AssessmentsheetforIRIScertification?auditsbasedonISO22163:2023IRIS審核檢查表Rev.04評分表（ISO22163:2023）,,,,,,,,,,

AssessmentsheetIRISrev.04,,,,,,,,,,

No.(標(biāo)準(zhǔn)條款號):,Defined(定義)/2分,Finding/Evidences（審核發(fā)現(xiàn)/證據(jù)）,Qualified(合格)/3分,Finding/Evidences（審核發(fā)現(xiàn)/證據(jù)）,Optimized(優(yōu)化)/)/4分,Finding/Evidences（審核發(fā)現(xiàn)/證據(jù)）,Example(示例):,滿分,Score(得分):,NCR/IAR

1,DataReview數(shù)據(jù)評審,,,,,,,,,

1.1,General總則,,,,,,,,,

1.1.1,,,,,,,,,,

1.1.2,,,,,,,,,,

1.1.3,,,,,,,,,,

1.1.4,,,,,,,,,,

1.1.5,,,,,,,,,,

1.1.6,,,,,,,,,,

1.1.7,,,,,,,,,,

1.2,"Reviewofthekeyprocessesforperformanceevaluationincludingthe

relatedPIs關(guān)鍵過程的績效評價包括相關(guān)PIs",,,,,,,,,

1.2.1,,,,,,,,,,

1.2.2,,,,,,,,,,

1.2.3,,,,,,,,,,

1.2.4,,,,,,,,,,

1.2.5,,,,,,,,,,

2,ReadinessReview準(zhǔn)備評審,,,,,,,,,

2.1,General總則,,,,,,,,,

2.1.1,,,,,,,,,,

2.1.2,,,,,,,,,,

2.1.3,,,,,,,,,,

2.2,Crossreferencecheckagainstallmandatoryprocesses所有強(qiáng)制性過程的交叉檢查,,,,,,,,,

2.2.1,,,,,,,,,,

2.2.2,,,,,,,,,,

2.2.3,,,,,,,,,,

2.2.4,,,,,,,,,,

2.2.5,,,,,,,,,,

2.2.6,,,,,,,,,,

2.2.7,,,,,,,,,,

2.2.8,,,,,,,,,,

2.2.9,,,,,,,,,,

2.2.10,,,,,,,,,,

2.2.11,,,,,,,,,,

2.2.12,,,,,,,,,,

2.2.13,,,,,,,,,,

2.2.14,,,,,,,,,,

2.2.15,,,,,,,,,,

2.2.16,,,,,,,,,,

2.2.17,,,,,,,,,,

2.2.18,,,,,,,,,,

2.2.19,,,,,,,,,,

2.2.20,,,,,,,,,,

2.2.21,,,,,,,,,,

2.2.22,,,,,,,,,,

2.2.23,,,,,,,,,,

2.3,Detailedpre-assessmentoftheK.O.requirementsK.O.項問題的詳細(xì)預(yù)評審,,,,,,,,,

2.3.1,,,,,,,,,,

2.3.2,,,,,,,,,,

2.3.3,,,,,,,,,,

2.3.4,,,,,,,,,,

2.3.5,,,,,,,,,,

2.3.6,,,,,,,,,,

2.3.7,,,,,,,,,,

2.3.8,,,,,,,,,,

2.3.9,,,,,,,,,,

2.3.10,,,,,,,,,,

2.4,Frameworkconditions框架條件,,,,,,,,,

2.4.1,,,,,,,,,,

2.4.2,,,,,,,,,,

2.4.3,,,,,,,,,,

2.4.4,,,,,,,,,,

2.4.5,,,,,,,,,,

2.4.6,,,,,,,,,,

2.5,ChangesimpactingtheRQMS影響RQMS的變化,,,,,,,,,

2.5.1,,,,,,,,,,

2.5.2,,,,,,,,,,

2.5.3,,,,,,,,,,

2.5.4,,,,,,,,,,

2.5.5,,,,,,,,,,

2.5.6,,,,,,,,,,

2.6,ChangesimpactingtheRQMS影響RQMS的變化,,,,,,,,,

2.6.1,,,,,,,,,,

2.6.2,,,,,,,,,,

4,Contextoftheorganization組織環(huán)境,,,,,,,,,

4.1,Understandingtheorganizationanditscontext理解組織及其環(huán)境,,,,,,,,,

4.1-1,"Theorganizationshalldetermineexternalandinternalissuesthatare

relevanttoitspurposeanditsstrategicdirectionandthataffectitsabilityto

achievetheintendedresult(s)ofitsqualitymanagementsystem.組織應(yīng)確定與其宗旨和戰(zhàn)略方向相關(guān)并影響其實現(xiàn)質(zhì)量管理體系預(yù)期結(jié)果的能力的各種外部和內(nèi)部因素。",,,,,,"NOTE2Understandingtheexternalcontextcanbefacilitatedbyconsideringissuesarisingfromlegal,

technological,competitive,market,cultural,socialandeconomicenvironments,whetherinternational,

national,regionalorlocal.NOTE3Understandingtheinternalcontextcanbefacilitatedbyconsideringissuesrelatedtovalues,culture,knowledge

andperformanceoftheorganization.注2：考慮來自于國際、國內(nèi)、地區(qū)或當(dāng)?shù)氐母鞣N法律法規(guī)、技術(shù)、競爭、市場、文化、社會和經(jīng)濟(jì)環(huán)境的因素，有助于理解外部環(huán)境。注3：考慮與組織的價值觀、文化、知識和績效等有關(guān)的因素，有助于理解內(nèi)部環(huán)境。",2,,

