企业机构翻译

Junier Han
Junier Han

发布于2019-05-20 10:58来源:原创 0 评论 1 点赞

【原文】

公司部门设置说明

一、总经理职能:

领导和动员全体员工认真贯彻执行《医疗器械监督管理条例》等国家有关医疗器械法律、法规和规章等,在合法经营,质量为本的思想指导下进行经营管理。对公司所经营医疗器械的质量负全面领导责任。合理设置并领导质量管理部门,保证其独立、客观的行使职权充分发挥其质量把关职能,支持其合理意见和要求,提供并保证其必要的质量活动经费。

总经理岗位职责

1、掌管公司重大事项的决策权。

2、向全体员工传达满足客户要求和法律法规要求的重要性意识。

3、制定并颁布质量方针,营造企业价值观。

4、任命各部门经理。

5、批准质量管理制度和程序文件。

6、确定选定经营产品种类。

7、合理配置资源,确保各部门正常运转。

8、负责对本企业质量管理工作的检查和考核。

 

二、质量管理部职能

 1、负责建立一个质量管理体系。实施质量否决权,指导各部门质量活动编制质量制度。执行国家有关医疗器械监督管理的法律、法规及规章等有关政策的规定,负责公司的全面质量的管理工作,确保医疗器械的质量。

2、负责起草或修订公司有关质量管理方面的规章制度,质量工作规划,并指导督促执行。

3、经营产品质量追溯,不良事件报告,根据不良事件等级及时上报国家不良反应检测中心。

4、负责医疗器械质量事故或质量投诉的调查处理及报告。

5、负责产品召回:发现医疗器械不符合强制性标准、经注册或者备案的产品技术要求或者存在其它缺陷的,立即停止经营、通知使用单位和消费者停止经营和使用,召回已经上市销售的医疗器械,采取补救、销毁等措施,记录相关情况,发布相关新信息,并将医疗器械召回和处理情况向食品药品监督管理部门和卫生计生主管部门报告。

6、健全登记产品信息、供应商信息、产品流向信息发现不合格产品能够及时追回。

7、定期向质量管理领导小组汇报质量工作开展情况,对存在问题 提出改进措施,对在质量工作中取得成绩的部门和个人提出具体的奖惩意见。

8、开展对公司员工进行有关医疗器械智联管理方面的教育和培训。

9、负责执行医疗器械质量验收制度和医疗器械入库验收过程、负责医疗器械验收入库等相关工作。

 

验收员职能:严格执行医疗器械质量验收制度和医疗器械入库验收程序,主要负责医疗器械入库验收工作。组织学习医疗器械质量专业知识,努力提高验收水平。

1、验收人员凭到货通知单货随货通行逐批进行验收,在入库凭证上签字,与保管员办理交接手续。验收人员对医疗器械的漏检、错检负具体质量责任。

2、对验收不符合验收内容,不符合相关法律标准和质量条款或其他怀疑质量异常的医疗器械,填写拒收报告单,并通知总经理处理处理。

3、验收时应对医疗期器械的包装,标签,说明书以及有关要求的证明文件逐一检查,整件包装中应有产品合格证。

4、验收首营品种,应查看首批到货医疗器械同批号的医疗器械出厂检验合格证明。

5、验收进口医疗器械,应检查包装的标签是否有中文注明的医疗器械名称,主要成份以及进口注册证号,检查中文说明说及合法的相关证明文件。

6、及时填写有关报表和验收记录,并签字负责,按规定保存备查。

库管员职能:

1、按照医疗器械的理化性质和储存条件分类分区储存,对因储存不当发生的质量问题负责。

2、按安全、方便、节约的原则,堆垛整齐、牢固、五距规范,合理利用仓容,并按规定做好货位编号。层批数量,包标明显。

3、做好医疗器械管理工作,严格按(出库单)及相关规定发货。

4、在养护员的指导下做好库房温湿度管理工作。

5、负责填写“不合格医疗器械报告,处理审批表”

