Medical enterprise self-examination report sample (selected 5)
Time flies, time is like an arrow, the hard work has come to an end, review the hard work of this period of time, there are defects, at this moment we need to write a self-examination report. How to write a self-examination report will not be the same? The following is my collection of medical enterprise self-examination report sample (selected 5), welcome to share.
Medical enterprise self-examination report 1
First, the guiding ideology
tightly around the "to ensure that the people with the safe and effective use of firearms," the central task, the practice of supervision for the people of the core concepts, and effectively do for the people, science, according to the law, the long term effect, Harmony, through the self-correction inspection, further standardize the operation and use of medical devices, comprehensively improve the quality management level, to ensure that no major medical device quality incidents.
The purpose of the inspection
To increase the management of medical equipment business, the use of management efforts to eliminate the sale, use of expired, invalid, out of diagnostic equipment and a variety of behavior. Through this special self-corrective inspection, to ensure that the people use safe and secure medical equipment, and reduce the incidence of medical errors, improve hospital visibility.
Three, self-correction focus
Focus on self-check since January 20xx sales of single-use sterile medical devices, in vitro diagnostic reagents, sterile sanitary materials and other provisions of the expiration date of the implementation of the quality management system of medical devices, against the check whether the product has the manufacturer's license, the product registration certificate and the product qualification certificate; product purchase records; the product purchase records; and the product quality management system. The company's products have been used in a variety of ways, including the purchase of products, the use of products, and the establishment of an adverse event reporting system and reporting.
Four, according to the specific circumstances of our hospital, the results of its self-correction report are as follows:
1, self-check the types of: one-time use of sterile medical devices, in vitro diagnostic reagents, sterile sanitary materials three major blocks.
2, product qualification certificates, certificates are strictly verified, each procurement, receiving personnel strictly control, no case of unqualified products.
3, procurement records carefully, detailed records, to ensure that the problematic events have a place to check, can be based on.
4, receiving personnel to check the procurement records and products, to confirm that the product is legal, correct, qualified,
5, product storage is strictly in accordance with the requirements of the product description completed.
6, product use carefully check its integrity, expiration date, sterility. Fill in the use record.
7, under the leadership of the dean is gradually improving our hospital's adverse event reporting system, the safe use of medical devices in the further development.
8, but in the actual work and implementation, there may be some easy to be ignored, subtle aspects of the problem, hope that the higher leadership of the work of our hospital to put forward valuable advice.
Fifth, through this self-examination and self-correction activities, our hospital to seriously study the law, standardize the operation and use of behavior, and further self-improvement, to strengthen the safe use of medical equipment system, standardize the operation and use of medical equipment behavior, to strengthen the quality of their own management system, to enhance the knowledge of law-abiding awareness, to improve the overall level of hospitals.
Medical enterprise self-examination report 2
Enterprise Name: xx Pharmaceutical Co. /p>
Warehouse address changed to:
The scope of business was increased to: Class Ⅱ, Ⅲ: implantable materials and artificial organs, interventional devices; injection and puncture instruments, medical polymer materials and products, extracorporeal circulation and blood treatment equipment, clinical testing and analyzing instruments, stomatology materials, medical laser instrumentation, medical electronic instrumentation and equipment
The person in charge of quality was changed to: Chih Shuhua
The person in charge of quality was changed to: Chih Shuhua
The person in charge of quality was changed to: Chih Shuhua<
July 24, 20xx
The registered address was changed to:
May 26, 20xx
The registered address was changed to:
November 20, 20xx
The scope of business was increased to Class III: medical optical instruments, instruments and endoscopic equipment
The address of the warehouse was changed to:
Quality management personnel: 6 after-sales service personnel: 2 professional and technical personnel: 3
Contact:
Contact number:
Medical enterprise self-examination report 3Since the xx Food and Drug Administration organized the "Tiexi District Drugs and Medical Devices Quality and Safety Remediation Mobilization Conference Pharmaceutical laws and regulations and related systems of training to ensure the smooth progress of the work; annual organization of direct contact with drugs and pharmaceuticals staff health checks, and build health records.
2, duty management:
The hospital has 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 and nursing staff 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 drugs and medical equipment purchased from the business enterprise, and signed with the supplier enterprise quality agreement, with legitimate bills; acceptance of personnel can be strictly in accordance with the development of the inventory acceptance system and operating procedures Acceptance inspection of drugs and medical devices, save a complete . Purchase and acceptance records.
4, pharmacy management:
Our hospital has a comprehensive pharmacy, safety and hygiene, sign conspicuous; pharmacy divided into the appropriate functional areas, so that the drugs according to the dosage form of the classification of the arrangement, neat and orderly; the bureau is equipped with rodent-proof and anti-mosquito facilities; pharmacists in the dispensing of prescriptions can be strictly audited in accordance with the system of dispensing and the operating norms of the dispatch, and according to the requirements of the daily inspection of drugs, and the daily inspection of the drugs.
5, pharmacy management:
Our hospital pharmacy partition is distinct 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 drugs and medical devices in our hospital, and in the future work, we will further improve.
Enterprise Name:
Signature of the legal representative (person in charge of the enterprise): (stamped)
Date of completion of the enterprise: month and year
Date of receipt of the regulatory department: month and year
Requirements for filling in
All the requirements are set out in the following table.
I. Fill out the report truthfully, and strictly prohibit falsehoods.
Second, the classification of the frequency of reporting requirements:
Class III medical device manufacturers reported within five working days after the end of each quarter; the end of the second class of medical device manufacturers reported within five working days after the end of each half-year; the end of the first class of medical device manufacturers reported within five working days after the end of each year.
Third, the main post personnel refers to:
The person in charge of the enterprise, the management representative, the person in charge of technology, the person in charge of production, the person in charge of quality and inspectors.
Fourth, the requirement to fill in writing, the party officer needs to sign in person.
V. The number of spaces in the table is insufficient, can be copied and renewed.
Basic situation of the enterprise
Product list
Self-inspection and rectification of the enterprise
List of the main positions of the staff
List of the main inspection instruments and facilities
Self-inspection report of the medical enterprise 5City Food and Drug Administration:
According to the requirements of the Municipal Bureau of the store on the 20xx year of the medical devices. Daily business activities, carried out a serious self-examination, is now self-test self-examination report as follows:
1, in the purchase, sale and inventory management of medical equipment, I store in strict accordance with the management of the GSP, the medical device record management, the development of a management system for the purchase of medical equipment with the conditions and the qualifications of the supplier to make a rigorous provision to ensure that the quality of medical equipment and the use of safety, to prevent unqualified medical devices into the medical equipment, and to prevent the use of medical equipment to ensure that the quality of medical equipment and the use of safety. To prevent unqualified medical devices from entering the pharmacy, to ensure the legitimacy and quality of medical devices, and to 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, the problems found immediately formulate a rectification program and implementation. Through this self-inspection activities, our store seriously study the 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 management.
Pharmacy