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0 General 0.1 Introduction The implementation regulation on compulsory product certification for electric wires and cables (hereinafter referred to as the "Implementation Regulation") was prepared as per “Implementation Rule on Compulsory Certification - Electrical Wires and Cables” (CNCA-C01-01: 2014) (hereinafter referred to as the "Implementation Rule") as an auxiliary document for certification implementation rules. This Implementation Regulation was prepared and published on the basis of the Implementation Rule as well as the quality manual, procedure documents and operation instructions of the China Quality Certification Center (hereinafter referred to as CQC) and on the principles of maintaining the validity of product certification, improving product quality, serving certification enterprises and controlling certification risk. This Implementation Regulation was prepared according to and shall apply in combination with the Implementation Rule. Product range and certification basis applicable for the Regulation shall comply with relevant provisions in the Implementation Rule and shall be adapted in accordance with announcements on the definition and adjustment of contents issued by Certification and Accreditation Administration of the People's Republic of China (hereinafter referred to as “CNCA”). Based on the certification implementation rule, CQC has established requirements for classification management of manufacturers and, in combination with manufacturer classification, specified those for implementation of compulsory product certification for electric wires and cables. 0.2 Terms and Definitions 0.2.1 Testing at Manufacturer's Premises (Hereinafter Referred to as TMP) Testing conducted by designated personnel from testing body using manufacturer's equipment with the assistance of testing personnel from the manufacturer, of which the testing report is issued by designated testing body. 0.2.2 Witnessed Manufacturer's Testing (Hereinafter Referred to as WMT) Testing conducted by manufacturer's test personnel using his equipment, with testing items and conditions witnessed by designated personnel from testing body, original record issued by and test report drafted by manufacturer’s test personnel but reviewed and validated by designated personnel from the testing body, and test report issued by designated testing body. 0.2.3 Original Design Manufacturer (ODM) The factory designing, processing and producing identical products for one or more producers (manufacturers), using identical quality assurance capacity requirements and identical requirements for product design, production process control and inspection. 0.2.4 ODM Initial Certificate Holder The organization whose ODM products have initially earned product certificate. 0.2.5 Verification on Product Conformity Product inspection carried out to assess the conformity in safety performance of manufactured goods and to verify the compliance with product standards concerned. 0.3 Principle for Manufacturer Classification CQC acquires and reorganizes all kinds of information relevant to certification product and its manufacturer quality so as to realize classification management of manufacturer in a dynamic way. Certification client, producer and manufacturer shall coordinate with CQC. Manufacturers are classified into Category A, Category B, Category C and Category D, according to information at least including: ① Factory inspection (including initial factory inspection and post-certification follow-up inspection) result; ② Testing result of supervision sampling (production site sampling or market sampling); ③ Conclusions on national and provincial random inspections and CCC special random inspection; ④ Quality information feedback from media exposure, product user and the public; ⑤ Certification product's testing capacity; ⑥ Other information. CQC classifies and grades manufacturers based on the following basic principles for classification; it also, periodically or aperiodically, reclassifies and grades them according to all kinds of information so as to realize dynamic management. The result of manufacturer classification in principle must be upgraded by successive level of D-C-B-A and degraded by successive or cross level of A-B-C-D. Table 1 Principle for Classification of Manufacturers Category of enterprise Classification prinicple Category A Category B provides relevant information for certification authority while the latter makes an integrated risk assessment and determines classification result according to acquired quality information and the information provided by the former. The assessment at least covers the following contents: a) Factory inspection: initial factory inspection and post-certification follow-up inspection in the last two years are qualified or not verified on site; b) Results of product testing and random inspection: no non-conformance terms are found in the supervision and inspection within the last 2 years after certified, and the national and provincial quality supervisions and random inspections for all kinds of products as well as conformity verification turn out to be "qualified"; c) Passing the CQC review on the manufacturer's testing capacity or qualified as declared AA enterprise by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; d) Other information related to the manufacturer and the quality of certified products. Category B Other, except Category A, Category C and Category D, manufacturers. As for manufacturers without any quality information, its classification grade is Category B by default. Category C Meeting any of the following conditions: a) Manufacturers whose factory inspection conclusion is judged as "on-site verification" (except for the reasons of revised standard); b) Manufacturers whose certified product is found with quality problem by the media and who are liable but without certificate suspension and cancellation involved; c) Manufacturers which need to be adjusted to Category C as considered by CQC as per the results of comprehensive assessment on quality information related to the manufacturers and their certified products. Category D Meeting any of the following conditions: a) The initial factory inspection and post-certification follow-up inspection are judged as "No pass"; b) Safety in post-certification supervision is tested as unqualified; c) Manufacturers rejecting sampling for inspection and/or supervision without justifiable reasons; d) Manufacturers who are liable for the major quality problem of certified product revealed by the media; e) All kinds of national and provincial supervisions and random inspections on product quality are judged as unqualified and the unqualified items have a strong impact on the quality of certified products; f) The authentication certificate is suspended or revoked due to the manufacturer's failing in meeting other requirements of compulsory product certification; g) Manufacturers which need to be adjusted to Category D as considered by CQC as per comprehensive assessment result of the relevant quality information of manufacturers and certified products. Note: If there is any change, classification is subject to CQC public documents. 1 Selection of Certification Mode 1.1 Basic Certification Mode Basic certification mode: type test + post-certification supervision. 