6、保管员凭验收员签字或盖章收货。对货单不符、质量异常、包装不牢或破损、标志模糊等情况,有权拒收并报告企业有关部门处理。

7、自觉学习医疗器械业务知识,提高保管工作技能。

三、采购部职能

1、组织学习并执行上级质量方针、政策、法规和指令。严格遵守《医疗器械监督管理条例》,正确理解并积极推进本公司质量体系的正常进行。

2、牢固树立“合法经营,质量为本”的思想,按照“按需进货,择优选购”的原则指导业务经营活动,当经营数量、进度和质量发生矛盾时,应在保证质量的前提下,求数量和进度,严把“计划采购”第一关。

3、检查监督本部门工作,坚持采购的医疗器械必须是从具有法人资格的供货单位购进的,并收集供货单位的营业证照等资质的证明材料,严禁从私人及证照不全的单位进货,建立供货单位档案。

4、配合质量管理部门搞好首营企业,首营品种的审核工作,并检查收集有关的资料,经质管部门审核合格报总经理批准后方可进货。

5、掌握经营进度的同时,掌握质量动态,发现质量问题及时与质管部门联系,对重大质量的改进措施在本部门的落实负责。制定采购部门业务培训计划并组织实施,加强对采购人员的质量意识教育并进行质量意识考核。

采购员职责:

1、坚持“按需进货,择估采购”的原则,把好进货质量关。

2、负责填写《购进计划表》,并具体实施。

3、向财务提供资金需求和付款计划。

4、收集供应商和市场信息资料,建立、健全供应商档案。

5、负责供应商的前期考察、筛选,供应商业绩考核、评价,认真审查供货单位的法定资格。

6、负责医疗器械货源和价格行情的调研。

7、负责采购合同的起草,并提交审核、批准,合同必须明确必要的质量条款,并索取质量标准。

8、负责将采购记录(合同)输入微机系统,索取合法票据,到货后与微机核对,做到三者相符。

9、负责通知医疗器械返厂及报损工作。

四、销售部职能

1、组织学习执行《医疗器械监督管理条例》等有关条例,规范销售员工作行为。

2、严格选择销售对象,不允许将医疗器械销售给无合法证照的或证照不全的经营单位或无《医疗机构执业许可证》的医疗单位,防止医疗器械流向非法经营单位。

3、了解本公司库存医疗器械的质量,数量情况,正确向用户介绍医疗器械的用法和性能,不得虚假夸大和误导用户,医疗器械营销宣传应严格执行国家有关广告管理的法律法规,宣传的内容必须以国家医疗器械监督管理部门批准的医疗器械使用说明书为准。

4、销售医疗器械应开具合法票据,做到票、账、货相符。销售票据应按规定保存,建立医疗器械销售记录,记载医疗器械的销售日期、品名、规格型号、批号、有效期、生产单位、购货单位、单价、数量等项内容。销售记录应保存到有效期满后二年或保持期满后二年。

5、对校期较近,库存较长的合格产品,要积极推销,避免损失。

6、定期征询和反馈用户对医疗器械质量和服务质量的评价意见,做好用户访问工作,配合有关人员处理客户查询的意见,为质量改进提供市场质量动态信息。

销售员职责:

1、负责公司与销售人员的联系,传达公司的管理规定与指令,询问市场信息、质量动态或不良反应信息,并及时上报。

2、负责客户电话记录

3、负责缺货登记,及时向采购员反馈

4、负责各类资料、票据的分类及归档管理

5、负责与库管员联系及时发运销售人员所需医疗器械

6、负责对应收货款进行统计上报

7、做好销售人员的报账等工作

8、负责各类宣传资料、促销品、样品的保管和发放、

五、售后服务部门职能

1、产品售出后,业务部门应定期进行质量跟踪及售后服务。及时掌握用户对商品使用情况。

2、业务员要会同工程技术人员对用户进行现场技术指导,包括:设备的安装、调试、操作、培训、维护等系列服务。

3、对用户在使用产品过程中发生的问题要认真对待及时给予解决并详细作好记录。对产品质量问题要积极与供货单位或生产厂家联系,在规定的时间内给予修复或调换。

4、因用户使用不当造成商品损坏,应根据企业有关规定进行妥善处理。

5、售后人员对产品售后服务过程应做好详细记录,并建立售后服务档案,按规定妥善保存。

6、公司不定期举办产品知识讲座,使客户更好的了解和使用产品。


【译文】

Company Department Setting Instructions

一、总经理职能:(General manager)

 