4.1-2,"Theorganizationshallmonitorandreviewinformationabouttheseexternal

andinternalissues.組織應(yīng)對這些外部和內(nèi)部因素的相關(guān)信息進(jìn)行監(jiān)視和評審",,,,,,"NOTE1Issuescanincludepositive

andnegativefactorsorconditionsfor

consideration.注1：這些因素可能包括需要考慮的正面和負(fù)面要素或條件。",2,,

4.1.1,Understandingtheorganizationanditscontext-Supplemental理解組織及其環(huán)境—補(bǔ)充,,,,,,,,,

,,,,,,,,,,

-1,"Whenplanningthestrategicdirectionofanorganization,businessplanning

shallbeconsideredtoensuresustainableproductandservicequality.在規(guī)劃組織的戰(zhàn)略方向時，應(yīng)考慮經(jīng)營計劃，以確保產(chǎn)品和服務(wù)質(zhì)量的可持續(xù)性",,"PLUS:Thisbusinessplanningshouldconsider:a)changeofexternaltrendsandinterestedparties'needs

(1);經(jīng)營計劃考慮：a）外部趨勢和相關(guān)方需求的變化。",,"PLUS:Theinnovationmanagementprocessfornewproducts,servicesandtechnologiesshouldinclude:a)theidentificationofchangesintheorganization’sbusinessenvironment;b)planningofinnovations;c)prioritizationofinnovationsbasedonthebalance

betweentheirurgency,theavailabilityofresources,andtheorganization'sstrategy;d)involvementofinterested

parties(2).Thebusinessplanningincludesthestrategiclongtermperspective新產(chǎn)品、服務(wù)和技術(shù)的創(chuàng)新管理過程包括：a）識別組織業(yè)務(wù)環(huán)境的變化；b）創(chuàng)新規(guī)劃；c）創(chuàng)新的優(yōu)先級基于其緊迫性，資源的可獲得性和組織的戰(zhàn)略之間的平衡；d）利益相關(guān)方的參與（2）經(jīng)營計劃包括長期戰(zhàn)略思維。",,"NOTE:thebusinessplanningisrelatedtothepurposeoftheorganization(1)e.g.economicpolicies,environmentalprotection,socialorculturalissues,

informationsecurityneedsforproductsandservices(2)e.g.externalprovidersNOTE2Researchanddevelopmentactivitiescanbeconsideredaspartof

innovationactivities.注：經(jīng)營計劃應(yīng)與組織的目的相關(guān)（1）如政策經(jīng)濟(jì)、環(huán)境保護(hù)、社會或文化問題，產(chǎn)品和服務(wù)的信息安全;(2)如外部供方.注2：設(shè)計與開發(fā)可作為創(chuàng)新活動的一部分。",4,,

-2,"Theorganizationshalldocumentatleastasummarizedbusinessplanand

reviewitonayearlybasis.組織應(yīng)至少應(yīng)保留一份總結(jié)性的經(jīng)營計劃，并對其進(jìn)行年度評審",,PLUS:Thisbusinessplanningshouldconsider:b)thefiscalyearcalendaroftheorganization;經(jīng)營計劃考慮：b)組織的財務(wù)年度日歷;,,PLUS:Amulti-yearbusinessplanconsidersallrelevantinterestedparties.一個多年的經(jīng)營計劃考慮了所有利益相關(guān)方。,,NOTE1Theorganizationcandecidetoexcludeconfidentialinformationfromthesummarizedbusinessplan.注1：組織可將機(jī)密信息排除在總結(jié)性經(jīng)營計劃之外。,4,,

-3,"Thebusinessplanningshallconsidera)businessobjectives;b)market

strategy;c)productandservicestrategy,includingdevelopmentplansof

newproductsandservices,and/(or)processes,innovationsandphase-

outstrategies;d)outputsofmanagementreviews(see9.3.3);e)resource

planning(see);f)risksandopportunitiesoftheorganization(see

6.1);g)businesscontinuity(see6.1.2);h)needsandexpectationsof

customers;i)inputsfrominterestedparties;j)impactofchangesin

technologiesandinstatutoryandregulatoryrequirements;k)company

capacityconsideringtheforecast;l)merger,acquisition,outsourcingand

transfer,ifapplicable.經(jīng)營計劃應(yīng)考慮：a）經(jīng)營目標(biāo)；b）市場戰(zhàn)略;

c）產(chǎn)品和服務(wù)策略，包括新產(chǎn)品和服務(wù)開發(fā)計劃，和（或）過程、創(chuàng)新和逐步淘汰戰(zhàn)略;d）管理評審的輸出（見9.3.3）；e）資源策劃（見）;f）組織的風(fēng)險和機(jī)遇（見6.1）;g)業(yè)務(wù)連續(xù)性（見6.1.4）；h)顧客的需求和期望;i)相關(guān)方的輸入；j)技術(shù)和法律法規(guī)要求變化的影響;k)考慮組織產(chǎn)能預(yù)測;l)適用時的兼并、收購、外包和轉(zhuǎn)移。",,PLUS:Thisbusinessplanningshouldconsider:c)anappropriatecommunicationofplanningoutputs;經(jīng)營計劃考慮：c）經(jīng)營計劃的輸出得到適當(dāng)?shù)臏贤ā?,"PLUS:Incasebusinessplanningisnotachievedasexpected,theorganization

