第三章术语及工厂质量保证能力要求理解

1、第三章第三章Chapter Three术语及工厂质量保证能力要求理解术语及工厂质量保证能力要求理解Terms and Understanding of Requirements of Factorys Quality Assurance Ability 一、术一、术 语语 Terms申请人 Applicantl申请产品认证的组织 An organization for applying product certification注1. 通常，申请人在获得认证证书后就成为持证人 Note1: The applicant becomes a certificate holder after get

2、ting certificate usually.注2. 申请代理人：代替申请人办理认证申请手续的组织Note2: Application agent: an organization for handling application procedures for certification on behalf of the applicant.持证人 Certificate Holderl持有产品认证证书的组织 An organization to hold and own product certificate(s) 注: 通常，持证人在认证申请阶段是申请人 Note: The certi

3、ficate holder is an applicant in the phase of applying for certification usually.制造商 Manufacturerl控制认证产品制造的组织 An organization of controlling the manufacture of certified products. 注: 一个制造商可以有多个工厂 Note: One manufacturer may have several factories. 工厂Manufacturers Premise/Factory Locationl对认证产品进行最终装配和

4、/或试验以及加施认证标志的场所 The location carrying out the final assembly and /or testing certified products, and applying the certification mark. 注1: 检查的场所内至少有最终装配、例行检验、加贴产品铭牌和认证标志等工序Note1: The processes of final assembly, routine test, bearing nameplate of product and the Certification Mark should be in the in

5、spected location at least. 注2: 当以上工序不能在一个场所完成时，保留到其余场所进一步检查的权利Note2: When the processes above-mentioned cannot be completed in one location, the rights for further inspection to other locations shall be kept. 注3: 同一产品在不同场所均有生产，应作为不同的工厂分别申请Note3: The application shall be submitted respectively for th

6、e same product produced at different factories.OEM厂 (Original Equipment Manufacturer） l按委托人提供的设计、生产过程控制及检验要求生产认证产品的工厂 The factory undertakes the production of certified products according to the requirements specified by the consigner for the design, control of production process, test and inspectio

7、n. OEM厂 (Original Equipment Manufacturer） 注1: 委托人可以是申请人/持证人或制造商Note1:The consigner may be the applicant/certificate holder or the manufacturer.注2: OEM厂根据委托人提供的设计、生产过程控制及检验要求，在OEM厂的体系下生产认证产品Note2:OEMs factory shall produce the certified products under its own system according to the requirements spec

8、ified by the consigner for design, control of production process, test and inspection.注3:不同的委托人，OEM厂应分别接受检查，体系要素不重复检查，但产品的生产过程控制及检验、一致性检查不可免除Note3: For the different consigners, OEMs factory shall respectively accept the inspections on the control of production process, test and inspection, consiste

9、ncy of certified products, but not repeating the elements of quality system.ODM厂（Original Design Manufacturer） l利用同一质量体系、设计、生产过程控制及检验要求为委托人生产认证产品的工厂 A factory produces certified products for consigner using the same quality system, design, control of production process and the requirements of inspec

10、tion and test. 注1: 委托人可以是申请人/持证人或制造商Note1:The consigner may be the applicant/certificate holder or the manufacturer 注2: ODM厂确定设计、生产过程控制及检验要求Note2:ODMs factory determines the design, control of production process as well as the requirements of inspection and test. ODM厂（Original Design Manufacturer） 注

11、3: 认证产品使用制造商的商标Note3: The trademark of manufacturer is applied to the certified products. 注4: 经认证机构文件审核确认，可以免除工厂检查Note4: Factory inspection may be exempted after examining the documents by certification body. 注5: 在生产条件相同情况下，对产品结构型式完全相同，仅商标或产品型号不同，经文件审核确认可免于型式试验Note5: The type testing may be exempted

12、 after examining the documents to the same production condition with totally identical structure of certified products, and only different in the trade mark or the model/type of product. 供应商 Supplierl为工厂生产认证产品提供元器件、零部件、原材料的组织 An organization that provides components, parts and materials to the facto

