A, quality policy and management objectives
1, do a good job in medical device quality management, is an important part of the company's work, is the key to do a good job in business and service quality, we must earnestly strengthen the leadership of business operations, constantly improve the ideological and professional quality of all employees, ensure the quality of goods and improve service quality.
2. Organize all employees to seriously study and implement the Measures for Supervision and Management of Medical Device Enterprises, Detailed Rules for Classification of Medical Devices, Economic Contract Law and other laws and regulations and company rules and regulations to ensure the quality of medical devices and ensure the safe and effective use of medical devices by the people.
3. Medical device management must understand and implement the national principles and policies, adapt to the needs of medical and health development, adhere to quality first, operate according to law, and pay attention to practical results in business policies and marketing strategies; Adhere to the purpose of serving people's health, medical care and human health, disasters and epidemics, industrial and agricultural production and scientific research, and establish the policy of "customer first".
4. Establish a complete quality management system, pay special attention to commodity quality acceptance, in-store maintenance and out-of-store audit, and do a good job in tracking, understanding and analyzing users' inquiries and suggestions on commodity quality during after-sales service. Link all aspects of the company's quality management with the economic benefits of the department. Divide the responsibility into people's heads, investigate the responsibility of individuals and department heads in case of problems, and implement the quality management responsibility system step by step.
Second, the quality system audit
1. In order to conscientiously implement the national laws and regulations on medical device quality management, formulate the enterprise medical device operation quality management system, and guide and supervise the implementation of the system, the company implements the general manager responsibility system and is fully responsible for device quality management, with the general manager as the first responsible person, the deputy general manager in charge as the second responsible person, and the company's quality inspection department as the third responsible person, specifically responsible for all aspects of the company's operation quality work.
2, the company set up a special quality management organization-quality inspection department, to exercise quality management functions. Within the company, it has the right to decide the operating quality of medical devices, guide and supervise the quality management of operating departments, and inspect, judge and decide the product quality of the company.
3, establish and improve a complete quality management system, the head of each department is responsible for the quality of goods and work of the department, the employees of each functional department are responsible for the quality of work, service and related goods, and the quality management of each link is implemented to the head.
4. The quality inspection department is fully responsible for the specific work of quality management in all aspects of the company, and is responsible for regular inspection, assessment and appraisal of the implementation of quality management work and system in this department. Department heads and responsible persons who fail to meet the requirements shall be investigated for responsibility, dealt with severely and rectified within a time limit.
Third, the quality responsibility system at all levels
(A), the quality responsibility of the person in charge of the enterprise
1, organize the implementation of relevant laws and regulations on the supervision and management of medical devices;
2. Engaged in medical device business activities in strict accordance with the approved business scope and mode;
3. Educate employees to establish the idea of "quality first";
4, examination and approval of relevant quality documents, to ensure the quality management personnel to exercise their functions and powers;
5. Check and evaluate the implementation of the system.
(2) Quality responsibilities of quality management personnel
1, responsible for collecting, publicizing and implementing relevant laws, regulations and normative documents on the supervision and management of medical devices;
2, responsible for collecting the quality standards of medical device products;
3, responsible for drafting the quality management system;
4, responsible for the quality audit of the first camp enterprises and the first camp varieties;
5. Guide product acceptance and after-sales service;
6, check the implementation of the system.
(3) Quality responsibility of quality acceptance personnel
1, strictly implement the product quality acceptance system;
2, according to the relevant standards and contract quality terms of medical device product quality acceptance;
3. Establish a true and complete acceptance record and keep it properly.
(4), the quality responsibility of maintenance personnel
1, strictly implement the product storage and maintenance system;
2, the implementation of color code management, partition storage, and clearly marked;
3. Strengthen the management of expired products;
4. Control unqualified products;
5. Do a good job of dust, moisture, mildew, pollution, insects and rats.
(five) the quality responsibility of sales and after-sales service personnel
1, correctly introduce product performance and provide consulting services;
2. The products should be examined and inspected before sale;
3. Deal with and solve the problems reflected by customers in time;
4. After-sales quality inquiries and complaints should be recorded in detail and handled in time.
Fourth, the quality veto system.
1, medical device suppliers, after examination or investigation, do not have legal production and operation qualifications and corresponding quality assurance conditions, have the right to ask the commercial department to stop purchasing.
2, medical device sales target, audited does not have the legal qualification to buy medical devices, have the right to ask the business department to stop selling and take back the medical devices that have been sold.
3. In the process of incoming goods acceptance, we have the right to reject medical devices that do not meet the company's medical device acceptance system.
4. The unqualified medical devices found in the maintenance inspection have the right to issue a notice to stop selling and sealing, and decide to return, report the loss and destroy the medical devices.
5, sold medical devices found quality problems, have the right to ask the operating department to recover.
6. Have the right to decide to stop using equipment, facilities, instruments and appliances that do not meet the needs of quality management, and put forward suggestions for supplement, transformation and improvement.
7. Have the right to refuse the first-instance enterprises and first-instance varieties that do not meet the company's first-instance enterprise audit system and first-instance variety audit system.
8. The first batch of approved enterprises have poor quality assurance ability in actual supply; If the quality of the first approved varieties is unstable or does not meet the market needs, put forward a veto opinion to the operation department and the general manager's office, terminate the relationship and stop purchasing.
9. Have the right to veto the procurement plan of enterprises with poor quality assurance or varieties with quality problems.
10, other matters affecting the quality of medical devices.
Verb (abbreviation of verb) runs quality management system.
1. Strictly abide by the Regulations on the Supervision and Administration of Medical Devices and relevant regulations on the administration of medical devices, standardize the business behavior of enterprises in accordance with the Measures for the Supervision and Administration of Medical Device Business Enterprises formulated by the national drug supervision and administration department, and engage in medical device marketing activities within the business mode and scope approved by the business license.
2, the person in charge of the enterprise, medical device quality personnel should be familiar with the relevant laws and administrative regulations of medical devices, and implement them.
3. Personnel engaged in medical device business must have a high school education or above, and have received corresponding professional knowledge and training in medical device laws and regulations, have good business ethics, and have no defective product records in law. Its quality personnel should be certified by the municipal drug supervision and administration department after passing the examination.
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