1. The shareholders' general meeting exercises the following powers and functions:
(1) to decide on the company's business policy and investment plan;
(2) to elect and replace the directors, and to decide on matters relating to the remuneration of the directors;
(3) to elect and replace the supervisors, who shall be the representatives of the shareholders, and to decide on matters relating to the remuneration of the supervisors; (4) to To consider and approve the report of the Board of Directors;
(v) To consider and approve the report of the Board of Supervisors;
(vi) To consider and approve the Company's annual financial budget and final accounts;
(vii) To consider and approve the Company's plan for distribution of profits and the making up of losses;
(viii) To make a resolution on the Company's increase or reduction of registered capital;
(i) To make a resolution on the issuance of corporate bonds;
(ii) To decide on matters relating to the remuneration of directors; and (ix) to make resolutions on the issuance of corporate bonds;
(x) to make resolutions on the merger, demerger, dissolution and liquidation of the Company;
(xi) to amend the Articles of Association of the Company;
(xii) to make resolutions on the employment and dismissal of accounting firms;
(xiii) to consider other matters to be decided by the shareholders' general meeting as stipulated by the laws, regulations and the Articles of Association of the Company;
(xiii) to consider other matters to be decided by the shareholders' general meeting. other matters.
The Board of Directors exercises the following powers and functions:
(1) to convene the general meeting of shareholders and report to the general meeting on its work;
(2) to execute the resolutions of the general meeting of shareholders;
(3) to decide on the Company's business plans and investment programs;
(4) to formulate the Company's annual financial budget plan and final account plan;
(5) to To formulate the Company's profit distribution plan and plan for making up losses;
(vi) To formulate the Company's plan for increasing or decreasing its registered capital, issuing bonds or other securities, and listing; (vii) To formulate the Company's plan for major acquisitions, repurchase of the Company's shares, or merger, demerger, and dissolution; (viii) To decide on the setting up of the Company's internal management organization;
(ix) To appoint or dismiss the General Manager of the Company, Secretary of the Board of Directors; appointing or dismissing the deputy general manager, financial controller and other senior management personnel of the Company upon the nomination of the general manager, and deciding on their remuneration, rewards and punishments;
(x) formulating the basic management system of the Company;
(xi) administering the disclosure of information of the Company;
(xii) any other powers and functions as stipulated in the Articles of Association or conferred by the shareholders' general meeting.
The Supervisory Committee exercises the following powers and functions:
(i) to inspect the Company's finances;
(ii) to supervise the acts of the directors, general manager and other senior executives which are in violation of the laws, regulations or the Articles of Association in the performance of their duties for the Company;
(iii) to require the directors, general manager and other senior executives to rectify the acts when such acts are detrimental to the interests of the Company and to report to the shareholders' meeting or to the shareholders' meeting when necessary. (c) to request the directors, general manager and other senior management to rectify their acts when such acts are detrimental to the interests of the Company, and to report to the shareholders' general meeting or the relevant state competent authorities when necessary;
(d) to propose the convening of an extraordinary shareholders' general meeting;
(e) to attend the meetings of the Board of Directors;
(f) to exercise any other powers and functions as stipulated in the Articles of Association of the Company or as conferred by the general meeting of the Company.
2. Medical Device Quality Management Documents
Medical Device Procurement System
1. Purpose
To ensure that the purchased medical devices comply with the "Regulations for the Supervision and Administration of Medical Devices" and related laws and regulations
2. Scope
Applicable to the procurement of medical device products, and to select qualified suppliers.
3. Qualified supplier selection process
3. 1 supplier should have a "business license", the second to have a "medical device manufacturer license" or "medical device business license". The supplier to provide a copy of the "industrial and commercial business license", "medical device manufacturer's license" or "medical device business enterprise license" copy, should be stamped with the corporate seal.
3.2 Referring to the Catalogue of Medical Device Classification, review whether the product scope of the license includes the products to be purchased.
3.3 License expired, beyond the product range, shall not be purchased. There is no annual inspection record or the annual inspection has a bad record should find out why, otherwise, shall not be purchased. (Note: Beijing has canceled the annual inspection of business enterprises)
3.4 The supplier shall provide a copy of the "Medical Device Product Registration Certificate" and its annex "Medical Device Manufacturing Approval Form", and should be stamped with the seal of the enterprise.
3.5 Medical device products whose product registration certificates have expired or are beyond the approved scope of the "Manufacturing Approval Form" shall not be purchased.
3.6 Medical device packaging or packaging should have a certificate of conformity. No proof of conformity, shall not be purchased.
3.7 For the first time for the variety of business, quality audits should be carried out, including obtaining product technical standards, quality standards, if necessary, can be assessed at the site of the supplier, the signing of the quality assurance agreement and so on.
3.8 All of the above information should be established files and archives.
4, in order to facilitate the search, the establishment of qualified suppliers catalog.
Medical device product purchase and acceptance system
1 Purpose
To ensure that the medical devices used in the hospital comply with the "Regulations for the Supervision and Administration of Medical Devices" and related regulations, and to prevent the use of unqualified medical devices.
2 Scope
Applicable to the acceptance process of medical devices after purchase.
3 Acceptance process
3.1 Newly purchased medical devices from the purchasing department should be placed in the pending inspection area of the finished medical device warehouse. (Or use the form of hanging signs)
3.2 Key inspection items:
(1) Whether the outer packaging is intact.