performsrootcauseanalysis.Thisbusinessplanningshouldconsider:d)actionsasoutputofbusinessplanningreview.Theorganizationshouldconsiderthesocialresponsibilityprinciples.一旦經(jīng)營計劃沒有達(dá)成預(yù)期目標(biāo)，組織應(yīng)進(jìn)行根本原因發(fā)現(xiàn)。經(jīng)營計劃考慮：d）經(jīng)營計劃評審輸出的相關(guān)措施。組織宜考慮社會責(zé)任原則。",,"NOTE3SWOTanalysiscanbeappliedformanagingrisksinbusinessplanning.NOTECoresubjectsdefinedinISO26000areorganizationalgovernance,humanrights,labourpractices,theenvironment,fair

operatingpractices,consumerissues,communityinvolvementanddevelopmentinterestedpartiescan

e.g.beexternalproviders注3：SWOT分析可用于經(jīng)營計劃中的風(fēng)險管理。注：ISO26000中定義的核心主題是組織治理、人權(quán)、勞工實踐、環(huán)境、公平經(jīng)營、消費者問題、社區(qū)參與和利益相關(guān)方開發(fā)，如外部供方。",4,,

4.2,Understandingtheneedsandexpectationsofinterestedparties理解相關(guān)方的需求和期望,,,,,,,,,

4.2-1,"Duetotheireffectorpotentialeffectontheorganization’sabilityto

consistentlyprovideproductsandservicesthatmeetcustomerand

applicablestatutoryandregulatoryrequirements,theorganizationshall

determine:a)theinterestedpartiesthatarerelevanttothequality

managementsystem.由于相關(guān)方對組織穩(wěn)定提供符合顧客要求及適用法律法規(guī)要求的產(chǎn)品和服務(wù)的能力具有影響或潛在影響，因此，組織應(yīng)確定：a）與質(zhì)量管理體系有關(guān)的相關(guān)方；",,,,,,SeeIRISGUIDELINE11:CUSTOMERPERCEPTION.參見IRIS指南11：顧客感知,2,,

4.2-2（K.O.）,"Duetotheireffectorpotentialeffectontheorganization’sabilityto

consistentlyprovideproductsandservicesthatmeetcustomerand

applicablestatutoryandregulatoryrequirements,theorganizationshall

determine:b)therequirementsoftheseinterestedpartiesthatarerelevant

tothequalitymanagementsystem.由于相關(guān)方對組織穩(wěn)定提供符合顧客要求及適用法律法規(guī)要求的產(chǎn)品和服務(wù)的能力具有影響或潛在影響，因此組織應(yīng)確定：b）與質(zhì)量管理體系有關(guān)的相關(guān)方的要求。",,,,,,,,,

4.2-3,"Theorganizationshallmonitorandreviewinformationaboutthese

interestedpartiesandtheirrelevantrequirements組織應(yīng)監(jiān)視和評審這些相關(guān)方的信息及其相關(guān)要求。",,,,,,SeeIRISGUIDELINE11:CUSTOMERPERCEPTION.參見IRIS指南11：顧客感知,2,,

4.3,Determiningthescopeofthequalitymanagementsystem確定質(zhì)量管理體系的范圍,,,,,,,,,

4.3-1,"Theorganizationshalldeterminetheboundariesandapplicabilityofthe

qualitymanagementsystemtoestablishitsscope.組織應(yīng)確定質(zhì)量管理體系的邊界和適用性，以確定其范圍。",,,,,,,2,,

4.3-2,"Whendeterminingthisscope,theorganizationshallconsider:a)the

externalandinternalissuesreferredtoin4.1;b)therequirementsof

relevantinterestedpartiesreferredtoin4.2;c)theproductsandservicesof

theorganization.在確定范圍時，組織應(yīng)考慮：a）4.1中提及的各種外部和內(nèi)部因素；b）4.2中提及的相關(guān)方的要求；c）組織的產(chǎn)品和服務(wù)。",,,,,,,2,,

4.3-3,"TheorganizationshallapplyalltherequirementsofthisInternational

Standardiftheyareapplicablewithinthedeterminedscopeofitsquality

managementsystem.如果本標(biāo)準(zhǔn)的全部要求適用于組織確定的質(zhì)量管理體系范圍，組織應(yīng)實施本國際標(biāo)準(zhǔn)的全部要求。",,,,,,,2,,

4.3-4,"Thescopeoftheorganization’squalitymanagementsystemshallbe

availableandbemaintainedasdocumentedinformation.組織的質(zhì)量管理體系范圍應(yīng)形成文件化信息，可獲得并得到保持。",,,,,,,2,,

4.3-5,"Thescopeshallstatethetypesofproductsandservicescovered,and

providejustificationforanyrequirementofthisInternationalStandardthat

theorganizationdeterminesisnotapplicabletothescopeofitsquality

managementsystem.ConformitytothisInternationalStandardmayonlybeclaimediftherequirementsdeterminedasnotbeingapplicabledonot

affecttheorganization’sabilityorresponsibilitytoensuretheconformityof

itsproductsandservicesandtheenhancementofcustomersatisfaction.范圍應(yīng)描述所覆蓋的產(chǎn)品和服務(wù)類型，如果組織確定本標(biāo)準(zhǔn)的某些要求不適用于其質(zhì)量管理體系范圍，應(yīng)說明理由。只有所確定的不適用的要求不影響組織確保其產(chǎn)品和服務(wù)合格的能力或責(zé)任，對增強(qiáng)顧客滿意也不會產(chǎn)生影響，方可聲稱符合本標(biāo)準(zhǔn)的要求。",,,,,,,2,,

4.3.1,Determiningthescopeofthequalitymanagementsystem-supplemental確定質(zhì)量管理體系的范圍—補(bǔ)充,,,,,,,,,