1.2 Refinement of Certification Mode Relevant certification elements shall be added appropriately in the certification mode for different categories of enterprises according to the basic mode of certification and by combining the classification management principle of manufacturers; specific refinement is as follows: Mode 1: Type test + post-certification supervision; Mode 2: Type test + initial factory inspection (conformity verification) + post-certification supervision; Mode 3: Type test (sampling) + initial factory inspection + post-certification supervision. Relevant requirements of post-certification supervision are detailed in 5.1 Schemes of Post-certification Supervision. 1.3 Applicability of Certification Mode Based on his own actual situation and the following Table 2, certification client may file an application for applicable certification mode. Table 2 Applicability of Certification Mode Category of enterprise Application type a Initial application Category-extended application Non-extended application Certificate-based ODM application Category A / Mode 1 Mode 1 Mode 1b Category B Mode 2 or 3 Mode 2 or 3 Mode 1, 2 or 3c Mode 1 Category C / Mode 2 or 3 Mode 2 or 3 Mode 2 or 3 Category D / Mode 2 or 3 Mode 2 or 3 Mode 2 or 3 a: "Initial application": with no CCC certificate acquired for the product within the application scope of this Regulation, the manufacturer claims for initial certification; "category-extended application": with CCC certificate acquired for the product within the application scope of this Regulation, the manufacturer re-claims for certification for the product whose subcategory is different with that of the certified one; "non-extended application": with CCC certificate acquired for the product within the application scope of this Regulation, the manufacturer re-claims for certification for the product whose subcategory is the same as that of the certified one; "certificate-based ODM application": ODM application using the certificate obtained by the manufacturer. b: If only the applicant or manufacturer is changed, with the product to be certified identical with the originally certified product, the manufacturer may provide information for conformity verification instead of type test. c: If there is appreciable difference in production process between the product to be certified and the certified product, mode 2 or 3 shall be considered. According to the characteristics of products applied for certification and the principles of certification risk control, CQC shall determine an applicable certification mode for certification client in combination with the management results of manufacturers by classification. 2 Certification Unit Division See Article 4 of the Implementation Rule. Products from the same manufacturer (producer) but different production enterprises (sites) shall be regarded as different application units; products from the same manufacturing enterprise (site) but different manufacturers (producers) shall be regarded as different application units. 3 Certification Procedure and Time Limit 3.1 Certification Procedure The certification procedure includes: certification entrustment, acceptance and data review, type test and initial factory inspection, expense collection, certification result assessment and approval, issuance of certification decision and post-certification supervision, etc. 3.2 Time Limit of Certification It refers to that the duration from the acceptance to the issuance of certification is limited to within 90 days (except for product with long inspection period), e.g. type test, initial factory inspection and