The company for medical device license, quality inspector and quality control should be what responsibility?

Enterprise manager of the quality of the person in charge

A, seriously study, implement the "supervision and management of medical devices regulations" and laws and regulations, fully responsible for the management of medical equipment enterprises, quality management. The quality of the products operated by the full responsibility.

Second, fully responsible for the work of the procurement department, to ensure that the procurement of products in line with the statutory quality requirements.

Three, to ensure the implementation of the quality policy, quality objectives.

Four, strictly check the realization of the responsibilities and rights of each department and each type of work.

V. Review the quality management system on an annual basis to ensure its continued suitability, adequacy and effectiveness.

Quality inspector's job responsibilities are as follows:

I. Under the direct leadership of the general manager, responsible for the overall quality management and inspection work. Seriously study the supervision and management regulations of medical devices and national laws, regulations, technical standards.

Two, the person in charge of enterprise quality within the enterprise on the quality of medical device products alone to exercise authority without the influence of others. Responsible for the development of quality responsibility system at all levels, the organization of the company's staff to learn about quality management, and is responsible for training, assessment.

Three, responsible for the purchase and sale of the company's products, inspection of quality, establish "quality first, the user first," the idea of the quality of the product is responsible for all the problems, to achieve timely treatment, resolution, customer satisfaction.

Four, is responsible for the company's regular annual physical examination of all employees,

Five, is responsible for the company's business products related to licenses, inspection reports for.

Sixth, supervision, inspection and inspection of products into the warehouse, prohibit unqualified products into the warehouse, strictly grasp the quality.

VII, is responsible for the company's relevant information on the archives, archiving work, so that there is evidence.

VIII, is responsible for regular purchasers, warehouse custodians, sales, salesman's quality assessment work.

A company's products have problems, if the person in charge of quality and quality inspectors in strict accordance with the requirements of the implementation of the company's quality inspection system, but also in the report on the existence of quality problems in the product, issued a report, the person in charge of the company, the legal person ignored, you have the right to complain to the higher administrative supervision and management departments. Then, you both perform the functions of the work, and fulfill the authority to recommend to the company, but also to fulfill the obligations of a citizen, in this case, the product out of the problem with you can get out of responsibility.

If you do not perform in the work, or do not act, resulting in medical equipment unqualified products into the warehouse, the consequences will be directly traced; if you perform the job duties, but in the knowledge that there is a problem ignored, will be pursued jointly and severally liable. However, the main responsibility will be borne by the legal person. Of course, the law pursues evidence, so, when submitting the product inspection quality report should be written clearly and explicitly, stubs.

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