领导和动员全体员工认真贯彻执行《医疗器械监督管理条例》等国家有关医疗器械法律、法规和规章等,在合法经营,质量为本的思想指导下进行经营管理。lead and mobilize all employees to conscientiously implement the "Regulations on the Supervision and Administration of Medical Devices" and other relevant national medical device

gal management and quality-oriented thinking.对公司所经营医疗器械的质量负全面领导责任。fully responsible for the quality of the medical devices operated by the company.合理设置并领导质量管理部门,保证其独立、客观的行使职权充分发挥其质量把关职能,支持其合理意见和要求,提供并保证其必要的质量活动经费。reasonably set up and lead the quality management department to ensure that its independent and objective exercise of its powers to give full play to its quality control functions, support its reasonable opinions and requirements, and provide and guarantee the necessary quality activities.

总经理岗位职责general manager job responsibilities

1、掌管公司重大事项的决策权。take control of the company's decision-making on major issues.

2、向全体员工传达满足客户要求和法律法规要求的重要性意识。communicate to all employees the importance of meeting customer requirements and legal and regulatory requirements.

3、制定并颁布质量方针,营造企业价值观。develop and promulgate quality policies to create corporate values.

4、任命各部门经理。appoint all department managers.

5、批准质量管理制度和程序文件。approved quality management systems and procedures.

6、确定选定经营产品种类。determine the type of business product selected.

7、合理配置资源,确保各部门正常运转。rationally allocate resources to ensure that all departments are functioning properly.

8、负责对本企业质量管理工作的检查和考核。responsible for the inspection and assessment of the quality management of the company.

 

二、质量管理部职能quality Management Department

 1、负责建立一个质量管理体系。 1. Responsible for establishing a quality management system.实施质量否决权,指导各部门质量活动编制质量制度。implement quality veto power and guide the quality system of quality activities in each department.执行国家有关医疗器械监督管理的法律、法规及规章等有关政策的规定,负责公司的全面质量的管理工作,确保医疗器械的质量。implement national laws, regulations and rules on medical device supervision and management, and be responsible for the overall quality management of the company to ensure the quality of medical devices.

2、负责起草或修订公司有关质量管理方面的规章制度,质量工作规划,并指导督促执行。responsible for drafting or revising the company's rules and regulations on quality management, quality work planning, and guiding supervision and implementation.

3、经营产品质量追溯,不良事件报告,根据不良事件等级及时上报国家不良反应检测中心。the quality of the products is traced back, and adverse event reports are reported to the National Center for Adverse Drug Reactions in a timely manner according to the level of adverse events.

4、负责医疗器械质量事故或质量投诉的调查处理及报告。responsible for the investigation and handling of medical device quality accidents or quality complaints.

5、负责产品召回:发现医疗器械不符合强制性标准、经注册或者备案的产品技术要求或者存在其它缺陷的,立即停止经营、通知使用单位和消费者停止经营和使用,召回已经上市销售的医疗器械,采取补救、销毁等措施,记录相关情况,发布相关新信息,并将医疗器械召回和处理情况向食品药品监督管理部门和卫生计生主管部门报告。responsible for product recall: If the medical device does not meet the mandatory standards, the technical requirements of the registered or filed products, or other defects, immediately stop the operation, notify the users and consumers to stop operation and use, and recall the medical devices that have been on the market. Take measures such as remediation and destruction, record relevant information, issue relevant new information, and report the recall and handling of medical devices to the food and drug supervision and management department and the health and family planning department.

6、健全登记产品信息、供应商信息、产品流向信息发现不合格产品能够及时追回。improve registered product information, supplier information, and product flow information. Unqualified products can be recovered in time.

7、定期向质量管理领导小组汇报质量工作开展情况,对存在问题 提出改进措施,对在质量工作中取得成绩的部门和个人提出具体的奖惩意见。regularly report the quality work development to the quality management leading group, propose improvement measures for existing problems, and put forward specific reward and punishment opinions for departments and individuals who have achieved results in quality work.

8、开展对公司员工进行有关医疗器械智联管理方面的教育和培训。conduct education and training on the management of medical devices.

