3C认证工厂质量保证能力要求中英文版.doc

1、为保证批量生产的认证产品与已获型式试验合格的样品的一致性，工厂应满足本文件规定的产品质量保证能力要求。Factory shall meet the requirements for factorys quality assurance ability in this document, in order to ensure that all certified products are identical within accepted manufacturing tolerances to the sample or samples against which the type test w

2、as approved.1 职责和资源/Responsibility, Authority and Resource1.1职责/Responsibility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：Factory shall regulate the responsibilities and inter-relations of all the personnel involved in qualityactivities. And factory shall appoint a respo

3、nsible person for quality from the organization who,irrespective of other responsibilities, shall have responsibility and authority that include.a. 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；Ensuring that quality system, which meets the requirements of this document, is established, implemented and maintained.b. 确保

4、加贴强制性认证标志的产品符合认证标准的要求； Ensuring that the products with the certification label are produced in conformity with the standards to which they were certified.c. 建立文件化的程序，确保认证标志的妥善保管和使用； Establishing documented procedure to ensure that certification labels are kept and used appropriately.d. 建立文件化的程序，确保不合

5、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 证标志。Establishing documented procedure to ensure that the certification label is not borne on anynon-conforming product or changed product that was not notified by certification body. 质量负责人应具有充分的能力胜任本职工作。The responsible person for quality shall be competent to perform the w

6、ork.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、储存等必备的环境。Factory shall equip with necessary production facility and testing equipment in order to consistentlymanufacture the products in conformity with certification standards. In additi

7、on, factory shallprovide relevant human resources, to ensure that personnel performing work affecting productquality is competent, and establish and maintain necessary environment suitable for manufacturing,test and inspection, storage etc.2. Documents and Records文件和记录2.1 Factory shall establish and

8、 maintain documented quality plan or relevant documents for certifiedproducts, and needed documents in order to ensure that related processes to product quality areoperated and controlled effectively. Quality plan shall define the objective of product design,realization process, test and related res

9、ource, as well as the requirements for changes (i.e. standard,workshop, critical components etc.) to certified products, use and management of labels.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。 Design standard or specif

10、ication, as one essential part of quality plan, shall not be lower than therequirements of national standard for the product.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。2.2 Factory shall establish and maintain documented procedure to control the documents required in this document, to ensure that工厂应建立并

11、保持文件化的程序以对本文件要求的文件和资料进行有效的控制。这些控制应确保：a)documents are approved by authorized personnel prior to issue and re-approved after changes.文件发布前和更改应由授权人批准，以确保其适宜性；b)changes and current revision status of documents are identified to prevent unintended use of obsoletedocuments.文件的更改和修订状态得到识别，防止作废文件的非预期使用；c)re

12、levant versions of applicable documents are available at points of use.确保在使用处可获得相应文件的有效版本。2.3 Factory shall establish and maintain documented procedure to define the controls for the identification, storage, protection and disposition of records. Records shall remain legible, integral to provide evi

13、dence of product conformity to requirements.2.3 工厂应建立并保持质量记录的标识、储存、保管和处理的文件化程序，质量记录应清晰、完整以作为产品符合规定要求的证据。Records shall be retained for an appropriate period.质量记录应有适当的的保存期限。3. Purchasing and Incoming Inspection3 采购和进货检验3.1 Control of Supplier3.1 供应商的控制Factory shall establish the procedure that defines

14、 the criteria for selection, evaluation and routine supervision of supplier, which provide critical components and material, to ensure the supplier has ability to provide the critical components and material in accordance with requirements.工厂应制定对关键元器件和材料的供应商的选择、评定和日常管理的程序，以确保供应商具有保证生产关键元器件和材料满足要求的能力

15、。Records of the evaluations and routine supervision shall be maintained.工厂应保存对供应商的选择评价和日常管理记录。3.2 Inspection/Verification for Critical Components and Material3.2 关键元器件和材料的检验/验证Factory shall establish and maintain procedure of inspection or verification for purchased critical components and material,

16、 and procedure of periodic verification inspection, to ensure that critical components and material meet specified certification requirements.工厂应建立并保持对供应商提供的关键元器件和材料的检验或验证的程序及定期确认检验的程序，以确保关键元器件和材料满足认证所规定的要求。Inspection for purchased critical components and material may be carried out by factory or by supplier. Wh