Time is silent, in a blink of an eye, the years are in a hurry, and a period of work has come to an end. Looking back on a period of work, the overall situation is good and bad. You might as well sit down and write a self-inspection report. How to focus the self-inspection report? The following is the medical device management self-inspection report (5 selected articles) I collected for you, hoping to help you.
Medical device management self-inspection report 1 Our company was established on April 22nd, 20xx. According to the spirit of the Notice of Jining Municipality on Rectifying the Business Behavior in the Field of Medical Device Circulation (No.Ji 127), our company organized relevant personnel to conduct a comprehensive inspection of all medical devices operated by our company, and now the specific situation is reported as follows:
1. An operating enterprise engaged in the wholesale business of medical devices sells it to an unqualified operating enterprise or user; Medical device management enterprises purchase medical devices from unqualified production and management enterprises.
After verification, the company has never been sold to unqualified operating enterprises or users; Not purchasing medical devices from unqualified production and operation enterprises. From the general manager to the person in charge of quality to the employees of all departments, the corresponding management system is formulated in strict accordance with the Measures for the Supervision and Administration of Medical Devices, and the procurement conditions, supplier qualifications and sales customer qualifications of medical devices are strictly stipulated to ensure the quality and safety of purchased medical devices and prevent unqualified medical devices from entering the hospital.
Two, the operating conditions change, no longer meet the requirements of medical device management quality management standards, not in accordance with the provisions of the rectification; Changing the address of business premises or warehouses, expanding the business scope or setting up warehouses without authorization.
The company was changed from xxx Co., Ltd. to Shandong Medical Devices Co., Ltd. on March 20th, 12, and its operation mode was changed from wholesale to wholesale. Business conditions, warehouse, address and business scope have not changed, business premises or warehouse address have not been changed without authorization, business scope has not been expanded or warehouses have been set up without authorization. Meet the requirements of medical device management quality management standards.
Three, provide false information or take other deceptive means to obtain the "medical device business license"; Providing false information without filing or filing; Forge, alter, buy, sell, lease or lend the Medical Device Business License or the Medical Device Business Record Certificate. On April 22nd, 20xx, the company applied to issue a medical device business license. Adhering to the principle of "quality first, customer first", the company has never forged, altered, bought, sold, rented or lent the Medical Device Business License.
Four, engaged in the third kind of medical device business activities without permission, or after the expiration of the "medical device business license", shall not continue to engage in medical device business activities.
The company issued the Medical Device Business License on April 22nd, 20xx. Scope of business: Class II and Class III medical device products (excluding contact lenses and nursing solutions, hearing AIDS and in-vitro diagnostic reagents). 20xx65438+1October 28th, apply for the renewal of the old certificate of medical device business enterprise, and 20xx will issue a new medical device business license on March 5th. Business scope: Class III 68 15 puncture instrument for injection, 6866 medical polymer materials and products will be valid until March 4th, 20xx.
Five, operating the second and third types of medical devices without obtaining the medical device registration certificate, especially the domestic agents of imported medical devices operating unlicensed products.
The three types of medical devices operated by the company are mainly 68 15 puncture instruments for injection and 6866 medical polymer materials and products (with product management catalogue and product registration certificate attached) produced by Nanyang Jiukang Medical Devices Co., Ltd. The company does not deal in Class II medical devices and imported medical devices.
Six, operating medical devices that do not meet the mandatory standards or do not meet the technical requirements of registered or filed products; Operating medical devices without certificates, expired, invalid or eliminated.
The products operated by the company are all medical devices that meet the technical requirements, as well as unlicensed, expired, invalid and obsolete medical devices (attached with medical device production license, quality management system certification certificate and medical device registration form).
Seven, the instructions and labels of medical devices do not meet the relevant provisions; Failing to transport and store medical devices according to the requirements of medical device instructions and labels, especially failing to implement full chain cold chain management for medical devices that need to be refrigerated at low temperature.
The company's inspectors shall inspect all purchased medical devices as required, and report the unqualified products to the Quality Management Department, which shall cooperate with the business department to communicate with agents or manufacturers for recall. The company has hardware and facilities to meet the requirements of warehousing, acceptance, storage and transportation of medical devices. Medical devices are stored independently and classified, and the latest storage management system has been established.
