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Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative. Detailed Rules for the Implementation of Compulsory Product Certification - Motorcycle Engine (the Detailed Rules) is developed in accordance with Rules for the Implementation of Compulsory Product Certification - Motorcycle Engine (CNCA-C11-03: 2014) and relevant general implementation rules including Rules for the Implementation of Compulsory Product Certification - Manufacturing Enterprise Classification Management, Certification Mode Selection and Determination (CNCA-00C-003), Rules for the Implementation of Compulsory Product Certification - Utilization of Testing Resources and Other Certification Results of Manufacturing Enterprises (CNCA-00C-004), Rules for the Implementation of Compulsory Product Certification - Requirements of Factory Quality Assurance Capacity (CNCA-00C-005) and Rules for the Implementation of Compulsory Product Certification - General Requirements for Factory Inspection (CNCA-00C-006). The Detailed Rules is issued by China Quality Certification Center (CQC) and its copyright is held by CQC. Any organization or individual shall not use all or any part hereof in any way without the approval of CQC. The Detailed Rules was amended firstly on January 5, 2017. The major amendments hereto are as follows: 1) The certification modes are adjusted two; 100% inspection for single certification of motorcycle engine is added; 2) The requirements on single certification are added for certification unit division; 3) The requirements specified in Attachment 2 and Attachment 3 are amended; the content relevant to GB 14622-2016 and GB 18176-2016 is added; 4) Attachment 7 "Requirements for Management of Single Motorcycle Engine Certification" is added. The Detailed Rules was amended secondly on November 21, 2017. The major amendments hereto are as follows: 1) The requirements of GB 7258-2017 are added in Attachment 2 "Type Test Scheme of Motorcycle Engine"; the error in "the starting time shall not be greater than 15.0s" (starting performance) is amended; 2) The requirements of GB 7258-2017 are added in Attachment 3 "Standards and Items of Type Tests"; 3) The requirements of GB 7258-2017 are added in Table 2 of Attachment 7 "Requirements for Management of Single Motorcycle Engine Certification". Developing organization: China Quality Certification Center Contents 0 Introduction 1 1 Application Scope 1 2 Terms and Definitions 1 3 Certification Standards 1 4 Certification Mode 2 4.1 Certification Mode of Motorcycle Engine 2 4.2 Single Certification Mode of Motorcycle Engine 2 5 Certification Unit Division 3 6 Certification Entrustment 3 6.1 Proposal and Acceptance of Certification Entrustment 3 6.2 Certification Entrustment Data 3 6.3 Implementation Arrangement 4 6.4 Certification Process 4 7 Certification Implementation 4 7.1 Type Test 5 7.2 Initial Factory Inspection 6 7.3 Adoption of Relevant Certification Results 8 7.4 Certification Evaluation and Decision 8 7.5 Time Limit