体系审核表

1Is there a documented quality policy?是否有文件化的质量方针？a. Does it address objectives and define its commitment to quality? 是否明确目标并界定了其对质量的承诺？b. How does the company ensure the quality policy is understood, implemented and maintained at all levels? 如何确保公司的质量方针在各层级间的理解，实施和维护？2Is there a management representative who has defined authority and responsibility for implementation and maintenance of the quality systems? 是否有定义了管理者代表，并拥有实施和维护质量体系的的权力和责任？3Are the organizational structure, responsibilities and authority of management personnel documented? 组织架构是否文件记录管理人员的责任和权力？4Does upper management periodically review and approve all aspects of the quality system to ensure its continuingsuitability and effectiveness? 高层管理人员是否定期审查和批准质量体系内容，以确保其可持续的适宜性和有效性？a. Are quality records and indicators included in this review? 质量记录和指标有列入审查内容吗？b. Is there a documented process for these reviews? 是否有审查工作的文件程序？c. Are there documented records of the reviews?有无文件体现审核记录？1Does the facility have a formal QA System? 是否有质量保证体系a. Are the procedures documented?有受控程序吗？2Is the QA Manual and/or Inspection Plan approved by company management?质量保证手册“和/或检查计划是否经公司管理层批准？a. Does it include or reference to procedures?手册是否包含或引用程序b. Does it outline the structure of the quality system?它体现出质量体系的结构吗？c. Request a copy of the manual. 索取手册副本3Is there a flow chart for the manufacturing process? If “yes”, give us a copy.是否有制造过程的流程图？如果“有”，给我们一个副本。

4Have all processes affecting product quality/performance been identified?所有影响产品质量/性能的关键流程有被定义？a. Are they controlled?他们是否有控制1Is there a documented procedure to control and verify the design of the product?有无受控的程序去控制和验证产品的设计？2Does the procedure include the establishment of a design plan?程序是否包括设计方案的建立？a. Does the plan define responsibilities/activities of qualified personnel?计划是否定义合格的人员及其职责？b. Does the plan describes the interfaces between different departments from the design until the transfer inmanufacturing?计划有无描述从设计到生产不同部门之间的转移对接窗口？c. Does the plan include review, update and approval of plans as design and development evolve?计划内是否包括对设计和开发发展过程的审查，更新和批准计划？3Are design inputs identified, documented and reviewed?设计有无被确定，受控和审查？a. Do they address the intended use including the needs of the user and the patient?他们是否有明确预定用途，包括用户和患者的需求？4Are design outputs documented?设计输出有无记录受控？a. Are they verified and validated against stage inputs?他们有无核实并针对现阶段进行验证？b. Do they contain acceptance criterias ? 设计是否包含可接受的要求特性吗？c. Are they reviewed and approved prior to release?设计在发布之前是否有审查和批准呢？A. Management Responsibility 管理责任B. Quality System 质量体系C. Design Control 控制设计5Are design reviews planned and conducted at appropriate stages?有无设计评估计划，并进行适当的阶段性评论？a. Do they involve representatives from all functions? Do they includes Risk Analysis ?设计是否包含及代表涉及的所有功能？包括风险分析吗？b. Do assigned individuals have direct responsibility for the design development? 设计开发直接责任是否有分配到个人？c. Are the reviews documented? 这些评估有记录吗？6Are procedures documented for verifying and validating the device design?是否有核查和验证设备设计的程序？7Is design verification performed at appropriate stages and are results recorded ?是否在适当阶段进行设计验证，并记录结果？8Does validation include testing of production units under actual or simulated use conditions before distribution?验证是否包含对产品的实际或模拟使用条件测试？9Does validation include software validation and risk assessment?验证是否包括软件验证和风险评估？#Is there a procedure for translating the design basis into production specifications?是否有设计依据转化成实际产品规格要求的程序？#Are design changes identified, reviewed and approved by authorized personnel prior to implementation?设计变更落实前是否由授权人员进行识别、审核及批准。

#Is there a documented history file for each product design?每个产品设计是否有独立的文件历史档案a. Does it contain or refers to all records that show the design was developed according to the design plan?是否有记录并显示设计开发的落实符合设计计划？1Is there a documented procedure regarding document control?是否有文件控制程序？a. Does the procedure include hard copies, electronic medias, and applicable external origin documents (i.e., customer furnished drawings and specifications)?程序中是否包含硬件备份、电子文档及外来文件（如客户填报图纸及要求）2Are documents reviewed and approved by authorized personnel prior to use?程序发放前是否获得授权者审核并批准3Is current revision status controlled with a master list or equivalent?现有修订版本状态有被总表记录控制4Are documents available at all essential locations? 文件在所有重要地点有效使用吗？5Is there a procedure to remove obsolete document from use or prevent from inadvertent use?是否有过时的文件的回收程序，以防止误用？6Are any obsolete documents retained?任何作废文件有保留？7Are document changes reviewed and approved by original approving functions?文件变更是否被原职能进行审核及批准a. Do reviewers have access to pertinent background informations ?评论是否有相关的变更背景信息的访问？b. Is the nature of the change identified in the document or attachments?文件或附件中有无定义变更的性质及内容？8Are controls in effect to assure that the current applicable revision of documents are in use at the time of production and inspection operations?有效的控制，以保证在生产和检验时，使用最新版本的修订文件？9Are the purchase orders reviewed to ensure that the revision written on the order match with the work order's revision?采购订单是否被审核确保订单内的版本描述对应生产工单版本#Do change control records the following informations : the description of the change, the affected documents, approving authority, approval date and effective date? 变更控制有记录以下信息：变化说明，受影响的文件，批准机关，批准日期和生效日期？#If the document database is electronic, has the system been validated? How is access controlled? 如果是电子文档数据，系统是否被验证？如何控制访问权限？1Is there a procedure for supplier (subcontractor) selection, purchasing or otherwise received product or service? 是否有对供应商的管理控制程序？a. Is the supplier verified or approved?供应商是否被核实或批准？2Are suppliers evaluated and selected based on their ability to provide acceptable quality? 是否评价和选择供应商，以提供可接受的质量？D. Document and Data Control 文件及数据控制E. Purchasing Control 采购控制3Do each supplier has an inspection plan applicable or a certificat of compliance program for each products ? 是否有对每个供应商进行产品适用性或证书符合性的审查计划？4Is there a list of approved suppliers?是否有合格供应商清单5Do purchasing documents contain enough information to clearly describe the product ordered and its revision (if applicable)? 采购文件是否包含足够的信息清楚地描述产品订单要求及最新版本（如适用）6Do they include an agreement to notify the supplier of any changes on the product?采购文件内对于供应商的任何产品变更是否有协议7Are the purchasing documents reviewed and approved for adequacy prior to release? 采购订单发放前是否充分被审核并批准8Are the verification arrangements contained in the purchasing documents or in other official specification documents ?(i.e., receiving inspection, test verification, performance evaluation, release criteria).采购文件或其他正式的规范性文件中是否包含核查检验的安排？ （即，来料检验，测试验证，绩效评估，验收标准）1Are there procedures for the control of customer (as ArjoHuntleigh)-supplied product? 是否有客供件控制程序？2Is any damaged or nonconforming customer (as ArjoHuntleigh) owned product recorded and reported to the customer?对于不良客供件是否有记录及报告给客户？1Are there procedures for identifying product at all times to prevent mixups?是否有全程的产品标识及可追溯性管理程序？2Are there procedures for identifying individual product or batches that facilitate corrective action?产品是否有独立标志或批次标识的程序管理，有利于纠正行动程序运行。