13、ry for certified products.初始工厂检查 Initial Factory Inspection 获证前进行的工厂检查 The inspection of factory before issuing the certificate获证后监督 Follow-up Inspection为确保持续满足认证机构的规定要求，对持证组织的工厂质量保证能力和认证产品进行的管理活动 It is the management activities on factory quality assurance ability and the certified products to ensu

14、re the specified requirements of the Certification Body to be met continuously. 注：“监督”可以按规定的频次进行，也可以是按非规定的频次进行Note : The “follow-up inspection” may be implemented according to the specified frequency, or to the frequency not specified.关键件 Critical Components对产品的安全、EMC、健康、环保、主要质量特性以及其它认证特性有重要影响的元器件和材

15、料 Components and materials having a critical impact on major quality characteristics of the products (mainly for safety, EMC, health and environmental protection ) and other certification characteristics.例行检验 Routine Testl为剔除生产过程中偶然性因素造成的不合格品，通常在生产的最终阶段，对产品进行的100检验 It is the test performed on 100% o

16、f products and normally at the final stage of production to eliminate the non-conforming products caused by accidental factors in the process of production.确认检验 Verification Test l为验证产品是否持续符合标准要求进行的抽样检验 It is the sampling test to verify whether the products continuously comply with the requirements

17、of standard. 注1: 确认检验通常按标准规定的条件进行，是在生产线检验和例行检验基础上进行的随机抽样检验Note1: Verification test is normally performed in accordance with the requirements of standards, and is the randomly sampling test on the basis of the production line inspection and the routine test. 确认检验 Verification Test 注2: 对产品实施确认检验的项目、频次

18、应满足认证实施规则的要求Note2: The items and frequency of verification test shall comply with the requirements specified in the Implementation Rules for certification. 注3: 工厂可以委托外部机构进行确认检验Note3: The factory can entrust external test body to carry out the verification test.指定试验On-Site Appointed Test为评价产品的一致性，按检查

19、员依据标准选定的项目进行的检验 The test of selecting items from standard by inspector to evaluate the consistency of certified products. 注1: 指定试验是产品一致性检查的补充手段Note1: The appointed test is a kind of complementary measure for checking the consistency of products. 注2: 通常按认证标准的要求抽取样品、进行检验Note2: Normally, it takes sampl

20、es according to the requirements of certification criteria and testing.指定试验On-Site Appointed Test 注3: 检验可在工厂或指定的检测机构进行Note3: The test may be carried out at factory location or the designated test body. 注4: 指定试验在工厂进行时，通常由工厂的检验员操作并记录相关数据和结果，检查员根据试验的条件、方法和结果，对产品的一致性作出判断Note4: When the appointed test is

21、 implemented at factory , the operator of the factory usually carries out the test and records relevant data and result. The inspector judges the consistency of product based on the test conditions, methods and results.验证 Verificationl通过提供客观证据对规定要求已得到满足的认定 It is a confirmation that the specified req

22、uirements have been fulfilled through providing the objective evidence. 注: 对产品而言： Note: For the product: “客观证据”可以是检验报告、检测数据、质保书等 The “objective evidence” can be the test and inspection report, test data, guarantee for quality and etc.“规定要求”可以是产品标准、采购文件等 The “specified requirements” can be the produc

23、t standards, purchasing documents etc.监督检验 Surveillance Inspection/Samplingl为评价获证产品的持续符合性，由认证机构组织实施的检验 It is the inspection implemented by certification body to appraise the sustained conformity of certified products. 注1: 通常，由实施规则规定监督检验的要求，或者由认证机构依据实施规则、面临的风险等确定监督检验要求Note1: The requirements of surve

24、illance inspection shall be prescribed by Implementation Rules usually , or determined by certification body based on Implementation Rules, risks etc.监督检验 Surveillance Inspection/Sampling 注2: 用于检验的样品应随机抽取。因此，有时也称“抽样检验”Note2:The samples for inspection shall be taken randomly. so it is called “Samplin