of Certification 8 8 Post-certification Supervision 9 8.1 Post-certification Follow-Up Inspection 10 8.2 Production Site Sample Testing or Inspection 10 8.3 Market Sampling Testing or Inspection 11 8.4 Use of Quality Information 11 8.5 Frequency and Time of Post-certification Supervision 11 8.6 Post-certification Supervision Record 11 8.7 Evaluation of Post-certification Supervision Result 11 8.8 Conformity Parameter Management 11 9 Certification Certificate 12 9.1 Maintenance of Certification Certificate 12 9.2 Contents of Certification Certificate 12 9.3 Requirements of Certification Change (including Standard Edition Change) 12 9.4 Suspension, Cancellation and Revocation of Certification Certificate 14 9.5 Use of Certification Certificate 14 10 Certification Mark 14 10.1 Certification Mark 14 10.2 Mark Print or Post 14 11 Fee Charging 14 12 Certification Responsibility 15 13 Requirements for Process and Time Limit Related to Technology Disputes and Appeal 15 Attachment 1 List of Certification Entrustment Materials 16 Attachment 2 Motorcycle Engine Type Test Scheme (Sample) 18 Attachment 3 Standards and Items of Type Test 19 Attachment 4 Manufacturing Enterprise Resource Utilization 21 Attachment 5 Manufacturing Enterprise Classification Principles 23 Attachment 6 Content Requirements for Production Conformity Control Plan and Executive Report 28 Attachment 7 Requirements for Management of Single Motorcycle Engine Certification 36 0 Introduction The Detailed Rules for the Implementation of Compulsory Product Certification - Motorcycle Engine (hereinafter referred to as "the Detailed Rules") is developed in accordance with Rules for the Implementation of Compulsory Product Certification - Motorcycle Engine (CNCA-C11-03: 2014) (hereinafter referred to as "the Rules"); as the supportive documents for the Rules, it is applied together with the Rules. In accordance with a series of implementation rules Rules for the Implementation of Compulsory Product Certification - Manufacturing Enterprise Classification Management, Certification Mode Selection and Determination (CNCA-00C-003), Rules for the Implementation of Compulsory Product Certification - Utilization of Testing Resources and Other Certification Results of Manufacturing Enterprises (CNCA-00C-004), Rules for the Implementation of Compulsory Product Certification - Requirements of Factory Quality Assurance Capacity (CNCA-00C-005) and Rules for the Implementation of Compulsory Product Certification - General Requirements for Factory Inspection (CNCA-00C-006) (hereinafter presented with the code hereof) as well as the relevant requirements of China Quality Certification Center (hereinafter referred to as "CQC") quality manuals, procedure documents, operation guides and other documents, the Detailed Rules is developed and issued with a view to maintaining the effectiveness of product certification, improving product quality, facilitating certification applicant enterprises and controlling certification risks. The product coverage and certification standards that apply in the Detailed Rules are in accordance with the relevant requirements of the Rules, and adjusted according to the announcements on directory definition and adjustment issued by the Certification and Accreditation Administration of the People's Republic of China (hereinafter referred to as "CNCA"). 