Organization chart:
Department setting description:?
First of all, the manager's function
Lead and mobilize all employees to conscientiously implement the Regulations on Supervision and Administration of Medical Devices and other national laws, regulations and rules on medical devices, and carry out business management under the guidance of the idea of "legal operation and quality-oriented". Take overall leadership responsibility for the quality of medical devices operated by enterprises. Set up and lead the quality organization reasonably, ensure that it can perform its functions independently and objectively, give full play to its quality control function, support its reasonable opinions and requirements, and provide and guarantee the necessary funds for its quality activities. ?
Second, the quality management function?
1, responsible for establishing the quality management system. Implement the quality veto power, guide the quality activities of various departments, formulate the quality system, and ensure the implementation of first-class variety approval and first-class enterprise quality training. To implement the national laws, regulations, rules and other relevant policies on the supervision and management of medical devices, and be responsible for the total quality management of enterprises to ensure the quality of medical devices. ?
2. Traceability of product quality, reporting of adverse events and timely reporting to the National Adverse Reaction Testing Center according to the level of adverse events.
3, responsible for the investigation and report of medical device quality accidents or quality complaints. ?
4. Responsible for product recall. ?
5, responsible for the implementation of medical device quality acceptance system.
Inspector's function:?
Strictly implement the quality acceptance system of medical devices. ?
1. The acceptance personnel shall accept the goods batch by batch with the arrival notice or peers. ?
2. For medical devices that do not meet the acceptance content, relevant legal standards and quality terms or other suspected abnormal quality, fill in the rejection report and notify the quality control department for handling. ?
3. At the time of acceptance, the packages, labels, instructions and related documents of medical devices shall be inspected one by one, and the whole package shall have the product certificate. ?
4, acceptance of the first camp varieties, should check the first batch of medical devices with the batch number of medical devices factory inspection certificate. ?
5. When accepting imported medical devices, check whether the label of the package has the name, main components and import registration number of the medical device indicated in Chinese, and check the Chinese manual and relevant legal certificates.
Ming dang ?
6. Fill in the relevant statements and acceptance records in time, and sign them for future reference as required. ?
Three. Functions of purchasing department
1. Check and supervise the work of the purchasing department, insist that the purchased medical devices must be purchased from suppliers with legal qualifications, and collect the certification materials of suppliers' legal licenses and other qualifications. It is strictly forbidden to purchase from private and incomplete units, and establish supplier files. ?
2. Supervise and inspect the quality assurance agreement signed by this department, cooperate with the quality management department to do a good job in auditing the first camp enterprises and the first camp varieties, and check and collect relevant information. The manager can only approve it after it is approved by the Quality Control Department. ?
Buyer's responsibilities:?
1、? Collect supplier and market information, establish and improve supplier files; ?
2. Be responsible for the preliminary investigation and screening of suppliers, the performance assessment and evaluation of suppliers, and carefully examine the legal qualifications of suppliers; ?
3. Assist the quality department to complete the supplier audit of the first camp variety and the first camp enterprise, ask the supplier for the inspection report of the first camp variety, and cooperate with the quality department to conduct on-site evaluation when necessary; ?
4. Be responsible for drafting the purchase contract and submitting it for approval. The contract must stipulate the necessary quality clauses and require quality standards; ?
5. Insist that medical devices must be purchased from suppliers with legal qualifications, and collect the supplier's legal license and other qualification certification materials. It is strictly forbidden to purchase from private and incomplete units and establish supplier files; ?
6. Input the purchase record (contract) into the microcomputer system, ask for legal bills, and check with the microcomputer after arrival to ensure the consistency of the three;
Fourth, the function of the sales department?
1. Organize to study and implement the Regulations on the Supervision and Administration of Medical Devices and other relevant regulations, and standardize the work behavior of salespeople. ?
2, sales of medical devices should be issued by legal bills, so that tickets, accounts, goods. Sales bills shall be kept in accordance with regulations, and sales records of medical devices shall be established, recording the sales date, product name, specifications, batch number, expiration date, production unit, procurement unit, unit price and quantity of medical devices. Sales records shall be kept until two years after the expiration of the validity period. ?
Verb (abbreviation for verb) What is the function of after-sales service department?
1. After the products are sold, the business department shall regularly conduct quality tracking and after-sales service. Keep abreast of users' use of goods. ?
2. Take seriously the problems in the process of product use, solve them in time and make detailed records. For product quality problems, we should actively contact suppliers or manufacturers and repair or replace them within the specified time. ?
3. Goods damaged due to improper use by users shall be properly handled according to relevant regulations of the enterprise. ?
4. Sales personnel should record the after-sales service process of products in detail, establish after-sales service files and keep them properly according to regulations.