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0. Introduction The Detailed Rules for the Implementation of Compulsory Product Certification - Devices for Indirect Vision of Motor Vehicles (hereinafter referred to as the Detailed Rules) is prepared according to the requirements of the Rules for the Implementation of Compulsory Product Certification - Devices for Indirect Vision of Motor Vehicles (CNCA-C11-08:2014) (hereinafter referred to as the Rules), and shall be used jointly with the Rules as an auxiliary document for the Rules. The applicable product scope, certification basis and all other contents of the Detailed Rules are consistent with the relevant requirements of the Rules and are subject to adjustment according to the announcement on catalogue definition and adjustment issued by the Certification and Accreditation Administration of the People's Republic of China (hereinafter referred to as CNCA). CQC formulates and publishes the Detailed Rules according to the requirements of the Rules and in line with the principles of maintaining the effectiveness of product certification, improving product quality, serving for certification enterprises, controlling the certification risk, etc. The Detailed Rules specifies the implementation requirements for compulsory product certification of devices for indirect vision of motor vehicles through establishing requirements for classified management of manufacturing enterprises and in combination with classification of manufacturing enterprises. 0.1 Terms and Definitions 0.1.1 Devices for indirect vision: devices used by the driver to observe the traffic areas which are adjacent to the vehicle but cannot be observed in the direct vision, including: Automobile view mirror: assembly of optical view mirrors, including various interior view mirrors, exterior view mirrors and surveillance rear-view mirrors, used for clearly observing the images behind and beside the vehicle in the specified field of vision through the reflection plane; Motorcycle rear-view mirror: rear-view mirror assembly of motorcycle and moped, used for providing a clear rear field of vision; Camera-monitor device: device used for clearly observing the images of adjacent area of vehicle through the system composed of camera and monitor. It includes camera, monitor and recording device. See GB 15084 for the specific definitions. 0.1.2 Testing at Manufacturing Enterprise's Premises (hereinafter referred to as TMP mode) The engineer from the designated laboratory conducts testing with the testing equipment that belongs to the factory laboratory; the factory shall dispatch testing personnel to assist. Relevant designated laboratory shall be responsible for approval and issuance of testing report. 0.1.3 Witnessed Manufacturing Enterprise's Testing (hereinafter referred to as WMT mode) The engineer from the designated laboratory witnesses all the testings completed under the factory laboratory testing conditions and with the equipment of the factory laboratory or witnesses partial testing conditions and items in allusion to the testing plan submitted by the factory. The testing personnel of factory laboratory is responsible for issuing original record and drafting, in conjunction of the witness engineer from designated laboratory, the testing repot according to the format required. The relevant designated laboratory is responsible for approval and issuance of testing report. 