25、g inspection” sometimes. 注3: 通常，监督检验由认证机构派员抽样，检测机构实施检验Note3: The certification body designates personnel to take samples for the surveillance inspection, and inspecting by the testing body usually.校准 Calibrationl在规定条件下，为确定测量仪器或测量系统所指示的量值，或实物量具或参考物质所代表的量值与对应的由标准所复现的量值之间关系的一组操作 Under specified conditi

26、ons, a set of operation to determine the relationship between values indicated by a measuring instrument or measuring system, or the values representing by a material measure or a reference material and the corresponding values reproduced by the standard. 注: 校准一般不进行合格与否的判定 Note: The calibration is n

27、ot with the judgment of conformity or non-conformity usually. 溯源性 Traceability l通过一条具有规定的不确定度的不间断的比较链，使测量结果或测量标准的值能够与规定的参考标准，通常是与国家测量标准或国际测量标准联系起来的特性 The property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or internation

28、al standards, through an unbroken chain of comparisons all having stated uncertainties.运行（功能）检查Functional Checkl在校准周期内，为判定测量装置的预期功能是否适用于产品检验，对测量装置进行的检查 Checking the functions of a measuring instrument within the period of calibration to judge whether the due function of the measuring instrument is a

29、pplicable for testing product. 注: 检查方法可以为预先设定的故障条件，也可以是根据产品特性制作的样件，或其它规定的方法 Note: The checking method can be the failure conditions set in advance or using a dummy made on characteristic of products, or other specified methods.可追溯性 Traceability l追溯所考虑对象的历史、应用情况或所处场所的能力 The ability to trace the histo

30、ry, application or location of the considering object. 注: 对产品而言，可追溯性可涉及：Note: For the product, the traceability can relate to :原材料和零部件的来源 the origin of materials and parts,产品交付后的分布和场所 the distribution and location after the product delivered, 加工过程的历史 the processing history.产品一致性Consistency of Produc

31、tsl批量生产的认证产品与型式试验合格样品的符合程度 The conformity degree of the certified products in mass production and the samples approved by type testing. 注: 产品一致性的要求由产品认证实施规则规定Note: The requirement on consistency of product is specified by the Implementation Rules for certification.二、工厂质量保证能力要求理解二、工厂质量保证能力要求理解Compuls

32、ory Product Certification Requirements for Factorys Quality Assurance Ability 工厂质量保证能力： 工厂保证批量生产的认证产品符合认证要求并与型式试验合格样品保持一致的能力 Factorys Quality Assurance Ability: Factory ensures the capability that the certified products in mass production comply with the certification requirements and keep consisten

33、cy with the samples approved by type testing.工厂质量保证能力要求作用 Functions of Requirements for Factorys Quality Assurance Ability实施工厂质量保证能力检查的主要依据 It is the mainly basis for inspecting Factorys Quality Assurance Ability.工厂建立质量体系的主要依据 It is the mainly basis for establishing the quality system of factory. 工厂

34、质量保证能力要求的内容The Contents of Factorys Quality Assurance Ability1. 职责和资源 Responsibilities and Resources 2. 文件和记录 Documents and Records 3. 采购和进货检验 Purchasing and Receiving Inspection 4. 生产过程控制和过程检验 Process Control and Inspection 5. 例行检验和确认检验 Routine Tests and Verification Tests 工厂质量保证能力要求的内容The Contents

35、 of Factorys Quality Assurance Ability6.检验试验仪器设备 Inspection and Test Equipment 7.不合格品的控制 Control of Non-conforming Product8.内部质量审核 Internal Audit9.认证产品的一致性 Changes to Certified Product10.包装、搬运和储存 Packing, Handling and Storage1.职责和资源 Responsibilities and Resources 1.1 职责职责 工厂应规定与质量活动有关的各类人员职责及相互关系，且工

36、厂应规定与质量活动有关的各类人员职责及相互关系，且工厂应在组织内指定一名质量负责人，无论该成员在其他方面工厂应在组织内指定一名质量负责人，无论该成员在其他方面的职责如何，应具有以下方面的职责和权限的职责如何，应具有以下方面的职责和权限：1.1 Responsibility Manufacturer shall define the responsibilities and inter-relations of all the personnel involved in quality activities; and should appoint a management representat