4.3.1-1,"InadditiontoISO9001:2015,4.3theorganizationshallalsodeterminethe

boundariesandapplicabilityofthespecificrequirementsoftheRQMS.除滿足ISO9001:20154.3條款要求外，組織還應(yīng)確定RQMS鐵路特定要求的邊界和適用性。",,,,,,"NOTEThisdocumentallowsorganizationstohavethesameflexibilityasdescribedinISO

9001:2015,4.3(activities,productsandservices)andsites注本補(bǔ)充要求允許組織與ISO9001:20154.3條款描述的（活動、產(chǎn)品和服務(wù)）和場所保持同樣靈活性。",2,,

4.4,Qualitymanagementsystemanditsprocesses質(zhì)量管理體系及其過程,,,,,,,,,

4.4.1,,,,,,,,,,

4.4.1-1,"Theorganizationshallestablish,implement,maintainandcontinually

improveaqualitymanagementsystem,includingtheprocessesneeded

andtheirinteractions,inaccordancewiththerequirementsofthis

InternationalStandard.組織應(yīng)按照本標(biāo)準(zhǔn)的要求，建立、實施、保持和持續(xù)改進(jìn)質(zhì)量管理體系，包括所需過程及其相互作用",,,,,,NOTEBasedonexistingKPIs.注：基于現(xiàn)有的KPIs,2,,

4.4.1-2,"Theorganizationshalldeterminetheprocessesneededforthequality

managementsystemandtheirapplicationthroughouttheorganization.組織應(yīng)確定質(zhì)量管理體系所需的過程及其在整個組織中的應(yīng)用。",,,,,,,2,,

4.4.1-3,"Theorganizationshall:a)determinetheinputsrequiredandtheoutputs

expectedfromtheseprocesses;b)determinethesequenceandinteraction

oftheseprocesses;c)determineandapplythecriteriaandmethods

(includingmonitoring,measurementsandrelatedperformanceindicators)

neededtoensuretheeffectiveoperationandcontroloftheseprocesses;d)

determinetheresourcesneededfortheseprocessesandensuretheir

availability;組織應(yīng)：a）確定這些過程所需的輸入和期望的輸出；b）確定這些過程的順序和相互作用；c）確定和應(yīng)用所需的準(zhǔn)則和方法（包括監(jiān)視、測量和相關(guān)績效指標(biāo)），以確保這些過程的有效運行和控制；d）確定這些過程所需的資源并確保其可獲得；",,,,,,,2,,

4.4.1-4,"Theorganizationshall:e)assigntheresponsibilitiesandauthoritiesfor

theseprocessesf)addresstherisksandopportunitiesasdeterminedin

accordancewiththerequirementsof6.1;g)evaluatetheseprocessesand

implementanychangesneededtoensurethattheseprocessesachieve

theirintendedresults;h)improvetheprocessesandthequality

managementsystem.組織應(yīng)：e）分配這些過程的職責(zé)和權(quán)限；f）按照6.1的要求應(yīng)對風(fēng)險和機(jī)會；g）評價這些過程，實施所需的變更，以確保實現(xiàn)這些過程的預(yù)期結(jié)果；h）改進(jìn)過程和質(zhì)量管理體系。",,,,,,,2,,

4.4.2,,,,,,,,,,

4.4.2-1,"Totheextentnecessary,theorganizationshall:a)maintaindocumented

informationtosupporttheoperationofitsprocesses;b)retaindocumented

informationtohaveconfidencethattheprocessesarebeingcarriedoutas

planned.在必要的范圍和程度上，組織應(yīng)：a）保持成文信息以支持過程運行；b）保留成文信息以確信其過程按策劃運行。",,,,,,,2,,

4.4.3,Qualitymanagementsystemanditsprocesses—Supplemental質(zhì)量管理體系及其過程—補(bǔ)充,,,,,,,,,

4.4.3-1,"Thedocumentedinformation(4.4.2a))fortheprocessdescriptionof

mandatoryandrecommendedprocesses(seeAnnexA)shallcoverasa

minimumtherequirementsdescribedin4.4.1a)to4.4.1e).本標(biāo)準(zhǔn)要求制定的強(qiáng)制性和推薦性過程（附錄A）的文件化信息（4.4.2a）），此過程至少應(yīng)包括4.4.1a）至e）中描述的要求。",,"PLUS:Thedocumentedinformation(4.4.2a))fortheprocessdescriptionofatleastthekeyprocessescoverstherequirementsdescribed4.4.1f)Processdescriptioncontains

identificationofsuppliersandcustomers(externalandinternalaswell)oftheprocess.Thedocumentedinformation(4.4.2a))fortheprocessdescriptionofatleastthekeyprocessescoverstherequirementsdescribed4.4.1f)關(guān)鍵過程的過程描述文件化信息（4.4.2a））至少涵蓋了4.4.1f)描述的要求，過程描述包含過程供方和客戶（內(nèi)部和外部）的識別。",,"PLUS:Thedocumentedinformation(4.4.2a))fortheprocessdescriptionofatleast

thekeyprocessescoverstheneedsandexpectationsoftheinterestedpartiesoftheprocesses關(guān)鍵過程的過程描述文件化信息（4.4.2a））至少涵蓋了過程利益相關(guān)方的需求和期望。",,"NOTE1Processescanbedocumentedinprocedures,instructions,methoddescriptions,

flowchartsorworkflowsetc.supportedbysoftwaretoolandtemplates.NOTE2ProcessescanbecoveredbytheorganizationaccordingtotheirRQMS.

