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福州管理变更程序翻译

3 职责 

3. Responsibility   

3.1变更申请部门:

   a) 向主管部门提出变更申请;

   b) 负责提供变更申请所需的支持性材料;

c) 变更批准后,实施变更前培训及执行变更;

d) 变更实施后的跟踪;

e)收集相关的数据并送质检部归档。

3.1 Change Application Department     

a. Apply to the department in charge of change;   

b. Be in charge of supplying supportive materials for application of change;       

c. After the change is approved, carry out the training before change and implement the change;   

d. Follow-up after the change is implemented; 

e. Collect related data and submit them to the Quality Inspection Dept. for placing on file;    

3.2变更所属系统主管部门:

   a) 组织相关部门人员进行变更评估;

b) 填写评价报告;

   c) 负责变更项目的审核;

   d)变更批准后,监督执行部门进行变更的实施;

e)组织进行变更实施后的再评价。

3.2 Competent Department for the System of Change

a. Organize staff of related departments in carrying out the change appraisal;

b. Complete the appraisal report; 

c. Be in charge of reviewing the items of change; 

d. After the change is approved, the Supervision Implementation Department shall implement the change;     

e. Organize re-appraisal after the change is implemented.    

3.3质保部

a) 参与变更的评估;

b) 审核变更项目;

    c )监督变更的实施过程及部分变更后的跟踪确认;

d) 变更相关资料的归档保存。

e)批准变更

3.3 Quality Assurance Department

a. Participate in the appraisal of change; 

b. Review the items of change;

c. Supervise the implementation process of change and trace and confirm part of the change; 

d. Place on file of the changed related materials; 

e. Approve the change. 

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