37、ive for quality, who, irrespective of other responsibilities, shall be responsible to: 1.职责和资源 Responsibilities and Resources a) a)负责建立满足本文件要求的质量体系，并确负责建立满足本文件要求的质量体系，并确保其实施和保持保其实施和保持 b)b)确保加贴强制性认证标志的产品符合认证标确保加贴强制性认证标志的产品符合认证标准的要求准的要求 c)c)建立文件化的程序，确保认证标志的妥善保建立文件化的程序，确保认证标志的妥善保管和使用管和使用 d)d)建立文件化的程序，确

38、保不合格品和获证产建立文件化的程序，确保不合格品和获证产品变更后未经认证机构确认，不加贴强制性认证标品变更后未经认证机构确认，不加贴强制性认证标志志 质量负责人应具有充分的能力胜任本职工作质量负责人应具有充分的能力胜任本职工作1.职责和资源 Responsibilities and Resourcesa) Ensuring that quality system, which meets the requirements of this document, is established, implemented and maintained.b) Ensuring that the produ

39、cts bearing compulsory certification mark are in conformity with the certification standards.c) Establishing documented procedures to ensure that compulsory certification marks are kept and used appropriately.d) Establishing documented procedure to ensure that the compulsory certification mark is no

40、t affixed on any non-conforming product or changed product that was not confirmed by certification body.The management representative for quality shall be competent to perform the work.与质量活动有关的人员 The personnel involved in quality activities质量负责人Management representative 技术/设计人员Technical personnel /d

41、esigner质量管理/质量检验人员Personnel of quality management/quality inspection 采购人员 Purchasing personnel校准人员Personnel of calibration 内审员 Internal auditor 生产现场操作人员 Operators on site of production与质量活动有关的人员 The personnel involved in quality activities职责、权限及相互关系应形成文件 Responsibilities, authority and inter-relatio

42、ns shall be defined in documents可以集中描述，也可在相关文件中体现 It may be described in one document, or in the relevant documents.质量负责人Management Representative 应是组织内的人员 The management representative shall be within the organization.原则上应是最高管理层的或至少是能直接同最高管理者沟通的人员 In principle, the management representative shall c

43、ome from top management or can directly communicate with the top management at least. 应被赋予并有效履行规定的职责和权限 The responsibilities and rights of the management representative should be authorized and exercised effectively.可指定一名代理人 An attorney may be appointed.质量负责人和代理人的指定、职责和权限的规定应形成文件 The provision of ap

44、pointment, responsibilities and authority for the management representative and attorney shall be documented.对质量负责人能力的评价Appraising on Ability of Management Representative 教育、培训、经验、经历 Education, training, experience and working course.有关认证的法律法规、规则、程序的熟悉程度 Acquaintance with relevant laws, regulations,

45、 rules and procedures of certification. 工厂质量体系建立的符合性、适宜性，实施的有效性以及认证产品的符合性 The conformity, suitability and effectiveness of factorys quality system with the conformity of certified products.质量负责人职责和权限的理解 Understanding of responsibilities and authorities of management representative 质量负责人对工厂质量体系的建立、实施

46、和保持负主要责任 The management representative is mainly liable for establishing implementing and maintaining factorys quality system.质量负责人对工厂加贴认证标志的产品符合认证要求负主要责任 The management representative is mainly liable for the products bearing certification mark in compliance with the certification requirements.认证标志

47、的管理和使用程序应符合质检总局、认监委和认证机构规定，质量负责人对程序的制定和实施负主要责任 The procedure for controlling and using the certification marks shall comply with the prescription of AQSIQ, CNCA and Certification Body. Management representative is mainly responsible for working out and implementing the procedure.质量负责人职责和权限的理解 Unders

48、tanding of Responsibilities and Authorities of Management Representative 对产品使用认证标志的管理和控制 Preserving and controlling the certification marks used for products.应有文件化的程序 The documented procedure shall be had.不符合要求产品,变更后未经确认不得加贴认证标志 To ensure that the compulsory certification mark is not affixed on any