9、负责执行医疗器械质量验收制度和医疗器械入库验收过程、负责医疗器械验收入库等相关工作。responsible for the implementation of medical device quality acceptance system and medical device storage acceptance process, responsible for medical device inspection income library and other related work.

 

验收员职能:严格执行医疗器械质量验收制度和医疗器械入库验收程序,主要负责医疗器械入库验收工作。responsible for the implementation of medical device quality acceptance system and medical device storage acceptance process, responsible for medical device inspection income library and other related work.组织学习医疗器械质量专业知识,努力提高验收水平。organize the study of medical equipment quality expertise and strive to improve the acceptance level.

1、验收人员凭到货通知单货随货通行逐批进行验收,在入库凭证上签字,与保管员办理交接手续。the acceptance personnel shall check and accept the goods in accordance with the arrival notice, and sign the warehousing certificate and handle the handover with the custodian.验收人员对医疗器械的漏检、错检负具体质量责任。the inspection and acceptance personnel shall bear specific quality responsibility for the missed inspection and wrong inspection of medical equipment.

2、对验收不符合验收内容,不符合相关法律标准和质量条款或其他怀疑质量异常的医疗器械,填写拒收报告单,并通知总经理处理处理。for those medical devices that do not meet the acceptance criteria, do not comply with relevant legal standards and quality provisions or other suspected quality abnormalities, fill in the rejection report form and notify the general manager to handle the treatment.

3、验收时应对医疗期器械的包装,标签,说明书以及有关要求的证明文件逐一检查,整件包装中应有产品合格证。at the time of acceptance, the packaging, labels, instructions and relevant documents of the medical requirements shall be inspected one by one, and the product certificate shall be in the whole package.

4、验收首营品种,应查看首批到货医疗器械同批号的医疗器械出厂检验合格证明。for the acceptance of the first batch of varieties, the first batch of medical equipment with the same batch number of medical equipment factory inspection certificate should be reviewed.

5、验收进口医疗器械,应检查包装的标签是否有中文注明的医疗器械名称,主要成份以及进口注册证号,检查中文说明说及合法的相关证明文件。for the acceptance of imported medical devices, the label of the package should be checked for the name of the medical device indicated in Chinese, the main components and the registration certificate number, and the relevant Chinese and relevant legal documents.

6、及时填写有关报表和验收记录,并签字负责,按规定保存备查。fill in the relevant statements and acceptance records in a timely manner, sign and be responsible for them, and keep them for future reference.

库管员职能:library manager functions:

1、按照医疗器械的理化性质和储存条件分类分区储存,对因储存不当发生的质量问题负责。classification and storage according to the physical and chemical properties and storage conditions of medical devices are responsible for quality problems caused by improper storage.

2、按安全、方便、节约的原则,堆垛整齐、牢固、五距规范,合理利用仓容,并按规定做好货位编号。according to the principle of safety, convenience and economy, the stacking is neat, firm, and five-way standard, and the warehouse capacity is used reasonably, and the cargo number is completed according to the regulations.层批数量,包标明显。the number of batches is obvious.

3、做好医疗器械管理工作,严格按(出库单)及相关规定发货。do a good job in the management of medical devices, and strictly follow the (outbound order) and related regulations.

4、在养护员的指导下做好库房温湿度管理工作。under the guidance of the maintenance staff, do the temperature and humidity management of the warehouse.

5、负责填写“不合格医疗器械报告,处理审批表”responsible for filling out the "unqualified medical device report, processing approval form"

6、保管员凭验收员签字或盖章收货。the clerk receives the goods by signing or stamping the acceptance.对货单不符、质量异常、包装不牢或破损、标志模糊等情况,有权拒收并报告企业有关部门处理。if the goods are inconsistent, the quality is abnormal, the packaging is not strong or damaged, the signs are blurred, etc., the right to refuse and report to the relevant departments of the enterprise.

7、自觉学习医疗器械业务知识,提高保管工作技能。organize the study of medical equipment quality expertise and strive to improve the acceptance level.

三、采购部职能 quality Management Department

1、组织学习并执行上级质量方针、政策、法规和指令。organize and implement superior quality policies, policies, regulations and directives.严格遵守《医疗器械监督管理条例》,正确理解并积极推进本公司质量体系的正常进行。strictly abide by the "Regulations on the Supervision and Administration of Medical Devices", correctly understand and actively promote the normal conduct of the company's quality system.

