How to write the organization and function of the application for medical device business enterprise license

Panzhihua City, East Medical and Medical Devices Department

Enterprise management functions

In business activities should be conscientiously carry out the "supervision and management of medical devices regulations", "supervision and management of medical device business enterprises", "Economic Contract Law", "Measurement Law" and other relevant laws and regulations. In an effort to improve economic efficiency at the same time, the social benefits in the first place. Firmly establish the idea of "quality first". Ensure the safety and effectiveness of medical devices, to protect human health and safety of life.

The implementation of the enterprise manager as the quality of the first person responsible for the implementation of the hierarchical management of the target responsibility system to ensure the implementation of the quality management system to promote the healthy development of enterprises.

Enterprise is divided into four areas of responsibility: manager, quality control department, marketing department and finance department.

Responsibility of the Manager Department:

Development of the enterprise's overall development plans and goals;

Development and supervision of the implementation of the enterprise's rules and regulations;

Selection of the distribution of product varieties; according to the "first time to operate the quality of varieties of auditing system" and "business management system" to implement;

Enterprise training arrangements for personnel; according to the "education and training of workers Assessment System".

Responsibilities of the Quality Inspection Department:

Product inspection; according to the "Incoming Goods Quality Acceptance System", "Sampling Principles and Procedures", "Quality Inspector Job Responsibility", "Unqualified Commodity Management System" implementation

Warehouse storage according to the "five prevention" management system, "storage and storage system", "return management system" implementation. Management System".

Responsibility of the Marketing Department:

Product sales are carried out according to the "Sales System".

Instrument Installation:

Product maintenance, maintenance; according to the "after-sales service, quality complaint handling record system", "three packages of repair provisions" carried out

Quality tracking: according to the "quality of tracking and adverse reactions to the report system", "user access system" carried out

Finance Department Responsibility:

Strictly in accordance with the laws and regulations, Handle all economic activities inside and outside the company, and need to be signed by the company manager to recognize. Implementation of the "financial system"

Medical equipment business quality information work is to ensure the quality of medical equipment business, to prevent and eliminate unqualified goods into the market is one of the important means, all employees should seriously carry out the collection of quality information, feedback work. Quarterly by the manager of a quality analysis will be held to analyze the situation of the products operated by the enterprise, and put forward to improve and strengthen the quality management of opinions and measures.

Departments should actively collaborate, *** with the observance of laws and regulations, rules and regulations, "operating in accordance with the law, quality first, customer first" as the guiding ideology, hard work, *** with the development, to establish a new image!