0.2 Requirements for Classified Management of Manufacturing Enterprises CQC acquires and reorganizes all kinds of information relevant to the quality of certified product and its manufacturing enterprise so as to realize classified management of manufacturing enterprise in a dynamic way. The certification client, producer and manufacturing enterprise shall coordinate with CQC. CQC classifies the manufacturing enterprises into four categories which are expressed as A, B, C and D respectively. The quality information on which manufacturing enterprise classification is based contains at least the following aspects: (1) Factory inspection (including initial factory inspection and post-certification follow-up inspection) results; (2) Sample testing and/or supervision sampling testing (including type test, production site sampling or market sampling) results and sample authenticity; (3) Results of national or provincial random inspection, CCC special random inspection, etc.; (4) Coordination of certification client, producer (manufacturer) and manufacturing enterprise in post-certification supervision; (5) Judicial decision, complaint, arbitration, media exposure, consumer quality information feedback, etc.; (6) Quality condition of certified product; (7) Other information. See the table below for the principles for classification of manufacturing enterprises. Table 1 Principles for Classification of Manufacturing Enterprises Enterprise category Classification principle Category A Category B enterprises provide conformity data to CQC which conducts comprehensive risk assessment on the collected quality information and data provided by the enterprise and determines the category result. The assessment shall at least cover the following aspects: 1. Factory inspection: initial factory inspections/post-certification follow-up inspections in the last two years (including the current year) are free of nonconforming item affecting the product conformity; 2. Results of testing and random inspection for products: there is no nonconforming item found in post-certification supervision and testing in the last two years (including the current year); the conclusion of all national and provincial inspections and CQC special inspections is "qualified"; 3. Product testing capacity: the manufacturing enterprise (or its manufacturer and parent company) shall possess testing capacity required by certification standards. (Conforming to technical capacity requirements specified in Chapter 5 of GB/T 27025 (IEC 17025)); 4. Output: the output of the product covered by CCC certificate is maintained at a certain level within the supervision period; 5. Other information related to the quality of the certified product and its manufacturing enterprise. Category B Other manufacturing enterprises except those of Categories A, C and D. Manufacturing enterprises without any quality information are classified into Category B by default. Category C Manufacturing enterprise meeting any of the following conditions: 1. Conclusion of factory inspection is judged as "site verification" (except for version change of standard); 2. There is product quality problem for the reason of enterprise, but the problem is not serious enough to result in suspension of certificate; 3. The manufacturing enterprise needs to be adjusted to Category C as considered by CQC as per the result of comprehensive assessment on the relevant quality information of manufacturing enterprise and certified product. Category D Manufacturing enterprise meeting any of the following conditions: 1. Conclusion of factory inspection is judged as "rejected"; 2. The result of post-certification supervision and testing is "unqualified" (except for unqualified instructions/identifications); 3. Reject inspection and/or supervision sampling without justifiable reasons; 4. There is relatively big product quality problem for the reason of enterprise and the problem results in suspension or revocation of certificate; 5. The conclusion of national and provincial inspections and CCC special inspections is judged as "unqualified" and the product