2、牢固树立“合法经营,质量为本”的思想,按照“按需进货,择优选购”的原则指导业务经营活动,当经营数量、进度和质量发生矛盾时,应在保证质量的前提下,求数量和进度,严把“计划采购”第一关。firmly establish the idea of "legal management, quality-oriented", and guide business operations in accordance with the principle of "receiving goods on demand, selecting preferred purchases". When there is a contradiction in the quantity, progress and quality of operations, it should be based on the premise of ensuring quality. Quantity and progress, strictly control the first level of "planned procurement."

3、检查监督本部门工作,坚持采购的医疗器械必须是从具有法人资格的供货单位购进的,并收集供货单位的营业证照等资质的证明材料,严禁从私人及证照不全的单位进货,建立供货单位档案。inspect and supervise the work of the department, and insist that the purchased medical equipment must be purchased from a supplier with legal person qualifications, and collect the certification documents of the business licenses of the supplier, etc. It is strictly forbidden to purchase goods from private and incomplete units. Provider file.

4、配合质量管理部门搞好首营企业,首营品种的审核工作,并检查收集有关的资料,经质管部门审核合格报总经理批准后方可进货。cooperate with the quality management department to do a good job in the first-run enterprise, review the first-run varieties, and check and collect relevant information. After the quality management department has passed the audit and passed the approval of the general manager, it can be purchased.

5、掌握经营进度的同时,掌握质量动态,发现质量问题及时与质管部门联系,对重大质量的改进措施在本部门的落实负责。while mastering the business progress, we will grasp the quality dynamics, find out the quality problems and contact the quality management department in a timely manner, and be responsible for the implementation of major quality improvement measures in this department.制定采购部门业务培训计划并组织实施,加强对采购人员的质量意识教育并进行质量意识考核。formulate business training plans for procurement departments and organize implementation, strengthen quality awareness education for procurement personnel and conduct quality awareness assessment.

采购员职责:buyer duties:

1、坚持“按需进货,择估采购”的原则,把好进货质量关。adhere to the principle of “receiving goods on demand, selecting purchases” and keeping the quality of incoming goods closed.

2、负责填写《购进计划表》,并具体实施。responsible for filling out the "Purchasing Plan" and implementing it.

3、向财务提供资金需求和付款计划。provide financial needs and payment plans to finance.

4、收集供应商和市场信息资料,建立、健全供应商档案。collect supplier and market information, and establish and improve supplier files.

5、负责供应商的前期考察、筛选,供应商业绩考核、评价,认真审查供货单位的法定资格。responsible for the supplier's preliminary inspection, screening, supplier performance evaluation, evaluation, and carefully review the legal qualifications of the supplier.

6、负责医疗器械货源和价格行情的调研。responsible for the investigation of medical equipment supply and price.

7、负责采购合同的起草,并提交审核、批准,合同必须明确必要的质量条款,并索取质量标准。responsible for the drafting of the procurement contract, and submit for review and approval. The contract must clarify the necessary quality terms and request quality standards.

8、负责将采购记录(合同)输入微机系统,索取合法票据,到货后与微机核对,做到三者相符。responsible for importing the procurement record (contract) into the microcomputer system, requesting legal bills, and checking with the microcomputer after arrival, so that the three match.

9、负责通知医疗器械返厂及报损工作。responsible for notifying medical equipment to return to the factory and reporting damages.

四、销售部职能quality Management Department

1、组织学习执行《医疗器械监督管理条例》等有关条例,规范销售员工作行为。organize and study the implementation of the "Regulations on the Supervision and Administration of Medical Devices" and other relevant regulations to regulate the salesperson's work behavior.

2、严格选择销售对象,不允许将医疗器械销售给无合法证照的或证照不全的经营单位或无《医疗机构执业许可证》的医疗单位,防止医疗器械流向非法经营单位。strict selection of sales targets is not allowed to sell medical devices to business units without legal licenses or incomplete licenses or medical units without “medical institution practice licenses” to prevent medical devices from flowing to illegal business units.

