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1、RegulationsofthePeople*sRepublicofChinaonCertificationandAccreditation(2023Revision)DocumentNumber:OrderNo.764oftheStateCouncilofthePRCAreaofLaw:GeneralProvisionsonCertificationandAccreditation1.evelofAuthority:AdministrativeRegulationsIssuingAuthority:StateCouncilDateIssued:07-20-2023EffectiveDale.
2、07-20-2023Status:EffectivePkuIawNote:OfficialReplyoftheStateCouncilonApprovingTemporaryAdjustmentstotheImplementationoftheProvisionsofRelevantAdministrativeRegulationsinHainanFreeTradePort(Issuedon10-27-2023Effectiveon10-27-2023)2020-2023AnnotationVersion2016-2020AnnotationVersion2003-2016Annotation
3、VersionRegulationsofthePeoplesRepublicofChinaonCertification中华人民共和国认证认可条例andAccreditationArticle 1 The present Regulations are hereby formulated for第一条 为了规范认证认可活动,提高产品、服务(PromulgatedbytheOrderNo.390oftheStateCouncilofthePeoplesRepublicofChinaonSeptember3,2003,revisedforthefirsttimeinaccordancewithth
4、eDecisionoftheStateCouncilonAmendingCertainAdministrativeRegulationsonFebruary6,2016,revisedforthesecondtimeinaccordancewiththeDecisionoftheStateCounciltoAmendandRepealCertainAdministrativeRegulationsonNovember29,2020,andrevisedforthethirdlimeinaccordancewiththeDecisionoftheStateCounciltoAmendandRep
5、ealCertainAdministrativeRegulationsonJuly20,2023)ChapterIGeneralPrinciples(2003年9月3日中华人民共和国国务院令第390号公布根据2016年2月6日国务院关于修改部分行政法规的决定第一次修订根据2020年11月29日国务院关于修改和废止部分行政法规的决定第二次修订根据2023年7月20日国务院关于修改和废止部分行政法规的决定第三次修订)第一章总则thepurposeofregulatingthecertificationandaccreditationactivities,improvingthequalityofp
6、roductsandservicesandthelevelofadministration,aswellaspromotingtheeconomicandsocialdevelopment.Article2The“certification“asmentionedinthepresentRegulationsreferstotheassessmentactivitiescarriedoutbythecertificationbodiestotestifywhethertheproducts,services,andmanagementsystemsareinconformitywithther
7、elevanttechnicalnormsandtheircompulsiverequirementsorstandards.The“accreditation“asmentionedinthepresentRegulationsreferstotheassessmentactivitiescarriedoutbytheaccreditationbodiestorecognizethecapabilitiesandqualificationsofthecertificationbodies,inspectionorganizationsandlaboratories,andpracticing
8、personnelengaginginsuchcertificationactivitiesastheappraisalandexamination,etc.Article 3 ThepresentRegulationsshallbeobsen,edwhenthecertificationandaccreditationactivitiesareundertakenwithintheterritoryofthePeoplesRepublicofChina.Article 4 TheStateshallimplementauniformcertificationandaccreditations
9、upervisionsystem.TheStaleshallapplytheworkingmechanismoncertificationandaccreditationunderwhichalltherelevantdepartmentsshallimplementtheworktogetherundertheuniform的质量和管理水平,促进经济和社会的发展,制定本条例。第二条本条例所称认证,是指由认证机构证明产品、服务、管理体系符合相关技术规范、相关技术规范的强制性要求或者标准的合格评定活动。本条例所称认可,是指由认可机构对认证机构、检查机构、实验室以及从事评审、审核等认证活动人员的能
10、力和执业资格,予以承认的合格评定活动。第三条在中华人民共和国境内从事认证认可活动,应当遵守本条例。第四条国家实行统一的认证认可监督管理制度。国家对认证认可工作实行在国务院认证认可监督管理部门统一管理、监督和综合协调下,各有关方面共同实施的工作机制。administration,supervisionandcomprehensivecoordinationofthecertificationandaccreditationadministrationdepartmentoftheStateCouncil.Article 5 Thecertificationandaccreditationadmi