safety performance is affected (except for unqualified instructions/identifications); 6. The manufacturing enterprise needs to be adjusted to Category D as considered by CQC as per the result of comprehensive assessment on the relevant quality information of manufacturing enterprise and certified product. CQC will determine the classification result (category) of manufacturing enterprises according to the above classification principles based on various quality information acquired in real time. CQC will reclassify the manufacturing enterprises periodically or aperiodically according to various information so as to realize dynamic management. If there is any change, classification is subject to CQC's public documents. In principle, the result of manufacturing enterprise classification must be gradually upgraded in the sequence of D-C-B-A while degraded in the sequence of A-B-C-D, or directly adjusted to corresponding category after risk assessment. 0.3 Requirements for Utilization of Testing Resources of Manufacturing Enterprise 0.3.1 Scope Application scope: post-certification supervision sampling testing, and difference testing supplemented at certificate alteration. 0.3.2 Implementation If the manufacturing enterprise possesses the testing equipment and testing capacity as required by Rules for the Implementation of Compulsory Product Certification - Utilization of Testing Resources and Other Certification Results of Manufacturing Enterprises and certification standard, the certification client, producer or manufacturing enterprise may file an application for utilizing the testing resources of manufacturing enterprise (hereinafter referred to as factory laboratory) and conduct self-inspection. Then the self-inspection result and relevant information shall be submitted to CQC for review. Only the factory laboratory judged as qualified after the data review can utilize the testing resources of manufacturing enterprise to conduct TMP or WMT on production site (hereinafter referred to as site testing). In principle, CQC doesn't separately organize review for factory laboratory. The factory laboratory review application from the certification client shall be proposed simultaneously with the production site testing application. CQC organizes technical experts from the designated laboratory to conduct laboratory review and site testing simultaneously. The review team conducts laboratory capacity review first and preserves corresponding review assessment record, and then conducts production site testing after acceptance of laboratory review. 0.3.3 Qualification maintenance CQC shall conduct periodical supervision (such as annual supervision, which may be determined according to utilization frequency) for the approved factory laboratory. In principle, laboratory supervision needs to be conducted in combination with the post-certification supervision of factory. Factory laboratory shall participate in contrast test to guarantee the accuracy and effectiveness of testing result and maintain the qualification. If required by the manufacturing enterprise, single checking may be conducted for the site testing item proposed by the certification client, and the checking result is only valid for this site testing item. Factory laboratory may not be subject to the supervision of qualification maintenance. Where site testing for the same item is required, the examination shall be applied again. 