submittal of report after the factory inspection (if applicable), certification result evaluation and approval, certificate preparation. The duration for completing the certification activities above excludes that for correcting nonconformities, re-testing and conformity verification. CQC/laboratory shall effectively inform the client of the nonconformity with the certification requirements and give the reason. The certification procedure and time limit, if not specified in the Regulation shall be subject to the requirements of related procedure documents and operation instructions of CQC. CQC shall control the certification time limit so as to complete related works and the certification client, producer and manufacturer shall give their support. The certification client, producer (manufacturer) and production enterprise shall support and closely coordinate with CQC in certifying work. If certification is delayed resulting from delayed certification activities due to the certification client, producer and production enterprise themselves, it shall not be considered in the time limit of certification. 4 Pre-certification Requirements 4.1 Certification Entrustment 4.1.1 Proposal and Acceptance of Certification Entrustment The certification client proposes certification entrustment to CQC via internet (www.cqc.com.cn). The client shall fill in enterprise and product information necessary for certification entrustment, including business registration certification, organization code, product description, etc. CQC shall review the application according to relevant requirements, and inform of the acceptance or refusal without delay, or require the certification client for re-proposing the certification application after correction. 4.1.2 Information and Relevant Requirements for Certification Entrustment After the application is accepted, the certification client shall provide relevant application information and technical materials to CQC and/or laboratory according to the requirements of certification scheme, usually including: (1). formal application; (2). description of electrical wires and cables; (3). survey schedule for factory inspection; (4). certifications for the registration of certification client, producer (manufacturer) and production enterprise; (5). quality certificates of the producer (manufacturer) and/or production enterprise for critical raw materials (if any); (6). other information (e.g. certification documents for quality management system and affiliated trademark); (7). relevant agreements or contracts signed between the certification client, producer (manufacturer) and production enterprise, e.g. copies of ODM agreement, letter of authorization and original certificate (if necessary); (8). documented evidence for the relevant change items of changed application. The enterprise shall be responsible and accordingly liable for the legal conformity and authenticity of the application data or information, e.g. name and address. 4.2 Type Test 4.2.1 Type Test Scheme If certification entrustment requires type test, and the application information is checked as qualified, CQC will develop a type test scheme and inform the certification client. The type test scheme includes information e.g. sample requirements and quantity, testing standards and items, laboratory. 4.2.2 Sample Requirements 4.2.2.1 Principle for Selecting Samples CQC shall lay down sample requirements for sampling/sampling submittal of unit or unit combination according to the unit division as specified in the attachments of the Implementation Rule as well as the sample submittal requirements and principles specified in Attachment 1 of this Implementation Regulation. For certification applied for series products, samples shall be drawn from the representative model & specification of series products and the samples selected shall cover the safety requirements, structural requirements and critical materials manufacturers of series products. 