Theycanbecombinedorsplitbytheorganizations,providedthatallrequirementsofthisstandardare

fulfilled.NOTE3Detailedrequirementsforperformanceevaluationoftheprocessesaredescribedin9.1.1andfurtherexplainedinAnnexC.注1：過程成文過程可以是程序、指導(dǎo)書、方法說明書、流程圖或工作流程等，并由軟件工具和模板支持。注2：組織可根據(jù)其RQMS確定所涵蓋的過程。在滿足本標(biāo)準(zhǔn)的所有要求下，過程可以是合并的或分開的。注3：9.1.1中描述了過程績效評價的詳細(xì)要求，并在附錄C中作了進(jìn)一步解釋。",4,,

4.4.3-2,"Theorganizationshall:a)documentahierarchicalstructureofits

processes;b)communicateprocessesandprocesschanges(see7.4)and

ensurethatpeopleareawareoftheprocesses;c)trainpeopleon

processesby:1)definingcriteriawhentrainingisneeded;2)identifying

peopletobetrainedonprocesses;3)executingtraining;4)ensuring

understandingoftrainingcontent[(seed)]);組織應(yīng)：a）過程按照層級結(jié)構(gòu)形成文件；b）溝通過程和過程變更（見7.4），并確保員工了解這些過程；c）針對這些過程，對員工進(jìn)行培訓(xùn)；1）在需要培訓(xùn)時制定標(biāo)準(zhǔn)；2）確定需要培訓(xùn)的人員；3）實施培訓(xùn)；4）確保理解培訓(xùn)的內(nèi)容（見d）",,"PLUS:Thehierarchicalstructureofitsprocesses(1)includesprocesstemplatesandrelatedapplicationsoftware.Theorganizationshould(7.4.1)establish,implementandmaintainaprocessforinternalandexternalcommunicationrelevanttotheRQMS.(1)過程層級結(jié)構(gòu)包括過程模板和相關(guān)應(yīng)用軟件。組織宜建立，實施和保持一個與RQMS相關(guān)的內(nèi)外部溝通過程。",,"PLUS:Thehierarchical

structureofitsprocesses(2)

includesthelinktoPIsor

KPIs.過程層級結(jié)構(gòu)包括與PIs或KPIs的鏈接。",,(1)see7.4.&7.4.1(2)e.g.processhouse（1）見7.4.&7.4.1(2)如過程屋,4,,

4.4.3-3,"Theorganizationshall:d)ensureprocessesareappliedandpeopleadhere

toprocesses(see9.2);e)ensureandmaintainconformityoftheRQMS

anditsprocesseswithapplicablestatutoryandregulatoryrequirements

andstandards;f)definecriteria,utilizingarisk-basedmethodology(1)to

determinethetypeandextentofcontrolsinitsprocesses.組織應(yīng)：d）確保過程得到應(yīng)用，并且員工能堅持執(zhí)行這些過程（見9.2）；e）確保并保持RQMS質(zhì)量管理體系和過程滿足適用的標(biāo)準(zhǔn)和法律法規(guī)要求；f）定義準(zhǔn)則，利用基于風(fēng)險的方法來確定過程控制的類型和程度。",,PLUS:Upcomingstatutoryorregulatoryrequirementsandstandardsareincorporated.考慮了即將出臺的法律法規(guī)要求和標(biāo)準(zhǔn)。,,PLUS:Thereisevidencethatemployeeproposalsareusedasaninputforprocessesimprovement.有證據(jù)表明，員工建議被用作過程改進(jìn)的輸入。,,"(1)e.g.FMEA,SWOT（1）如FMEA,SWOT",4,,

4.4.3-4,Implementedprocessesshallbeverifiedagainsttheapplicablerequirementsofthisdocument.實施的過程應(yīng)根據(jù)本標(biāo)準(zhǔn)的適用要求進(jìn)行驗證。,,,,,,,2,,

5,Leadership領(lǐng)導(dǎo)作用,,,,,,,,,

5.1,Leadershipandcommitment領(lǐng)導(dǎo)作用和承諾,,,,,,,,,

5.1.1,General總則,,,,,,,,,

5.1.1-1,"Topmanagementshalldemonstrateleadershipandcommitmentwith

respecttothequalitymanagementsystemby:a)takingaccountabilityfor

theeffectivenessofthequalitymanagementsystem;b)ensuringthatthe

qualitypolicyandqualityobjectivesareestablishedforthequality

managementsystemandarecompatiblewiththecontextandstrategic

directionoftheorganization;c)ensuringtheintegrationofthequality

managementsystemrequirementsintotheorganization’sbusiness

processes;d)promotingtheuseoftheprocessapproachandrisk-based

thinking;e)ensuringthattheresourcesneededforthequalitymanagement

systemareavailable;最高管理者應(yīng)通過以下方面，證實其對質(zhì)量管理體系的領(lǐng)導(dǎo)作用和承諾：a）對質(zhì)量管理體系的有效性負(fù)責(zé)；b）確保制定質(zhì)量管理體系的質(zhì)量方針和質(zhì)量目標(biāo)，并與組織環(huán)境相適應(yīng)，與戰(zhàn)略方向相一致；c）確保質(zhì)量管理體系要求融入組織的業(yè)務(wù)過程；d）促進(jìn)使用過程方法和基于風(fēng)險的思維；e）確保質(zhì)量管理體系所需的資源是可獲得的；",,,,,,"NOTEReferenceto“business”inthisInternationalStandardcanbeinterpretedbroadlytomeanthose

activitiesthatarecoretothepurposesoftheorganization’sexistence,whethertheorganizationispublic,private,forprofitornotforprofit.注：本標(biāo)準(zhǔn)使用的“業(yè)務(wù)”一詞可廣義地理解為涉及組織存在目的的核心活動，無論是公有、私有、營利或非營利組織。",2,,