1 Application Scope The application scope of motorcycle engine products shall comply with Chapter 1 of the Rules. 2 Terms and Definitions For purpose of the Detailed Rules, the terms and definitions about motorcycle engine product listed Chapter 2 of the Rules apply. The terms and definitions relevant to certification listed in "Provisions on the Management of Compulsory Product Certification" and the implementation rules apply. 3 Certification Standards The certification standards listed in Attachment 1 "Items and Standards of Type Tests" to the Rules apply. On principle, the certification standards shall be the latest editions hereof issued by the administrative department of national standardization. Where new applicable standards or new editions of standards are adopted, the announcement of CNCA for the requirements of relevant applicable standard or the technical resolutions made by the motorcycle and parts expert group (TC12) of CNCA shall apply. 4 Certification Mode 4.1 Certification Mode of Motorcycle Engine The certification modes of motorcycle engine products comply with Chapter 4 of the Rules. In accordance with the requirements of the rules for the implementation and CNCA-00C-003, CQC will conduct differentiated certification modes in the concrete implementation of type tests, initial factory inspections and post-certification follow-up inspections in consideration of production mode, business management level and product characteristics. The basic certification modes are as follows: Type test + initial factory inspection (inspection on enterprise quality assurance capacity and product conformity) + post-certification supervision. The inspection on quality assurance capacity and product conformity of a motorcycle engine manufacturing enterprise shall be conducted according to the manufacture conformity inspection mode. The post-certification supervision mode shall be one or combination of post-certification follow-up inspection, production or port site sampling testing / inspection, and market sampling testing / inspection. One or combination of the following modes may be adopted if necessary: (1) Obtaining the actual test sample from market / production site samples; (2) Conducting follow-up inspection without advance notice / unannounced inspection; (3) Increasing the frequency of post-certification supervision; (4) Adding the coverage of testing and inspection and raising the probability of nonconformity detection. 