Eight, failing to establish and implement the medical equipment procurement inspection record system; Business enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices fail to establish and implement the sales record system as required.
The company has special buyers, inspectors and salesmen who regularly check and assess the implementation of the procurement inspection records and sales records system. According to the requirements of the new edition of Quality Management Standard for Medical Device Operation, the company upgraded the computer system and installed the latest software management system of Yaoshen, which can meet the whole process management and quality control of medical device operation, and established relevant records and files.
Our company always maintains the quality policy of "quality first, customer first", and conducts regular self-inspection in strict accordance with the "Quality Management Standard for Medical Device Operation" to ensure the effective operation of various systems.
Self-inspection report on medical device management 2 According to the requirements of the Municipal Bureau, our store conducted a serious self-inspection on the daily business activities of medical devices in 20xx, and now the self-inspection report is as follows:
1. In the procurement, sales and storage management of medical devices, our store strictly follows GSP management, implements medical device filing management, and makes strict regulations on the conditions for purchasing medical devices and the qualifications of suppliers to ensure the quality and safety of medical devices, prevent unqualified medical devices from entering pharmacies, ensure the legitimacy and quality of medical devices, and conscientiously implement the acceptance system to ensure the safe use of medical devices. Strengthen the quality management of medical devices, and have special personnel to do the daily maintenance of medical devices. If there are any medical device adverse events, they should be recorded in time and reported to the US Food and Drug Administration quickly.
2, according to the requirements of medical device management quality management specification, the implementation of medical device partition management, obvious signs. The appearance, internal and external packaging, labels and instructions of the purchased instruments were inspected in detail. Do not use expired, invalid or obsolete medical devices. The storage of medical devices is completed in strict accordance with the requirements of medical device instructions and labels.
3. According to the management requirements of GSP, formulate management rules and regulations related to medical devices; Improve the purchase, sales and acceptance records of medical devices, and immediately formulate and implement the rectification plan for the problems found. Through this self-inspection activity, our store has carefully studied the standardized operation and use behavior of medical devices, strengthened the staff's study of medical device management system, enhanced their business knowledge and improved the overall level. In the future work, we will further improve the management system, improve the management level and ensure the safety of medical devices.
Self-inspection report on medical device management 3 According to the announcement (No.58) of China Food and Drug Administration on the implementation of medical device management norms, our department organized relevant personnel to conduct a comprehensive inspection of all medical devices operated by our company. The specific situation is now reported as follows:
First, strengthen management, improve the quality management system, and ensure the quality and safety of products in the process of operation.
The company has established a safety management organization with the general manager as the main leadership core, department managers as the main organizational members, and all employees as the main supervisory and executive members, and regards the safety management of medical devices as the top priority of the company. Strengthen leadership, strengthen responsibility, and enhance the sense of quality responsibility. The company has established and improved a series of management systems related to medical devices: effective quality control measures are taken in the procurement, acceptance, storage, sales, transportation and after-sales service of medical devices to ensure the safe and smooth development of the company's business activities.
Two, clear job responsibilities, strict management system, improve and save the management system of relevant records or files.
From the general manager to the person in charge of quality to the employees of all departments, the company has formulated corresponding management systems in strict accordance with the quality management standards of medical devices, and made strict provisions on the conditions for purchasing medical devices and the qualifications of suppliers to ensure the quality and safety of purchased medical devices and prevent unqualified medical devices from entering the hospital. Ensure the legality and quality of medical devices in storage, and seriously implement the outbound system to ensure the safe use of medical devices.
The person in charge of enterprise quality is responsible for the quality management of medical devices and has independent ruling power. He mainly organizes the formulation of quality management system, guides and supervises the implementation of the system, checks, corrects and continuously improves the implementation of the quality management system, collects relevant laws and regulations on medical device management in time, and implements dynamic management. Organize or assist in quality management training on a regular basis for the confirmation of unqualified medical devices, the collection and reporting of adverse events, the real-time supervision of quality complaints and device recall information. According to the requirements of the new version of "Quality Management Standard for Medical Device Management", the company has reformed and upgraded all computer systems and installed professional software systems for medical devices. The software has been recognized and recommended by many regulatory authorities, which can meet the whole process management and quality control of medical device operation, and has established relevant records and files. In view of the imperfect qualifications of some suppliers that have been archived before, it is also required to supplement them in time for further improvement and preservation.
