最少应具备的文件记录Annex1 Documents and records necessary.docVIP

Annex1 必须检查的文件和记录 Documents and records necessary for checking in the time of factory audit. 1 工厂应建立并保持至少包括以下文件化的程序或规定：（12个） The factory shall establish and maintain the following documented procedures or regulations :（12 articles） （1） 认证标志的保管使用控制程序； Procedure for controlling the use and preservation of the certification marks; （2） 产品变更控制程序； Procedure for controlling the modification on the product; （3）文件和资料控制程序； Procedure for documents and data control; （4）质量记录控制程序； Procedure for quality records control; （5）供应商选择评定和日常管理程序； Procedure for selection, evaluation and routine supervision of suppliers; （6）关键元器件和材料的检验或验证程序； Procedure for inspection or verification for purchased critical components and materials; （7）关键元器件和材料的定期确认检验程序； Procedure for periodical verification for purchased critical components and material; （8）生产设备维护保养制度； Regulation for maintenance of production equipment; （9）例行检验和确认检验程序； Procedure for routine routine tests and verification tests （10）不合格品控制程序； Procedure for non-conforming product control; （11）内部质量审核程序； Procedure for internal audit; （12）与质量活动有关的各类人员的职责和相互关系； regulation for the responsibilities and inter-relations of all the personnel involved in quality activities; 此外，工厂还必须保持有质量计划或类似文件，包括必要的工艺作业指导书、检验标准、仪器设备操作规程、管理制度等 Besides the above-mentioned procedures and regulations, the factory must maintain documented quality plan or relevant documents, including necessary process working instructions, test and inspection criteria, operation instructions of apparatus and equipment, management regulations and so on 2 工厂应保存至少包括以下的质量记录：（11个） The factory shall maintain at least the following quality records:（11 items） （1）对供应商进行选择、评定和日常管理的记录； Records of selection, evaluation, routine supervision of suppliers; （2）关键元器件和材料的进货检验/验证记录及供货商提供的合格证明； Records of inspection or verification for purchased critical components and material and the certificate provided by the supplier; （3）产品例行检验和确认检验记录； Records of product routine tests and verificatio