4.2 Single Certification Mode of Motorcycle Engine Basic single certification mode: 100% inspection. It is applicable to the imported products for manufacturing and living consumption with a small batch which have not passed compulsory product certification due to special function or reason. The corresponding detailed rules are established by the certification authority in accordance with the relevant policies and requirements of the country. Note: ① The application scope of "special function or reason" refers to counter-terrorism security, disaster relief, emergency commanding, athletics, road test, country-level major production and construction project and end customer use (the import objective or use purpose indicated in the import permit issued by the commercial department must be "self use of organization or individual"). 5 Certification Unit Division The basis of unit division of motorcycle engine product shall comply with the requirements of Chapter 5 of the Rules. The certification client proposes the certification entrustment according to the unit division principle, and CQC will confirm the certification entrustment unit division with the certification client upon verification on the related data. Single certification product of motorcycle engine will not be subject to unit division, and it will be issued with certificate by model and engine number, a certificate for an engine. 6 Certification Entrustment 6.1 Proposal and Acceptance of Certification Entrustment Certification entrustment and acceptance of motorcycle engine product shall comply with the requirements of 6.1 of the Rules. The certification client shall submit the certification entrustment data in accordance with CQC certification process and requirements, and it shall be responsible for the authenticity and legality of the certification entrustment data submitted. The certification entrustment will be rejected in case of one of the following circumstances: (1) The scope of business does not cover the product to be certificated in the registration supporting documents of the certification client and/or the producer (manufacturing enterprise); the legal supporting document is deficient; (2) The circumstances that the certification entrustment shall be rejected in according to other laws and regulations. 6.2 Certification Entrustment Data The certification client shall submit the related certification entrustment data in accordance with Attachment 1 "List of Certification Entrustment Data" of the Detailed Rules after the certification entrustment intention is accepted. At the first certification entrustment, the certification client shall submit all relevant certification data involved in Attachment 1 to the Detailed Rules, in which, the certification unit information in Item 3 shall be submitted together with each certification unit; the submission time of the execution report for the manufacture conformity control plan shall be in accordance with 7.5 of the Detailed Rules. CQC will conduct the compliance verification on the certification entrustment data in accordance with the relevant review requirements after receipt of the available certification entrustment data. If the data cannot meet the requirements, CQC shall inform the certification client of supplementing it. CQC is in charge of the review, management, preservation and confidentiality of relevant data, and shall inform the certification client of the result of data review. 