Third, personnel management.
Our company's medical equipment work is undertaken by professional and technical personnel, and regular training on relevant laws, regulations and related systems is conducted to ensure the smooth progress of the work; Organize employees who have direct contact with medical devices to have annual health check-ups and establish health records.
Fourth, storage management.
The company has hardware facilities and equipment that meet the requirements of storage, acceptance, storage and transportation of medical devices. Medical instruments are stored independently and classified, and instruments and non-instruments are stored separately. The latest storage management system and medical device maintenance system have been established, the quality management of stored devices has been strengthened, and special personnel have been assigned to do the daily maintenance of devices. Prevent unqualified medical devices from entering the market and formulate an adverse accident reporting system.
Our company always adheres to the quality policy of "quality first, quality first", and in strict accordance with the requirements of "Quality Management Standard for Medical Device Operation", strengthens the inspection of safety items of medical devices in storage, promptly investigates hidden dangers of medical devices, and conducts self-inspection on a regular basis to ensure the effective implementation of various systems.
Self-inspection report on medical device management 4 Since Tiexi District of the US Food and Drug Administration organized the "Tiexi District Drug and Medical Device Quality and Safety Remediation Mobilization Conference", our hospital actively participated in the cooperation and immediately organized a self-inspection team to conduct a comprehensive investigation on the quality and safety of drugs and medical devices in the hospital. Now the self-inspection results are reported as follows:
1. personnel management:
The work of pharmaceutical machinery in our hospital is undertaken by professional and technical personnel, and medical laws, regulations and related systems are regularly trained to ensure the smooth progress of the work; Organize the staff who are in direct contact with drugs and medical devices to carry out health examination every year and establish health records.
2. Responsibility management:
The management system established in our hospital includes: the procurement and acceptance system of drugs and medical equipment; Drug delivery and storage system; Adverse drug reactions (events) monitoring and reporting system; Drug distribution and review system; The custody and maintenance system of drugs and medical equipment; Post responsibility system for medical staff; Safety and health management system. The above system is complete, reasonable and feasible, and there are corresponding implementation records.
3 drugs and medical devices purchase and sale management:
Our hospital is divided into procurement, quality acceptance and other work by professionals; Being able to purchase drugs and medical devices from legal production and operation enterprises, and signing quality agreements with suppliers, with legal bills; Acceptance personnel can accept drugs and medical devices in strict accordance with the established warehousing acceptance system and operating procedures, and keep complete procurement acceptance records.
4. Pharmacy management:
There is a comprehensive pharmacy in our hospital, which is safe and hygienic with eye-catching signs; Pharmacy is divided into corresponding functional areas, so that drugs can be placed in an orderly manner according to dosage forms; There are anti-rodent and anti-mosquito facilities in the bureau; Pharmacists can strictly review prescriptions when dispensing, allocate drugs according to dispensing system and operating specifications, and check drugs daily as required. In case of damaged or expired drugs, it will be reported to a special person for unified treatment and registered carefully.
5. Pharmacy management:
The drug storeroom in our hospital is clearly divided and reasonable, and the storage distance is suitable. Drugs can be stored at room temperature according to the classification and dosage form requirements. Managers can keep drugs in strict accordance with the requirements; The principle of "first-in, first-out" should be followed when the drugs are out of the library, and the records should be complete.
The above is the present situation of the quality and safety of drugs and medical devices in our hospital, and we will further improve it in the future work.
Self-inspection report on medical device operation 5 Our company was established in 20xx and obtained the medical device operation license in March of 20xx. The company's address is located at No.89 Minzu Avenue, xx City. In order to ensure the better implementation and improvement of the company's medical device operation quality management, the self-inspection results are now reported as follows:
1. personnel management: the quality management department of our company is equipped with professional and technical personnel with certificates, and regularly conducts training on medical laws, regulations and related systems to ensure the smooth progress of the work; Organize company employees to have health check-ups every year and establish health records.