4.2.2.2 Sample Quantity For common electrical wires and cables, the sample quantity is 50m. For plastic insulated products ≥50mm2 in conductor section per core and rubber insulated products ≥16mm2 in conductor section per core, the sample quantity is ≥30m. 4.2.2.3 Sampling/Submittal Method Generally, the certification client prepares and submits samples to designated laboratory according to the requirements of type test scheme. Test samples shall be produced by the production enterprise entrusting certification and using normal processing method and the certification client shall guarantee the samples provided are consistent with actual products. CQC and/or laboratory shall check the authenticity of the sample provided by the certification client. The laboratory, which has any doubt in the sample authenticity, shall explain to CQC, and CQC shall make corresponding treatment decision. In case of sampling method adopted for the type test in certification mode, CQC shall assign persons to the production site for sampling and sample sealing according to the sample requirements for type test and shall ensure at least one sample (whose structure shall be representative) for each product category is drawn at the production line terminal. CQC may assign inspectors for factory inspection while sampling; in this case, the factory inspection of the samples shall be concluded as acceptable or in the presence of nonconformity, shall be carried out under the premise of written verification on the effectiveness of corrective actions. 0 General 0.1 Introduction 0.2 Terms and Definitions 0.2.1 Testing at Manufacturer's Premises (Hereinafter Referred to as TMP) 0.2.2 Witnessed Manufacturer's Testing (Hereinafter Referred to as WMT) 0.2.3 Original Design Manufacturer (ODM) 0.2.4 ODM Initial Certificate Holder 0.2.5 Verification on Product Conformity 0.3 Principle for Manufacturer Classification 1 Selection of Certification Mode 1.1 Basic Certification Mode 1.2 Refinement of Certification Mode 1.3 Applicability of Certification Mode 2 Certification Unit Division 3 Certification Procedure and Time Limit 3.1 Certification Procedure 3.2 Time Limit of Certification 4 Pre-certification Requirements 4.1 Certification Entrustment 4.1.1 Proposal and Acceptance of Certification Entrustment 4.1.2 Information and Relevant Requirements for Certification Entrustment 4.2 Type Test 4.2.1 Type Test Scheme 4.2.2 Sample Requirements 4.2.2.1 Principle for Selecting Samples 4.2.2.2 Sample Quantity 4.2.2.3 Sampling/Submittal Method 4.2.3 Testing Items and Requirements 4.2.4 Implementation of Type Test 4.2.5 Type Test Report 4.3 Factory Inspection 4.3.1 Definition for Object and Requirements for Coverage of Factory Inspection 4.3.2 Contents of Initial Factory Inspection 4.3.2.1 Inspection Contents 4.3.2.2 Factory Quality Assurance Capacity Inspection 4.3.2.3 Product Conformity Inspection 4.3.3 Opportunity for and Duration of Initial Factory Inspection. 4.3.4 Inspection Conclusion. 4.4 Verification on Product Conformity 4.5 Assessment and Approval of Certification Results 5 Post-certification Supervision Requirements 5.1 Post-certification Supervision Scheme. 5.1.1 Contents of Post-certification Supervision 5.1.2 Frequency of Post-certification Supervision. 5.1.3 Man-Days of Post-certification Supervision. 5.2 Requirements of Post-certification Follow-up Inspection. 