6.3 Implementation Arrangement When accepting the certification entrustment intention, CQC will send Product Assessment Activity Plan to the certification client, which specifies the agreed responsibilities and arrangement of CQC and certification client in all the links of the certification process. Based on the actual condition and sort management of the production (manufacturing) enterprise, CQC will develop the type test scheme jointly with the certification client and the laboratory 6.4 Certification Process The certification client submits the entrustment intention letter (CQC website: http://www.cqc.com.cn), and then CQC accepts the entrustment intention and start the certification process. The normal certification process is as follow: The certification client submitting the certification data (on-line or in writing) → CQC conducting the data examination according to the entrustment unit, determining the testing scheme and issuing the type test requirements → the certification client submitting the sample in accordance with the type test requirements, the appointed laboratory conducting the type tests and issuing the type test report to CQC → CQC developing the factory inspection scheme according to the production conformity control plan submitted by the certification client and arranging the factory inspection → conducting factory site inspection → verifying the type test report and the factory inspection report, giving the assessment and approval of the certification results, and issuing the authentication certificate → conduct routine supervision on the certificated production enterprise. Special certification process: failing to conduct the type test but directly providing the type test report; failing to complete product type test (for certification) but conducting the factory inspection. If failing to conduct the type test but directly providing the type test report, the type test results shall be judged acceptable upon the results of all test items shall meet the requirements of the standard and all type test samples pass the conformity inspection; if failing to complete product type test (for certification) but conducting the factory inspection, the certification client needs to file an application to CQC and the factory inspection shall be conducted upon the approval of CQC. Note: prior to factory inspection, the letter of invitation shall be sent to foreign manufacturing enterprise, certification client and producer (manufacturing enterprise) in an appropriate time be convenient for arrangement of foreign review. 