Introduction: in the medical device business enterprise, there is a sacred and important position, that is, the quality administrator of the enterprise. The following is I bring you the medical device quality administrator how to carry out the work, I hope to help you.
In the enterprise within the quality management of medical devices has the right to rule, in the enjoyment of quality power behind, bear more responsibility. In the operation of quality management activities, every detail is closely related to this quality manager.
As a quality manager, how to work in the actual business process?
First, clear responsibilities:
In the CFDA issued the "medical device quality management standards" in the quality of the administrator should be clearly defined responsibilities:
Medical devices
1, the organization to develop a quality management system, guidance, supervision of the system's implementation, and the implementation of the quality management system for the inspection, correction and continuous improvement;
The quality management system is not only to improve the quality of the product, it is also to improve the quality of the product, but also to improve the quality of the product, so that it can be used to improve the quality of the product. Improvement;
2, is responsible for the collection of laws and regulations related to the operation of medical devices and other relevant provisions, the implementation of dynamic management;
3, supervise the relevant departments and positions in the implementation of medical equipment regulations, rules and norms;
4, is responsible for medical equipment suppliers, products, purchasers qualification audit;
5, is responsible for the unqualified medical devices Confirmation of unqualified medical devices, unqualified medical devices to supervise the process;
6, responsible for medical device quality complaints and quality incident investigation, handling and reporting;
7, the organization of verification, calibration of relevant facilities and equipment;
8, the organization of medical device adverse events. Collection and reporting;
9, responsible for the management of medical device recall;
10, the organization of the carrier entrusted with the transport conditions and quality assurance capabilities of the audit;
11, the organization or to assist in the development of quality management training;
12, and other should be carried out by the quality management body or quality management personnel to perform the duties.
Since the regulations clarify the quality of the quality manager quality responsibilities, then in the actual business process how to effectively carry out quality management?
Second, the quality management process such as operation?
1, first of all, to be familiar with the provisions of the medical device GSP and the meaning behind each article;
Especially now to ensure the implementation of the GSP, the State Board issued more and more rules "medical device business quality management on-site inspection of the amount of guiding principles," the guide (the medical device cold chain, transportation management guidelines), the correct understanding of the regulations, is the implementation of the prerequisite;
2
The GSP requirements, the establishment of a full set of quality management system, and strictly in accordance with the implementation;
Regulations, the need to establish the management system of up to 20, but also includes the corresponding work procedures, but the work procedures do not provide for the specific content of the establishment of the enterprise themselves (generally including: purchase, acceptance, storage and maintenance, warehousing, transportation, sales, after-sales service, defective products management, return, adverse events, recall).
3, regular attention to the implementation of regulations issued by the dynamic, and the existing documents to update and adjust the existing business management requirements;
In the new regulatory situation, the introduction of more and more regulations and bylaws, the requirements of business management, more specific and refined. Now the authority to approve and supervise the operation of the device is generally decentralized to the districts and counties, as the quality of the enterprise administrator should pay regular attention to the CFDA and local regulations and regulatory developments.
4, do a good job in the business process to supervise the departments and related personnel in accordance with the regulatory requirements of the operation and implementation; and regularly organize the training of all relevant personnel;
A set of good management system, such as the implementation of the implementation of everything is equal to zero, the emphasis on the implementation.
5, strictly on the first business, the first varieties of good control, save all the first cooperation enterprise approval, the first business product approval, and save the supplier's relevant documents and approval records, which is the focus of the site audit
6, regular attention to the sale of medical devices in the market use of the situation (such as: adverse events, quality incidents, if any, to be reported in a timely manner), the existence of quality problems should be promptly reported. For the existence of quality problems, the necessary measures should be taken in a timely manner, such as: product recall;
7, the establishment of the existing relevant instruments, refrigerated storage facilities, verification work, which is also the focus of the current on-site audits, including: measurement of instrument calibration (thermometers, transport refrigerators, etc.), verification of refrigerated facilities;
8, such as cooperation in the transportation unit, should be commissioned to the transportation carrier Transportation conditions and quality assurance capabilities of the audit, including: the audit of its transportation qualifications, specifically based on the introduction of the local "third-party logistics of medical devices regulations.