Medical device business self-examination report (Selected 5)
Time is silent, in the blink of an eye, the years rush, a period of time the work comes to an end, review a period of time to pay for the work of the overall situation is both good and bad, it may be worthwhile to sit down and write a good self-examination report. How to make the self-examination report to focus on it? The following is my collection of medical device business self-examination report (selected 5), I hope to help you.
Medical device business self-inspection report 1
My company was established in April 22, 20xx in compliance with the Jining Food and Drug Administration on the rectification of medical device circulation area management behavior of the notice (Jinjiang Food and Drug Supervision and Inspection of Measurement 〈201X〉 No. 127) the spirit of the document, the organization of the relevant personnel focusing on the operation of my company all the medical equipment to carry out a comprehensive inspection, is now the specific situation reported as follows. The specific situation is reported as follows:
First, engaged in the wholesale business of medical equipment business enterprise sales to non-qualified business enterprises or the use of units; medical equipment business enterprises from the production of non-qualified, business enterprises to purchase medical equipment.
The company verified that it has never sold to unqualified business enterprises or use units; not from the unqualified production and operation of enterprises to purchase medical devices. From the general manager to the person in charge of quality to the staff of each department each link is strictly in accordance with the "supervision and management of medical devices" to develop the appropriate management system, the conditions for the purchase of medical equipment and the qualifications of suppliers and sales customers qualifications to make strict provisions to ensure that the quality of medical equipment purchased and used to ensure the safety of the hospital to prevent unqualified medical equipment into the hospital.
Second, the business conditions have changed, no longer meet the requirements of the quality management standard for the operation of medical devices, not in accordance with the provisions of the rectification; unauthorized change of business premises or warehouse address, expanding the scope of business or unauthorized establishment of the warehouse.
The company since March 12, 20xx by xxx Co., Ltd. changed to Shandong Medical Devices Co., Ltd. business mode from wholesale to wholesale and retail. Business conditions, warehouse, address, scope of business have not occurred in the development of unauthorized changes in the business premises or warehouse address, not to expand the scope of business or unauthorized establishment of the warehouse. In line with the requirements of the quality management standard for the operation of medical devices.
Third, to provide false information or take other deceptive means to obtain a "medical device license"; not for the record or record the provision of false information; forged, altered, trading, leasing, lending, "Medical Device License" or "Medical Device Business Record Certificate". The company applied for the issuance of medical device license on April 22, 20xx, the company has been adhering to the sincerity of the "quality first, customer first" this policy of legal business, and did not occur in the forgery, alteration, sale, lease, loan "medical device license" and other matters.
Fourth, without permission to engage in the third class of medical equipment business activities, or "medical equipment business license" validity expires after the continuation of the law, still continue to engage in the business of medical equipment.
The company in April 22, 20xx issued "Medical Device Business License" business scope: Class II, III medical device products (contact lenses and care fluids, hearing aids, in vitro diagnostic reagents are excluded). 20xx January 28, 20xx applied for medical device business enterprise old license for a new license March 5, 20xx issued a new "Medical Device Business License" business scope: Class III 6815 injection puncture instruments, 6866 medical polymer materials and products valid until March 4, 20xx.
Fifth, the operation of medical equipment without obtaining a medical device registration certificate of the second class, the third class of medical devices, especially imported medical equipment in the territory of the agent operating unlicensed products.
The company's operation of Class III medical devices are mainly produced by the Nanyang City, Jukang Medical Devices Co. 6815 injection puncture instruments, 6866 medical polymer materials and products (attached to the product business directory and product registration certificate), the company did not operate the second class of medical devices and imported medical devices.
Six, the operation does not meet the mandatory standards or does not meet the registration or filing of the product technical requirements of medical devices; operating without a qualified document, expired, expired, out of medical devices.
The company's business products do not meet the technical requirements of medical devices, and no qualified documents, expired, expired, out of medical devices (attached to the medical device production license, quality management system certification and medical device registration form).
VII, the operation of medical devices, instructions, labels do not meet the relevant provisions; not in accordance with the instructions and labels of medical devices labeling requirements for the transport and storage of medical devices, in particular, the need for low-temperature, refrigerated medical devices to carry out the whole chain of cold chain management.
The company's acceptance personnel on all purchases of medical devices in accordance with the requirements of inspection, non-compliance with the provisions of the product reported to the Department of Quality Management by the Department of Quality Management in conjunction with the Department of Business and agents or manufacturers to communicate with the manufacturer to carry out the recall process. The company has the hardware and facilities and equipment to meet the requirements of warehousing, acceptance and storage and transportation of medical devices operated by the company, medical devices are stored independently, categorized storage and the establishment of the latest warehouse management system.