1. Application Scope The Detailed Rules is applicable to the devices for indirect vision installed on Categories M, N and L motor vehicles, including automobile view mirror, motorcycle rear-view mirror and camera-monitor device. The adjustment of application scope caused by the changes of laws, regulations, relevant product standards, technologies, industrial policies and other factors shall be subject to the announcement issued by CNCA. 2. Certification Standards GB 15084 Motor Vehicles - Devices for Indirect Vision - Requirements of Performance and Installation GB 17352 Performance and Installation Requirements of Rear Views Mirrors for Motorcycles and Mopeds In principle, the latest editions of above standards issued by the administrative department of national standardization shall apply. Other editions of the standards, if required, shall be subject to the CNCA's announcement on applicability to the requirements of relevant standards. 3. Certification Mode 3.1 Basic Certification Mode Basic certification mode for compulsory certification of devices for indirect vision is as follows: Type test + initial factory inspection + post-certification supervision; The post-certification supervision in the above-mentioned basic certification mode includes two modes: post-certification follow-up inspection and supervision sampling testing; thereinto, supervision sampling testing is further divided into sampling testing or inspection on production site and market sampling testing or inspection. The combination of relevant certification elements shall be appropriately considered for the post-certification supervision of different categories of enterprises in combination with the principle of classified management of production enterprises. 3.2 Applicability of Certification Mode Category A: one of or the combination of post-certification follow-up inspection, sample testing or inspection on production site and market sampling testing or inspection may be adopted for the post-certification supervision. Categories B, C and D manufacturing enterprises: post-certification follow-up inspection + supervision sampling testing (production site sampling and/or market sampling) shall be adopted for the post-certification supervision. The certification mode for manufacturing enterprise of service part products of off-production vehicle type may be selected according to Attachment 2 herein. The certification client may propose application for applicable certification mode according to its own actual situation. According to the characteristics of product applied for certification and the certification risk control principle, CQC shall determine an applicable certification mode for the certification client in combination with the classified management result of manufacturing enterprises. 4. Certification Unit Division In principle, the devices for indirect vision of motor vehicles produced by the same producer (manufacturer) in the same manufacturing enterprise (site) and free of significant difference in the following aspects shall be regarded as a certification unit: (1) Design of device (including the design of the connecting pieces with vehicle body if related), e.g.,: structure and material of retention components, structure and material of connecting pieces (support member), connection mode with the vehicle body, and mirror regulation mode, etc.; (2) As for view mirror, the class and shape of view mirror, and the dimension and radius of curvature of reflection plane; (3) As for camera-monitor device, the detection distance and vision field. The certification client shall propose certification entrustment according to unit division principle. One unit may contain multiple models of products. Products of the same model refer to the products having no effect on compliance with standards in design. For the same products (with the same production process and the same key part/raw material supplier) with the same producer but different manufacturing enterprises or the same products with different producers but the same manufacturing enterprise, they may be regarded as different application units, but type test may only be conducted on the samples within one unit; and for the products of other manufacturing enterprises/producers, necessary data shall be provided for conformity check. 