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0 Introduction Implementation Rules for Motor Vehicle Tyres (hereinafter referred to as "the Rules") is prepared according to the requirements of Implementation Regulations for Compulsory Product Certification-Motor Vehicle Tyres (CNCA-C12-01:2015) (hereinafter referred to as "the Regulations") and used together with the Regulations as their auxiliary documents. The applicable product scope and certification basis of the Rules keep consistent with those in the Regulations and are adjusted according to the announcement on catalogue definition and adjustment issued by Certification and Accreditation Administration of the People's Republic of China (hereinafter referred to as "CNCA"). The Rules is prepared and published by reference to the Regulations and requirements of China Quality Certification Center (hereinafter referred to as "CQC") for quality manual, program file and operation instructions in the principles of maintaining effectiveness of product certification, improving product quality, serving certification enterprises and controlling certification risk. The Rules define requirements for compulsory product certification of motor vehicle tyres by establishing manufacturer classification management requirements in combination with manufacturer classification. 0.1 Definition 0.1.1 Testing at Manufacturer'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, assisted by the testing personnel dispatched by the factory. The testing report is issued by the relevant designated laboratory upon examination and approval. 0.1.2 Witnessed Manufacturer's Testing (hereinafter referred to as "WMT mode") The engineers of designated laboratory witness the testing conditions of the factory laboratory and the factory laboratory completes all inspections with their own equipment or witness partial testing conditions and inspection items against testing plan submitted by the factory. Testing personnel of the factory laboratory are responsible for issuing the original records and draft the testing report with the designated laboratory engineers according to the prescribed form. The testing report is issued by the relevant designated laboratory upon examination and approval. 0.2 Requirements for Manufacturers Classification Management CQC collects and arranges information related to certified product and its manufacturer quality for dynamic classification management on the manufacturers with the assistance of certification client, producer and manufacturer. CQC classifies the manufacturers into four classes which are expressed as A, B, C and D respectively. The quality information on which manufacturer classification is based contains at least the following information: (1) Result of factory inspection (including initial factory inspection and follow-up inspection after certification); (2) Testing results of sample testing and/or supervisory sampling (including type test, production site sampling or market sampling) and sample authenticity; (3) Testing results of national or provincial random inspection, special CCC random inspection, etc.; (4) Coordination of certification client, producer and manufacturer for post-certification supervision; (5) Judicial decision, complaint arbitration, media exposure, consumer quality information feedback, etc.; (6) Quality of certified product; (7) Other information. See Table 1 for manufacturer classification principle. Table 1 Manufacturer Classification Principle Category Classification principle A Category B enterprises provide conformity data to CQC which conducts integrated risk assessment on the collected quality information and data provided by the enterprise and determines the category. The assessment shall at least cover the following information: 1. Production conditions: complete production line (rubber mixing-vulcanizing) (including equipment and capacity of producer or group company); 2. Factory inspection: no non-conformance items affecting the product consistency upon initial factory inspections/follow-up inspections after certification in the last two years (including the current year). 