11、nistrationdepartmentoftheStateCouncilshallstrengthenthesupervisionovertheactivitiesofthecertificationtraininginstitutionsandcertificationconsultationinstitutions.Article 6 Theprinciplesofimpersonalityandindependence,opennessandjustice,andgoodfaithshallbefollowedincarryingoutthecertificationandaccred
12、itationactivities.Article 7 TheStateencouragestheinternationalmutualrecognitionactivitiesofcertificationandaccreditationtobecarriedoutonthebasisofequalityandmutualbenefits,whichshallnotimpairthenationalsecurityandpublicinterests.Article 8 Theorganizationsandpersonsengaginginthecertificationandaccred
13、itationactivitiesshallhavethedutyofkeepingconfidentialforthestatesecretsandcommercialsecretslearned.ChapterIICertificationBodiesArticle 9 TobequalifiedasacertificationbodyshallbesubjecttotheapprovalofthecertificationandaccreditationadministrativedepartmentoftheStateCouncil,andcertificationactivities
14、shallbeconductedwithintheapprovedscope.第五条国务院认证认可监督管理部门应当依法对认证培训机构、认证咨询机构的活动加强监督管理。第六条认证认可活动应当遵循客观独立、公开公正、诚实信用的原则。第七条国家鼓励平等互利地开展认证认可国际互认活动。认证认可国际互认活动不得损害国家安全和社会公共利益。第八条从事认证认可活动的机构及其人员,对其所知悉的国家秘密和商业秘密负有保密义务。第二章认证机构第九条取得认证机构资质,应当经国务院认证认可监督管理部门批准,并在批准范围内从事认证活动。Noentityorpersonmayundertakecertificationa
15、ctivitieswithoutapproval.Article 10 Forqualificationasacertificationbody,thefollowingconditionsshallbemet:(1) Havingthelegalpersonstatus;(2) Havingafixedlocationandnecessaryfacilities;(3) Havingmanagementrulesinconformitywiththerequirementsofcertificationandaccreditation;(4) Havingregisteredcapitalo
16、fnotlessthanthreemillionyuan;(5) Havingtenormorefull-timecertificationstaffmembersinthecorrespondingfields.Certificationbodiesengaginginproductcertificationactivitiesshallpossesssuchtechnicalcapabilityforexaminationandinspectionfittinginwiththerelativeproductcertificationactivitiesinaddition.Article
17、 11 Theproceduresfortheapplicationforandapprovalofqualificationasacertificationbodyshallbeasfollows:(1) Theapplicantforqualificationasacertificationbodyshall未经批准,任何单位和个人不得从事认证活动。第十条取得认证机构资质,应当符合下列条件:(一)取得法人资格;(二)有固定的场所和必要的设施;(三)有符合认证认可要求的管理制度;(四)注册资本不得少于人民币300万元:(五)有10名以上相应领域的专职认证人员。从事产品认证活动的认证机构,还应
18、当具备与从事相关产品认证活动相适应的检测、检查等技术能力。第H一条认证机构资质的申请和批准程序:(一)认证机构资质的申请人,应当向国务院认证认可监督管理部门提出书面申请,并提交符合本条例第卜条规定条件的证明文件;fileawrittenapplicationwiththecertificationandaccreditationadministrativedepartmentoftheStateCouncilandsubmitsupportingdocumentsinconformitywiththeconditionsasprescribedinArticle10ofthisRegulati
19、on.(二)国务院认证认可监督管理部门自受理认证机构资质 申请之日起45日内,应当作出是否批准的决定。涉及国务 院有关部门职责的,应当征求国务院有关部门的意见。决 定批准的,向申请人出具批准文件,决定不予批准的,应 当书面通知申请人,并说明理由。(2) ThecertificationandaccreditationadministrativedepartmentoftheStateCouncilshall,within45daysofacceptanceoftheapplicationforqualificationasacertificationbody,makeadecisiononwh
20、ethertoapprovetheapplication.IftheresponsibilitiesoftherelevantdepartmentsoftheStateCouncilareinvolved,theopinionsoftherelevantdepartmentsoftheStateCouncilshallbesolicited.Ifadecisiontoapprovetheapplicationismade,anapprovaldocumentshallbeissuedtotheapplicant;orifadecisiontodisapprovetheapplicationis
