iso 9001 2015 中英文

1、135QualityQualitymanagementmanagementsystemssystems—RequirementsRequirementsISOISO9001:2015(E)9001:2015(E)IntroductionIntroduction........1ScopeScope....2NmativeNmativereferencesreferences.....3TermsTermsdefinitionsdefin

2、itions.......4ContextContextofofthetheganizationganization.....4.1Understingtheganizationitscontext.4.2Understingtheneedsexpectationsofinterestedparties4.3Determiningthescopeofthequalitymanagementsystem....4.4Qualitymana

3、gementsystemitsprocesses..5LeadershipLeadership.........5.1Leadershipcommitment..5.1.1General........5.1.2Customerfocus...........5.2Policy........5.2.1Establishingthequalitypolicy......5.2.2Communicatingthequalitypolicy

4、......5.3ganizationalrolesresponsibilitiesauthities6PlanningPlanning........6.1Actionstoaddressrisksopptunities........6.2Qualityobjectivesplanningtoachievethem..6.3Planningofchanges...........7SupptSuppt............7.1R

5、esources....7.1.1General....7.1.2People...7.1.3Infrastructure.......7.1.4Environmentftheoperationofprocesses.7.1.5Monitingmeasuringresources..7.1.6ganizationalknowledge......7.2Competence....7.3Awareness...7.4Communicati

6、on.....7.5Documentedinfmation.............7.5.1General......7.5.2Creatingupdating...........7.5.3Controlofdocumentedinfmation質(zhì)量管理體系要求GBT19001—201XISO9001:2015代替GBT19001—2008(ISO9001:2015，IDT)引言1范圍2規(guī)范性引用文件3術(shù)語(yǔ)和定義4組織環(huán)境4.1理解

7、組織及其環(huán)境4.2理解相關(guān)方的需求和期望4.3確定質(zhì)量管理體系的范圍4.4質(zhì)量管理體系及其過程5領(lǐng)導(dǎo)作用5.1領(lǐng)導(dǎo)作用和承諾5.1.1總則5.1.2以顧客為關(guān)注焦點(diǎn)5.2方針5.2.1制定質(zhì)量方針5.2.2溝通質(zhì)量方針5.3組織內(nèi)的角色、職責(zé)和權(quán)限6策劃6.1應(yīng)對(duì)風(fēng)險(xiǎn)和機(jī)遇的措施6.2質(zhì)量目標(biāo)及其實(shí)現(xiàn)的策劃6.3變更的策劃7支持7.1資源7.1.1總則7.1.2人員7.1.3基礎(chǔ)設(shè)施7.1.4過程運(yùn)行環(huán)境7.1.5監(jiān)視和測(cè)量資源7.1.

8、6組織的知識(shí)7.2能力7.3意識(shí)7.4溝通7.5成文信息7.5.1總則7.5.2創(chuàng)建和更新7.5.3成文信息的控制335IntroductionIntroduction0.10.1GeneralGeneralTheadoptionofaqualitymanagementsystemisastrategicdecisionfanganizationthatcanhelptoimproveitsoverallperfmanceprovide

9、asoundbasisfsustainabledevelopmentinitiatives.ThepotentialbenefitstoanganizationofimplementingaqualitymanagementsystembasedonthisInternationalStardare:a)theabilitytoconsistentlyprovideproductsservicesthatmeetcustomerappl

10、icablestatutyregulatyrequirementsb)facilitatingopptunitiestoenhancecustomersatisfactionc)addressingrisksopptunitiesassociatedwithitscontextobjectivesd)theabilitytodemonstrateconfmitytospecifiedqualitymanagementsystemrequ

11、irements.ThisInternationalStardcanbeusedbyinternalexternalparties.ItisnottheintentofthisInternationalStardtoimplytheneedf:—unifmityinthestructureofdifferentqualitymanagementsystems—alignmentofdocumentationtotheclausestru

12、ctureofthisInternationalStard—theuseofthespecificterminologyofthisInternationalStardwithintheganization.ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStardarecomplementarytorequirementsfproductsservic

13、es.ThisInternationalStardemploystheprocessapproachwhichincpatesthePlanDoCheckAct(PDCA)cycleriskbasedthinking.Theprocessapproachenablesanganizationtoplanitsprocessestheirinteractions.ThePDCAcycleenablesanganizationtoensur

14、ethatitsprocessesareadequatelyresourcedmanagedthatopptunitiesfimprovementaredeterminedactedon.Riskbasedthinkingenablesanganizationtodeterminethefactsthatcouldcauseitsprocessesitsqualitymanagementsystemtodeviatefromthepla

15、nnedresultstoputinplacepreventivecontrolstominimizenegativeeffectstomake引言0.1總則采用質(zhì)量管理體系是組織的一項(xiàng)戰(zhàn)略決策，能夠幫助其提高整體績(jī)效，為推動(dòng)可持續(xù)發(fā)展奠定良好基礎(chǔ)。組織根據(jù)本標(biāo)準(zhǔn)實(shí)施質(zhì)量管理體系的潛在益處是：a）穩(wěn)定提供滿足顧客要求以及適用的法律法規(guī)要求的產(chǎn)品和服務(wù)的能力；b）促成增強(qiáng)顧客滿意的機(jī)會(huì)；c）應(yīng)對(duì)與組織環(huán)境和目標(biāo)相關(guān)的風(fēng)險(xiǎn)和機(jī)遇；d）證實(shí)符

16、合規(guī)定的質(zhì)量管理體系要求的能力。本標(biāo)準(zhǔn)可用于內(nèi)部和外部各方。實(shí)施本標(biāo)準(zhǔn)并非需要：——統(tǒng)一不同質(zhì)量管理體系的架構(gòu)；——形成與本標(biāo)準(zhǔn)條款結(jié)構(gòu)相一致的文件；——在組織內(nèi)使用本標(biāo)準(zhǔn)的特定術(shù)語(yǔ)。本標(biāo)準(zhǔn)規(guī)定的質(zhì)量管理體系要求是對(duì)產(chǎn)品和服務(wù)要求的補(bǔ)充。本標(biāo)準(zhǔn)采用過程方法，該方法結(jié)合了“策劃—實(shí)施—檢查—處置”（PDCA）循環(huán)和基于風(fēng)險(xiǎn)的思維。過程方法使組織能夠策劃過程及其相互作用。PDCA循環(huán)使組織能夠確保其過程得到充分的資源和管理，確定改進(jìn)機(jī)會(huì)并采