3. Results of product inspection and random inspection: no non-conformance item upon 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". 4. Product testing capacity: the manufacturer (or its producer and parent company) shall possess testing capacity required by certification standards. (Conforming to technical capability requirements specified in Chapter 5 of GB/T 27025 (IEC 17025)) 5. Products imported into China within supervision period shall reach a certain quantity. 6. Other information related to the quality of the certified product and its manufacturer. B Other manufacturers except those of Classes A, C and D. The manufacturer without any quality information is classified into Class B by default. C Those that meet one of the following conditions are classified into Class C enterprises: 1. Where the conclusion judgment is "site verification" upon initial factory inspection and post-certification follow-up inspection; 2. Where quality problems exist and are caused by the enterprises but not serious enough to suspend or revoke the certificate; 3. Where CQC adjusts the enterprises into Class C as per the results of comprehensive evaluation on quality information related to the manufacturers and their certified products. D Those that meet one of the following conditions are classified into Class D enterprises: 1. Where conclusion of factory inspection is judged as "rejected" and the certified product has quality problems; 2. Where the result of the supervision sampling testing is “rejected” and the product safety performance is affected; 3. Where inspections and/or supervision sampling are rejected without justifiable reasons; 4. Where serious quality problems exist as revealed by the media and are caused by the enterprise; 5. Where the conclusions of national and provincial and CCC special inspection are "rejected" and the safety performance of the product is affected (with the exception of nonconformity of instruction/identification); 6.Where CQC adjusts the enterprises into Class D as per the results of comprehensive evaluation on quality information related to the manufacturers and their certified products. CQC will determine the classification result (class) of manufacturers according to the above classification principles based on various quality information acquired in real time. CQC reclassifies the manufacturers periodically or aperiodically according to various information so as to realize dynamic management. If there is any change, public documents of CQC shall prevail. In principle, the manufacturer level shall be upgraded according to D-C-B-A or degraded from A-B-C-D or adjusted to the level required after the risk assessment. 0.3 Requirements for Utilization of Manufacturer's Testing Resources They are applied to post-certification supervision and sampling inspection. For compulsory product certification of tyres, see public documents of CQC for requirements for utilization of manufacturer's testing resources. 1 Application Scope The Rules is applicable to the new pneumatic tyre for motor vehicles, including passenger car tyre, truck tyre, motorcycle tyre and originally aims to the tyres for motor vehicles of M, N, O, and L categories (see GB/T 15089 for definitions of vehicle category). The Rules is not applicable to retreaded tyres and those designed specifically for competition. The adjustment of application scope caused by the changes of laws, regulations, relevant products standards, technologies, and industrial policies, shall be subject to the announcement issued by CNCA. 2 Terms and Definitions For the purpose of the Rules, the terms and definitions in laws and regulations related to compulsory product certification apply. 2.1 The worst Condition (TWC) of Tyre conditions where tyres in the same certification unit and loaded with the same type are given maximum load index and maximum speed. 