21、made,theapplicantshallbenotifiedinwritingofthedecisionwithanexplanationofthereasonsforthedisapproval.国务院认证认可监督管理部门应当公布依法取得认证机构资质的企业名录。ThecertificationandaccreditationadministrativedepartmentoftheStateCouncilshallpublishadirectoryofenterpriseslegallyqualifiedascertificationbodies.第十二条境外认证机构在中华人民共和国境内
22、设 立代表机构,须向市场监督管理部门依法办理登记手续 后,方可从事与所从属机构的业务范围相关的推广活动, 但不得从事认证活动。Article 12 ArepresentativeofficeestablishedwithintheterritoryofthePeoplesRepublicofChinabyaforeigncertificationbodymayconductpromotionalactivitiesrelatedtothebusinessscopeoftheforeigncertificationbodyonlyafterundergoingtheregistrationfor
23、malitieswiththemarketregulatorydepartmentaccordingtothelaw,butmaynotcarryoutanycertificationactivity.境外认证机构在中华人民共和国境内设立代表机构的登TheregistrationofarepresentativeofficeestablishedwithintheterritoryofthePeoplesRepublicofChinabyaforeigncertificationbodyshallbehandledundertherelevantforeigninvestmentlawsand
24、administrativeregulationsandtherelevantprovisionsissuedbythestate.Article 13 Thecertificationbodiesmaynothaveinterestsrelationsofanykindwiththeadministrativedepartments.Thecertificationbodiesareprohibitedfromacceptinganygrantsthatmayinfluencetheimpersonalityandjusticeofthecertificationactivities;and
25、areprohibitedfromundertakinganysuchactivitiesthatmayinfluencetheimpersonalityandjusticeofthecertificationactivitiesasthedevelopmentandsaleoftheproducts,etc.Thecertificationbodiesmaynothaveinterestsrelationsofanykindwiththecertificationclientsinsuchaspectsascapitalandmanagement.Article 14 Thepersonse
26、ngaginginthecertificationactivitiesshallpracticeinonecertificationbody,andmaynotpracticeinmorethantwocertificationbodiesatthesametime.Article 15 Theinspectionorganizationsandthelaboratoriesthatissuetothepublicthedataandresults,whichhavethefunctionofverification,shallpossessthebasicconditionsandcapab
27、ilitiesasrequiredbytherelevantlawsandadministrativeregulations,andmaycarryouttherelativeactivitiesafterbeingrecognizedinaccordancewiththelaw.TheresultsoftheaccreditationshallbepublicizedbythecertificationandaccreditationadministrationdepartmentoftheStaleCouncil.记,按照有关外商投资法律、行政法规和国家有关规定办理。第十三条认证机构不得与
28、行政机关存在利益关系。认证机构不得接受任何可能对认证活动的客观公正产生影响的资助;不得从事任何可能对认证活动的客观公正产生影响的产品开发、营销等活动。认证机构不得与认证委托人存在资产、管理方面的利益关系。第十四条认证人员从事认证活动,应当在一个认证机构执业,不得同时在两个以上认证机构执业。第十五条向社会出具具有证明作用的数据和结果的检查机构、实验室,应当具备有关法律、行政法规规定的基本条件和能力,并依法经认定后,方可从事相应活动,认定结果由国务院认证认可监督管理部门公布。Chapter III Certification第三章认 证Article 16 The State shall popu
29、larize the certification on products, services and management systems in conformity with the requirements of the economic and social development.Article 17 The certification bodies shall carry out the certification activities in accordance with the basic certification standards and certification rul