5. Certification Entrustment 5.1 Proposal and Acceptance of Certification Application The certification client shall propose certification entrustment to CQC online (www.cqc.com.cn) and then fill in necessary enterprise information and product information as required. CQC shall examine the application according to relevant requirements, and send out the acceptance or refusal notice within 2 workdays, or require the certification client to re-propose the certification application after correction. 5.2 Application Data After the application is accepted, the certification client shall provide relevant application data and technical materials to CQC and/or the designated laboratory according to the requirements of certification scheme; these data and materials generally include: (1) Certification application form; (2) The following registration certificate and relevant documents of the certification client, producer and manufacturing enterprise: a. Business License and Organization Code Certificate (upon initial application and alteration); b. In case of any inconsistency among the above three parties, the relevant agreement or contract (e.g., agreement on consigned processing, and power of attorney) (if applicable) signed by parties concerned shall also be submitted; c. If the applicant is a seller or an importer, it shall submit copies of relevant contracts concluded between the seller and the producer or between the importer and the producer (upon initial application and alteration); d. Power of attorney for the agent (if applicable); e. The certification of overseas manufacturer from domestic entity capable of assuming legal liabilities (if required by relevant laws and regulations). (3) Technical data like product description, picture and product drawing of each certification unit shall be provided according to Annex 1 of the Rules. As for an unit containing multiple models/specifications of products, description to the differences between different models shall also be provided. Such data shall be filled in according to the format of specific technical document issued by CQC, and electronic data shall be submitted. (4) List of key parts/raw materials The list of key parts/raw materials of each certification unit shall be provided according to the requirements of Attachment 1 herein. As for the key parts/raw materials (e.g., direction-indicator lamp, etc.) purchased domestically within the scope of compulsory product certification, the manufacturing enterprise shall provide the CCC certificate; As for other key parts/raw materials, the manufacturing enterprise may provide corresponding certificate for voluntary certification or the valid testing report issued by the laboratory with the qualification approved as per GB/T 27025 (ISO/IEC 17025). (5) Production conformity control plan prepared in accordance with Annex 2 in the Rules and Attachment 1 herein (upon initial application and alteration); (6) Questionary for factory inspection (if applicable); (7) Other documents required by the certification authority. 