3 Certification Standards Mandatory terms in GB 9743 Passenger Car Tyres, GB 9744 Truck Tyres and GB 518 Motorcycle Tyres. For certification and testing basis standards, the latest edition issued by the administrative department of national standardization applies in principle. When it is required to add new applicable standards or use other editions, follow CNCA's announcements about applicable standards requirements. 4 Certification Mode 4.1 Basic Certification Mode Basic certification mode: type test + initial factory inspection + post-certification supervision. Among the basic certification mode, initial factory inspection is to evaluate the production consistency control; Post-certification supervision is one or combination of post-certification follow-up inspection, sampling inspection on production site and/or inspection and market sampling testing and/or inspection. 4.2 Applicability of Certification Mode Certification client may propose application for applicable certification mode from basic 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 classification management result of manufacturer. 5 Certification Unit Division In principle, those produced by the same producer (manufacturer) at the same manufacturer’s (site) and with the same category [Note 1], the same structure [Note 2] and the same series [Note 3] shall be regarded as one certification unit. Certification client proposes certification entrustment according to unit division principle. For certification unit division, see Compulsory Certification Unit Division of Motor Vehicles Tyres (Annex 1 to the Regulations). Note 1: Categories: passenger car tyre, truck tyre and motorcycle tyre. Note 2: Structure: radial tyre (including all-steel and semisteel), bias tyre and bias-belted tyre. Note 3: Series: refer to the product series specified in the standards GB/T 2978 Size Designation, Dimensions, Inflation Pressure and Load Capacity for Passenger Car Tyres, GB/T 2977 Size Designation, Dimensions, Inflation Pressure and Load Capacity for Truck Tyres and GB/T 2983 Series of Motorcycle Tyres. Final result of unit division will be determined by the CQC product certification engineer after examination of all product information; if necessary, the applicant can discuss with the engineer with regard to combination and separation scheme of the unit. 6 Certification Entrustment 6.1 Proposal and Acceptance of Certification Application Certification client proposes certification application to CQC on the Internet (www.cqc.com.cn), and then fill in necessary corporation information and product information. CQC shall examine the application according to relevant requirements, and notice the acceptance or refusal within 2 workdays, or require the certification client to re-propose the certification application after rectification. Certification client shall provide relevant certification entrustment information and technical data according to the requirements of CQC upon acceptance of the certification entrustment (see Annex 1 for details). CQC will check the relevant information upon receipt according to review requirements, and notify the result to certification client. If the information fails to meet the requirements, it shall notify the certification client to complement and improve it. Certification client shall be responsible for the authenticity of the provided information. CQC manages and preserves the certification information provided by certification client, and is responsible for keeping it secret. 6.2 Implementation Plan After acceptance, CQC shall prepare certification scheme and notify it to the certification client. The certification scheme generally includes the following contents: (1) Adopted certification mode and unit division; (2) Application information list submitted; (3) Type test scheme; (4) Information of the designated laboratory; (5) Required certification procedure and time limit; (6) Estimated certification costs; (7) Contact method of relevant CQC staff; (8) Other matters required to be noted. 6.3 Rejection Situations Certification entrustment will be rejected under one of the following circumstances: 1) In nonconformity to national industrial policy; 2) Where the application, manufacture and factory are inconsistent, agreements or contracts (such as agreement and letter of attorney for consigned processing), letter of attorney (original and duplication, including producer (manufacturer), processing plant and original holder) signed by the parties are not provided; 3) Other conditions as specified in laws and regulations. 