3c认证工厂质量保证能力要求中英文版.docVIP

- PAGE 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 factory’s 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 was approved. 1 职责和资源/Responsibility, Authority and Resource 1.1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 quality activities. And factory shall appoint a responsible 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 any non-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 work. 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 consistently manufacture the products in conformity with certification standards. In addition, factory shall provide relevant human resources, to ensure that personnel performing work affecting product quality is competent, and establish and ma