2. Responsibility management: the management system established by our company includes: the responsibilities of quality management institutions or quality management personnel; Quality management regulations; Provisions on procurement, acceptance and acceptance; Provisions on supplier qualification examination; Provisions on storage, storage and transportation management of warehouses; Provisions on sales and after-sales service; Provisions on the administration of unqualified medical devices; Provisions on the return and exchange of medical devices; Provisions on monitoring and reporting of medical device adverse events; Regulations on the recall of medical devices; Provisions on maintenance, verification and calibration of facilities and equipment; Provisions on personnel hygiene and health status; Provisions on quality management training and assessment; Provisions on medical device quality complaints, accident investigation and handling reports; Audit records of the first enterprise/variety; Purchase records; Incoming inspection records; Maintenance and inspection records of the warehouse; Outbound, transportation and sales records; After-sales service records; Records of quality inquiries, complaints and spot checks; Return record; Records related to the disposal of nonconforming products; Monitoring records of warehouse storage conditions (temperature and humidity); Monitoring records of transportation cold chain/heat preservation; The use and verification records of measuring instruments; Quality accident investigation and handling report records; Records of adverse event monitoring reports; Medical device recall records; Quality management system implementation inspection and evaluation records, etc. The above system is complete, reasonable and feasible, and there are corresponding implementation records.
3. Facilities and equipment management: divide the warehouse into corresponding areas and manage them in different areas, including areas to be inspected, qualified areas, unqualified areas, delivery areas, shelves effectively isolated from the ground, etc., so as to be placed in an orderly manner according to the areas. The warehouse is equipped with anti-rodent and anti-mosquito facilities, equipped with thermometers, and the equipment is verified once a year.
4. Management of purchase, receipt and acceptance: Before purchase, the business license of the manufacturer, the production/operation license of medical devices, the registration certificate or filing certificate of medical devices, and the authorization letter of sales personnel must be checked. When signing a purchase contract with the manufacturer, the name, specifications, registration certificate number or filing certificate number, manufacturer, supplier, quantity, unit price, amount and after-sales service terms of the equipment must be clearly stated. After receiving the equipment, it is necessary to check the contract and attached bills with the arriving equipment, put them in the corresponding area after checking them correctly, and then notify the acceptance personnel to put them in storage. The warehouse personnel shall check with the arrival equipment according to the name, specification, registration number, batch number, production date, manufacturer, supplier, arrival quantity and arrival date of the equipment, and make strict records.
5. Warehousing management: Store the instruments according to the storage requirements indicated in the instruction manual or the package, and store them by region and classification. Medical devices and non-medical devices shall be stored separately, and articles unrelated to storage management shall not be stored. For unqualified products, put them into unqualified areas, mark unqualified items, and take disposal measures such as return and destruction. Monitor and record the temperature and humidity meter in the warehouse every day, and check the appearance and packaging validity of the medical devices in stock. If there is any damaged or expired equipment, it should be reported to a special person for unified treatment and registered carefully. Products that have expired are prohibited from being sold.
6. Sales delivery management: sales records include name, specification, registration certificate number or filing certificate number, quantity, unit price, amount, production batch number, validity period, sales date, manufacturer, manufacturer's license number and hospital name, address and contact information. Check the name, specification, registration certificate number or filing certificate number, production batch number, production date and validity period, manufacturer, quantity and factory date of hospitals and medical devices. It is forbidden to leave the warehouse for goods with damaged packaging, pollution, unstable sealing, broken seal, label falling off, illegible handwriting or marked content inconsistent with the real thing. Follow the principle of "first in, first out" when leaving the warehouse, and keep complete records.
7. After-sales management: After-sales management personnel must respond within 2 hours after receiving the failure notice. If the phone can't solve the problem, go to the site for maintenance within 24 hours and pay a regular visit to the customer. In case of any device adverse events, they will immediately find out the location, time, adverse reactions or basic information of the adverse events, make records and report to the regional US Food and Drug Administration quickly.
Through this self-examination, our company earnestly studied the law, standardized the operation and use behavior, further improved itself, strengthened the safe use system of medical devices, standardized the operation and use behavior of medical devices, strengthened its own quality management system, enhanced the awareness of knowing the law and abiding by the law, and improved the overall level of the company. In actual work and implementation, there may be some subtle problems that are easily overlooked. I hope that the superior leaders will put forward valuable opinions on the work of our company.
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