I. Quality policy and management objectives
1, grasp the quality management of medical devices, is an important part of the company's work, is the key to improve the operation of the work and the quality of service, we must effectively strengthen the leadership of the business operations, and constantly improve the ideological and operational quality of all staff, to ensure that the quality of goods, and improve the quality of service.
2, the organization of all staff to seriously study and implement the "supervision and management of medical equipment business enterprises", "Medical Device Classification Rules" and "Economic Contract Law" and other laws and regulations and rules and regulations of the company, to ensure that the quality of medical equipment commodities, to ensure that the people use medical equipment safe and effective.
3, medical equipment business must recognize the implementation of national policies to meet the needs of health care development, adhere to the quality first, according to the law, and pragmatic business policy and marketing strategy; adhere to the people's health services, medical and health care and human health services, for the purpose of disasters and epidemics, industrial and agricultural production and scientific research services, and to establish a "user-first" policy. "
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4, the establishment of a complete quality management system, to grasp the quality of goods acceptance, in the warehouse maintenance and out of the warehouse to review the quality management work, do a good job in the after-sales service process of the user on the quality of goods put forward by the query, consulting views of the tracking and analysis of research. The company's quality management of all aspects of the economic benefits of the department linked. Decomposition of responsibility to the head, which link problems should be held responsible for individuals and department heads, the implementation of the quality management system of responsibility at all levels.
Two, quality system audit
1, in order to conscientiously implement the national quality management of medical devices laws and regulations, the development of business quality management system of medical devices, and guidance, supervision and implementation of the system, the company implemented the general manager is responsible for the quality management of equipment is fully responsible for the general manager of the general manager is the first person responsible for the general manager to assist the general manager to assist the work of the second responsible for, the company's quality inspection department is the third responsible for the quality management, and the company's quality control department is the third responsible for the quality management of the company's quality management. The company's quality control department is the third responsible person, specifically responsible for the quality of the company's operations in all aspects of the work.
2, the company set up a specialized quality management institutions - Quality Inspection Department, to exercise quality management functions. It has the right to adjudicate the quality of medical equipment operation within the company, to guide and supervise the quality management of the operation department, and to test, judge and adjudicate the quality of the company's commodities.
3, the establishment of a sound and complete quality management system, the person in charge of each department is responsible for the quality of the department's goods, work quality, the functional departments of the staff of the quality of the work of their positions, the quality of the service and the quality of the relevant goods is responsible for the quality of the work, the quality of service and the quality of the goods concerned, the quality of management of all aspects of the work is implemented to the head.
4, the quality control department is fully responsible for all aspects of the company's quality management of specific work, and is responsible for the quality of the department's management work and the implementation of the system on a regular basis for inspection, assessment, evaluation, to meet the requirements of the department responsible for the person in charge and the responsible person should be held accountable for seriousness and rectification of the deadline.
Three, the quality of responsibility at all levels
(a), the quality of the person in charge of the enterprise responsibility
1, the organization of the implementation of supervision and management of medical devices and the relevant statutes and regulations;
2, strictly in accordance with the approved scope of business and business operations engaged in the business activities of medical devices;
3, the education of workers to establish " quality first" idea. Quality first" idea;
4, approval of relevant quality documents, to ensure that the quality management personnel to exercise their powers;
5, the implementation of the system for inspection and evaluation.
(2), the quality of quality management personnel quality responsibility
1, is responsible for the collection of publicity and implementation of the supervision and management of medical devices and the relevant laws and regulations and normative documents;
2, is responsible for the collection of the quality standards of the medical device products;
3, is responsible for the drafting of the quality management system;
4, is responsible for the first enterprise and the first variety of Quality audit;
5, guide product acceptance, after-sales service work;
6, check the implementation of the system.
(C), the quality of quality acceptance personnel quality responsibility
1, strict implementation of product quality acceptance system;
2, according to the relevant standards and contractual quality terms of acceptance of medical device product quality;
3, the establishment of a true and complete acceptance of the record, and properly preserved.
(D), maintenance and custody of the quality of personnel responsibility
1, strict implementation of the product storage and maintenance system;
2, the implementation of color-coded management, zoning storage, and have a clear sign;
3, to strengthen the management of the product expiration date;
4, unqualified products for the control of the management;
5, do a good job in dustproof, moisture-proof, mold, pollution and insect and rodent prevention.
(E), sales and after-sales service personnel quality responsibility
1, the correct introduction of product performance, provide consulting services;
2, product sales should be reviewed before and quality checks;
3, the customer reflects the problem of timely treatment and resolution;
4, after-sales quality inquiries, complaints should be recorded in detail and timely handling.
Four, quality veto system
1, medical device supply units, after audit or inspection does not have the production and operation of legal qualifications and the corresponding quality assurance conditions, the right to request the operating department to stop purchasing.
2, the medical device sales target, the audit does not have the legal qualifications for the purchase of medical devices, the right to request the business sector to stop selling and retrieve the sold medical devices.
3, the incoming inspection, the company does not meet the "medical device acceptance system" of medical devices, the right to refuse.
4, on the maintenance of medical devices found to be unqualified during the inspection, the right to issue a stop-sale, sealing notice, and decide on the return of the medical device, report loss, destruction.
5, sold medical devices found to be quality problems, the right to request the operating department to recover.
6, the equipment, facilities, instruments, appliances that do not meet the needs of quality management, the right to decide to stop using, and put forward proposals for additions, remodeling, improvement.
7, the company does not meet the "first enterprise audit system", "the first varieties of audit system" of the first enterprise, the first varieties, the right to veto.
8, the approval of the first enterprise in the actual supply of poor quality assurance capabilities; the approval of the first varieties in the operation of the quality of unstable or not adapt to market needs, to the Department of Management and the General Manager's Office of the termination of the relationship, to stop the purchase of the veto.
9, the right to purchase plans for poor quality assurance of enterprises or quality problems in the veto varieties.
10, the quality of medical devices have an impact on other matters.
Fifth, the business quality management system
1, strict compliance with the "supervision and management of medical devices regulations" laws and regulations and the relevant medical device management provisions, according to the state drug regulatory authorities to develop the "supervision and management of medical device business enterprises" to regulate the business behavior, in the "business license" approved business methods and scope of medical device marketing activities.
2, the person in charge of the enterprise, medical device quality personnel should be familiar with the relevant medical device regulations and administrative regulations, and implement.
3, engaged in the medical device business personnel must have a high school or above (including high school) literacy level, and receive appropriate professional knowledge and medical device regulations and training, have good business ethics, in the legal record of no bad character, the quality of its personnel should be municipal drug supervision and management department examined and certified to work.
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