Made (Revised) by: Made (Revised) Date:
Reviewed by: Approved by:
Approval Date: Execution Date:
1, Purpose: To stipulate the responsibilities and authority of the various functional positions and personnel within the company in order to promote effective quality management.
2, based on: "Medical Device Supervision and Administration Regulations".
3, the scope of application: applicable to the company's quality management positions and personnel.
4, responsibilities:
4.1, quality manager job responsibilities
4.1.1, implementation of laws, rules and regulations relating to the quality management of medical devices, implementation of the quality management system of the enterprise.
4.1.2, the management of all aspects of quality management and supervision and implementation.
4.1.3, supervise the acceptors, caretakers, custodians to implement quality standards and various management systems.
4.1.4, to carry out research on the quality of medical devices, reflect and put forward rationalization suggestions to the person in charge of the enterprise in a timely manner.
4.1.5, supervise the control process of unqualified medical devices.
4.1.6, collect the quality standard of the medical devices operated, and establish the quality file of the main varieties.
4.1.7, carry out education and training on quality awareness and quality work.
4.1.8, is responsible for dealing with the quality of medical devices, consulting, inquiries and quality accidents, quality complaints investigation, processing, reporting, timely grasp of quality information.
4.2, the acceptance of the job responsibilities of the inspector
4.2.1, is responsible for the legal standards and contractual quality terms and acceptance of the system for the purchase of medical devices and the sale of returned medical devices batch by batch acceptance.
4.2.2, in accordance with the provisions of the sampling method and the number of samples, acceptance inspection methods and judgment standards for inspection and acceptance, focusing on checking the appearance of quality and packaging quality.
4.2.3, the acceptance of the completion of the acceptance, the correct acceptance of the conclusion, immediately make a good record of the relevant signatures and responsible, clear handover procedures.
4.2.4, can not judge the quality of medical devices and quality changes found in the acceptance should be immediately reported to the quality manager to make a ruling.
4.3, custodian duties
4.3.1, in accordance with the storage conditions of medical devices are categorized and stored.
4.3.2, in accordance with the principle of safety, convenience, compliance with the provisions of the neat, standardized, firm in stacking medical equipment. Reasonable use of warehouse capacity, classification norms, color coding obvious and accurate.
4.3.3, the establishment of the custody of the account card, the correct record of medical equipment in, out, inventory dynamics, to ensure that the account, the account card, the account of goods in line. Adhere to the dynamic review, day and month, and timely analysis, feedback medical equipment inventory and marketability.
4.3.4, do a good job in the near expiration date of the management of medical equipment, in strict accordance with the "first production first, the recent first out, according to the batch number of shipments," the principle of the warehouse.
4.3.5, do a good job in the warehouse temperature and humidity control records, as well as anti-rodent, pest control, mold, fire safety.
4.4, out of the warehouse reviewer duties
4.4.1, in accordance with the warehouse vouchers batch by batch to check the physical, and check; to ensure that out of the warehouse of medical equipment goods in line with the list, the number of accurate, quality-qualified.
4.4.2, the shipment should pay attention to check whether the outer packaging is firm and reliable and complete, such as found in the box is broken, fluid spillage and other phenomena, should be detected in a timely manner, replacement and replenishment; found that the packaging materials due to moisture, breakage or scattered, it should be replaced or reinforced packaging before shipment.
4.4.3, the discrepancies found in the review should be re-reviewed and confirmed.
4.4.4, make a good review of the record, so that the handwriting is clear, complete, accurate and responsible for the contents of the signature.