ISO9001 内审问题清单-Check List 检查表参考

ISO9001 内审问题清单-Check List 检查表参考

ISO9001 内审问题清单-Check List 检查表参考

Top Management Interview:最高层访谈
 (4.1/4.2) What is the usage of the product 产品用途是什么?
 Who is the customer 客户群有哪些?
 How do you find out the expectation and need of the customer如何了解客户的需求?
 What is the requirement of the customer 客户的需求是什么，有什么特殊要求?
 Is there any new developed customer 近期有没有新客户?
 What’s the specially requirement compare with the elder one 新客户的要求有什么不同?
 Why chose to enter the China market 为什么选择进入中国市场?
 Who is the competitor in China 在中国有哪些竞争对手？
 How to beat the competitor 如何超越竞争对手？
 (5.2) What is the quality policy of the company 公司的质量方针是什么?
 How do you keep the policy march with the customer requirement 如何使方针和客户需求

一致?
 How do you make the policy of the company understood by all of the staff 如何让员工了解

方针?
 What is the benefit of the certificate?做质量体系和认证有什么益处？

 (6.2.1/6.2.2) What is the quality objective 质量目标是什么?
 How do you keep the objective be established at relevant function and levels 如何在不同职

能和层次上建立质量目标?
 How do you keep the objective march with the policy 如何让方针和目标保持一致?

 How do the relevant departments make the objective achieved 相关部门的方针如何实现?
 If there is any change in the company, how do you keep the QMS fit the changes 质量管理体

系作用是什么?
 What is the result of the objective realization 目标实现情况怎样?

 (5.1) As a senior management, what is the responsibility of yours高层的职责是什么?
 What is the responsibility of the staffs? How do you make sure that they understand their

responsibility 各级员工的职责如何分配，如何保证他们了解这些职责?
 (5.3) How do you keep the information communicated in the company 如何将这些信息沟通

给员工?
 What is the channel for the staffs to communicate 员工沟通的渠道是什么?

 (9.3) What is the frequency for you to review the QMS 多久对质量管理体系进行管理评

审?
 What is the decision and action when you review QMS 上次管理评审和的结果是什么?

 What should the company make improvement with the QMS 评审后对管理体系有什么改

进?
 (7.1) How do you make sure that the resource (including HR, facility and environment)

enough for manufacturing product which meet the customer requirement. 如何确保资源 的充分？

Management Representative 管理代表:
 (5.3) Please introduce the main job of the MR.请管代介绍其主要工作。
 (6.3) What is the change in the QMS/Quality Manual 体系文件有什么变化?
 How do you keep the change suitable 如何保证变化的适宜性?
 How do you keep the other document march with the changes如何保证受到影响的其他文

件得到更新?
 (5.1.2, 8.2) How do you make sure the requirement of customer be identified and met 如何了

解客户的需求?
 How do you turn the requirement of the customer into the requirement of the company?如何

将客户的要求转化为公司的要求？
 How and who to deal this the feedback of the customer,especially the complaining 如何处理

客户的投诉?
 Please show the feedback information from the customer, and record the trail of the

complaints of customer.查阅客户投诉的记录。
 How do the feedback from the customer will be deal with 客户的反馈如何处理的?

 Who are in charge of dealing with the customer feedback 谁对客户的反馈进行处理?
 How do you analysis the information of the customer satisfaction 如何分析客户满意的信

息?
 (10.2)What is the action you using the information from the customer 如何应用客户的反馈?

 How do you improve the customer satisfaction, when you got any feedback from customer 如

何提高客户满意?
 What is the verification action to the effectiveness corrective/preventive action 对纠正和预

防措施如何进行确认?
 (6.2.1/6.2.2) What do you think about the present objective 目前的目标是哪些?

 What is the result of the realization of the objective 查目标实现情况?
 What objective had been realized 哪些目标实现了?
 What action you will take to reach it 采取了什么措施来实现目标?
 What objectives haven’t been realized 哪些没有实现?
 (6.3) Is there any change might cause the change of the QMS process 体系过程中有什么变

化?
 What process will be modified to keep the QMS meet thechanges 体系变化中，流程如何变

化?
 (9.2.2) When did you make the latest internal audit 上次内审是什么时候?

 Please show the procedure of IA 查阅审核报告和记录.
 Check the IA planning 查内审计划.
 Check the qualification and the independency of the auditor 查审核员的资格.
 Check if every functions, products, departments and clause were covered by the IA 是否每个

部门都在内审中审核到.
 Trail the IA finding for coming assessment 记下线索，一边继续跟踪.

 (9.3) When did the top management review the QMS 管理评审合时进行?
 How did the top management take part in the review action 高层如何参与评审?
 Check the plan and notice of the management review; check if the frequency meet the

requirement of the quality manual or the procedure 检查评审的周期.
 Check the content of the input of the review, (should including result of IA and TPA,

feedback of customer, follow up to last review, corrective/preventive action situation)检查评 审的内容.