30、es, which shall be formulated by the certification and accreditation administration department of the State Council; in case the standards and rules have to do with the functions of the relative departments of the State Council, they shall be formulated by the certification and accreditation adminis
31、tration department of the State Council together with the relative departments of the State Council.If the certification is in a new field, and no corresponding certification rules have been formulated by the departments as mentioned in the preceding paragraph, the certification bodies may make cert
32、ification rules by themselves, which shall be put on records at the certification and accreditation administration department of the State Council.Article 18 Any legal entity, organization or individual may entrust a legally established certification body of his own accord to make the certification
33、on products, services and management systems.第十六条国家根据经济和社会发展的需要,推行产品、服务、管理体系认证。第十七条认证机构应当按照认证基本规范、认证 规则从事认证活动。认证基本规范、认证规则由国务院认 证认可监督管理部门制定;涉及国务院有关部门职责的, 国务院认证认可监督管理部门应当会同国务院有关部门制 定。属于认证新领域,前款规定的部门尚未制定认证规则的, 认证机构可以自行制定认证规则,并报国务院认证认可监 督管理部门备案。第十八条任何法人、组织和个人可以自愿委托依法设立的认证机构进行产品、服务、管理体系认证。Article 19 Noce
34、rtificationbodiesshallrefusetoprovidethe第十九条认证机构不得以委托人未参加认证咨询certificationserviceswithinthebusinessscopeoftheirowncertificationbodiesforthereasonthattheclientsfailtotakepartinthecertificationconsultationorcertificationtraining,etc.,norshalltheyputforwardtotheclientstherequirementsorrestrictedconditi
35、onsirrespectivetothecertificationactivities.Article 20 Thecertificationbodiesshallmakepublicsuchinformationasthebasiccertificationstandards,certificationrulesandchargingstandards,etc.Article 21 Thecertificationbodiesandtheinspectionorganizationsinrelationtocertification,aswellasthelaboratoriesshall,
36、whencarryingoutthecertificationactivitiesandinspectionandexaminationactivitiesinrelationtocertification,completetheproceduresasprescribedinthebasiccertificationstandardsandcertificationrules,soastoensuretheintegrity,impersonalityandtruthfulnessofthecertification,inspectionandexamination,noprocedures
37、shallbeincreased,reduced,oromitted.Thecertificationbodiesandinspectionorganizationsinrelationtocertification,aswellasthelaboratoriesshallmakefullrecordsontheprocessofcertification,inspectionandexamination,whichshallbekeptonfileforfuturereference.Article 22 Thecertificationbodiesandtheirpersonnelshal
38、lmakethecertificationconclusionsinlime,andensuretheimpersonalityandtruthfulnessofthecertificationconclusions,whichshallthenbesubscribedbythepersoninchargeofthe或者认证培训等为理由,拒绝提供本认证机构业务范围内的认证服务,也不得向委托人提出与认证活动无关的要求或者限制条件。第二十条认证机构应当公开认证基本规范、认证规则、收费标准等信息。第二H一条认证机构以及与认证有关的检查机构、实验室从事认证以及与认证有关的检查、检测活动,应当完成认证基
39、本规范、认证规则规定的程序,确保认证、检查、检测的完整、客观、真实,不得增加、减少、遗漏程序。认证机构以及与认证有关的检查机构、实验室应当对认证、检查、检测过程作出完整记录,归档留存。第二十二条认证机构及其认证人员应当及时作出认证结论,并保证认证结论的客观、真实。认证结论经认证人员签字后,由认证机构负责人签署。certificationbodiesafterbeingsignedbythecertificationpersonnel.Thecertificationbodiesandtheirpersonnelshallberesponsibleforthecertificationconcl