5.3 Supervisory Sample Inspection. 5.3.1 Sampling Site 5.3.2 Sampling Quantity and Base Number 5.3.3 Items and Requirements of Sample Testing. 5.4 Assessment and Approval of Post-certification Supervision Result 5.4.1 Follow-up Inspection Assessment 5.4.2 Result Assessment of Supervisory Sample Inspection. 5.4.3 Comprehensive Assessment. 6 Certificate 6.1 Validity Period of Certificate 6.2 Change of Certificate 6.3 Expansion of Certification Scope 6.3.1 Product Model & Specification Expanded in the Same Unit 6.3.2 Addition of Certification Unit 6.4 Cancellation, Suspension and Revocation of Certificate 6.5 Application of Certificate 7 Certification Mark 8 Critical Raw Materials 9 Charge Basis and Requirement 10 Requirements of Process and Time Limit Related to Technical Disputes, Complaints and Appeals Attachment 1 Type Sample Requirement for Compulsory Certification of Wires and Cables Attachment 2 List of Critical Raw Materials for Compulsory Certification of Wires and Cables Attachment 3 Description Information for Compulsory Certification Product of Wires and Cables Attachment 4 Factory Quality Assurance Capacity Requirement for Compulsory Certification of Wires and cables Attachment 5 Quality Control and Inspection Requirements of Factory for Compulsory Certification of Electrical Wires and Cables Attachment 6 Operation Requirements of Testing (or Witness Testing) with Manufacturer's Testing Resources 0 通用要求 0.1 引言 电线电缆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 品认证实施规则电线电缆产品》(CNCA-C01-01:2014)(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。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。 本实施细则是依据实施规则的要求编制,与实施规则共同使用。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。 CQC 依据认证实施规则的规定,建立生产企业的分类管理要求,结合生产企 业的分类,明确电线电缆强制性产品认证的实施要求。 0.2 术语和定义 0.2.1 利用生产企业设备检测(简称 TMP 方式) 试验由指定的检测机构人员利用生产企业的设备进行检测,生产企业检测人 员予以协助,检测报告由指定检测机构出具。 0.2.2 生产企业目击检测(简称 WMT 方式) 试验由生产企业试验人员利用其设备进行检测,指定检测机构的人员对检测 项目及检测条件进行目击,生产企业试验人员出具原始记录、起草试验报告,指 定检测机构的人员审核并确认,试验报告由指定检测机构出具。 0.2.3 ODM(Original Design Manufacturer)生产厂 利用同一质量保证能力要求、同一产品设计、生产过程控制及检验要求等, 为一个或多个生产者(制造商)设计、加工、生产相同产品的工厂。 0.2.4 ODM 初始认证证书持证人 ODM 产品初次获得产品认证证书的组织。 0.2.5 产品一致性确认检验 为评价所制造产品安全性能的一致性,并确认符合相应产品标准,而进行的 产品检验。 0.3 生产企业分类原则 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。 生产企业分为四类,分别用 A 类、B 类、C 类、D 类表示。分类依据至少包 括以下方面的信息: ①工厂检查(包括初始工厂检查和获证后的跟踪检查)结果; ②监督抽样的检测结果(生产现场抽样或市场抽样); ③国抽、省抽、CCC 专项抽查等结论; ④媒体曝光及产品使用方、社会公众的质量信息反馈; ⑤认证产品的检测能力; ⑥其他信息。 CQC 依据以下分类的基本原则对生产企业进行分类定级,并根据各类信息定 期或不定期的对生产企业重新分类定级,实现动态化管理。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 的次序逐级或跨级下降。 表 1 生产企业的分类原则 企业类别 分类原则 B 类企业向认证机构提供相关资料,认证机构对所收集的质量信息和企业 提供的相关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: A 类 a)工厂检查:近 2 年内的初始工厂检查,获证后跟踪检查没有现场验证或 不通过的情况; b)产品检测、抽查结果:近 2 年内获证后监督检测未发现不符合项,国家 级、省级的各类质量监督抽查和一致性确认检验结果均为“合格”; c)通过 CQC 对生产企业检测能力的评审或者具备国家质量监督检验检疫 总局公告的 AA 类企业资质。 d)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: a)工厂检查结论判定为“现场验证”的(标准换版原因除外); b)被媒体曝光获证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; c)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: a)初始工厂检查、获证后跟踪检查结论判定为“不通过”的; b)获证后监督检测结果为安全项不合格的; c)无正当理由拒绝检查和/或监督抽样的; d)被媒体曝光获证产品质量存在较大影响且系企业责任; e)国家级、省级等各类产品质量监督抽查结果为不合格,且不合格项目对 获证产品质量存在严重影响; f)不能满足其他强制性产品认证要求被暂停、撤销认证证书的; g)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。 注:如有变化,以 CQC 公开文件为准。 1 认证模式选择 1.1 基本认证模式 基本认证模式为:型式试验+获证后监督 1.2 认证模式的细化 根据基本认证模式,结合生产企业分类管理原则,针对不同类别企业在认证 模式中酌情增加相关认证要素,具体细化如下: 模式 1:型式试验+获证后监督 模式 2:型式试验+初始工厂检查(一致性确认检验)+获证后监督 模式 3:型式试验(抽样)+初始工厂检查+获证后监督 其中,获证后监督的有关要求见 5.1“获证后监督方案”的规定。 1.3 认证模式的适用性 认证委托人可根据自身实际情况,参照表 2 认证模式的适用性,提出适用认 证模式的申请。 