5.1.1-2,"Topmanagementshalldemonstrateleadershipandcommitmentwithrespecttothequalitymanagementsystemby:f)communicatingtheimportanceofeffectivequalitymanagementandofconformingtothequalitymanagementsystemrequirements;g)ensuringthatthequalitymanagementsystemachievesitsintendedresults;h)engaging,directingandsupportingpersonstocontributetotheeffectivenessofthequalitymanagementsystem;i)promotingimprovement;j)supportingotherrelevantmanagementrolestodemonstratetheirleadershipasitappliestotheirareasofresponsibility.(1)最高管理者應(yīng)通過以下方面，證實其對質(zhì)量管理體系的領(lǐng)導(dǎo)作用和承諾：f）溝通有效的質(zhì)量管理和符合質(zhì)量管理體系要求的重要性；g）確保質(zhì)量管理體系實現(xiàn)其預(yù)期結(jié)果；h）促使人員積極參與，指導(dǎo)和支持他們?yōu)橘|(zhì)量管理體系的有效性作出貢獻(xiàn)；i）推動改進(jìn)；j）支持其他相關(guān)管理者在其職責(zé)范圍內(nèi)發(fā)揮領(lǐng)導(dǎo)作用。",,,,,,"NOTEReferenceto“business”inthisInternationalStandardcanbeinterpretedbroadlytomeanthose

activitiesthatarecoretothepurposesoftheorganization’sexistence,whethertheorganizationispublic,private,forprofitornotforprofit.注：本標(biāo)準(zhǔn)使用的“業(yè)務(wù)”一詞可廣義地理解為涉及組織存在目的的核心活動，無論是公有、私有、營利或非營利組織。",2,,

5.1.2,Customerfocus以顧客為關(guān)注焦點,,,,,,,,,

5.1.2-1,"Topmanagementshalldemonstrateleadershipandcommitmentwith

respecttocustomerfocusbyensuringthat:a)customerandapplicable

statutoryandregulatoryrequirementsaredetermined,understoodand

consistentlymet(1);b)therisksandopportunitiesthatcanaffect

conformityofproductsandservicesandtheabilitytoenhancecustomer

satisfactionaredeterminedandaddressed;c)thefocusonenhancing

customersatisfactionismaintained.最高管理者應(yīng)通過確保以下方面，證實其以顧客為關(guān)注焦點的領(lǐng)導(dǎo)作用和承諾：a）確定、理解并持續(xù)地滿足顧客要求以及適用的法律法規(guī)要求；b）確定和應(yīng)對風(fēng)險和機(jī)會，這些風(fēng)險和機(jī)會可能影響產(chǎn)品和服務(wù)合格以及增強(qiáng)顧客滿意的能力；c）始終致力于增強(qiáng)顧客滿意。",,,,,,(1)Thatincludesthefulfilmentofstatutoryandregulatoryrequirementsrelatedtocustomersneeds.包括和顧客需求相關(guān)的法律法規(guī)要求的符合。,2,,

5.2,Policy方針,,,,,,,,,

5.2.1,Establishingthequalitypolicy制定質(zhì)量方針,,,,,,,,,

5.2.1-1,"Topmanagementshallestablish,implementandmaintainaqualitypolicy

that:a)isappropriatetothepurposeandcontextoftheorganizationand

supportsitsstrategicdirection;b)providesaframeworkforsettingquality

objectives;c)includesacommitmenttosatisfyapplicablerequirements;d)

includesacommitmenttocontinualimprovementofthequality

managementsystem.最高管理者應(yīng)制定、實施和保持質(zhì)量方針，質(zhì)量方針應(yīng)：a）適應(yīng)組織的宗旨和環(huán)境并支持其戰(zhàn)略方向；b）為建立質(zhì)量目標(biāo)提供框架；c）包括滿足適用要求的承諾；d）包括持續(xù)改進(jìn)質(zhì)量管理體系的承諾。",,,,,,,2,,

5.2.2,Communicatingthequalitypolicy溝通質(zhì)量方針,,,,,,,,,

5.2.2-1,"Thequalitypolicyshall:a)beavailableandbemaintainedasdocumented

information;b)becommunicated,understoodandappliedwithinthe

organization;c)beavailabletorelevantinterestedparties,asappropriate.質(zhì)量方針應(yīng)：a）可獲取并保持成文信息；b）在組織內(nèi)得到溝通、理解和應(yīng)用；c）適宜時，可為有關(guān)相關(guān)方所獲取。",,,,,,,2,,

5.2.3,Qualitypolicy—Supplemental質(zhì)量方針—補(bǔ)充,,,,,,,,,

5.2.3-1,Thequalitypolicyshalladdress:a)failureprevention;b)customerexpectations;c)safetyaspects.質(zhì)量方針應(yīng)包括：a）缺陷預(yù)防；b）客戶期望；c）安全方面。,,"PLUS:Theorganizationimplementsaprocesstodefine,review,updateandcommunicatestrategyandqualitypolicy.Theprocesscontainsanalysisoftheneedsandexpectationsofcustomers,includinganalysisofstatutoryandregulatoryrequirements.Qualitypolicyaddressesexpectationstothesupplychain.APIrelatedtosafetyobjectivesisinplaceandismonitoredregularly;actionsaretakenwhennecessary.組織實施一個過程來定義、評審、更新和溝通公司戰(zhàn)略和質(zhì)量方針。該過程包括對客戶需求和期望的分析，包括對法律法規(guī)要求的分析。質(zhì)量方針明確了對供應(yīng)鏈的期望。與產(chǎn)品安全目標(biāo)相關(guān)的一個PI已制定，并定期進(jìn)行監(jiān)測，必要時采取行動。",,"PLUSCompanyqualityobjectivesandsafetyobjectivesarebrokendowntosub-objectivesallocatedtoinvolvedparties/personnel,whohavedirectcontributiontoachieveobjectives.