0 Introduction 1 Application Scope 2 Terms and Definitions 3 Certification Standards 4 Certification Mode 4.1 Certification Mode of Motorcycle Engine 4.2 Single Certification Mode of Motorcycle Engine 5 Certification Unit Division 6 Certification Entrustment 6.1 Proposal and Acceptance of Certification Entrustment 6.2 Certification Entrustment Data 6.3 Implementation Arrangement 6.4 Certification Process 7 Certification Implementation 7.1 Type Test 7.2 Initial Factory Inspection 7.3 Adoption of Relevant Certification Results 7.4 Certification Evaluation and Decision 7.5 Time Limit of Certification 8 Post-certification Supervision 8.1 Post-certification Follow-Up Inspection 8.2 Production Site Sample Testing or Inspection 8.3 Market Sampling Testing or Inspection 8.4 Use of Quality Information 8.5 Frequency and Time of Post-certification Supervision 8.6 Post-certification Supervision Record 8.7 Evaluation of Post-certification Supervision Result 8.8 Conformity Parameter Management 9 Certification Certificate 9.1 Maintenance of Certification Certificate 9.2 Contents of Certification Certificate 9.3 Requirements of Certification Change (including Standard Edition Change) 9.4 Suspension, Cancellation and Revocation of Certification Certificate 9.5 Use of Certification Certificate 10 Certification Mark 10.1 Certification Mark 10.2 Mark Print or Post 11 Fee Charging 12 Certification Responsibility 13 Requirements for Process and Time Limit Related to Technology Disputes and Appeal Attachment 1 List of Certification Entrustment Materials Attachment 2 Motorcycle Engine Type Test Scheme (Sample) Attachment 3 Standards and Items of Type Test Attachment 4 Manufacturing Enterprise Resource Utilization Attachment 5 Manufacturing Enterprise Classification Principles Attachment 6 Content Requirements for Production Conformity Control Plan and Executive Report Attachment 7 Requirements for Management of Single Motorcycle Engine Certification 1适用范围 摩托车发动机产品的适用范围依据产品实施规则第1条执行。 2术语和定义 摩托车发动机产品的相关术语和定义依据产品实施规则第2条执行。 认证相关术语和定义依据《强制性产品认证管理规定》及各规则规定执行。 3认证依据标准 认证依据的标准按照产品实施规则附件1《型式试验项目及依据标准》执行。 原则上,认证检测依据用标准应执行国家标准化行政主管部门发布的最新版本。当需增加新适用标准或使用标准的其他版本时,则应按国家认监委发布的适用相关标准要求的公告或国家认监委摩托车及部件技术专家组(TC12)的技术决议执行。 4认证模式 4.1摩托车发动机认证模式 摩托车发动机产品的认证模式依据产品实施规则第4条执行。 CQC依据产品实施规则及CNCA-00C-003的要求,在型式试验、初始工厂检查、获证后跟踪检查的具体实施中根据生产方式、企业管理水平和产品特点的不同采取差异化的认证模式。 基本模式: 型式试验+初始工厂检查(企业质量保证能力和产品一致性检查)+获证后监督 摩托车发动机生产企业质量保证能力和产品一致性检查按照生产一致性检查方式进行。 获证后监督方式为获证后的跟踪检查、生产或口岸现场抽样检测或检查、市场抽样检测或检查三种方式之一或各种组合。必要时采取以下方式之一或各种组合: (1)通过市场/生产现场抽取样品等方式获取真实的试验样品; (2)采取预先不通知方式的跟踪检查/飞行检查; (3)增加获证后监督的频次; (4)增加检测/检查的覆盖面,提高发现不合格的概率。 4.2摩托车发动机单机认证模式 单机认证基本模式:100%检验。适用于因特殊用途或因特殊原因 ①而未获得强制性产品认证的小批量用于生产和生活消费的进口产品。 由认证机构根据国家相关政策和规定制定相应的实施细则。 注:①特殊用途或因特殊原因的适用范围为反恐安全、抢险救灾、应急指挥、体育竞技、道路试验、国家重大生产建设项目和最终用户使用(商务部门进口许可证上列明的进口目的或使用用途须为单位或个人自用)。 5认证单元划分 摩托车发动机产品的单元划分依据产品实施规则第5条要求执行。 认证委托人依据单元划分原则提出认证委托,CQC在审核相关资料后与认证委托人最终确定认证委托单元划分。 摩托车发动机单机认证产品不进行单元划分,以型号和发动机编号为单位颁发证书,一机一证。 6认证委托 6.1认证委托的提出和受理 摩托车发动机产品的认证委托和受理依据产品实施规则第6.1条的要求执行。 认证委托人根据CQC的认证流程和要求提交认证委托资料,认证委托人应对提交认证委托资料的真实性和合法性负责。 有下列情形之一的不予受理: (1)认证委托人、生产者(制造商)、生产企业的注册证明材料中,经营范围未覆盖认证产品;法律证明材料缺失; (2)其他法律法规规定不得受理的情形。 6.2认证委托资料 认证委托人应在认证委托意向受理后,按本细则《附件1:认证委托资料清单》的要求提供有关认证委托资料。 本细则附件1涉及到的相关认证资料,认证委托人应在首次认证委托时完全提交,其中第3条认证单元信息应随同每一认证单元提交,生产一致性控制计划执行报告的提交时间依据本细则第7.5条要求执行。 CQC收到有效的认证委托资料后,依据相关评审要求对认证委托材料进行符合性审核。如资料不符合要求,应通知认证委托人补充完善。 