7 Certification Implementation 7.1 Type Test 7.1.1 Type test scheme After the information provided by the certification client is qualified upon examination, CQC shall develop a scheme for type test, if necessary for certification entrustment, and inform the certification client. Type test scheme includes sample requirements and quantity, testing standard and items and laboratory information. In principle, within the same certification unit, the priority is given to the specification/model with the maximum speed symbol grade and load index. For a unit including multiple models, the certification client shall also submit products of other models for full item or difference tests in addition to those of main models depending on the requirements for testing scheme. In addition, the samples of passenger car tyres shall be differentially selected from the enhanced type and standard type; samples of motorcycle tyres shall be differentially selected from light load type, standard type, enhanced type and heavy-duty type. If it is unlikely to meet requirements for maximum speed symbol grade and load index and loading type at the same time, all cases shall be included. CQC may also properly increase selected sample quantity according to risk assessment result. 7.1.2 Sample requirements In general, the certification client prepares samples and sends them to designated laboratory according to the requirements of type test scheme; if necessary, CQC may obtain samples by the methods of site sampling/sample sealing according to the requirements of type test scheme based on the risk assessment and also send the samples to designated laboratory. If required by the certification client, CQC may also arrange an inspector to conduct sampling where factory on-site inspection for production consistency is carried out according to 7.2.3. In this case, the sampling shall be judged as acceptable or non-conformance item available in the factory inspection conclusion. This shall be carried out provided that the effectiveness of corrective measures is verified in written form. Samples under test shall be produced in the manufacturer applying for certification according to normal processing mode; the certification client should ensure that the samples provided are identical to those in real production. The manufacturer shall provide a schematic diagram for tire side identification (for both sides and at least including contents in the table titled technical parameter of tyres). In principle, the manufacturer shall ensure to submit samples to the designated laboratory for type test within 20 days. If the certification client fails to submit samples within specified time due to exceptional circumstances, adequate reasons for the delay shall be given to CQC. The laboratory shall examine authenticity of samples provided by the certification client upon receipt of samples and submit the result to CQC. If the laboratory doubts authenticity of samples, it shall explain the circumstances to CQC and deal with properly. 0 Introduction 0.1 Definition 0.2 Requirements for Manufacturers Classification Management 0.3 Requirements for Utilization of Manufacturer's Testing Resources 1 Application Scope 2 Terms and Definitions 2.1 The worst Condition (TWC) of Tyre 3 Certification Standards 4 Certification Mode 4.1 Basic Certification Mode 4.2 Applicability of Certification Mode 5 Certification Unit Division 6 Certification Entrustment 6.1 Proposal and Acceptance of Certification Application 6.2 Implementation Plan 6.3 Rejection Situations 7 Certification Implementation 7.1 Type Test 7.2 Initial Factory Inspection 7.3 Certification Result Evaluation and Approval 7.4 Time Limit for Certification 8 Post-certification Supervision 8.1 Selection of Post-certification Supervision Method 8.2 Requirements for Post-Certification Follow-Up Inspection 8.3 Sampling Testing or Inspection on Production Site 8.4 Market Sampling Testing or Inspection 8.5 Frequency and Duration of Post-Certification Supervision 8.6 Post-certification Supervision Results Evaluation and Approval 9 Certificate 9.1 Maintenance of Certificate 9.2 Content of Certificate 9.3 Change of Certificate 9.4 Suspension, Resumption, Cancellation and Revocation of Certificate 9.5 Use of Certificate 10 Certification Mark 10.1 Marks Logo 10.2 Requirements for the Usage 11 Charge Basis and Requirements 12 Requirements for Process and Time Limit Related to Technology Disputes, Complaints and Appeals. 