3、了解本公司库存医疗器械的质量,数量情况,正确向用户介绍医疗器械的用法和性能,不得虚假夸大和误导用户,医疗器械营销宣传应严格执行国家有关广告管理的法律法规,宣传的内容必须以国家医疗器械监督管理部门批准的医疗器械使用说明书为准。understand the quality and quantity of medical instruments in the company, and correctly introduce the usage and performance of medical devices to users. Do not exaggerate or mislead users. Medical device marketing and publicity should strictly implement the national laws and regulations on advertising management. The content of publicity must be The instructions for the use of medical devices approved by the National Medical Device Supervision and Administration Department shall prevail.

4、销售医疗器械应开具合法票据,做到票、账、货相符。sales of medical devices should be issued with legal bills, so that the votes, accounts, and goods match.销售票据应按规定保存,建立医疗器械销售记录,记载医疗器械的销售日期、品名、规格型号、批号、有效期、生产单位、购货单位、单价、数量等项内容。the sales receipts shall be kept in accordance with the regulations, establish a medical device sales record, and record the sales date, product name, specification model, batch number, expiration date, production unit, purchase unit, unit price, quantity, etc. of the medical device.销售记录应保存到有效期满后二年或保持期满后二年。sales records should be kept for two years after the expiration of the validity period or two years after the expiration of the retention period.

5、对校期较近,库存较长的合格产品,要积极推销,避免损失。for qualified products with a shorter school schedule and longer inventory, they should be actively promoted to avoid losses.

6、定期征询和反馈用户对医疗器械质量和服务质量的评价意见,做好用户访问工作,配合有关人员处理客户查询的意见,为质量改进提供市场质量动态信息。regularly consult and feedback users' evaluation opinions on medical equipment quality and service quality, do a good job in user visits, cooperate with relevant personnel to handle customer inquiries, and provide market quality dynamic information for quality improvement.

销售员职责:buyer duties:

1、负责公司与销售人员的联系,传达公司的管理规定与指令,询问市场信息、质量动态或不良反应信息,并及时上报。responsible for the company's contact with the sales staff, communicate the company's management regulations and instructions, and ask for market information, quality dynamics or adverse reaction information, and report it in a timely manner.

2、负责客户电话记录responsible for customer phone records

3、负责缺货登记,及时向采购员反馈responsible for out of stock registration, timely feedback to buyers

4、负责各类资料、票据的分类及归档管理responsible for the classification and archiving management of various types of materials and bills

5、负责与库管员联系及时发运销售人员所需医疗器械responsible for contacting the library manager to timely deliver the medical equipment required by the salesperson

6、负责对应收货款进行统计上报responsible for the statistical reporting of the corresponding payment

7、做好销售人员的报账等工作do a good job of sales staff, etc.

8、负责各类宣传资料、促销品、样品的保管和发放、responsible for the preservation and distribution of all kinds of promotional materials, promotional items, samples,

五、售后服务部门职能after-sales service department functions

1、产品售出后,业务部门应定期进行质量跟踪及售后服务。after the product is sold, the business department should conduct quality tracking and after-sales service on a regular basis.及时掌握用户对商品使用情况。keep abreast of the user's use of the product.

2、业务员要会同工程技术人员对用户进行现场技术指导,包括:设备的安装、调试、操作、培训、维护等系列服务。the salesman should provide on-site technical guidance to the user with the engineering and technical personnel, including: equipment installation, commissioning, operation, training, maintenance and other services.

3、对用户在使用产品过程中发生的问题要认真对待及时给予解决并详细作好记录。the problems that occur during the use of the product by the user should be taken seriously and resolved in time.对产品质量问题要积极与供货单位或生产厂家联系,在规定的时间内给予修复或调换。the product quality problem should be actively contacted by the supplier or the manufacturer, and repaired or exchanged within the specified time.

4、因用户使用不当造成商品损坏,应根据企业有关规定进行妥善处理。if the goods are damaged due to improper use by the user, they should be properly disposed according to the relevant regulations of the enterprise.

5、售后人员对产品售后服务过程应做好详细记录,并建立售后服务档案,按规定妥善保存。after-sales personnel should make detailed records of the after-sales service process, and establish after-sales service files, and keep them in accordance with regulations.

6、公司不定期举办产品知识讲座,使客户更好的了解和使用产品。the company organizes product knowledge lectures from time to time to enable customers to better understand and use the products.


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