中环协(北京)认证中心公开文件Public files of CAEPI to anyone who may concernC C AEPI-GK-305-2009环境保护产品认证工厂质量保证能力要求MANUFACTURERS’ QUALITY CONTROL ABILITY（QCA）REQUIRED BY CERTIFICA TION OF CHINA ASSOCIATION OF EVIROEMENT PROTECTIONINDUSTRY（CCAEPI）2009年*月*日颁布2009年*月*日实施Published at 2009.*.* Executed since 2009.*.*中环协(北京)认证中心发布ISSUED BY CAEPI环境保护产品认证工厂质量保证能力要求MANUFACTURERS’ QUALITY CONTROL ABILITY（QCA）REQUIRED BY CERTIFICA TION OF CHINA ASSOCIA TION OF EVIROEMENTAL PROTECTIONINDUSTRY（CCAEPI）(CCAEPI-GK-305-2009)本文件规定了申请环保产品认证企业工厂质量保证能力应达到的要求。
申请环保产品认证的企业应满足并持续满足本文件的要求。
本文件是CCAEPI-GK-305-2005的改版。
This file stipulated the requirements on QC ability of manufactures who’s applying for CCAEPI. The applier shall meet the requirements listed in this file as long as it needed. This file is the revised version of CCAEPI-GK-305-2005.1．职责和资源1. Responsibilities and Resources1.1 职责1.1 Responsibilities工厂应规定与产品质量活动有关的各类人员的职责及相互关系。
The manufacturer shall prescribe the responsibilities and relationships of and between every person who’s related to QC activities.工厂应指定一名质量负责人，授权其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。
The manufacturer shall assign a QC manager, authorized to establish QC system which can meet the requirements stipulated in this file, and make sure the QC system is well implemented during producing processes.质量负责人应具有充分的能力胜任本职工作。
The QC manager shall be competent for this job.1.2 资源1.2 Resources工厂应配备必要的生产设备和检验设备以满足稳定生产符合认证标准的产品要求。
应配备相应的人力资源，确保对产品质量有影响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、储存等必要的环境。
The manufacturer shall be equipped with essential equipments for producing and QC processing, to make sure that they can stably producing products with quality that can meet the requirements of CCAEPI; and shall provide correspondingly the human resources, to insure that the persons related to QC system has the necessary capability; and shall establish and keep a suitable and essential environment for producing/QC/testing/storage etc.2．质量文件和产品标准2. QC files and Standards for the production2.1工厂应建立并保持文件化的产品质量管理文件，以确保产品质量的相关过程有效运作。
2.1 The manufacturer shall establish and keep a QC file system, to insure every processing related to QC can be operated effectively.2.2 应有完整的产品设计文件和工艺文件，审批手续完备2.2 The manufacturer shall provided integrated files on the products’ designs and producing procedures, with an intact approval procedure.2.3 产品生产应按照相应的标准（一般为企业标准）组织生产，并能有效指导和控制产品质量；产品企业标准应在当地质量监督管理部门备案（登记），且产品标准技术性能要求应不低于该产品的认证标准要求。
2.3 The producing procedures shall be according to the relevant standards (enterprise standard as usual), which can effectively guide and control the production quality; the enterprise standard shall be registered at local production quality regulatory agencies, and the technical standards for this production shall not lower than as required in this file.3. 供应商质量控制3. Quality control on the suppliers3.1 工厂应制定《关键元器件和原材料供应商清单》，并建立供应商档案。
3.1 The manufacturer shall make a list of suppliers of the key components and raw materials, and make the records archives.3.2 工厂应对外协件加工方提出文件化的质量要求，并建立质量验收档案记录。
3.2 The manufacturer shall put forward a claim on quality requirements to suppliers, and make the records archives.3.3 工厂应对关键元器件和原材料供应商、外协件加工方进行定期评审，确保其提供的产品持续符合认证及相关标准要求。
相关记录完整有效。
3.3 The manufacturer shall examine and comment on the QC of key components suppliers regularly, to make sure that they can stably supply the standard products, and make the integrated records archives.4. 生产过程控制4. Producing procedures control4.1 工厂应对影响产品质量的关键生产工序进行识别，如果该工序没有文件规定就不能保证产品质量时，则应制定相应的工艺文件、作业指导书，使生产过程受控。
4.1 The manufacturer shall recognize every key procedure during producing, and shall constitute relevant technical files & operation guidance if it is not available in the key procedures, to make sure the producing procedures are always under control.4.2 关键工序操作人员应经过相关技能培训，具备相应能力。
4.2 The persons in the key producing processes shall be well trained, and competent for the key procedures.4.3 工厂应建立并保持生产设备管理（操作维护保养）制度。
4.3 The manufacturer shall establish and keep an integrated managing system on the producing equipments.5. 例行检验和型式检验例行检验包括关键元器件和原材料进厂检验/验证、工序检验和出厂检验。
型式检验是为验证产品持续符合企业标准要求进行的检验。
5. Regular testing and Performances testingRegular testing including the testing on the key components and raw materials before put into the producing procedures.Performance testing is for testing the quality of the production before leave the factory.5.1 关键元器件和原材料的检验/验证5.1 Testing on the key components and raw materials工厂应建立并保持对供应商提供的元器件和原材料的检验或验证的作业指导书，以确保其质量满足要求。