表 2 认证模式的适用性 企业类别 申请类型 a 初次申请 扩类申请 非扩类申请 利用已获证书的 ODM 申请 A 类 / 模式 1 模式 1 模式 1b B 类 模式 2 或 3 模式 2 或 3 模式 1,2 或 3c 模式 1 C 类 / 模式 2 或 3 模式 2 或 3 模式 2 或 3 D 类 / 模式 2 或 3 模式 2 或 3 模式 2 或 3 a:“初次申请”:生产企业未获得本细则适用范围内产品的 CCC 证书而进行的初次认证委托;“扩类申请”: 生产企业已获得本细则适用范围内产品的 CCC 证书而进行的再次认证委托,且产品小类与已获证的产品小 类不同;“非扩类申请”:生产企业已获得本细则适用范围内产品的 CCC 证书而进行的再次认证委托,且产 品小类与已获证的产品小类相同;“利用已获证书的 ODM 申请”:利用生产厂已获证书进行的 ODM 申请。 b:对于申请认证产品与原获证产品完全一致,仅申请人或制造商改变的情况,可考虑企业提供资料进行一 致性核查,替代产品型式试验。 c:对于申请认证产品的生产工艺与已获证产品有明显差异不可覆盖的申请,应考虑模式 2 或 3。 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。 2 认证单元划分 按照实施规则第 4 条执行。 相同制造商(生产者)、不同生产企业(场地)生产的产品应作为不同的申请 单元;相同生产企业(场地),不同制造商(生产者)生产的产品应作为不同的 申请单元。 3 认证流程及时限要求 3.1 认证流程 认证流程包括:认证委托、受理及资料评审、型式试验和初始工厂检查、收 费、认证结果评价及批准、认证决定发出和获证后监督等环节。 3.2 认证时限 自受理认证委托之日起至颁发认证证书之日止不超过 90 天(检测周期长的产 品除外),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、复试检测时间以及一致性 确认检验时间。对不符合认证要求的情况,CQC/实验室应以有效方式通知委托 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,不计入认证时限内。 4 获证前认证要求 4.1 认证委托 4.1.1 认证委托的提出和受理 认证委托人通过网络(www.cqc.com.cn)向 CQC 提出认证委托。提出认证委 托时,需提供必要的企业信息和产品信息,包括工商注册证明、组织机构代码和 产品描述等。CQC 依据相关要求对申请进行审核,及时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。 4.1.2 认证委托资料及相关要求 认证委托人应在申请受理后按认证方案的要求向 CQC 和/或实验室提供有关 申请资料和技术材料,通常包括: (1). 正式申请书; (2). 电线电缆产品描述; (3). 工厂检查调查表; (4). 认证委托人、生产者(制造商)、生产企业的注册证明材料; (5). 关键原材料生产者(制造商)和/或生产企业质量证明文件(如有); (6). 其他资料(如:质量管理体系认证证明文件、所属商标的证明文件等); (7). 认证委托人、生产者(制造商)、生产企业之间签订的有关协议书或合同, 如 ODM 协议书,授权书及原始证书复印件(需要时)等; (8). 对于变更申请,相关变更项目的证明文件。 企业对名称、地址等申报资料或信息的法律法规符合性、真实性负责,并承 担相应责任。 4.2 型式试验 4.2.1 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 应制定型式 试验方案,并通知认证委托人。型式试验方案包括样品要求和数量、检测标准及 项目、实验室信息等。 4.2.2 样品要求 4.2.2.1 样品选取原则 CQC 按照实施规则附件规定的单元划分,根据本实施细则附件 1 中的送样要 求及原则制定单元或单元组合抽样/送样的样品要求。 以系列产品申请认证时,样品应从系列产品中选取具有代表性的型号规格, 并且选取的样品应覆盖系列产品的安全要求、结构要求及关键原材料制造商。 4.2.2.2 样品数量 一般电线电缆产品,送样数量为 50m。 每芯导体截面≥50mm2 的塑料绝缘产品、每芯导体截面≥16mm2 的橡皮绝缘产 品,送样数量为≥30m。 4.2.2.3 抽样/送样方式 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。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 人应保证其提供的样品与实际生产的产品一致。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,CQC 做出相应处理决定。 对于认证模式中的型式试验为抽样方式的情况,CQC 应安排人员在生产现场 按照型式试验样品要求进行抽样并封样,并且确保每个产品类别至少有一件样品 (该样品结构应具有一定代表性)在生产线末端抽取。如认证委托人提出需求, CQC 可安排检查员在抽样的同时进行工厂检查,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。 4.2.3 检测项目及要求 按照实施规则 6.1.3 条执行。 4.2.4 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。 当型式试验有不合格项目时,允许认证委托人整改。整改和复试一般应在 3 个月内完成,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。 型式试验时间一般不超过 30 个工作日(从实验室收样并收到检测费用日期起 至型式试验报告签发日期止,检测周期长的产品除外),不包括企业进行整改的 时间。复试时间规定同型式试验时间规定。 4.2.5 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。 4.3 工厂检查 4.3.1 工厂检查对象的界定和工厂检查的覆盖性要求 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,应选择一个至少包括 例行和确认检验(如有)、加贴产品铭牌和认证标志环节在内的比较完整的场所 进行检查,并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;覆盖“申请认证/获证产品” 是指产品一致性检查的覆盖,产品一致性检查应对每类工厂界定编码的产品实施。 认证机构如果在生产现场无法完成本文附件 4 要求的工厂检查时,可延伸到认证 委托人、生产者等处进行检查。 4.3.2 初始工厂检查的内容 4.3.2.1 检查内容 初始工厂检查的内容为工厂质量保证能力和产品一致性检查。 4.3.2.2 工厂质量保证能力检查 按照附件 4 的要求进行检查。此外,还应按照《电线电缆产品强制性认证工 厂质量控制检测要求》(见附件 5)进行核查。 对于 ODM 模式,还依据《强制性产品认证实施规则中涉及 ODM 模式的补充 规定》进行检查。 4.3.2.3 产品一致性检查 工厂检查时,应在生产现场对委托认证的产品按照每个生产者(制造商)、每 类产品至少抽取一件样品,核实以下内容: 1)产品的合格证和包装物上所标明的产品名称、型号、规格应与产品标准的 规定一致; 2)产品表面印刷产品名称、型号、规格时,应与产品标准的规定一致; 3)产品表面印刷的生产者(制造商)名称、商标应与生产者(制造商)的注 册名称、注册商标一致; 4)产品的结构应与产品标准的规定、《型式试验报告》的描述一致; 5)产品所用原材料的名称、型号、规格、质量、生产者应与《型式试验报告》 /认证机构所确认的变更一致; 6)绝缘、护套的加工方式应与《产品描述报告》的描述一致。 每类产品至少抽取一件样品进行指定试验,指定试验项目为《电线电缆类产 品强制性认证工厂质量控制检测要求》(附件 5)中逐批进行的确认检验项目,必 要时应包括例行检验项目。 4.3.3 初始工厂检查时机和检查时间 一般情况下,型式试验合格后,再进行初始工厂检查。根据需要,型式试验 和工厂检查也可以同时进行。工厂检查原则上应在型式试验结束后一年内完成, 否则应重新进行型式试验。初始工厂检查时,工厂应生产申请认证范围内的产品。 工厂检查时间根据所申请认证产品的单元数量确定,并适当考虑工厂的生产 规模和分布,一般为 1~4 个人日。 对于 ODM 生产者(制造商)进行现场检查的人日数按《强制性产品认证实 施规则中涉及 ODM 模式的补充规定》执行。 |
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