40、usions.Article23Incasetheproducts,services,andthemanagementsystemsarecertifiedasinconformitywiththerequirementsofcertificationbythecertificationconclusions,thecertificationbodiesshallissuethecertificatetotheclientsintime.Article24Thosewhohaveobtainedthecertificatesshallusethecertificatesandcertifica
41、tionmarkswithinthecertificationscope.Noentityshall,byusingtheproductandservicecertificates,certificationmarksandtherelativecharactersandsymbols,misleadthepublictobelievethattheirmanagementsystemshavepassedthecertification;ormisleadthepublictobelievethattheirproductsandserviceshavepassedthecertificat
42、ionbyusingtheadministrationsystemcertificates,certificationmarksandtherelativecharactersandsymbols.Article25Acertificationb(xlymaydevelopitscertificationmarksindependently.Thestyle,wordsorcharacters,ornameofthecertificationmarksdevelopedbyacertificationbodyindependentlyshallnotviolatetheprovisionsof
43、lawsandadministrativeregulations,shallnotbeidenticalwithorsimilartothecertificationmarkspromotedbythestate,shallnotimpedesocialadministration,andshallnotimpairsocialmoralsorgoodsocialclimates.认证机构及其认证人员对认证结果负责。第二十三条认证结论为产品、服务、管理体系符合认证要求的,认证机构应当及时向委托人出具认证证书。第二十四条获得认证证书的,应当在认证范围内使用认证证书和认证标志,不得利用产品、服务认
44、证证书、认证标志和相关文字、符号,误导公众认为其管理体系已通过认证,也不得利用管理体系认证证书、认证标志和相关文字、符号,误导公众认为其产品、服务已通过认证。第二十五条认证机构可以自行制定认证标志。认证机构自行制定的认证标志的式样、文字和名称,不得违反法律、行政法规的规定,不得与国家推行的认证标志相同或者近似,不得妨碍社会管理,不得有损社会道德风尚。Article26Thecertificationbodiesshallimplementeffectivefbllowing-upinvestigationsontheproducts,sendeesandmanagementsystemstha
45、thavebeencertifiedbythem.Incasetheproducts,sen,icesandmanagementsystemsthathavebeencertifiedfailtomeettherequirementsofthecertificationcontinuously,thecertificationbodiesshallsuspendtheiruseandevenrevokethecertificates,andmakethatknowntothepublic.Article27Inordertosafeguardthenationalsecurity,preven
46、tfraudulentacts,protectthehealthorsafetyofhumanbody,safeguardthelifeorhealthofanimalsandplants,andprotecttheenvironments,noproducts,whichmustbecertifiedasprescribedbytheState,mayleavethefactory,ormaybesold,importedorusedinotherbusinessactivitiesuntilafterbeingcertifiedandlabeledwiththecertificationm
47、arks.Article28TheStateshallunifythecataloguesofproducts,thecompulsiverequirements,standardsandconformityassessmentproceduresofthetechnicalnorms,andthemarks,aswellasthechargingstandardsforthoseproductsthatmustbecertified.Theuniformcataloguesofproducts(hereinafterreferstoastheCatalogues)shallbeformula
48、tedandadjustedjointlybythecertificationandaccreditationadministrationdepartmentoftheStateCouncilandtherelevantdepartmentsoftheStateCouncil,andshallbepublicizedbythecertificationandaccreditationadministrationdepartmentoftheStateCouncil,andimplementedtogetherwiththerelativedepartmentsand第二十六条认证机构应当对其认
49、证的产品、服务、管理体系实施有效的跟踪调查,认证的产品、服务、管理体系不能持续符合认证要求的,认证机构应当暂停其使用直至撤销认证证书,并予公布。第二十七条为了保护国家安全、防止欺诈行为、保护人体健康或者安全、保护动植物生命或者健康、保护环境,国家规定相关产品必须经过认证的,应当经过认证并标注认证标志后,方可出厂、销售、进口或者在其他经营活动中使用。第二十八条国家对必须经过认证的产品,统一产品目录,统一技术规范的强制性要求、标准和合格评定程序,统一标志,统一收费标准。统一的产品目录(以下简称目录)由国务院认证认可监督管理部门会同国务院有关部门制定、调整,由国务院认证认可监督管理部门发布,并会同有关方面共同实