 What is the decision and action (output) of the review 评审的结果和措施是什么?
 How about the requirement of the resource 投入了哪些新的资源?
 How to follow up the effectiveness of the action 如何跟踪措施的有效性?

 (10.2) What is the daily corrective action and preventive action查纠正预防措施的结果?  Who will follow up the actions 如何跟踪这些措施的有效性?
 What is the result of the action 措施的结果怎样?

Purchasing department 采购部:
 (8.5.4/8.5.2/8.4/8.7/8.5.1) Interview the store keeper to check if it is clear how to protect the

goods in the store. 和库房管理人员访谈。
 Ask for the WI or procedure for the store 确认库房管理的规定.

 Check the environment for the storage 检查库存的条件和环境.
 Check the situation for keeping the goods in the store 检查库存的条件.
 Check the marks of the material in the store 检查材料的标识.
 Check if the goods in the store have been verified before coming in to the store 检查进货检

验的要求.
 If there is any non-conformity product, check how to deal with them 不合格产品的处理.

 Check the mark of the non-conformity product 检查不合格标识.
 Check if the non-conformity product separated from others 检查不合格品隔离存放的实施

状况.
 Sample in the store and find the important raw material to be purchased 抽样检查重要原料

的存储状况.
 Record the information of material as trail 记录查到的产品号码和批号.

 How to monitor the process of purchasing 如何监督采购过程?
 (5.3/4.4) What is the main job (responsibility) of your department 部门的主要职责?
 What is the structure of the department 部门的结构?
 What is the job of each group 每个小组的工作是什么?
 How to keep the purchasing process under control 如何保证采购过程受控?
 (7.5.3) Ask for the procedure or WI for the purchasing process. How does the procedure

classify the purchasing goods 采购的程序如何规定?
 How to control the purchasing process and the supplier for each class of the material 采购控

制如何控制，供应商如何管理?
 (6.2.1/6.2.2/9.1.3) what is the objective of the department 部门部标是什么?

 How do you make the data analysis of the objective 如何进行数据分析?
 What is the result of the objective realization 目标实现的情况如何?
 How do you make sure the objective realize 如何保证目标实现?
 If it not realized, what is the reason for that 没有实现的目标如何改进?
 What can be carry out as corrective action 采取了什么纠正措施?
 What is the result of the action 措施的结果如何?
 (8.4.3) Check the verification result for the incoming materials follow up the trails got from

the store. 检查进货检验的记录。
 Check if the verification action meet the requirement of the income goods receive criteria 对

照进货检验依据确认采购产品验证的情况.
 If need, how to verify the product on site of the supplier 如果需要如何在供方处确认?

 (8.4.2) Check if the purchasing information is integrative 检查采购信息的完整性.
 Who are in charge of determine the purchasing information (requirement for the purchased

product)谁负责采购信息的确认?

 Check the contract or purchasing plan or something else including the purchasing

information 检查采购合同或采购计划订单.
 Check if the practice meets the requirement of the WI orprocedure 检查采购要求的程序.

 (8.4.1) Check if the suppliers have been evaluated as the requirement of the Procedure 查查

供应商评价的记录.
 What is the criteria for selecting the suppliers 供方选择的标准是什么?

 Check if the practice meet the requirement of the procedure 检查程序实施的状况?
 What is the method to re-evaluate the supplier 重新评估供应商的方法是什么?
 (8.4.3) How did the process be monitored? What is the result 对采购过程如何监督?
 (9.1.3) How to analysis the data of the supplier 如何分析供方的业绩数据?
 What is the action following the analysis for the suppliers 分析供方后采取什么行动?
 How to keep the supplier improve their performance 如何保持供方绩效的提升?
 (9.1.3) How do you got the feedback from the other department (such as production or QA )

如何活动其他部门的反馈?
 Please show some sample of that feedback 抽样确认内部反馈的记录.

 What is the action to deal with that kind of feedback 如何处理这些反馈?

Sales Department 销售部、出口部
 (5.3/4.4) What is the main job (responsibility) of your department 询问部门主要职责?
 What is the structure of the department? 部门构架是怎样
 What is the job of each group 每个小组的工作是什么?
 How to keep the sales process under control 如何保持销售过程受控?
 (7.5.3) Ask for the procedure or WI for the customer relatedprocess 客户相关过程的控制.
 How does the procedure classify the purchasing orders 如何处理客户的订单?
 How to control the sales process to ensure the requirement of the customer is clear 如何保证

客户的要求得到识别?
 How to review the requirement to make sure company has the ability to provide the product

如何评审这些客户要求?
 (6.2/10.2) what is the objective of the department 部门目标是什么?