0. Introduction 0.1 Terms and Definitions 0.2 Requirements for Classified Management of Manufacturing Enterprises 0.3 Requirements for Utilization of Testing Resources of Manufacturing Enterprise 1. Application Scope 2. Certification Standards 3. Certification Mode 3.1 Basic Certification Mode 3.2 Applicability of Certification Mode 4. Certification Unit Division 5. Certification Entrustment 5.1 Proposal and Acceptance of Certification Application 5.2 Application Data 5.3 Implementation Arrangement 6. Certification Implementation 6.1 Type Test 6.2 Initial Factory Inspection 6.3 Certification Evaluation and Decision 6.4 Time Limit of Certification 6.5 Service Parts for Off-production Vehicle Type 7. Post-certification Supervision 7.1 Post-certification Follow-up Inspection 7.2 Sample Testing or Inspection on Production Site 7.3 Market Sampling Testing or Inspection 7.4 Frequency and Time of Post-certification Supervision 7.5 Post-certification Supervision Record 7.6 Evaluation of Post-certification Supervision Result 8. Certificate 8.1 Certificate Maintenance 8.2 Certificate Content 8.3 Certificate Alteration 8.4 Cancellation, Suspension and Revocation of Certificate 8.5 Use of Certificate 9. Certification Mark 9.1 Permissible Mark Form 9.2 Requirements for Use 10. Charge 11. Certification Responsibilities 12. Requirements for Process and Time Limit Related to Technical Dispute, Complaint and Appeal Attachment 1: Requirements of Production Conformity Control Plan Attachment 2: Certification Implementation of After-sale Service Parts for Off-production Vehicle Type 0.引言 机动车辆间接视野装置强制性产品认证实施细则(以下简称:实施细则)是依据《强制性产品认证实施规则机动车辆间接视野装置》(CNCA-C11-08:2014)(以下简称:实施规则)的要求编制,作为实施规则的配套文件,与实施规则共同使用。 本实施细则适用的产品范围、认证依据等所有内容与实施规则中的有关规定保持一致,并根据国家认证认可监督管理委员会(以下简称国家认监委)发布的目录界定、目录调整等公告实施调整。 CQC依据认证实施规则的规定,本着维护产品认证有效性、提升产品质量、服务认证企业和控制认证风险等原则,制定并公布本认证实施细则。本细则通过确立生产企业的分类管理要求,结合生产企业的分类,明确机动车辆间接视野装置强制性产品认证的实施要求。 0.1术语定义 0.1.1间接视野装置:驾驶员用来观察直接视野无法观察到的车辆邻近交通区域的装置,包括: 汽车视镜:通过反射面在规定的视野内看清车辆后方和侧方图像各类内视镜、外视镜和监视镜等光学视镜总成; 摩托车后视镜:用于提供清晰后方视野的摩托车和轻便摩托车的后视镜总成; 摄像机-监视器装置:通过摄像机与监视器组成的系统,看清车辆邻近区域图像的装置。包括摄像机、监视器、记录装置等,具体定义见GB15084。 0.1.2利用生产企业设备检测(简称TMP方式) 由指定实验室的工程师利用工厂实验室的检测设备进行检测,工厂应派检测人员予以协助。由相关指定实验室审核批准出具检测报告。 0.1.3生产企业目击检测(简称WMT方式) 由指定实验室的工程师目击工厂实验室检测条件及工厂实验室使用自己的设备完成所有检测或者针对工厂提交的检测计划,目击部分检测条件及检测项目。工厂实验室检测人员负责出具原始记录,并与目击指定实验室工程师一起按规定的格式起草检测报告。由相关指定实验室审核批准出具检测报告。 0.2生产企业分类管理要求 CQC搜集、整理各类与认证产品及其生产企业质量相关的信息,对生产企业进行动态化的分类管理。认证委托人、生产者、生产企业应予以配合。 CQC将生产企业分为四类,分别用A类、B类、C类、D类表示。 生产企业分类所依据的质量信息至少包含如下方面: (1)工厂检查结果(包括初始工厂检查和获证后的跟踪检查); (2)样品检测和/或监督抽样的检测结果(包括型式试验、生产现场抽样或市场抽样等)及样品真伪; (3)国家级或省级抽查、CCC专项抽查等检测结果; (4)认证委托人、生产者(制造商)、生产企业对获证后监督的配合情况; (5)司法判决、申投诉仲裁、媒体曝光及消费者质量信息反馈等; (6)认证产品的质量状况; (7)其他信息。 生产企业分类原则见下表。 表1生产企业的分类原则 企业类别 分类原则 A类 由B类企业向CQC提供符合性资料,CQC对所收集的质量信息和企业提供的资料进行综合风险评估并确定分类结果。评估的内容至少包括以下方面: 1.工厂检查:近2年内(含当年)的初始工厂检查/获证后跟踪检查无影响产品一致性的不符合项; 2.产品检测、抽查结果:近2年内(含当年)获证后监督检测未发现不符合项,国家级、省级及CCC专项检查等结论均为“合格”; 3.产品检测能力:生产企业(或其制造商、母公司)应具备认证依据标准要求的检测能力。(符合GB/T 27025(IEC 17025)的第5章技术能力要求); 4.产量:监督周期内,CCC证书覆盖产品的产量保持在一定水平; 5.其他与认证产品及其生产企业质量相关的信息。 B类 除A类、C类、D类的其他生产企业。 对没有任何质量信息的生产企业,其分类定级默认为B类。 C类 满足以下条件之一: 1.工厂检查结论判定为“现场验证”的(标准换版原因除外); 2.产品质量存在问题且系企业责任,但没有严重到暂停证书的; 3.CQC根据生产企业及认证产品相关的质量信息综合评价结果认为需调整为C类的。 D类 满足以下条件之一: 1.工厂检查结论判定为“不通过”的; 2.获证后监督检测结果为不合格的(除说明书/标识不合格外); 3.无正当理由拒绝检查和/或监督抽样的; 4.产品质量存在较大问题且系企业责任,涉及暂停、撤销认证证书的; 5.国家级、省级及CCC专项检查等结论为不合格且影响到产品安全性能问题的(除说明书/标识不合格外); 6.CQC根据生产企业及认证产品相关的质量信息综合评价结果认为需调整为D类的 CQC将依据所实时收集的各类质量信息,按照上述分类原则确定生产企业的分类结果(类别)。 CQC根据各类信息定期或不定期的对生产企业重新分类定级,实现动态化管理。如有变化,以CQC公开文件为准。原则上,生产企业分类结果须按照D—C—B—A的次序逐级提升,按A—B—C—D的次序逐级下降或经过风险评估后直接调整到相应类别。 0.3生产企业检测资源利用要求 0.3.1范围 适用于获证后监督抽样检测和证书变更时补充的差异测试。 0.3.2实施 如生产企业具备《强制性产品认证实施规则生产企业检测资源及其他认证结果的利用要求》和认证标准要求的检测设备和检测能力,认证委托人、生产者或生产企业可向认证机构提出利用生产企业检测资源(以下简称工厂实验室)申请,并进行自查。将自查结果及相关资料提交至CQC审查,资料经审核符合要求的工厂实验室,方可利用生产企业检测资源实施生产现场TMP检测或WMT检测,以下也简称现场检测。 原则上,CQC不单独组织对工厂实验室的审核。认证委托人的工厂实验室的审核申请应与生产现场检测申请同时提出。CQC组织指定实验室技术专家同时进行实验室审核和现场检测,审核组先进行实验室能力审核,并保存相应的审核评定记录,合格后进行生产现场检测。 0.3.3资格的维持 CQC应对获得批准的工厂实验室进行定期(如每年一次,可根据利用频度确定)的监督。原则上,实验室监督需结合工厂的获证后监督进行。工厂实验室应参加比对试验,保证检测结果的准确有效性,维持资格。 如生产企业有需求,可针对认证委托人提出的现场检测项目进行单次核查,核查结果只针对本次现场检测项目有效。工厂实验室可以不再进行监督维持资格。再有同项目需现场检测时,应再次申请审核。 1.适用范围 适用于安装在M类、N类和L类机动车辆上的间接视野装置,包括汽车视镜、摩托车后视镜和摄像机一监视器装置。 由于法律法规或相关产品标准、技术、产业政策等因素发生变化所引起的适用范围调整,应以国家认监委发布的公告为准。 2.认证依据标准 GB 15084机动车辆间接视野装置的性能和安装要求 GB 17352摩托车和轻便摩托车后视镜的性能和安装要求 上述标准原则上应执行国家标准化行政主管部门发布的最新版本。