CQC负责审核、管理、保存、保密有关资料,并将资料评审结果告知认证委托人。 6.3实施安排 CQC在受理委托认证意向时向认证委托人发送《产品评价活动计划》,其中规定了CQC与认证委托人约定双方在认证实施各环节中的相关责任和安排。 根据生产企业实际和分类管理情况,CQC将与认证委托人和实验室协调制定型式试验方案。 6.4认证流程 认证委托人向 CQC提交意向委托书(在CQC 网站http://www.cqc.com.cn上完成),CQC接受意向委托开始认证流程。 正常认证流程为: 认证委托人递交认证资料(网上或书面)→CQC按委托单元进行资料审查,确定试验方案并下达型式试验要求→认证委托人依据型式试验要求进行送样,指定实验室进行型式试验并向CQC出具型式试验报告→CQC依据认证委托人提交的生产一致性控制计划制定工厂检查方案并安排工厂检查→进行工厂现场检查→审核型式试验报告、工厂检查报告并作出认证结果的评价和批准,签发认证证书→对获证生产企业进行日常监督检查。 非正常认证流程为:未按正常认证流程进行型式试验而直接提供型式试验报告的;未完成认证产品型式试验而进行工厂检查的。 未按正常认证流程进行型式试验而直接提供型式试验报告的,需所有检测项目的检测结果全部符合标准要求且型式试验样品一致性审查通过后,方可判定型式试验结果合格;未完成认证产品型式试验而进行工厂检查的,认证委托人需向CQC提出申请,经批准后可同时进行。 注:在工厂检查前,对于国外生产企业,认证委托人、产品生产者(制造商)或生产企业应在适当的时间发邀请函,以便于安排国外审查的工作。 7认证实施 7.1型式试验 7.1.1型式试验方案 CQC受理认证委托并进行资料审核,确定试验方案后,方可进行型式试验。 型式试验方案包括型式试验的全部样品要求和数量、检测标准项目、实验室信息等。 认证委托人在国家认监委指定范围内可自行选择实验室,试验方案的制定应征询认证委托人及实验室的意见。 型式试验应以认证委托单元为基础进行,型式试验方案参见本细则《附件2:摩托车发动机产品型式试验方案》。 7.1.2型式试验样品要求 型式试验的样品要求应满足产品实施规则7.1.2条相关内容要求。 原则上,同一委托认证单元下,型式试验项目中涉及摩托车发动机结构和技术参数相同的可根据具体情况只进行1次试验;若执行标准有具体要求时,可依据标准内容进行扩展;同一委托认证单元下有多个认证产品时,差异部分应补充试验。 依据国家认监委发布的相关规定文件及产品实施规则7.3的要求,对已获得强制性产品认证或国家认监委承认的自愿性产品认证的部件、总成,仅需确认装机的部件、总成规格型号与证书的一致性以及该证书的有效性,无需随样机送样检测或追加工厂检查。 生产现场或市场抽样检查或检测时,认证委托人、生产者(制造商)、生产企业应积极配合,从合格产品中抽取样品,同型号样品至少抽取2个样本,其中1个封样留存至试验完结或进行复验。 7.1.3型式试验项目及要求 型式试验项目见本细则《附件3:型式试验依据标准及试验项目》。 原则上,认证检测依据用标准应执行国家标准化行政主管部门发布的最新版本。当需增加新适用标准或使用标准的其他版本时,则应按国家认监委发布的适用相关标准要求的公告或国家认监委摩托车及部件技术专家组(TC12)的技术决议执行。 对于因技术进步,整机或相关系统、零部件采用新设计、新工艺时,生产者和/或生产企业应提供摩托车发动机满足相关安全标准的验证结果,由CQC进行判定,涉及重大安全、环保等项目时,还需通过国家认监委摩托车及部件技术专家组(TC12)决议。 单机认证实施100%检验,按照本细则附件7执行。 7.1.4型式试验的实施 型式试验依据产品实施规则7.1.4条的要求进行,相关时限依据本实施细则7.5条要求进行。 若有试验项目不合格,允许在对不合格产生原因分析后进行整改,整改完成后重新进行复试。凡需复试的,实验室须将试验情况通报CQC,由CQC重新确认试验方案。当复试全部检测项目/整改验证合格时,方为产品型式试验复试通过;检测复试结果不合格,为产品型式试验不合格。整改和复试应在限定期限内完成,相关期限要求依据本细则第7.5条要求执行,超过该期限的视为认证委托人放弃认证委托,终止认证;认证委托人也可主动终止认证,认证委托人应按本细则第11条的收费要求支付已发生费用。 如生产企业具备CNCA-00C-004和认证标准要求的检测条件,CQC可利用生产企业检测资源组织实施生产现场抽样检测(或目击检测),并由指定实验室出具检测报告,具体要求及程序参考本细则《附件4生产企业资源利用》的相关规定。 7.1.5型式试验报告 CQC规定统一的型式试验报告格式。 型式试验结束后,实验室应及时向CQC、认证委托人出具型式试验报告。认证委托人应确保在获证后监督时能够向CQC和执法机构提供完整有效的型式试验报告。 7.2初始工厂检查 初始工厂检查为认证机构对确定生产企业质量保证能力、产品一致性和标准符合性控制能否符合认证要求而开展的现场检查和评价。 初始工厂检查应在型式试验合格后进行。根据需要,型式试验和初始工厂检查也可以同时进行。 7.2.1基本原则 CQC按照产品实施规则、(CNCA-00C-005)、(CNCA-00C-006)等文件的要求,根据审核通过后的生产企业生产一致性控制计划制定初始工厂检查方案,对生产企业的生产一致性控制体系进行符合性检查,确保工厂检查要求得到落实。 检查应覆盖所认证委托产品以及所认证委托产品的加工场所。必要时,CQC可到生产企业以外的场所实施延伸检查。对于不在生产企业现场进行的外包过程,检查应予以覆盖;若为自制关键零部件,检查应覆盖其制造过程;若为外购关键零部件,应按供应商管理方式进行控制。 对于生产企业搬迁等需要初始工厂检查的情况,原则上按照企业分类中的B类企业下达工厂检查任务和检查方案;工厂检查方案中应包含可能影响企业分类管理的因素,并在现场检查中加以覆盖。 初始工厂检查原则上应在型式试验合格后一年内完成,否则应重新进行产品型式试验。 7.2.2工厂检查 按生产一致性控制计划审查+生产一致性工厂现场检查方式进行。 7.2.2.1生产一致性控制计划审查 摩托车发动机产品的生产一致性控制计划审核依据产品实施规则7.2.2.1条执行,具体见本细则附件6《生产一致性控制计划及执行报告内容要求》,相关时限依据本细则7.5条要求进行。 7.2.2.2生产一致性工厂检查 CQC将在型式试验合格和生产一致性控制计划审查合格后,委派具有国家注册资格的强制性产品认证检查员组成检查组,对生产企业进行生产一致性检查的现场检查。 检查时,生产企业应有委托认证的产品在生产,且检查组能够在现场抽取到生产完成的样品用于检查活动。特殊情况下应有同类产品在生产。 生产一致性工厂现场检查是在生产者或生产企业生产一致性控制计划审查通过后,到生产一致性控制的现场对生产一致性控制计划的执行情况进行确认,应覆盖委托认证产品及委托认证产品的加工场所。 对于未按正常认证流程进行型式试验而直接提供型式试验报告的,CQC将在生产一致性现场检查时,追加产品实施规则附件4附录1产品结构及技术参数一致性审查中第1.1、1.2和1.3条审查,增加的人日数以实际检查时间为准。 生产一致性现场检查相关时限依据本细则7.5条要求进行。 