49、non-conforming products or changed products without approval by certification body. 质量负责人对程序的制定和实施负主要责任 The management representative is mainly responsible for working out and implementing the procedure.1.2 资源 Resources 工厂应配备必须的生产设备和检验设备以满足稳定生产符合强制性认工厂应配备必须的生产设备和检验设备以满足稳定生产符合强制性认证标准的产品要求；应配备相应的人力资源，

50、确保从事对产品质量有影响证标准的产品要求；应配备相应的人力资源，确保从事对产品质量有影响工作的人员具备必要的能力；建立并保持适宜产品生产、检验、试验、储工作的人员具备必要的能力；建立并保持适宜产品生产、检验、试验、储存等必备的环境存等必备的环境Factory shall be equipped with necessary production facility and testing equipment in order to consistently manufacture the products in conformity with relevant standards. In add

51、ition, and factory shall provide relevant human resources, to ensure that personnel performing work affecting product quality is competent, and shall establish and maintain necessary environment suitable for manufacturing, testing and inspection, storage etc.资源 Resources生产设备 Production facility 检验设备

52、 Testing equipment 人力资源 Human resources工作环境等 Working environment确定并提供所需资源的原则Principle of determining and providing resources根据产品特点、生产方式、规模大小、人员素质和认证机构的要求 It is on the basis of product characteristics, production mode, production scale, personnel quality as well as the requirements of certification b

53、ody. 能持续、稳定生产符合认证要求的产品 The products conforming to certification requirements can be manufactured continually and steadily.根据内、外部条件的变化重新确定和调整资源 Re-determining and adjusting the resources based on the changes of internal and external conditions.生产和检验设备Production and Testing Equipment 性能、精度、运行状况等满足生产和检

54、验的要求 The performance, precision and operation of the equipment should satisfy the requirements of production and testing. 数量满足正常批量生产的需要 The quantity of the equipment should be enough for normal lot production.人力资源Human Resources与质量活动有关的人员 The personnel involved in quality activities.能力胜任，数量满足持续稳定生产符

55、合认证要求产品的需要 The personnel should be competent for performing the work with enough quantity to meet the needs of products continuously conforming to the certification requirements. 能力评价：教育、培训、技能、经验 Appraising ability: education, training, skills and experience.环境Environment生产、检验/试验、存储等过程 Processes of

56、production, inspection/test, storage etc.识别环境要求，满足环境要求 Identifying and satisfying the requirements of environment.2.文件和记录Documents and Records 2.1 工厂应建立、保持文件化的认证产品的质量计划或类似文件，以及为确工厂应建立、保持文件化的认证产品的质量计划或类似文件，以及为确保产品质量的相关过程有效运作和控制需要的文件。质量计划应包括产品保产品质量的相关过程有效运作和控制需要的文件。质量计划应包括产品设计目标、实现过程、检测及有关资源的规定，以及产品获证

57、后对获证产设计目标、实现过程、检测及有关资源的规定，以及产品获证后对获证产品的变更（标准、工艺、关键件等）、标志的使用管理等的规定品的变更（标准、工艺、关键件等）、标志的使用管理等的规定2.1 Manufacturer shall establish and maintain documented quality plan or relevant documents for certified products, and the documents need to ensure that related processes to product quality are operated and

58、 controlled effectively. Quality plan shall define the objective of product design, realization process, test and related resource, as well as the requirements for changes (i.e. specification, processing, critical components etc.) to certified products, use and management of marks.2.文件和记录Documents a

59、nd Records 产品设计标准或规范应是质量计划的一个内容，其要求应产品设计标准或规范应是质量计划的一个内容，其要求应不低于有关该产品的国家标准要求不低于有关该产品的国家标准要求The design standard or specification of product is the essential part of quality plan, and shall not be lower than the requirements of relevant national standards for the products.文件类型 Types of Document 质量计划 Q

60、uality plan. 程序文件 Procedure documents. 设计文件 Design documents.工艺文件 Technology documents.检验文件 Test and inspection documents.作业指导书、操作规程 Working instructions and operating specifications.为确保过程有效运作和控制所需要的其他文件 The other documents to ensure the effective operation and control of process.质量计划 Quality plan 可