【十六】

internal audit 内部审核

internal audit procedure 内部审核程序

internally controlled standard 内控标准

internal audit 内审

results of internal and external audits

内外部审核结果

competence 能力

training 培训

training needs 培训需要

evaluate 评价

records of the results of the review

评审结果的记录

【十七】

review output 评审输出

review input 评审输入

Purchase Requisition 请购单

authority 权限

validation 确认

concession 让步

human resources 人力资源

job training of personnel 人员岗位培训

qualification of personnel 人员资格

equipment control procedure

设备控制程序

【十八】

device type 设备类型

order of design changes 设计更改通知单

design and development control procedure 设计和开发控制程序

design and development 设计开发

design and development planning

设计开发策划

control of design and development changes

设计开发更改控制

design and development review

设计开发评审

design and development validation

设计开发确认

design and development outputs

设计开发输出

design and development inputs

设计开发输入

【十九】

design and development verification

设计开发验证

design validation 设计确认

design documentation 设计文件编制

design acceptance criteria 设计验收准则

design verification 设计验证

audit program 审核大纲

conduct of audits 审核行为

audit criteria 审核准则

production process control 生产过程控制

production process control procedure

生产过程控制程序

【二十】

production and service provision

生产和服务提供

control of production and service provision 生产和服务提供的控制

validation of processes for production and service provision

生产和服务提供过程的确认

production order 生产令

identification and traceability

识别和可追溯性

identification and traceability maintenance and replacement

识别和可追溯性维护与替换

invalidate 使失效

market survey 市场调研

suitability 适宜性

scope 适用范围