Medical Device Quality Commitment Sample (Selected 5)
In the real world, many places will be used to the letter of commitment, the letter of commitment is signed by the signer of the true will of the heart of the expression of the taboo to engage in the form, go through the motions, taboo out of helplessness. Write a letter of commitment to be clueless? The following is I help you organize the quality of medical equipment commitment letter model (selected 5), welcome to read, I hope you can like.
Medical Device Quality Commitment 1
In order to strengthen the quality management, the user to provide safe and effective medical devices, test reagents, consumables and other used to establish a good corporate image, according to "Medical Device Supervision and Administration Regulations", "Medical Device Business License Management Measures" and other laws and regulations and relevant provisions of the industry, our company to make the following assurances:
A
Second, the packaging, labeling, labeling, instructions, etc. of medical devices, consumables and other appliances should be in line with national standards and industry standards.
Third, the first purchase of medical equipment, supplies and other appliances, should provide a complete license and authorization procedures, has been for sale for the record. And the authenticity of the information provided, the legitimacy of the legal responsibility. And timely provision of inspection reports, product registration certificate, registration form and other valid documents.
Fourth, because of the exaggerated function and efficacy of the product, product quality problems, resulting in user disputes and economic losses caused by the supply company to bear.
Fifth, responsible for the products operated by the unqualified and non-compliant products, return and exchange, in the operation of any quality problems arising from the supply company.
Six, the products supplied to provide technical guidance, market maintenance and promotion. The use of safe and effective medical devices is the people's basic rights and ardent expectations, the operation of safe and effective medical devices is the responsibility and obligation of the medical device business enterprises. In the face of fierce market competition, we y feel that law-abiding is the foundation of the enterprise, quality is the survival of the enterprise, integrity is the soul of the development of the enterprise. In order to standardize the management of the enterprise, and effectively assume the responsibility of the first responsible for the quality and safety of medical devices, to create a law-abiding, quality, integrity of the development of the environment, hereby, the enterprise solemnly to the whole society to make the following commitments:
A conscientious implementation of the national laws, rules and regulations, consciously do the study of the law, the use of the law, abide by the law, and strictly according to the law to carry out business activities, and resolutely safeguard the legitimate rights and interests of consumers. Legal rights and interests of consumers.
Second, firmly establish the concept of sincerity and respect for business, consciously accept the supervision of all sectors of society, and never provide false information, in order to operate a safe and effective, standards-compliant products to win the trust of the people.
Third, to strengthen the management of business quality, adhere to the quality first, establish and improve the quality assurance system, to ensure that the whole process of business is always under the effective control of the quality assurance system.
Fourth, strict purchasing behavior, conscientiously implement the first enterprise, the first varieties of audit system, adhere to the purchase from legitimate channels, strengthen the quality of acceptance, to eliminate unqualified medical devices into the warehouse.
Fifth, to ensure that there are qualified warehousing conditions, to strengthen the maintenance of medical equipment in the library, found that substandard products, immediately dealt with in accordance with the provisions.
VI. Standardize sales practices and strengthen after-sales management. Establish a quality traceability system, take seriously and timely processing of consumer feedback. After the listing of high-risk medical devices for tracking, once the discovery of quality problems or adverse events immediately reported and take recall measures.
vii. Strengthen the work of professional ethics education and business training, and constantly improve the overall quality of staff, and strive to provide customers with quality pre-sale, sale and after-sales service.
VIII, consciously accept the supervision of the regulatory authorities and the public. Firmly support the regulatory authorities in accordance with the law to investigate and deal with violations of the law, take the initiative to participate in the sincerity and respect to do business, *** with the promotion of the city's medical device industry `s healthy development.
The above commitment, if violated, voluntarily accept the supervision and investigation of the regulatory authorities, and is willing to assume the civil and even criminal liability.
We hereby commit ourselves.
Commitment unit: (seal)
20xx x month x day
Medical device quality commitment 3In order to conscientiously implement the "supervision and management of medical equipment regulations" and "supervision and management of medical equipment business enterprises" and other related regulations, to strengthen the enterprise is the first responsibility for the awareness of the quality of medical devices, to better fulfill the medical device business enterprise self-restraint
2, from the law to obtain valid qualifications of medical equipment manufacturers or business enterprises to purchase qualified medical equipment, take the initiative to the supplier to obtain and retain the official seal stamped with a copy of the valid qualifications.
3, the purchase of medical equipment to check the product certification, no license, incomplete license, no sales invoices of products or products of unclear origin, not purchased.