Continualimprovementofprocesses,basedonqualityandsafetyobjectivesmeasurementandappropriateactionplans,isimplemented.公司質(zhì)量和安全目標(biāo)被分解為子目標(biāo)并分配給那些對實現(xiàn)目標(biāo)有直接貢獻(xiàn)的相關(guān)方/人員，基于質(zhì)量和安全目標(biāo)監(jiān)測和適當(dāng)?shù)男袆佑媱澋某掷m(xù)改進(jìn)過程得到實施。",,"NOTE1Safetyinthisdocumentmeanssafetyofproductsandservices.NOTE2Qualityandsafetypolicycanbeaddressedseparately.NOTE3The

qualitypolicyformsapartoftheoverallcorporatepolicy.FormoreinformationseeISO9004:2018,7.2.注1：本文件中的安全是指產(chǎn)品和服務(wù)的安全。注2：質(zhì)量和安全方針可分別制定。注3：質(zhì)量方針是公司整體方針的一部分。如需了解更多信息，請參閱ISO9004:2018,7.2。",4,,

5.3,"Organizationalroles,responsibilitiesandauthorities組織的崗位、職責(zé)和權(quán)限",,,,,,,,,

5.3-1,"Topmanagementshallensurethattheresponsibilitiesandauthoritiesfor

relevantrolesareassigned,communicatedandunderstoodwithinthe

organization.最高管理者應(yīng)確保組織相關(guān)崗位的職責(zé)、權(quán)限得到分配、溝通和理解。",,,,,,,2,,

5.3-2,"Topmanagementshallassigntheresponsibilityandauthorityfor:a)

ensuringthatthequalitymanagementsystemconformstotherequirementsofthisInternationalStandard;b)ensuringthattheprocessesaredeliveringtheirintendedoutputs;c)reportingontheperformanceofthequalitymanagementsystemandonopportunitiesforimprovement(see10.1),inparticulartotopmanagement;d)ensuringthepromotionofcustomerfocusthroughouttheorganization;e)ensuringthattheintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.最高管理者應(yīng)分配職責(zé)和權(quán)限，以：a）確保質(zhì)量管理體系符合本標(biāo)準(zhǔn)的要求；b）確保各過程獲得其預(yù)期輸出；c）報告質(zhì)量管理體系的績效以及改進(jìn)機(jī)會（見10.1），特別是向最高管理者報告；d）確保在整個組織推動以顧客為關(guān)注焦點；e）確保在策劃和實施質(zhì)量管理體系變更時保持其完整性。",,,,,,,2,,

5.3.1,"Organizationalroles,responsibilitiesandauthorities—Supplemental組織的崗位、職責(zé)和權(quán)限-補(bǔ)充",,,,,,,,,

5.3.1-1,"Thetopmanagementshall:a)defineKPIstoenablesteeringandcontrolof

theRQMS(seeAnnexC);b)appointprocessowners(see4.4.1e));c)

documentandcommunicateupdatesofresponsibilitiesandauthoritiesfor

relevantroles(1);d)appointrepresentativesindependentfromtheprocess

executionandempowerthemtostoptheprocessorproductionorservice

provisionifquality,includingsafetyrequirements,arenotmet.最高管理層應(yīng)：a）定義關(guān)鍵績效指標(biāo)KPI，以指導(dǎo)和控制RQMS（見附錄C）；b）任命過程所有者（見4.4.1e）；c）文件化和溝通相關(guān)崗位的職責(zé)和權(quán)限更新（1）；d）如質(zhì)量或安全要求未能滿足時，任命獨立于過程執(zhí)行的代表，有權(quán)停止過程或產(chǎn)品或服務(wù)的提供。",,"PLUS:Responsibilitiesandauthoritiesaredocumentedandupdatesarecommunicatedthroughouttheorganization.Ownership,authoritiesandresponsibilitiesarereviewedat

leastannually.Incaseofdelegationoftasks,thisdelegationshouldbedefinedandcommunicated.文件化和更新職責(zé)和權(quán)限，在整個組織中進(jìn)行溝通。所有權(quán)、權(quán)限和責(zé)任至少每年評審一次。在任務(wù)授權(quán)的情況下，應(yīng)定義并傳達(dá)該授權(quán)。",,Plus:Knowledgeandlessonslearnedissharedbetweenprocessowners/coordinatorsforspecialprocesses(2)andorganization.知識和經(jīng)驗教訓(xùn)在特殊過程負(fù)責(zé)人/協(xié)調(diào)員與組織之間進(jìn)行分享。,,"(1)e.g.processownershiporproductownershipNOTE:Therequireddegreeofindependenceoftherepresentativesisproportionatetothesizeofthe

organization,e.g.smallorganizations.（1）如過程負(fù)責(zé)人或產(chǎn)品負(fù)責(zé)人注：代表所需的獨立程度應(yīng)與組織的規(guī)模適宜，如小型組織。",4,,

5.3.1-2,Theorganizationshallretainrelateddocumentedinformation.組織應(yīng)保留相關(guān)的文件化信息。,,PLUS:TheadequacyofdefinedKPIsisreviewedanddocumentedonanannualbasis(1)按年度對定義的KPIs充分性進(jìn)行評審并形成記錄（1）。,,PLUS:TheresultsoftheKPIsareinlinewiththeobjectivesandprovethattheyareadequatetosteerandcontroltheRQMSKPI的結(jié)果與目標(biāo)一致，并證明它們足以指導(dǎo)和控制RQMS,,"(1)e.g.,duringthemanagementreview,duringtheprocessreview,businessplanning（1）如通過管理評審、過程評審以及經(jīng)營計劃。",4,,

