The Quality Department shall be in charge of recording of review. The Management Representative shall be responsible for the preparing of review report.

质量部对评审过程做好记录,管理者代表编制评审报告。

属类：应用文体-质量手册-实例

The Management Representative shall take effective measures and verify the results of measures.

管理者代表对实施的效果进行验证,制定并实施相应的措施。

属类：应用文体-质量手册-实例

The General Manager shall provide the required resources in a timely manner so that the QMS can be carried out and maintained and the requirements of law, rule and customers can be satisfied.

总经理应及时确定并提供所需的资源,以便实施质量管理体系并保持其有效性并满足法律、法规和顾客要求。

属类：应用文体-质量手册-实例

The HR Department, subject to approval from the General Manager, is responsible for the allocation of human resource to meet the demands of various departments and the requirements of relevant codes.

人力资源部根据各部门提出的人力资源的需求,报总经理批准,配制的人力资源应符合法规的要求。

属类：应用文体-质量手册-实例

Training is provided to meet the planned demand.

提供培训,以满足所确定的需求.

属类：应用文体-质量手册-实例

Major content of training are job skills, professional knowledge, management knowledge, QMS standards, and codes/laws related to medical devices.

培训的主要内容是:岗位技能、专业知识、管理知识和质量体系标准,以及医疗器械的法律、法规性等文件

属类：应用文体-质量手册-实例

Human Resource Department is responsible for the establishment and retention of records related to education, experience, training and qualifications etc.

人力资源部建立和保存有关教育、经验、培训、资格的适当的记录.

属类：应用文体-质量手册-实例

Those special jobs require pre-job training and the operator shall be certified.

特殊工作岗位的人员应参加相应的各级培训,进行资格考核合格后持证上岗.

属类：应用文体-质量手册-实例

The relevant department shall apply for purchasing of certain equipment subject to final approval from the General Manager.

需要配置基础设施的部门提出申请,经总经理批准后采购。

属类：应用文体-质量手册-实例

Power Equipment Department shall be responsible for the acceptance of new equipment and new facility.

动力设备部负责新设备验收及厂房的竣工验收

属类：应用文体-质量手册-实例

Power Equipment Department is responsible for the maintenance and repairing of facilities to ensure they are serviceable.

动力设备部负责对厂房设施的维护,以防止设施失效。

属类：应用文体-质量手册-实例

Power Equipment Department shall check the precision and condition of equipment and tools as scheduled to ensure they are in good, controlled condition and serviceable.

动力设备部定期测定设备和工艺装备的精度和完好率,应确保所有的运行设备和工艺装备处于受控状态,以满足生产的要求。

属类：应用文体-质量手册-实例

Relevant functional departments shall identify the human and environment elements required for the compliance of products and put it under effective control.

公司各有关职能部门应识别实现产品符合所需的人和环境的因素,并对其实施有效控制.

属类：应用文体-质量手册-实例

Because our products are sterile medical devices for single use, their quality will be adversely affected due to contact between human and products.

因公司生产的产品为一次性无菌医疗器械产品,人员与产品的接触会影响产品的质量.

属类：应用文体-质量手册-实例

The company shall monitor and control the work environment and establish documented procedure.

公司对工作环境实施监视和控制,并形成文件化程序。

属类：应用文体-质量手册-实例

The Company shall give those working in special environment sufficient training or make them working under the supervision of trained staff, so as to control the product quality.

公司对特殊环境条件下的人员进行必要的培训或经过培训的人员的监督下工作,以控制产品质量。

属类：应用文体-质量手册-实例

The ambience and surrounding of clean room shall be monitored and controlled in accordance with Environment Control Procedure.

公司按《环境控制程序》监视和控制净化车间的生产环境和周围的工作环境。

属类：应用文体-质量手册-实例

Quality Department and Production Department shall be in charge of the monitoring and recording of technical data concerning clean room respectively.

质量部、生产部分别对净化车间的有关技术参数进行监测及记录。

属类：应用文体-质量手册-实例

To carry out the above activities, we prepare such documents as Human Resource Management Procedure, Equipment and Facilities Management Procedure, Environment Control Procedure and Hygiene Control Procedure.

为实施上述活动,本章编制了《人力资源管理程序》、《设备、设施管理程序》、《环境控制程序》《卫生控制程序》。

属类：应用文体-质量手册-实例

The Technology Department is responsible for the planning of production realization including the preparation of technology documents and quality plan.

技术部负责组织产品实现的策划工作,包括形成技术文件和编制质量计划.

属类：应用文体-质量手册-实例