13 Application Certification in ODM Method Annex 1 Materials to be Submitted in Certification Entrustment Annex 2 Technical Parameter Table of the Tyres for Motor Vehicles Annex 3 Requirements for Production Consistency Control Documents 0 引言 机动车辆轮胎实施细则(以下简称实施细则)是依据《强制性产品认证实施规则 机动车辆轮胎》(CNCA-C12-01:2015)(以下简称实施规则)的要求编制,作为认证实施规则的配套文件,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。 依据实施规则和中国质量认证中心(以下简称CQC)的质量手册、程序文件、作业指导书等有关要求,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。 本实施细则通过建立生产企业的分类管理要求,结合生产企业的分类,明确机动车辆轮胎产品强制性产品认证的实施要求。 0.1定义 0.1.1 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。 0.1.2 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表1。 表1:生产企业分类原则 类别 分类原则 A 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. 生产条件:具有完整生产线(炼胶-硫化)(可包括生产者或集团公司的设备、能力); 2.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。 3. 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”。 4. 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全部检测能力。(符合GB/T 27025(IEC 17025)的第 5章技术能力要求) 5.监督周期内进口到中国产品的产量应达到一定数量。 6.其他与认证产品及其生产企业质量相关的信息。 B 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 满足以下条件之一的,均可列入 C类企业: 1. 初始工厂检查、获证后跟踪检查结论判定为“现场验证”的; 2. 产品质量存在问题且系企业责任,但不涉及暂停、撤销认证证书的; 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 满足以下条件之一的,均可列入 D类企业: 1. 工厂检查结论判定为“不通过”且系认证产品质量问题的; 2. 监督抽样检测结果为不合格且影响到产品安全性能问题的; 3. 无正当理由拒绝检查和/或监督抽样的; 4. 被媒体曝光产品质量存在严重问题且系企业责任的; 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 适用于获证后监督抽样检测。轮胎产品强制性产品认证利用生产企业检测资源的要求详见CQC 的相关公开文件。 1 适用范围 本实施细则适用于新的机动车辆充气轮胎,包括轿车轮胎、载重汽车轮胎、摩托车轮胎,其原始设计的目的是在M、N、O 和L 类的机动车辆上使用的机动车辆轮胎(车辆类别定义参见GB/T15089)。 本细则不适用于翻新轮胎及专为竞赛设计的轮胎。 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 术语和定义 本规则采用强制性产品认证相关法规中的术语定义。 2.1轮胎最不利条件(简称 TWC 条件) 在同一认证单元中,相同负荷类型下,同时满足以下条件的轮胎规格:最大负荷指数和最高速度级别的轮胎。 3 认证依据标准 《轿车轮胎》(GB 9743)、《载重汽车轮胎》(GB 9744)、《摩托车轮胎》(GB 518)标准中的强制性条款。 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执行。 4 认证模式 4.1认证基本模式 基本认证模式:型式试验+初始工厂检查+获证后监督。 上述基本认证模式中,初始工厂检查为生产一致性控制的评价;获证后监督方式为获证后的跟踪检查、生产现场抽取样品检测和/或检查、市场抽样检测和/或检查等三种方式之一或组合。 4.2认证模式的适用性 认证委托人可根据自身实际情况,在基本认证模式前提下,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。 5 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)、同一类别[注1]、同一结构[注2]、同一系列[注3]为一个认证单元。 认证委托人依据单元划分原则提出认证委托。 认证单元原则划分见《机动车辆轮胎产品强制性认证单元划分》(实施规则附件1)。 注1:类别:轿车轮胎、载重汽车轮胎、摩托车轮胎。 注2:结构:子午线(包括全钢子午线、半钢子午线)、斜交、带束斜交。 注3:系列:参考《轿车轮胎规格、尺寸、气压与负荷》(GB/T 2978)、《载重汽车轮胎规格、尺寸、气压与负荷》(GB/T 2977)和《摩托车轮胎系列》(GB/T 2983)标准规定的产品系列。 单元划分的最终结果待CQC 产品认证工程师在具体审核每种产品资料后进行确认,必要时申请人可与CQC 产品认证工程师就单元的合并、拆分方案进行探讨。 6 认证委托 6.1 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。 认证委托人应在认证委托受理后按CQC 的要求提供有关认证委托资料和技术材料(详见附件1)。 CQC 收到有效的认证委托资料后,依据相关评审要求对委托材料进行符合性审核,向认证委托人发出资料审核结果的通知。如资料不符合要求,应通知认证委托人补充完善。 认证委托人应对提供资料的真实性负责。 CQC 对认证委托人提供的认证资料进行管理、保存,并负有保密的义务。 6.2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。 6.3不受理情形 认证委托有下列情形之一的不予受理: 1)不符合国家产业政策; 2)申请、制造、工厂若三者不一致时,未提供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)、授权书及原始证书复印件(含生产者(制造商)、加工厂及原始证书持有人); 3)其他法律法规规定不得受理的情形。 7 认证实施 7.1型式试验 7.1.1 型式试验方案 认证委托人提供的资料审核合格后,对于需要进行型式试验的认证委托, CQC 应制定型式试验方案,并通知认证委托人。型式试验方案包括送试样品的要求和数量、检测标准、检测项目、实验室信息等信息。 原则上,在同一认证单元内,优先选取速度符号等级最高和负荷指数最大的规格型号进行检测。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做全项或差异试验。 此外,轿车轮胎的样品选取应考虑选取增强型和标准型轮胎的差异;摩托车轮胎的样品选取应考虑选取轻载型、标准型、加强型和载重型轮胎的差异。 如不能同时满足速度符号等级最高和负荷指数最大,以及负荷类型的要求,应覆盖所有情况。 CQC 也可依据风险评估的结果适当增加选取的样品数量。 7.1.2 样品要求 通常情况下,认证委托人按型式试验方案的要求准备样品并送往指定的实验室;必要时,CQC 依据风险评估,可按型式试验方案的要求采取现场抽样/封样的方式获得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7.2.3 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。 