Eight, not in accordance with the provisions of the establishment and implementation of the medical device purchase inspection record system; engaged in the second, third class medical device wholesale business and the third class medical device retail business business business enterprises not in accordance with the provisions of the establishment and implementation of the sales record system.
The company has a special purchase, acceptance, salesman, and the purchase inspection records, sales record system implementation of regular inspection and assessment. The company has been in accordance with the requirements of the new version of the quality management standard for the operation of equipment to upgrade the computer system, the installation of the latest drug God software management system to meet the whole process of medical device management and quality control, and the establishment of relevant records and files.
Our company has always maintained the "quality first, customer first" quality policy, in strict accordance with the "medical device business quality management standard" requirements of regular self-examination, to ensure the effective operation of the system.
Medical device business self-inspection report 2
According to the requirements of the municipal bureau, I store on the 20xx year of medical equipment daily business activities, carried out a serious self-inspection, is now the self-inspection self-inspection report is as follows:
1, in the management of the purchase, sale, and inventory of medical devices, I store in strict accordance with the management of the GSP, the record of the management of the execution of the medical device, the development of a management system on the purchase of medical devices, the conditions and suppliers of medical equipment, and the management system is to ensure the effective operation of all systems, and to ensure the effective operation of all systems. The conditions and qualifications of the suppliers have made strict provisions to ensure the quality of medical devices and the use of safety, to prevent unqualified medical devices into the pharmacy, to ensure the legitimacy and quality of medical devices, and to conscientiously implement the acceptance system to ensure the safe use of medical devices. Strengthen the quality management of medical devices, there are specialized personnel to do a good job in the daily maintenance of medical devices, such as medical devices, adverse events occur, timely record, and quickly reported to the City Drug Administration.
2, in accordance with the requirements of the quality management standard for the operation of medical devices, the implementation of medical device management, the sign is obvious. The purchased devices of the appearance of the properties as well as internal and external packaging, labeling, instructions labeling and other content of a detailed inspection. There is no use of expired, invalid or obsolete medical devices. The storage of medical devices is completed in strict accordance with the requirements of medical device instructions and labeling.
3, according to the management requirements of the GSP, the development of medical device-related management rules and regulations, systems; improve the purchase of medical devices, sales, acceptance and other records, and the problems found immediately formulate a rectification program and implementation. Through this self-inspection activities, our store seriously study medical device standardized operation and use behavior, strengthen the store staff to learn the medical device management system, enhance business knowledge and improve the overall level. In the future work, we will further improve the operation and management system, improve the management level, to ensure the safety of medical equipment business.
Medical device business self-examination report 3
I comply with the State Food and Drug Administration on the implementation of the medical device business norms of the announcement (No. 58) the spirit of the document, the organization of the relevant personnel focused on my company's operation of all the medical devices to carry out a comprehensive inspection, the details are now reported as follows:
First, strengthen the management of the quality management system, improve the sound management of the system. To protect the quality and safety of products in the operation process
The company set up a general manager as the main leadership core, department managers as the main organization members, all employees as the main supervision and implementation of the members of the safety management organization, the management of medical equipment safety into my company's work is the most important thing. Strengthen the leadership, strengthen the responsibility, enhance the awareness of quality responsibility. The company has established and improved a series of medical device related management system: medical device procurement, acceptance, storage, sales, transportation, after-sales service and other aspects of the effective quality control measures to ensure that the company's business activities to ensure the safety of the smooth running of the system.
Second, clear job responsibilities, strict management system, improve and save the relevant records or file management system
The company from the general manager to the quality of the person in charge of the various departments of the staff of each link are strictly in accordance with the quality management standard for the operation of medical equipment management system to develop the corresponding management system, the purchase of medical equipment and the conditions of the supplier with strict provisions of the qualification. The company has made strict regulations on the conditions for the purchase of medical devices and the qualifications of suppliers to ensure the quality of purchased medical devices and the safety of their use, and to prevent unqualified medical devices from entering the hospital. To ensure the legitimacy and quality of incoming medical devices, the company carefully implements the in/out system to ensure the safe use of medical devices.
