；anyverificationactivitiesthattheorganization,oritscustomer,intendstoperformattheexternalprovider’spremisesand組織或其顧客擬在供方現場實施的驗證活動；therequirementsforhandlingofexternalprovider’spropertyprovidedtotheorganization將產品從外部供方到組織現場的搬運要求；Theorganizationshallensuretheadequacyofspecifiedrequirementspriortotheircommunicationtotheexternalprovider在與外部供方溝通前，組織應確保所規定的要求是充分與適宜的。Theorganizationshallmonitortheperformanceo