4, the purchase of medical equipment to take the initiative to obtain and retain valid bills, the establishment of a sound purchase, acceptance records.
5, the storage of products in custody, in strict accordance with the classification, zoning, batch management, adhere to the "first in, first out" principle.
6, the business premises display medical devices to implement classification management, according to a class, class II, class III classification, classification mark placement should be accurate, eye-catching.
7, to ensure that the sale of unregistered, no proof of conformity, expired, invalid or obsolete medical devices. Sales of Class II and Class III medical devices to establish a sound sales record of medical devices to ensure the traceability of medical devices.
8, seriously in accordance with the statutory conditions and requirements for medical equipment business activities, shall not remove or change the warehouse without authorization, shall not change the business address, business area.
9, the enterprise quality person in charge should be on duty. Staff in direct contact with medical devices, as required by an annual health checkup.
10, to strengthen staff training, the establishment of a sound business continuing education file.
11, not illegal to publish medical device advertising, active and conscientious monitoring of adverse events of medical devices.
Commitment unit:
Responsible person: (enterprise seal)
Year month
Medical Device Quality Commitment 4xx Provincial Food and Drug Administration:
The enterprise in the acquisition of xx Provincial Food and Drug Administration issued (including the record) the approval number of drugs, medical devices, health food advertising, in strict accordance with the following
Second, the media or other communication media (including leaflets, posters, etc.) published by the enterprise and the provincial food and drug supervision and management departments for the record are identical.
Third, the enterprise has formulated effective supervision and management measures, and has signed a guarantee with the enterprise's sales staff and any units and individuals selling the enterprise's products to ensure that the advertisements for drugs, medical devices and health food published in any media or other media in the country are in full consistency with the ones approved by the provincial food and drug supervision and management departments.
Fourth, the enterprise guarantees that it will not provide the drug, medical device, health food approval documents approved by the food and drug supervision and management department of XX province to any illegal units and individuals engaged in illegal drug, medical device, health food promotional activities.
Fifth, the enterprise's sales staff and sales of the enterprise's products of any unit or individual, published illegal drugs, medical devices, health food advertising (including distribution of leaflets, posters, etc.) and other illegal publicity by the enterprise to bear the legal responsibility.
Sixth, the enterprise guarantees to pursue illegal drugs, medical devices, health food advertising units and individuals responsible.
Seven, the above commitment, the enterprise to ensure strict compliance with the implementation of the publication (including distribution of leaflets, posters, etc.) of drugs, medical devices, health food advertising and other illegal and non-compliant behavior, the enterprise fully accept the xx provincial food and drug supervision and management department to make the withdrawal of drugs, medical devices, health food advertising approval number, within one year does not accept the approval of the product or the record, as well as to suspend the sale of drugs and other administrative decisions. The company fully accepts the decision of the Food and Drug Administration of XX Province to revoke the approval number of drugs, medical devices, health food advertising, not to accept the approval or filing of the product within one year, and to suspend the sale of drugs.
Commitment unit:
20xx x month x
Medical device quality commitment 5To ensure the quality of medical device products, to provide the public with safe and effective medical device products, as a medical device business enterprise solemn commitment is as follows:
First, the enterprise strictly implement the "Supervision and Administration of Medical Devices Regulations", "medical device business quality management standard" and other relevant laws and regulations.
First, the enterprise strictly implement the "supervision and management of medical devices regulations", "medical device business practices" and other relevant laws and regulations.
Second, the enterprise to effectively fulfill the quality and safety "the first person responsible for" the responsibility; bearing in mind the integrity of the business, the concept of quality first, commitment to the operation of medical equipment in line with national laws and regulations require qualified products, adhere to and abide by the quality and safety of medical equipment business for the loyal purpose.
Third, improve the medical device business management system, health and improve the quality of medical equipment traceability mechanism.
Fourth, in accordance with the legal conditions and requirements, legal business, not false and exaggerated publicity products.
V. Consumer feedback, and timely reporting of adverse events of medical devices to the Drug Administration.
Six, seriously accept the Food and Drug Administration inspection of enterprises, truthfully provide true and complete records of purchase and sale.
The enterprise will strictly fulfill the above commitments, if there is a violation or intention to avoid regulation, false, willing to bear the corresponding legal responsibility and all the consequences arising therefrom, and accept the supervision of the community.
The commitment to sign the date of entry into force, in duplicate. Drug Administration, the medical device business enterprises to implement a copy of each.
Commitment to the legal representative of the enterprise (signature):
Commitment to the enterprise (seal):
Month and year
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