As society continues to progress, the need to use the power of attorney more and more occasions, the power of attorney refers to the parties in order to grant the power of attorney to the proxy into a legal document. Do you know how to write a good power of attorney? The following is my collection of medical device production manager representative authorization, for reference only, welcome to read.
(hereinafter referred to as the authorizer) is hereby appointed on behalf of the company ______ for the production manager representative (hereinafter referred to as the manager representative), the term of office from ______ year ______ month ______ to ______ year ______ month ______ day. Authorized person in accordance with the "Guangdong Province, medical device production manager representative management approach (for trial implementation)" to develop this authorization.
Article 1 The manager's representative shall establish the awareness of medical device quality and responsibility, and shall put the public interest in the first place in the fulfillment of the relevant duties with the attitude of seeking truth from facts and adhering to principles, and shall take the highest guideline to ensure that the medical devices produced by this enterprise are safe and effective.
Article II of the manager's representative duties and responsibilities are as follows:
(a) the implementation of medical device quality management laws and regulations, organization and standardization of the enterprise quality management of medical device production.
(2) organization to establish, implement and maintain the enterprise quality management system for the production of medical devices.
(C) is responsible for the following quality management activities, exercise the right to decide:
1, the approval of each batch of raw materials and finished products release;
2, the approval of the quality management system documents;
3, process validation, key processes and special process parameters approval;
4, raw materials, semi-finished products and finished products quality control standards approval
5, the approval of the treatment of nonconforming products;
6, the approval of the risk management report;
7, the approval of the process validation program and process validation report.
(D) participate in the following activities that have a critical impact on product quality, exercise the right of veto:
1, key raw material suppliers. Selection;
2, the selection of key production and testing equipment;
3, production, quality, purchasing, equipment and engineering departments such as the selection of key position personnel;
4, other activities that have a critical impact on product quality.
(E) before the release of finished products, the management representative should ensure that the product meets the following requirements:
1, the batch of products have been approved for the production of medical devices or relevant production approvals, and with the "Medical Device Manufacturing License" scope of production, the scope of the assessment of the quality system of medical devices;
2, production and quality control documents are complete;
3 According to the relevant provisions of the various types (including equipment and processes, etc.) to complete the validation;
4, all the necessary checks and inspections have been carried out, the production conditions are under control, and the relevant production records are complete.
(F) in the process of medical device production quality management, the manager's representative should take the initiative to communicate and coordinate with the supervision and management of medical devices, specifically:
1, in the enterprise to accept the medical device quality system assessment or medical device quality system tracking inspection during the on-site inspection, the manager's representative should be the company's accompanying personnel to assist the inspection team to carry out the inspection; on-site inspection within 10 working days after the completion of the inspection. Within 10 working days after the inspection, supervise the enterprise to report the rectification of defective items to the local municipal Food and Drug Administration;
2, twice a year in January and July to the local municipal supervision and management of medical devices to report the implementation of the enterprise's quality system of medical devices, January at the same time to report the product's annual review of the quality of the situation of the analysis;
3, to supervise enterprises The relevant departments to fulfill the duties of monitoring and reporting of adverse events of medical devices;
4, other cases should be communicated and coordinated with the local municipal supervision and management of medical devices.
(7) other business authority:
Article 3 management representative shall be responsible for the authorizer, strictly implement the authorization matters of this authorization, according to this authorization to determine the duties and responsibilities of the authority to carry out all the work, beyond the authorization of the authority, do not have the right to deal with their own, need to be reported to the authorization of the person for approval and decision.
Article IV due to work needs, the management representative can be part of the quality management responsibilities delegated to the relevant professionals, but the management representative shall accept its delegated authority to accept the responsibility for the corresponding medical device quality management behavior, and must be retained at the same time to authorize the transfer of documents.
Article 5 of the authorizer shall provide the necessary conditions for the management representative to perform his duties, while ensuring that the management representative in the performance of his duties is not subject to the interference of internal factors.
Article 6 The authorization shall take effect from the date it is signed by the authorizer and the management representative.
Article VII of this authorization in one ______ copy, the authorizer has ______ copies for inspection, and the manager's representative has ______ copies for inspection.
Company: ______ (official seal)
Legal representative (authorized person): ______ (signature)
______ year ______ month ______ day
Manager's representative: ______ (signature)
______ year ______ month ______ day