7.2.3结构及技术参数核对及检查 CQC在经生产企业确认合格的产品中,随机抽取委托认证产品进行包括但不限于下述内容的检查: (1)认证产品与《摩托车发动机产品结构及技术参数》的一致性检查; (2)认证产品现场指定试验。 产品一致性检查应覆盖认证摩托车发动机产品类型,工厂检查组对抽取的审查样本负责。工厂检查组在现场审查时发现企业生产一致性控制计划存在缺陷,应向CQC提出意见和建议。 7.2.4工厂检查结果 工厂检查结果的决定依据产品实施规则7.2.4条执行。 7.2.5工厂检查时间 工厂检查相关时限依据本细则7.5条要求进行。 7.3对相关认证结果的采信 对于已获得国家认监委承认的相关机构颁发的质量管理体系认证证书的工厂,可承认质量管理体系认证中与质量保证能力审查相同部分的结果,并减免审查人日数。 对已获得强制性产品认证的零部件和系统,仅需确认装车的零部件规格型号与证书的一致性及该证书的有效性; 对已获得国家认监委发布的自愿性产品认证的零部件和系统,仅需确认装机的零部件、系统和单独技术总成规格型号与证书的一致性及该证书的有效性。 具体的实施要求参考CQC相应的程序文件。 7.4认证评价与决定 CQC对型式试验、初始工厂检查结果和有关资料/信息进行综合评价,评价通过,按单元颁发认证证书;评价不通过,认证终止。 7.5认证时限 CQC对认证流程制定的时限要求,认证委托人须对认证活动予以积极配合,以确保相关工作按时限要求完成。 一般情况下,自受理认证委托起90天内向认证委托人出具认证证书,包括型式试验时间、初始工厂检查时间及检查后提交报告时间(适用时)、认证结果评价和批准时间,以及证书制作时间。 以上认证活动完成时间,不包括认证委托人准备资料、试验样品不符合整改时间及复试检测时间。对不符合认证要求的情况,CQC应通知认证委托人,并说明理由。 CQC应在2个工作日内接受认证委托人的意向委托并发出受理通知,或告知认证委托人不受理原因。 资料审核,委托资料的齐全性、完整性、符合性审核一般在5个工作日内完成,其中,生产一致性控制计划的审查时间根据所委托认证产品数量和产品涉及认证标准的数量确定,一般每个生产企业的生产一致性控制计划的审查时间为0.5~2个人日。 型式试验方案制定及下达一般不超过2个工作日。 型式试验时间一般在30个工作日完成,若有检测项目不合格,可允许限期(不超过三个月)整改和复试,对于型式试验有特殊时间要求的,型式试验时间可以适当延长。 工厂检查方案制定一般不超过5个工作日。 生产一致性现场检查时间为2—4个人日,工厂检查存在不合格项,可允许限期(不超过3个月)整改。 审核型式试验报告、工厂检查报告并做出认证结果的评价和批准,签发认证决定的时间,一般为5个工作日。 生产一致性控制计划执行报告应于每年监督检查前2个月完成提交。 生产一致性控制计划执行报告审查的时间为0.5-1人日。 对获证后的跟踪检查时发现的不符合项应在3个月内完成整改,否则,跟踪检查不通过。 认证委托人、生产者(制造商)、生产企业对认证实施工作应予以积极配合和协助。由于认证委托人、生产者(制造商)、生产企业其自身原因逾期未完成认证活动导致认证超时,不计入认证时间内。 注:1、生产企业不在中国大陆时,认证周期允许适当延长。 8获证后监督 获证后监督是指认证机构对获证产品及其生产企业实施的监督。 CQC依据本实施细则《附件5:生产企业分类原则》的要求对生产企业进行分类管理,对获证生产企业及产品实施有效的跟踪检查,以确保获证产品持续符合标准要求并保持与型式试验样品的一致性,验证生产企业的质量保证能力持续符合认证要求。 8.1获证后的跟踪检查 8.1.1获证后的跟踪检查原则 依据本实施细则附件5的要求对分类企业采取不同类型的跟踪检查。 获证后的跟踪检查应在生产企业正常生产时进行,可采取预先通知被检查方和不预先通知被检查方两种方式。对于某些非连续生产的产品,认证委托人应向CQC提交相关生产计划,便于后续跟踪检查的有效开展。 检查应覆盖所认证委托产品以及所认证委托产品的加工场所。必要时,CQC可到生产企业以外的场所实施延伸检查。对于不在生产企业现场进行的外包过程,检查应予以覆盖;若为自制关键零部件,检查应覆盖其制造过程;若为外购关键零部件,应按供应商管理方式进行控制。 8.1.2获证后的跟踪检查内容 对于摩托车发动机产品生产企业获证后的跟踪检查内容包括生产一致性控制计划执行报告审查和生产一致性现场检查。在进行工厂现场监督检查之前,CQC将对认证委托人、生产者(制造商)、生产企业提交的生产一致性控制计划执行报告进行审查。 生产一致性控制计划执行报告审查具体见本细则附件6《生产一致性控制计划及执行报告内容要求》,时间依据本细则7.5条要求进行。 8.2生产现场抽取样品检测或者检查 8.2.1生产现场抽取样品检测或者检查原则 生产现场抽取样品检测或者检查至少覆盖摩托车发动机产品类型(不同燃油供给方式)。 采取生产现场抽取样品检测或者检查方式实施监督的,认证委托人、生产者、生产企业应予以配合。 8.2.2生产现场抽取样品检测或者检查内容 抽样要求:按摩托车发动机产品类型(不同燃油供给方式)在合格品中(包括生产线、仓库或口岸)随机抽取样品。 检测或者检查的内容:产品一致性核查(与型式试验的样品、申报摩托车发动机结构和技术参数的一致性)、摩托车发动机产品生产一致性控制计划中生产企业具备相关检测能力的试验项目。 8.3市场抽样检测或者检查 8.3.1市场抽样检测或者检查原则 采取市场抽样检测或者检查方式实施监督的,认证委托人、生产者、生产企业应予以配合并确认市场抽取的样品。 8.3.2市场抽样检测或者检查内容 抽样要求:按摩托车发动机产品类型(不同燃油供给方式)在出厂产品或市场销售的产品中(包括整机厂、4S店、经销商以及用户处等)随机抽取样品。从用户处抽样时,应向摩托车生产企业确认抽取的样品的状态。抽取的样品由抽样人封样后,送至指定的检测机构。 检测或者检查的内容:产品一致性核查(与型式试验的样品、申报摩托车发动机结构和技术参数的一致性)、摩托车发动机相关试验(根据审查目的确定)。 如生产企业具备标准和认证实施细则要求的检测条件(见本细则附件4),对于A、B类企业可利用生产企业检测资源实施检测(或目击检测),并承认相关结果;如生产企业不具备标准要求的检测条件,应将样品送指定实验室检测。 8.4质量信息应用 依据产品实施规则8.4条的要求执行。 8.5获证后监督的频次和时间 CQC依据本细则附件5的要求,对不同类别的生产企业采用不同的获证后监督频次和时间。 8.6获证后监督的记录 CQC对获证后监督全过程予以记录并归档留存,以保证认证过程和结果具有可追溯性。 8.7获证后监督结果的评价 获证后监督结果评价通过,可继续保持认证资格,使用认证标志。获证后监督结果评价不通过的,CQC根据相应情形做出暂停/注销/撤销认证证书的处理,并予公布。 获证后监督结果不满足认证要求,允许整改,CQC将采取适当方式对整改结果进行验证并评价,整改时间依据本实施细则7.5条执行。 8.8一致性参数管理 CQC依据产品实施规则8.8要求执行。 |
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