The quality manager of the enterprise is responsible for the quality management of medical devices, with independent decision-making power, mainly organizing the development of quality management system, guiding and supervising the implementation of the system, and checking, correcting and continuous improvement of the implementation of the quality management system, and timely collection of laws, regulations and other relevant provisions related to the operation of medical devices and the implementation of dynamic management. For the confirmation of unqualified medical devices, the collection and reporting of adverse events as well as quality complaints and device recall information and other events real-time supervision, regularly organize or assist in quality management training. The company has remodeled and upgraded all computer systems in accordance with the requirements of the new version of the quality management standard for the operation of devices, and installed a professional software system for medical devices, which has been recognized and recommended by the regulatory authorities of many places. The software has been recognized and recommended to meet the whole process of medical device management and quality control, and the establishment of relevant records and files, for the previous part of the supplier qualifications in the file is not perfect, but also timely request for supplementation to do further improve the preservation.
Three, personnel management
Our medical equipment work by professional and technical staff, and regularly carry out the relevant laws and regulations and related systems of training to ensure the smooth progress of the work; the organization of direct contact with the medical device staff health checks every year, and built health records.
Fourth, warehouse management
The company has hardware facilities and equipment to meet the requirements of warehousing, acceptance and storage and transportation of medical devices, independent storage of medical devices, categorized storage, separate storage of instruments and non-instrumentation, and the establishment of the latest warehousing management system and the medical device maintenance system, to strengthen the quality of the stored equipment management, there are Specialized personnel to do the daily maintenance of equipment. To prevent unqualified medical devices from entering the market, and to develop an adverse incident reporting system.
Our company has always adhered to the "quality first, quality first" quality policy, in strict accordance with the "Code for the Quality Management of Medical Devices" requirements, to increase the warehouse medical device safety program inspection, timely investigation of medical devices hidden danger, regular self-checks, to ensure that the effective implementation of the system.
Medical device business self-examination report 4Since the Tiexi District Food and Drug Administration organization held a "Tiexi District Drugs and Medical Devices Quality and Safety Remediation Mobilization Conference", I actively participate in the cooperation, and immediately organized the establishment of a self-examination team, the hospital's drugs and medical equipment quality and safety situation to conduct a comprehensive mapping, will now be the results of self-examination reported as follows:
2, duty management:
I have established a management system including: drug and medicine procurement and acceptance system; drug and medicine in and out of the warehouse system; adverse drug reactions (events) monitoring and reporting system; drug deployment and review system; drug and medicine storage and maintenance system; medical staff post responsibility system; safety and health management system. Safety and hygiene management system, etc. The above systems are complete, reasonable, feasible, and have the corresponding implementation records.
3. Drugs and medicines purchase and sale management:
Our hospital by professional staff assigned to the procurement, quality inspection and acceptance of the work; from the legitimate production and operation of the purchase of drugs and medical equipment, and signed a quality agreement with the supplier enterprises, with legitimate bills; acceptance of personnel can be strictly in accordance with the development of the inventory acceptance system and operating procedures Acceptance of drugs and medicines, save a complete record of purchase and acceptance.
4. Pharmacy management:
Our hospital has a comprehensive pharmacy, safe and hygienic, sign conspicuous; pharmacy divided into the appropriate functional areas, so that the drugs according to the dosage form classified and placed in a neat and orderly manner; the bureau is equipped with rodent-proof and anti-mosquito facilities; pharmacy staff in the transfer of prescriptions can be strictly audited in accordance with the system of transferring and operating norms of the transfer, and according to the requirements of the daily inspection of drugs, and the transfer of drugs.
5. Pharmacy management:
Our hospital pharmacy partition is distinctive and reasonable, the distance of drug storage is appropriate, according to the requirements of the classification, sub-dosage form at room temperature storage of medicines; management personnel can be strictly in accordance with the requirements of the custody of medicines; drugs out of the warehouse to follow the "first in first out" principle, complete records. The principle of "first in, first out" is followed when the drugs are taken out of the warehouse, and the records are complete.
The above is the existing situation of the quality and safety of the hospital's drugs and medical devices, and in the future work, we will further improve.
Medical device business self-examination report 5
My company was founded in 20xx, and in March 20xx to obtain a medical device license, the company's address is located in the city of xx National Avenue No. 89, in order to ensure a better implementation and improve the company's medical device business quality management, is now the results of the self-examination report is as follows:
1, personnel management: the quality control department of the work of the company by professional and technical personnel, licensed to work as a professional and technical personnel, the work of the company's quality control department by professional and technical personnel, licensed to work as a professional and technical personnel. Technical personnel, licensed to work, and regular training of medical laws and regulations and related systems to ensure the smooth progress of the work; the annual organization of the company's employees to carry out health checks, and build a health file.