(2) against the product registration certificate, check whether the product registration certificate number on the product packaging is correct, whether the production date is within the validity of the registration certificate. Incorrect number, beyond the validity of the registration certificate of the production of the product is treated as substandard.
(3) against the medical device manufacturing approval form, check whether the product specifications are consistent with the medical device manufacturing approval form, the product specification describes the performance of the product and the scope of application of the product is consistent with the description of the manufacturing approval form, whether to exaggerate the efficacy of the contraindications and concealment.
(4) If the product has a period of use, it is also necessary to check whether the product exceeds the limited period. Expired products are treated as substandard.
(5) shopping invoice check: shopping invoice describes the product name, model specifications, date of production (production batch number or product number) should be consistent with the actual product labeling. Inconsistency between the actual product and the shopping invoice should be returned.
3.3 Product quality acceptance is complete, the inspector should sign the acceptance conclusion and to be recorded. Each inspection record should be complete and standardized.
3.4 The inspector according to the test results to notify the warehouse administrator will be qualified products placed in the qualified area, unqualified products into the unqualified area, and notify the Purchasing Department for return procedures.
Medical equipment warehousing and storage management system
1, purpose: safe storage, reduce loss, scientific conservation, quality assurance, rapid receipt and delivery, to avoid accidents.
2, based on: "supervision and management of medical devices regulations.
3, the scope of application: medical devices in the warehouse management.
4, Responsibility: warehouse custodian is responsible for the implementation of this system.
5, the content of the system:
5.1, according to the different natural properties of medical devices are categorized for scientific storage.
5.2, do a good job in the warehouse temperature, humidity records, keep the warehouse environment clean and sanitary.
5.3, in handling and stacking and other operations should be strictly in accordance with the requirements of the goods packaging illustrated signs handling and storage, not inverted, to be gently put.
5.4, medical equipment according to the inspection area, qualified products area, non-qualified products area, return area and delivery area and other zones. Each area has a clear color code, which is to be inspected, the return area for yellow, shipping area, qualified products area for green, non-conforming products area for red.
5.5, the goods should not be stacked too high, to avoid the bottom layer of the load-bearing too large, the product shape, every six months to turn the stack of stacks.
5.6, the custodian of goods do not match the single, abnormal quality, packaging is not solid or broken, etc., the right to refuse to accept and report to the quality management department.
5.7, the establishment of accounts and cards, so that the number of accurate, clear accounts, accounts, goods, cards, etc., at the end of each month to do a good inventory.
Medical equipment out of the warehouse review management system
1, purpose: to strengthen the review of medical equipment out of the warehouse management, to ensure the safety and effectiveness of medical equipment sales.
2, based on: "supervision and management of medical devices regulations.
3, the scope of application: the management of medical devices out of storage review.
4, Responsibility: the reviewer is responsible for the implementation of this system.
5, the system content:
5.1, medical devices should follow the "first produced first out", "recent first out", "first in first out" and shipment by lot number. Principle.
5.2, medical equipment must be reviewed and quality checks, according to the warehouse receipt delivery or distribution vouchers to check the physical and quantity, item by item checking should be signed on the voucher before delivery.
5.3, the shipment should pay attention to check whether the outer packaging is firm and complete, such as found in the box is broken, fluid spillage and other phenomena, should be replaced in a timely manner to make up for the full; found that the packaging materials due to moisture, breakage, or scattered, it should be replaced or reinforced packaging before shipment.
5.4, medical devices out of the warehouse review, in order to facilitate the quality of tracking should be a good review record, save to the expiration date of the medical device a year later, but not less than two years.
5.5, medical equipment out of the warehouse delivery should pay attention to both accurate and timely.
Quality Tracking and Adverse Reaction Reporting Management System
1, Purpose: In order to promote the rational use of medical devices, improve the quality of medical devices and the utility level of medical devices, this system is hereby formulated.
2, based on: "Medical Device Supervision and Administration Regulations".
3, the scope of application: applicable to all medical devices quality tracking and management of adverse reaction reports.
4, Responsibility: all staff are responsible for the implementation of this system, the quality manager is responsible for supervision and management.
5, the content of the system:
5.1, the collection of information about manufacturers and medical device quality standards, and often keep in touch with manufacturers, attention to the changes in the quality of medical device production organized and archived.
5.2, the establishment of customers and medical device quality files, the company's quality management personnel should often keep in touch with customers, regular visits to the record, and organize and archive.
5.3, received from the customer to reflect the quality problems, we must attach great importance to, and immediately sent to the customer to understand the situation, analyze the causes of the problem, if it is due to improper use of the cause, to point out on the spot where the error, if it is the quality of the goods itself, it must be given in accordance with the actual situation to deal with.
5.4, the quality manager is responsible for the company's operation of medical devices adverse reactions to the report and organization of management.
5.5, each post should pay attention to collect the feedback of adverse reactions of medical devices sold from the company, once found, should be reported to the quality manager.
5.6, the quality administrator of the collection of feedback on the adverse reactions of medical devices, should be recorded in detail, investigation, verification, summarization, and timely report to the local Food and Drug Administration.
5.7, the collection of medical device adverse reaction information, should be the same day feedback to the quality manager, in order to verify the report.
5.8, of which serious, rare new adverse reactions to medical devices, must be used in an effective way to quickly report, the latest not more than 15 working days to report to the provincial Food and Drug Administration.
3. Guarantee statement is the manufacturer's license to be right... You do not want to operate the enterprise