试验样品应是在申请认证的生产企业内按正常加工方式生产的产品;认证委托人应保证其提供的样品与实际生产的产品一致。企业应随样品提供轮胎胎侧标识示意图(双侧,至少包括轮胎产品技术参数表的内容)。 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。 实验室应在收到样品后对认证委托人提供样品的真实性进行审查,并将审查结果上报CQC,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。 7.1.3 样品数量 表2 型式试验样品数量 产品类别 抽样数量 轿车轮胎 3套/规格 载重汽车轮胎 微型载重汽车轮胎 3套/规格 轻型载重汽车轮胎 3套/规格 载重汽车轮胎 2套/规格 摩托车轮胎 速度符号在 J以下 2套/规格 速度符号在 J以上(含J)且在 V以下 3套/规格 速度符号在 V以上(含V) 4套/规格 7.1.4 检测项目及要求 试验项目依据本实施细则第2 条中使用标准中规定的试验项目,按照实施规则附件4 的项目执行。 7.1.5 型式试验的实施 实验室对样品进行型式试验,应确保检测结论真实、准确,对检测的全过程做出完整记录并归档留存,以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,并做出相应处理。 当型式试验有不合格项目时,允许认证委托人进行整改;应在90 天内完成整改并向CQC 提交有效的整改资料和样品。复试时认证委托人应重新提供与初次检测相同规格样品进行全项检测(胎侧标记或磨耗标志不合格仅做单项双倍复试),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90 天内完成,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申请。 型式试验后,采用适当方式处置试验样品和相关资料。 型式试验时间一般不超过30 个工作日(从实验室收到样品之日起计算),不包括企业进行整改的时间,重新试验的时间规定同型式试验时间。 7.1.6 型式试验报告 CQC 负责组织编制统一的型式试验报告格式。 实验室应按统一格式出具型式试验报告,实验室及其相关人员应对其做出的型式试验报告内容及检测结论正确性负责。 7.2初始工厂检查 7.2.1 工厂检查的基本要求 生产者或生产企业应按照实施规则附件3 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文件审查+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。 7.2.2 生产一致性控制文件的审查 生产者或生产企业应按实施规则附件3 和本实施细则附件3 的要求制定生产一致性控制文件,并提交CQC 进行审查。CQC 应将审查结果告知认证委托人。 若生产一致性控制文件能够满足要求,审查通过。若CQC 认为生产一致性控制文件不能满足要求,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。 生产一致性控制文件审查通过后,CQC 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。 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0.5~1 个人日。 7.2.3 生产一致性工厂现场检查 初始生产一致性工厂现场检查是在生产者(制造商)和/或生产企业制定的生产一致性控制文件审核通过后,由CQC 委派检查组到生产一致性控制的现场对生产一致性控制文件的执行情况进行确认,应覆盖委托认证的产品及其加工场所。根据需要,工厂现场检查可以和型式试验可以同时进行。 7.2.3.1 检查范围 初始工厂检查应覆盖与委托认证的产品质量相关的所有部门、场所、活动、过程,应覆盖委托认证产品的类别、结构。 当生产企业有生产过程分包时,CQC 可对生产企业以外的分包场所实施延伸检查。 必要时,CQC 检查组可延伸到认证委托人、生产者(制造商)等处进行检查。 7.2.3.2 检查要求 初始工厂检查时,生产企业应有委托认证的不同类别和结构的产品在生产。 CQC 委派检查组,按照实施规则附件3 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,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: a.认证产品的标志与《机动车辆轮胎产品技术参数表》的一致性检查; b.认证产品现场指定试验(从工厂提交的生产一致性文件计划中规定的项目中选取)。 7.2.3.3 初始工厂检查时间 对需要进行初始工厂检查的认证委托,CQC 委派覆盖机动车辆轮胎专业的检查组实施生产企业现场检查。 检查人日数根据生产企业(场所)、检查内容和所委托认证产品的单元及覆盖的产品规格数量确定,并适当考虑生产企业的规模,一般为4~6人日/加工场所。 7.2.4 检查结论 初始工厂检查未发现不符合项或有轻微不符合项且现场已完成整改并经检查组确认有效的,工厂检查结果评价为合格。 初始工厂检查存在不符合项,可允许限期(不超过3个月)整改。生产企业应采取纠正措施,并将整改材料报CQC。 CQC 采取适当方式对整改结果进行确认(对整改情况进行书面验证或现场验证)。整改有效,工厂检查结果为合格;逾期未完成整改或整改结果不满足要求的,工厂检查结果为不合格,终止本次检查,终止认证。 工厂检查发现生产一致性控制文件的执行情况与申报并经CQC 确认的生产一致性控制文件存在严重偏差,或实际生产产品与型式试验合格样品或经确认的产品描述存在重大差异时,检查结果不合格,终止本次检查。 7.3 认证结果评价与批准 认证机构对型式试验、初始工厂检查的结论和有关资料/信息进行综合评价,对符合认证要求的,评价通过,按单元颁发认证证书。 当型式试验不合格、初始工厂检查不通过,CQC 做出不合格决定,终止认证。终止认证后认证委托人如要继续委托认证,应重新提出认证委托。 7.4认证时限 自受理认证委托之日起至颁发认证证书时止不超过90 天,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 应书面通知委托人,并说明理由。 本细则没有做出明确规定的认证流程及时限,以CQC 有关程序文件及作业指导书要求为准。CQC 将按照相关程序文件和作业指导书的要求控制认证时限完成相关工作,认证委托人、生产者、生产企业应予以配合。 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、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。 8 获证后监督 认证委托人、生产者(制造商)、生产企业应按《强制性产品认证管理规定》、《强制性产品认证标志管理办法》、《强制性产品认证证书注销、暂停、撤销实施规则》、《强制性产品认证实施规则中涉及ODM 模式的补充规定》、实施规则、本实施细则和认证标准的要求,确保其持续生产的获证产品符合法律法规和标准要求、企业质量保证能力和产品一致性控制持续符合认证要求。 认证委托人、生产者(制造商)、生产企业应在本实施细则第8.1 条规定的周期内接受监督,否则按不能接受获证后监督处置。对于非连续生产的产品,认证委托人、生产者(制造商)、生产企业应主动向CQC 提交生产计划,以便于后续跟踪检查的有效开展。 8.1 获证后监督方式选择 获证后的监督方式包括获证后跟踪检查、生产现场抽取样品检测/检查或市场抽样检测/检查;结合生产企业分类结果和实际情况,获证后监督为其中一种或多种方式的组合。 获证后监督方式的选择见表3。 表3 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/检查 市场抽样检测/检查 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 8.2 获证后跟踪检查的要求 8.2.1 获证后的跟踪检查原则 CQC 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。 8.2.2 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3 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)与《机动车辆轮胎产品技术参数表》的一致性和认证产品现场指定试验(从工厂提交的生产一致性文件计划中规定的项目中选取); (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、外部质量信息中有关认证产品不合格的纠正、纠正措施及其有效性的验证。 8.3生产现场抽样检测或者检查 8.3.1 抽样地点 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,按本细则8.3.2 的规定抽取样品,抽取的样品应是经生产者或生产企业确认的合格品。认证委托人、生产者或生产企业应在CQC 抽样后10 个工作日内寄出样品。 8.3.2 抽样规格和数量 CQC 根据生产企业分类结果(类别),确定监督抽样的产品规格和数量,原则上按表4 执行,应优先抽取以往未抽取过的获证产品。
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