Medical device company organization and departmental setup description:
Organization chart:
Departmental setup description:?
A manager function
Lead and mobilize all staff to conscientiously implement the "supervision and management of medical devices regulations" and other relevant state medical equipment laws, rules and regulations, in the "legal business, quality-oriented" idea under the guidance of business management. The quality of medical devices operated by the enterprise is responsible for the overall leadership. Reasonably set up and lead the quality organization, to ensure its independent and objective exercise of authority to give full play to its quality control functions, to support its reasonable views and requirements, to provide and ensure that the necessary funds for quality activities.
Two, quality management department functions?
1, responsible for the establishment of a quality management system. Implementation of the quality veto, guiding the quality activities of various departments to prepare quality system, and ensure the implementation of the approval of the first enterprise first varieties, quality training. Implementation of national laws, rules and regulations on the supervision and management of medical devices and other relevant policies, responsible for the overall quality management of the enterprise, to ensure the quality of medical devices.?
2, business product quality traceability, adverse event reporting, according to the level of adverse events reported in a timely manner to the National Adverse Reaction Testing Center.
3, responsible for medical device quality incident or quality complaint investigation and processing and reporting.?
4, responsible for product recall.
5, responsible for the implementation of medical device quality acceptance system.
Acceptance inspector function:?
Strictly implement the medical device quality acceptance system.?
1, acceptance inspection personnel with the arrival notice or with the shipment of the same batch by batch acceptance.?
2, the acceptance does not meet the acceptance of the content, does not meet the relevant legal standards and quality terms or other suspected quality abnormalities of medical devices, fill in the refusal to accept the report form, and notify the quality control department to deal with.?
3, acceptance should be the medical device packaging, labeling, instructions and related requirements of the supporting documents checked one by one, the whole package should be product certification.
4, acceptance of the first camp varieties, should check the first batch of arriving medical devices with the same batch number of medical devices factory inspection certificate.?
5, acceptance of imported medical devices, should check the label of the package whether the name of the medical device in Chinese, the main ingredients and the import registration number, check the Chinese instructions and legitimate related certificates
Minute documents.
6, fill out the relevant statements and acceptance records in a timely manner, and sign the responsibility, according to the provisions of the preservation for inspection.
Third, the Procurement Department functions
1, check and supervise the work of the procurement department, adhere to the procurement of medical equipment must be purchased from the supplier with legal qualifications, and the collection of supply units of the legal license and other qualifications of the material, is strictly prohibited from the private sector and incomplete licensing units, the establishment of the supply unit file.
2, supervise and inspect the department signed a quality assurance agreement, with the quality management department to do a good job of the first enterprise, the first varieties of audit, and inspection and collection of relevant information, by the quality management department qualified for the manager's approval before the purchase of goods.
Purchaser duties:?
1,? Collect supplier and market information data, establish and improve the supplier file;?
2, is responsible for the supplier's pre-inspection, screening, supplier performance assessment, evaluation, careful review of the supply unit's statutory qualifications;?
3,, to assist the Quality Department to complete the first varieties and the first enterprise supplier audit, the first varieties of inspection reports to the supplier, if necessary, with the Quality Department for its on-site assessment;?
4, responsible for the drafting of the procurement contract, and submitted for review and approval, the contract must specify the necessary quality terms and conditions, and ask for quality standards;?
5, adhere to the procurement of medical devices must be purchased from the supply unit with legal qualifications, and collect the legal license of the supply unit and other qualifications of the supporting materials, is strictly prohibited from private and incomplete license units, the establishment of the supply unit file;?
6, responsible for purchasing records (contracts) entered into the microcomputer system, to obtain legal bills, after the arrival of the microcomputer check, to achieve the three in line;
Four, the Sales Department functions?
1, organization and study the implementation of the "supervision and management of medical devices regulations" and other relevant regulations, standardize the salesman's work behavior.
2, the sale of medical devices should be issued legal bills, tickets, accounts, goods in line. Sales invoices should be kept in accordance with the provisions of the establishment of medical device sales records, medical equipment sales date, name, specifications, batch number, expiration date, production unit, purchasing unit, unit price, quantity and other items. Sales records should be kept until two years after the expiration of the validity period.
V. After-sales service department functions?
1, after the product is sold, the business sector should be regular quality tracking and after-sales service. Timely grasp of the user on the use of goods.
2, the user in the use of products in the process of the problem should be treated seriously and timely solution and detailed records. Product quality problems to actively contact with the supply unit or manufacturer, within the specified time to repair or replacement.
3, due to the user improper use of goods caused by damage, should be properly handled in accordance with the relevant provisions of the enterprise.
4, the sales staff of the product after-sales service process should be a detailed record, and the establishment of after-sales service files, according to the provisions of the proper preservation.