2, duty management: our company has established a management system includes: quality management organization or quality management personnel duties; quality management provisions; procurement, receipt, acceptance provisions; supplier qualification audit provisions; warehouse storage, access, transportation management provisions; sales and after-sales service provisions; provisions of unqualified medical device management; medical device return, replacement provisions; Medical device adverse event monitoring and reporting requirements; medical device recall requirements; facilities and equipment maintenance and verification and calibration requirements; health and personnel health status requirements; quality management training and assessment requirements; medical device quality complaints, accident investigation and handling of the report requirements; the first enterprise/first varieties of audit records; purchasing records; purchase inspection records; in-store maintenance, inspection records; out-of-store, transportation Sales records; after-sales service records; quality inquiries, complaints, sampling records; return records; records related to the disposal of substandard products; warehouse (temperature, humidity) storage conditions monitoring records; transportation cold chain/insulation monitoring records; the use of measuring instruments, calibration records; quality accidents investigation and handling report records; records of adverse event monitoring report; medical device recall records; quality management system implementation Inspection and assessment records, etc. The above systems are complete, reasonable and feasible, and there are corresponding implementation records.
3, facilities and equipment management: the warehouse is divided into corresponding areas, the implementation of district management, including the inspection area, qualified area, unqualified area, shipping area, effective isolation of equipment and the ground between the shelves, according to the regional arrangement, neat and orderly, the warehouse is equipped with anti-rodent and anti-mosquito facilities, equipped with a temperature and humidity meter, and the annual verification of apparatus.
4, purchase receipt and acceptance management: before purchasing goods must check the manufacturer's business license, medical device manufacturing / business license, medical device registration certificate or record certificate, and the sales staff's authorization. Sign a purchase contract with the manufacturer, which must state the name, specification, registration number or record certificate number, manufacturer, supplier, quantity, unit price, amount and after-sales service terms of the device. Upon receipt of the device, the contract and the accompanying counterparts must be checked with the arrival of the device, after checking into the appropriate area, and then notify the receiving and inspection personnel for warehousing, warehousing personnel in accordance with the name of the device, specification number, registration certificate number, batch number, date of production, manufacturer, supplier, arrival number, arrival date, etc. and the arrival of the device to check, and strictly do a good job of record-keeping.
5, storage management: storage requirements according to the instructions or packaging labeling storage device, partition, classification storage, medical equipment and non-medical equipment stored separately, and shall not be stored with the storage management of irrelevant items. For unqualified products, put them in the unqualified area, indicate the unqualified matters, and take measures such as return and destruction. Daily temperature and humidity monitoring records of the warehouse, the appearance of the inventory of medical equipment, packaging, expiration date and other quality conditions for inspection, in the event of damage or expiration date of the device reported by the person unified processing, and carefully registered, more than the expiration date of the product, prohibit the sale.
6, sales management: sales records include the name of the device, specifications, registration certificate number or record certificate number, quantity, unit price, amount, production batch number, expiration date, date of sale, manufacturer, manufacturer's license number, and the name of the hospital, address, contact information. Outbound review of the hospital, the name of the medical device, specifications, registration certificate number or record certificate number, production lot number, date of production and expiration date, manufacturer, quantity, date of discharge and so on. Packaging damage, contamination, sealing is not secure, seal damage, labeling, blurred handwriting or labeling content does not match the physical, more than the expiration date of the goods are prohibited from leaving the warehouse. Follow the "first in, first out" principle, complete records.
7, after-sales management: after-sales management personnel such as fault notification must respond within two hours, such as not being able to resolve the phone, within 24 hours to arrive at the scene of the maintenance, and regular return visits to customers, such as the occurrence of adverse events of the device, and immediately find out where the incident occurred, the time, the adverse reaction or the basic situation of the adverse event, and make a good record of it, and quickly reported to the District Drug Administration.
Through this self-examination, our company seriously study the law, standardize the operation and use of behavior, and further self-improvement, strengthen the safe use of medical equipment system, standardize the operation and use of medical equipment behavior, strengthen their own quality management system, enhance the knowledge of law-abiding awareness, and improve the overall level of the company. In the actual work and implementation, there may be some easily overlooked, subtle aspects of the problem, hope that the higher leadership of my company's work to put forward valuable advice.
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