 How do you make the data analysis of the objective 如何实现这些目标?
 What is the result of the objective realization 目标实现情况怎样?
 How do you make sure the objective realize 如何保证目标的实现?
 If it not realized, what is the reason for that 如果没有实现原因是什么?
 What can be carried out as corrective action 纠正措施是什么?
 What is the result of the action 采取措施的结果是什么?
 (8.2.1) How do you determine the requirement of the client 如何确认客户的要求?
 How do you turn the customer requirement into the requirement of the organization 如何将客

户的要求转化为公司的要求?
 Check if the requirement including the legal requirement 法规的要求是什么.

 (8.2.2) What review action should be carried out for the contract as the procedure 如何实施

订单评审?
 Who are in charge of the review to the requirement for theproduct 水对评审结果负责?

 Sample some contract or Purchase Orders, check the requirement in the PO, Check if the PO had been reviewed before commitment of the product delivery 抽样确认订单或合同的评审

情况.
 Check the delivery record of the product to find if the requirement had been met 检查交货记

录?
 If the delivery date is delayed check the confirmation by the customer 如果延迟交货如何处

理?
 What should you do when the PO changed 订单变更是如何处理?

 Check if it meets the requirement of the procedure 检查是否满足程序的要求.
 Record the sample as trail 记录并作为线索.
 (9.2.1) How to monitor the customer satisfaction 客户满意如何调查和了解?
 How to analysis the data of the 如何分析这些数据?
 Check the result of the customer satisfaction 检查客户的满意结果?
 How to make usage of the customer information 如何使用客户的信息?
 What is the action following the analysis for the customer satisfaction 客户满意度分析后如

何采取措施?
 Who will follow up effectiveness of the action against the customer satisfaction 如何跟踪措

施的有效性?
 (8.2.3/9.1.3) How do you transmit the customer feedback to the other department (such as

production or QA)如何传递客户的信息到其他部门?
 Please show some sample of that feedback 抽样确认客户反馈处理的情况.

 Who will follow up the action to deal with that kind of feedback 如何跟踪这些纠正措施?
 (8.5.4/8.5.2/8.4.3/8.7) Interview the store keeper to check if it is clear how to protect the

goods in the store. 和库房管理人员访谈。
 Ask for the WI or procedure for the store 确认库房管理的规定.

 Check the environment for the storage 检查库存的条件和环境.
 Check the situation for keeping the goods in the store 检查库存的条件.
 Check the marks of the material in the store 检查材料的标识.
 If there is any non-conformity product, check how to deal withthem. Check the mark of the

non-conformity product. 是否有不合格品在库房，如何标识？
 Check if the non-conformity product separated from others 检查不合格品是否能和合格品

区分开.
 Follow up the trail from the sales department office, check the output record to verify the

delivery date met the requirement of the customer. 赶着线索，查阅发货记录，看是否实现 客户的要求

 Trail for the QA department to check if the FQC and OQC have finished before the product put into the warehouse or delivery to the customer.给质量部门提供线索，确认出货检验的 记录

Production Dept.
生产部门

5.3 Dept organization structure, and the main responsibility 部门组织结构和职责?

What is the operation flow of the processes 核心工序是什么?
7.5.3 What is the document of each process 每个工序的控制文件是什么? Sample the document

used in site of the S&P dept 抽样确认文件的使用.
6.2.1 What is the objective of the Dept.部门目标是什么?

What is the result of the objective 实现情况如何?

9.1.3 Is there any analysis for the quality performance 质量绩效如何分析?
10.2 What do you act against the result of the analysis to make improvement?采取何种措施以进 行改进？

8.1/8.2 product plan sample and follow up the daily report of the product.生产计划如何实现？ 8.5/7.1.3/7.1.4/8.5.1 Go to the workshop to check the operation of the production.现查检查操作 状况

Sample in the workshop of the 抽取下面的样本

personal qualification(7.2),人员资格

and equipment maintaining(7.1.3); 设备维护

and the working environment,(7.1.4)工作环境
and material verification(8.4.1/8.5.2/8.5.4);材料确认

and method approved,(8.5.1)方法确认
and the measurement to the product and process (8.5.1)过程的监视和测量如何进行
8.5 Check the WI of the operation.检查操作的文件
Sample from the stuff working in the workshop to ask question about the operation and let

them demonstrate the operation.在工作现查找到员工访谈，看是否了解操作的主要要求。 Sample the device for measure and the equipment of the production the check the maintain

and calibration to them.现查抽查监视测量装置的校准状态和记录。

Quality Dept 质量部
8.1 What is the testing and measure plan for the production?

产品需要进行哪些检验？

8.5.1 check the inspection and testing on site？ 现场检查检验活动并验证试验参数，例如气密性试验的水压和时间是否满足规定的要求？ 8.6 checkthe record of the testing and measurement 抽样验证以往的检验结果和记录。
8.7 how to treat the found non-conformity product？检查不合格品的处理记录.
7.5.1 confirm the measurement equipment calibration validation. 验证使用到的测量装置校准的 有效期，例如水压试验的压力表，机加工尺寸测量的卡尺等。
7.2 How to confirm the competence of the inspection staff? 检验人员的能力如何确认？

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