ISO13485内部质量审核检查表实例_.docVIP

F018 Version 4 PAGE 6/ NUMPAGES 6 内部质量审核检验表-设计控制 INTERNAL QUALITY AUDIT CHECKLIST- Design Controls 被审核部门Auditees: ________________________________ 日期Date: ________________ 适用法规Applicable regulation: ISO 13485/9001 7.1、7.3、4.2.3/ FDA 820.30、820.40/ China GMP 28、29、30、31、 32、 33、 34、35、 36、37、38/ Japan MHLW Ordinance No. 169 序No. 问题 Questions Y/N/NA 意见与客观依据 Comments Objective Evidence 1 General 1.1 Is there a documented and implemented Design Control procedure(s) for the development of product? Does the procedure cover all clauses in relevant standards and regulations, such as design plan, design input, design output, design review, verification and validation, design transfer, and changes?是否有程序定义有关产品的设计控制流程？此程序是否涵盖了所有相应法规及标准中的内容，例如设计计划、设计输入、设计输出、设计评审、设计验证及确认、设计转移、设计变更？ 1.2 Are projects being run under Phase Review Discipline? Does the documentation show compliance to the overall process? 项目是否有阶段评审？相应文件是否能说明符合整个流程？ 1.3 Have all known open issues undergone an evaluation/justification prior to approval to proceed to the next development formal review? 是否所有已知的未决问题在进入下一个开发评审阶段前，都有被批准的评估/适当理由。 2 Design Planning 2.1 Are the Design Development Plans documented, reviewed, updated and approved? 是否有文件化的设计开发计划、并被评审、更新和批准？ 2.2 Do the Design Development Plans include significant elements/tasks such as design inputs, design outputs, design reviews, clinical trials, risk analysis, verification, validation, and design transfer? Do they define responsibilities, interfaces, and timing? Does the Design Development Plan include all tasks defined in BDA local Design Development and Design Transfer procedure? 设计开发计划是否包含重要环节/工作，例如设计输入、设计输出、设计评审、临床试验、风险分析、验证、确认，以及设计转移？相应的负责人、接口及时间点是否被定义？设计开发计划是否包含BDA设计开发及设计转移程序中定义在相应阶段应完成的工作？ 3 Design Input 3.1 Are the Design Input requirements documented, under revision control, reviewed, and approved? Are they clearly explained, complete, and maintained up to date? 设计输入要求是否被记录，并有版本控制、评审并批准？它们是否清晰、完整并保持实时更新？ 3.2 Do the Design Inputs c