当需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执行。 3.认证模式 3.1认证的基本模式 实施间接视野装置产品强制性认证的基本认证模式为: 型式试验+初始工厂检查+获证后监督; 上述基本认证模式中的获证后监督包括获证后的跟踪检查和监督抽样检测两种方式,其中监督抽样检测又包括生产现场抽取样品检测或者检查和市场抽样检测或者检查。 结合生产企业分类管理原则,针对不同类别企业在获证后监督中酌情考虑相关认证要素的组合。 3.2认证模式的适用性 A类:获证后监督可采用获证后的跟踪检查、生产现场抽取样品检测或者检查、市场抽样检测或者检查三种方式之一或者组合。 B类、C类、D类生产企业:获证后监督应采用获证后的跟踪检查+监督抽样检测(生产现场抽样和/或市场抽样)。 已停产车型维修部件产品生产企业的认证模式选择可根据本实施细则附件2进行。 认证委托人可根据自身实际情况,提出适用认证模式的申请。 CQC根据申请认证产品特点及认证风险控制原则,结合生产企业分类管理结果,决定认证委托人所能适用的认证模式。 4.认证单元划分 原则上,同一生产者(制造商)、同一生产企业(场所)生产的在以下方面没有显著差异的机动车辆间接视野装置产品为一个认证单元: (1)装置的设计(如果相关,包括与车身连接件的设计),如:保持件结构和材料,连接件(支撑件)的结构与材料、与车体连接方式和镜面调节方式等; (2)对于视镜而言,视镜的类别、形状以及反射面的尺寸和曲率半径; (3)对于摄像机一监视器装置而言,发现距离和视野范围。 认证委托人应依据单元划分原则提出认证委托。同一单元中可包含多个型号的产品。同一型号是指在设计上对标准符合性没有影响的产品。 相同生产者、不同生产企业生产的相同产品(应具备相同的生产工艺和相同关键零部件/原材料供应商),或不同生产者、相同生产企业生产的相同产品,应为不同申请单元,但可考虑仅在一个单元的样品上进行型式试验,其他生产企业/生产者的产品需提供资料进行一致性核查。 5.认证委托 5.1认证申请提出和受理 认证委托人通过网络(www.cqc.com.cn)向CQC提出认证委托,认证委托人需按要求填写必要的企业信息和产品信息。CQC依据相关要求对申请进行审核,在2个工作日内发出受理或不予受理的通知,或要求认证委托人整改后重新提出认证申请。 5.2申请资料 认证委托人应在申请受理后按认证方案的要求向CQC和/或指定实验室提供有关申请资料和技术材料,通常包括: (1)认证申请书; (2)认证委托人、生产者、生产企业的下述注册证明及相关文件: a.营业执照、组织机构代码证书(初次申请及有变更时); b.若三者不一致时,还需提交相关各方签订的有关协议书或合同(如委托加工协议书、授权书等)(适用时); c.申请人为销售者、进口商时,还须提交销售者和生产者、进口商和生产者订立的相关合同副本(初次申请及有变更时); d.代理人的授权委托书(适用时); e.对于境外生产企业,能够承担法律责任的国内的实体证明(相关法律法规有要求时)。 (3)每个认证单元需按实施规则附件1的要求提供产品描述、照片及产品图纸等技术资料。同一单元中包含多个型号/规格的,还需提供不同型号间的差异描述。需按照CQC发出的具体的技术文件格式填写,并提交电子版资料。 (4)关键零部件/原材料清单 每个认证单元需按本实施细则附件1的要求提供关键零部件/原材料清单。 对于在境内购买获得的强制性产品认证范围内的关键零部件/原材料,如转向信号灯等,生产企业应提供强制性产品认证证书;对于其他关键零部件/原材料,生产企业可提供相应的自愿认证证书或具备GB/T 27025(ISO/IEC 17025)认可资质的实验室出具的有效的检测报告。 (5)按实施规则附件2和本细则附件1编写的生产一致性控制计划(初次申请及有变更时) (6)工厂检查调查表(适用时); (7)其他认证机构要求的文件。 5.3实施安排 CQC在受理后制定认证方案,并将其通知认证委托人。认证方案通常包括如下内容: (1)所采用的认证模式和单元划分; (2)需要提交的申请资料清单; (3)型式试验方案; (4)指定实验室信息; (5)所需的认证流程及时限; (6)预计的认证费用; (7)有关CQC工作人员的联系方式; (8)其他需要说明的事项。 6.认证实施 6.1型式试验 6.1.1型式试验方案 对于需要进行型式试验的认证委托,申请资料审核合格后,CQC应按照单元划分原则,根据认证标准,制定型式试验方案,并通知认证委托人。型式试验方案包括单元或单元组合送样/抽样的样品要求、检测标准及项目、实验室信息等。同一单元中包含多个型号/规格时,样品应选取具有代表性的型号/规格,并且选取的样品应尽量覆盖其他产品的结构参数及关键零部件/原材料制造商。 6.1.2型式试验样品要求 6.1.2.1型式试验样品应是委托认证的生产企业按照正常加工方式生产的产品。认证委托人应保证其所提供的样品与实际生产产品的一致性,不得借用、租用、购买样品等方式用于检测。CQC和/或实验室应对认证委托人提供样品的真实性进行审查。实验室对样品真实性有疑义的,应当向CQC说明情况,并做出相应处理。 6.1.2.2送样/抽样方式 认证委托人应按照型式试验方案的要求准备样品并送往指定的实验室。如认证委托人提出需求,CQC也可安排检查员在按6.2.3条进行生产一致性工厂现场检查时进行抽样,此种情况下,抽样应在工厂检查结论为合格,或者存在不符合项,需以书面方式验证纠正措施有效性的前提下进行。 原则上,生产企业应确保在20天内将样品送指定实验室进行型式试验。如认证委托人因特殊情况未在规定时间内送出样品,需向CQC提供其延迟送样的充分理由。 6.1.2.3型式试验样品规格和数量 (1)视镜产品 a.I类~Ⅵ类视镜,送同一型号后视镜2套;对于免做撞击试验的后视镜,每型号送1套;所有样品均应带安装支架; 对于安装在风窗玻璃上的I类视镜,还应提供玻璃; 对于包含多个类别组合视镜,还需提供夹具。 b.VII类视镜和摩托车后视镜,送同一型号后视镜3套和安装支架2套。 (2)摄像机-监视器装置 送同一型号的装置2套,试验所需安装支架和控制系统各1套。 (3)同一单元中包含多个型号的,认证委托人还应依据试验方案的要求送主检型号外其他型号的产品或部件做差异试验。 6.1.2.4关键零部件/原材料相关要求 对于试验方案中涉及到关键零部件/原材料,如组合的视镜、转向信号灯等,若生产者或生产企业可提供符合要求的强制性产品认证证书或指定认证机构颁发的自愿认证证书,CQC在审核相应证书的基础上采信认证结果,可免除相应零部件/原材料的检测项目。对于技术专家组技术决议规定的特定零部件/原材料检测项目也可接受符合GB/T 27025(ISO/IEC 17025)认可的实验室出具的有效的检测报告。 6.1.3检测项目及要求 型式试验项目为本细则第2条中依据标准的适用条款。 国家认监委强制性产品认证技术专家组有特殊要求的,按其相应技术决议执行。 对于未纳入本规则的涉及机动车辆间接视野装置产品的安全、环保的国家法律、法规及相关标准的强制性要求,生产者应自觉执行且符合要求。 6.1.4型式试验的实施 6.1.4.1型式试验应在国家认监委指定的实验室完成。实验室对样品进行型式试验,应确保检测结论真实、准确,对检测全过程做出完整记录并归档留存,以及保证检测过程和结果的记录具有可追溯性。型式试验过程发现异常情况时,应及时与CQC沟通,并作相应处理。 6.1.4.2若有试验项目不合格,允许认证委托人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试验。凡需重新试验的,实验室须将试验情况通报认证机构,由认证机构重新确认试验方案。 认证委托人一般情况下应在90天内完成整改,并向指定实验室和/或CQC提交有效的整改资料和/或样品,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委托。对于抽样方式的整改样品,应由CQC安排人员进行现场抽样,如已完成工厂检查,需根据不合格项目及原因,评价判断是否需补充进行工厂检查。 6.1.4.3型式试验时间不超过20个工作日(从样品送达指定实验室之日起计算),因样品或检测项目不合格,企业进行整改和重新试验的时间不计算在内。重新试验的时间规定同型式试验时间。 6.1.5型式试验报告 CQC制定统一的型式试验报告格式。 实验室应按统一的格式出具型式试验报告,实验室及其相关人员应对其作出的型式试验报告内容及检测结论正确性负责。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。试验报告应包含对申请单元内其他产品(CQC有要求时)和认证相关信息的描述。 认证委托人应确保在获证后监督时能够向认证机构和执法机构提供完整有效的型式试验报告。 