Pharmacy medical equipment self-inspection report selected
Pharmacy medical equipment self-inspection report 1 In order to implement the "** City to rectify the city's medical equipment circulation area business behavior program" (Bafa Food and Drug Administration Office {20xx} No. 88) the spirit of the document, I attach great importance to our company on July 8, 20xx by the company's quality management department to organize the company's relevant positions in accordance with the contents of the announcement of the combination of the actual company, article by article and item by item to seriously carry out self-inspection work. The company's actual item by item to seriously carry out self-examination work, now the self-examination report is as follows:
(a) 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 non-qualified production and operation of medical equipment purchased from the enterprise.
Self-inspection: our company's purchasing and sales channels are legal, strictly in accordance with the relevant requirements of the state audit of the supply unit and the purchase of units of legal qualifications, the company's all the supply unit and the purchase of units of legal qualifications, effective.
(B) changes in business conditions, no longer meet the requirements of the quality management standard for medical device business, not in accordance with the provisions of the rectification; unauthorized change of business premises or warehouse address, expand the scope of business or unauthorized establishment of the warehouse. Self-inspection: Our company strictly in accordance with the requirements of the quality management standard for the operation of medical devices to carry out business, there is no unauthorized change of business premises or warehouse address, expanding the scope of business or unauthorized establishment of the illegal act of the warehouse.
(C) provide false information or take other deceptive means to obtain a "medical device business license"; not for the record or provide false information for the record; forged, altered, trading, leasing, lending, "medical device business license" or "medical device business filing certificate".
Self-inspection: Our company solemnly undertakes: for the "Medical Device Business License" to provide information is true, accurate and complete, there is no forgery, alteration, trading, leasing, lending "Medical Device Business License" illegal.
(D) unauthorized to engage in the third class of medical equipment business activities, or "Medical Device License" expires after the continuation of the law, still continue to engage in the operation of medical equipment.
Self-inspection: my company's "Medical Device License" is valid until September 27, 20xx, at present my company is actively preparing for the renewal of the license.
(E) the operation of medical devices without obtaining a medical device registration certificate of the second class, the third class of medical devices, especially imported medical devices in the territory of the agent operating unlicensed products.
Self-inspection: our company's purchase and sales channels are legal, not over the scope of business.
(F) business does not meet the mandatory standards or do not meet the technical requirements of the registered or filed products of medical devices; business without qualified documents, expired, expired, out of medical devices.
Self-inspection: our company in accordance with the approved mode of operation, the scope of business engaged in the operation of medical devices; not operating without a qualified document, expired, invalid, out of medical equipment.
(G) 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 transportation 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.
Self-inspection: the company's medical devices instructions, labeling in line with the relevant provisions; our company does not operate the need for refrigeration medical devices.
(H) not in accordance with the provisions of the establishment and implementation of the medical device purchase inspection records system; engaged in the second class, the third class of medical equipment wholesale business and the third class of medical equipment retail business business business enterprises are not in accordance with the provisions of the establishment and implementation of the sales record system.
Self-inspection: has been in accordance with the provisions of the implementation of medical equipment purchase inspection and sales record system.
Through this self-examination and self-correction work, more standardized and supervise our . Business behavior, in order to the company's healthy and sustainable development, to better serve the people, in the future business work we will, as always, in strict accordance with the food and drug supervision and management departments to carry out the work of deployment requirements, the quality of the good pass, to ensure that the people of the equipment safety and effective.
Pharmacy medical equipment self-inspection report 2 To protect the people of the county with drugs and medical equipment effective, I store special organization of the relevant personnel on the store drugs and medical equipment to carry out a comprehensive inspection, now the specifics of the report is as follows:First, to strengthen the responsibility to enhance the awareness of quality responsibility. The company's main goal is to provide the best quality products and services to its customers. The store has established and improved a series of drug and medical equipment related systems: drug and medical equipment substandard treatment system, medical equipment adverse event supervision and management system, medical equipment storage, maintenance, use, maintenance system, etc., to ensure that the system to ensure that the hospital clinical work of the safe and smooth operation.
Second, in order to ensure the quality of purchased drugs and medical equipment and the use of safety, to prevent the entry of unqualified drugs and medical equipment, the store specially formulated drugs and medical equipment purchase management system. The conditions for the purchase of drugs and medical equipment and the qualifications of suppliers have made strict provisions.
Third, in order to ensure that the legal and quality of medical equipment, we conscientiously implement the drug and medical equipment warehousing system to ensure the safe use of medical equipment.
Fourth, do a good job of daily storage
Fifth, in order to ensure that the quality of stored medicines and medical equipment in the library, we also organize special personnel to do a good job of daily maintenance of medicines and medical equipment.
Six, to strengthen the management of unqualified drugs and medical devices, to prevent unqualified drugs and medical devices
into the store, the store specially formulated adverse event reporting system. If there is an adverse event of medicines and medical devices, we should find out the location, time, adverse reactions or adverse events, and make a good record, and quickly reported to the county drug and medical device supervision and management bureau.
VII, the focus of my future work on drugs and medical devices, and effectively strengthen the safety of drugs and medical devices in the store, to prevent the occurrence of drug and medical device safety time, to ensure that the majority of patients with drug and medical device safety, in the future work, we intend to:
1, to further increase the publicity of the safety of drugs and medical devices, the implementation of the relevant system, to enhance the drug and medical device safety responsibility awareness of the store. Medical device safety awareness of responsibility.
2, to increase the safety of drugs and medical devices in the store daily inspection, supervision and frequency, timely investigation of drugs and medical equipment safety hazards, firmly establish the "safety first" 'awareness, customer service.
3, continue to cooperate actively with the higher authorities, consolidate the hospital drug and medical equipment safety work to achieve results, *** with the creation of a good atmosphere of drugs and medical equipment, to build a harmonious society to make greater contributions.