5.3.2,Responsibilitiesandauthoritiesofprocessowners過程負(fù)責(zé)人的職責(zé)和權(quán)限,,,,,,,,,

5.3.2-1,"Processownersshallberesponsiblefortheprocesscomplianceto

requirementslistedin4.4exceptavailabilityofresources(see4.4.1d)).過程負(fù)責(zé)人應(yīng)對過程符合性負(fù)責(zé)，確保符合4.4中列出的要求，除“資源可獲得性要求”（見4.4.1d）外。",,"PLUS:Processownersleadimprovementofresponsible

processes.過程負(fù)責(zé)人主導(dǎo)相應(yīng)負(fù)責(zé)過程的改進(jìn)",,"PLUS:Processownersimplementamethodtomanagetheinteractionsof

theprocesses過程負(fù)責(zé)人實施了一種方法來管理過程之間的相互作用。",,,4,,

5.3.2-2,Thisresponsibilityshallbedefinedandensuredbytopmanagement.最高管理層應(yīng)制定并確保過程負(fù)責(zé)人的職責(zé)和權(quán)限,,PLUS:Theprocessownershipissetwithannualtargets(1)過程負(fù)責(zé)人設(shè)定有年度目標(biāo)（1）,,PLUS:Thereisevidencethatthetargetsaremet.有目標(biāo)達(dá)成的證據(jù)。,,"(1)e.g.,relatedtoprocessperformance,competence,processquality（1）如與過程績效、能力和過程質(zhì)量相關(guān)。",4,,

6,Planning策劃,,,,,,,,,

6.1,Actionstoaddressrisksandopportunities應(yīng)對風(fēng)險和機(jī)遇的措施,,,,,,,,,

6.1.1,,,,,,,,,,

6.1.1-1,"Whenplanningforthequalitymanagementsystem,theorganizationshall

considertheissuesreferredtoin4.1andtherequirementsreferredtoin

4.2anddeterminetherisksandopportunitiesthatneedtobeaddressedto:

a)giveassurancethatthequalitymanagementsystemcanachieveits

intendedresult(s);b)enhancedesirableeffects;c)prevent,orreduce,

undesiredeffects;d)achieveimprovement.在策劃質(zhì)量管理體系時，組織應(yīng)考慮到4.1所提及的因素和4.2所提及的要求，并確定需要應(yīng)對的風(fēng)險和機(jī)遇，以：a）確保質(zhì)量管理體系能夠?qū)崿F(xiàn)其預(yù)期結(jié)果；b）增強(qiáng)有利影響；c）預(yù)防或減少不利影響；d）實現(xiàn)改進(jìn)。",,,,,,,2,,

6.1.2,,,,,,,,,,

6.1.2-1,Theorganizationshallplan:a)actionstoaddresstheserisksandopportunitiesb)howto:1)integrateandimplementtheactionsintoitsqualitymanagementsystemprocesses(see4.4);2)evaluatetheeffectivenessoftheseactions.組織應(yīng)策劃：a）應(yīng)對這些風(fēng)險和機(jī)遇的措施；b）如何：1）在質(zhì)量管理體系過程中整合并實施這些措施（見4.4）；2）評價這些措施的有效性。,,,,,,,2,,

6.1.2-2,"Actionstakentoaddressrisksandopportunitiesshallbeproportionateto

thepotentialimpactontheconformityofproductsandservices.應(yīng)對措施應(yīng)與風(fēng)險和機(jī)遇對產(chǎn)品和服務(wù)符合性的潛在影響相適應(yīng)",,,,,,"NOTE1Optionstoaddressriskscanincludeavoidingrisk,takingriskinordertopursueanop-opportunity,

eliminatingtherisksource,changingthelikelihoodorconsequences,sharingtherisk,orretainingriskby

informeddecision.NOTE2Opportunitiescanleadtotheadoptionofnewpractices,launchingnew

products,open-ingnewmarkets,addressingnewcustomers,buildingpartnerships,usingnewtechnologyandotherdesirableandviablepossibilitiestoaddresstheorganization’soritscustomers’needs.注1：通過信息充分的決策，應(yīng)對風(fēng)險可選擇規(guī)避風(fēng)險，為尋求機(jī)會承擔(dān)風(fēng)險，消除風(fēng)險源，改變風(fēng)險的可能性或后果，分擔(dān)風(fēng)險，或保留風(fēng)險。

注2：機(jī)遇可能導(dǎo)致采用新實踐，推出新產(chǎn)品，開辟新市場，贏得新顧客，建立合作伙伴關(guān)系，利用新技術(shù)和其他可行之處，以應(yīng)對組織或其顧客的需求。",2,,

6.1.3,Actionstoaddressrisksandopportunities—Supplemental應(yīng)對風(fēng)險和機(jī)遇的措施—補(bǔ)充,,,,,,,,,

,,,,,,,,,,

-1,"Theorganizationshallestablish,implementandmaintainariskand

opportunitymanagementprocess.組織應(yīng)建立、實施和保持一個風(fēng)險與機(jī)遇管理過程",,,,,,,2,,

-2,"Thisprocessshallinclude:a)therequirementsdescribedin6.1.1and

6.1.2;b)aregularreviewandupdateofrisks,opportunitiesandactions;此過程應(yīng)包括：a）6.1.1和6.1.2條款中描述的要求；b）定期評審和更新風(fēng)險、機(jī)遇和措施；",,"