6.2初始工厂检查 6.2.1工厂检查的基本要求 6.2.1.1生产者或生产企业应按照实施规则附件2的要求,建立、实施并持续保持其生产一致性控制体系,以确保认证产品持续满足强制性产品认证要求。 工厂检查为认证机构对生产者或生产企业的生产一致性控制体系能否符合认证要求的评价。初始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。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。 6.2.1.2工厂检查对象的界定和覆盖性要求 强制性产品认证的工厂是指:对认证产品进行最终装配和/或试验以及加施认证标志的场所。当产品的上述工序不能在一个场所完成时,CQC保留到其它场所进一步检查的权利。 工厂检查应覆盖“申请认证/获证产品”及其所有“加工场所”。“加工场所”是指与产品认证质量相关的所有部门、场所、人员、活动;“申请认证/获证产品”是指生产一致性控制计划覆盖的产品。CQC如果在生产现场无法完成实施规则附件2要求的生产一致性检查时,可延伸到认证委托人、生产者等处进行检查。 6.2.2生产一致性控制计划审查 6.2.2.1审查的实施 生产者或生产企业应按实施规则附件2和本实施细则附件1的要求制定生产一致性控制计划,并提交CQC进行审查。CQC应将审查结果告知认证委托人。 若生产一致性控制计划能够满足要求,审查通过。若CQC认为生产一致性控制计划不能满足要求,生产者或生产企业应进行整改并重新提交。CQC重新审查后将审查结果告知认证委托人。 6.2.2.2生产一致性控制计划审查通过后,CQC机构根据其编制生产一致性工厂现场检查方案,方案应包括检查的产品、场所及范围。 6.2.2.3生产一致性控制计划的审查时间根据申请认证产品的单元数量确定,并适当考虑工厂的生产规模,一般每个工厂为1~2个人日。 6.2.3生产一致性工厂现场检查 6.2.3.1工厂现场检查的实施 一般情况下,型式试验合格和生产一致性控制计划审查合格后,再到工厂现场进行生产一致性检查。根据需要,型式试验和工厂现场检查也可以同时进行。 CQC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,按照实施规则附件2对认证产品的生产一致性控制情况进行现场检查。工厂现场检查时,应有委托认证的产品在生产,必要时检查组可延伸到认证委托人、生产者等处进行检查。 6.2.3.2工厂现场检查时,工厂检查组应在认证产品的加工场所,随机抽取已经检验合格的产品,进行包括但不限于下述内容的检查: (1)认证产品的结构及参数(包括型号规格和关键零部件); (2)认证产品现场指定试验(从生产一致性控制计划中选取)。 6.2.3.3工厂检查的结果 (1)工厂检查未发现不合格项,则检查结果为合格; (2)工厂检查存在不合格项,可允许整改,认证机构采取适当方式对整改结果进行确认。整改时间不得超过3个月,若逾期不能完成整改,或整改结果不合格,检查结果不合格。 (3)工厂检查发现生产一致性控制计划的执行情况与生产一致性控制计划存在严重偏差,或实际生产产品的结构及参数与型式试验样品一致性存在重大差异时,检查结果不合格 检查结果为不合格的,本次认证终止。 6.2.3.4检查时间 工厂现场检查时间根据所委托认证产品的单元数量确定,并适当考虑工厂的生产规模,一般每个工厂为2~4个人日,摩托车后视镜工厂为1~2个人日。 6.2.3.5在实施强制性产品认证时,对获得认监委授权的认证机构颁发的服务、管理体系认证证书,证书在有效期内的工厂,由CQC视实际情况进行评估,做出免于实施规则附件2的附录1中的部分条款的审查决定,初始工厂检查中的其他内容,不能免除。 6.3认证评价与决定 CQC对型式试验结果、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。终止认证后如要继续申请认证,应重新进行认证申请。 6.4认证时限 CQC应对认证各环节的时限做出明确规定,并确保相关工作按时限要求完成。认证委托人须对认证活动予以积极配合。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。 6.5已停产车型维修部件 按本实施细则附件2的要求实施。 7.获证后监督 结合生产企业分类管理和实际情况,获证后监督方式的选择见表2。 表2获证后监督方式的选择 企业 类别 获证后监督 频次 通知/ 不通知 内容 跟踪检查 生产现场抽样检测 市场抽样检测 A类 2年1次 通知 之一或组合 必要时 B类 1年1次 通知或优先不通知 必做 必做 必要时 C类 至少1年1次 优先不通知 必做 必做 必要时 D类 至少1年2次 不通知 必做 必做 必要时 7.1获证后的跟踪检查 7.1.1获证后的跟踪检查原则 CQC应在生产企业分类管理的基础上,对获证产品及其生产企业实施有效的跟踪检查,以验证生产企业的生产一致性控制持续符合认证要求、确保获证产品持续符合标准要求并保持与获得批准的产品的一致性。 获证后的跟踪检查应在生产企业正常生产时,优先选择不预先通知被检查方的方式进行。对于非连续生产的产品,认证委托人应向CQC提交相关生产计划,便于获证后跟踪检查的有效开展。 7.1.2获证后的跟踪检查内容 跟踪检查至少包括以下内容: (1)生产一致性控制计划的实际执行情况,包括生产者或生产企业按照实施规则附件2完成的生产一致性控制计划执行报告; (2)认证产品的结构及参数(包括型号规格和关键零部件)和认证产品现场指定试验(从生产一致性控制计划中选取); (3)认证标志和认证证书的使用情况; (4)前次工厂检查不符合项的整改措施及其有效性的验证。 7.2生产现场抽样检测或者检查 7.2.1生产现场抽样检测或者检查原则 采取生产现场抽取样品检测或者检查方式实施获证后监督的,认证委托人、生产者、生产企业应予以配合。 7.2.2生产现场抽样检测或者检查内容 7.2.2.1 CQC根据企业分类管理及认证风险情况,制定年度或特殊生产现场抽样检测方案,方案应包括抽样/封样要求、检测标准及项目和实验室信息等。检测项目应按照国家认监委技术专家组的相关技术决议执行,需要时也可视风险,增加抽样检测项目或减少抽样检测的样品数量。 由CQC指定人员在工厂生产线、仓库或口岸(仅限境外获证工厂)等地,按抽样检测方案抽取样品,抽取的样品应是经生产者或生产企业确认的合格品。生产者或生产企业应在CQC抽样后10个工作日内寄出样品。 7.2.2.2工厂检测资源的利用 对于企业分类分A类或B类的工厂,如生产企业具备认证标准、《强制性产品认证实施规则生产企业检测资源及其他认证结果的利用要求》和本实施细则第0.3条要求的条件,并且同意利用工厂检测资源实施现场检测,生产者或生产企业可提出现场检测的申请,经CQC审核通过后,由指定实验室派出相应资质的人员利用工厂检测资源实施现场检测。现场检测应按抽样检测方案进行,检测合格后由指定实验室出具检测报告。同一生产者或生产企业利用工厂资源检测连续五年的,原则上应送样至指定实验室检测,避免系统性风险。 7.3市场抽样检测或者检查 7.3.1市场抽样检测或者检查原则 CQC根据企业分类管理及认证风险情况,必要时,对B、C、D类企业进行市场抽样。 7.3.2市场抽样检测或者检查内容 CQC根据不同产品的质量情况,制定市场抽样检测或者检查方案,从型式试验检测项目中选取部分或全部项目进行抽样检测。由指定人员在市场销售的(包括整车厂或用户处等)认证产品中按抽样检测方案抽取样品,样品应送指定实验室进行检测或者检查。 7.4获证后监督的频次和时间 7.4.1获证后监督的频次 原则上,生产企业自初次获证后或初始工厂检查后,需按照表2规定的基本频次接受监督。且每二年至少进行一次获证后的跟踪检查和生产现场抽取样品检测。 当A、B、C、D类生产企业出现以下情况时,在基本监督频次的基础上增加监督频次: (1)获证产品出现严重质量问题(如发生国家级或省级质量监督抽查不合格等)或用户提出质量投诉并造成较大影响,或经查实为认证委托人/生产者/生产企业责任的; (2)CQC有理由对获证产品与标准安全要求的符合性提出质疑时; (3)当生产企业分级结果(类别)下降时。 增加频次的监督检查采取不预先通知的方式进行。 对于非连续生产的情况,认证委托人、生产企业应主动向CQC提交生产计划,以便获证后监督的有效开展。 7.4.2获证后监督的时间 获证后的跟踪检查的时间根据获证产品的类别数量确定,并适当考虑工厂的规模,一般每工厂为1-2人日。 生产现场或市场抽样检测的,指定实验室应在确认样品合格后的20个工作日内完成检测工作。 7.5获证后监督的记录 认证机构应当对获证后监督全过程予以适当记录并归档留存,以保证认证过程和结果具有可追溯性。 |
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