Qaulity Policy
Qaulity Policy
Gentlefile specializes in the manufacture of dental products for the field of endodontics and has been active in the field of root canal treatments for 20 years.
Gentlefile management is committed to provide high-quality dental products that improve patient care, meet regulatory and customer requirements through an effective Quality Management System.
To achieve our goals, Gentlefile operates a Quality Management System that meets the requirements of EN ISO 13485:2016.
Gentlefile’s management strives to comply with the requirements of the EU MDR 2017/745 and the MDSAP standard
Medic is committed to the highest level of quality of its products in accordance with modern manufacturing methods and technology validated and proven consistently.
MEDIC management is committed to:
√ Fulfill customers’ needs and expectations by delivering a quality product constantly respecting the specified delivery time.
√ Produce and supply safe and high-quality products for the benefit and satisfaction of Gentlefile’s customers.
√ Comply with legal and regulatory requirements rules of all markets, and to maintain an effective quality management system, in accordance with EN ISO 13485:2016 as well as other standards as required by a manufacturer of medical devices with full responsibility to his customers.
√ keeping a positive corporate culture, through internal communication, teamwork, cooperation and mutual respect.
√ Encourage and maintain commitment to continuous improvement and communicate its quality policy to employees in all sectors of the organization.
√ Maintaining a safe and healthy work environment while constantly protecting the environment and the safety of employees.
√ Ensure compliance with environmental standards and environmental sustainability to mitigate climate changes impact and maintain environmental sustainability with compliance to applicable standards and regulatory demands.
√ Create a safe working environment and provide necessary training and tools for all employees so as to enable them to function in an efficient manner.
√ Supply the necessary resources for training the employees in all organization departments, so as to maintain high skills and competence of the human resources.
√ Gentlefile is committed to continuous improvement of production processes and product quality in order to provide a reliable product that meets the customer’s requirements and expectations, by setting clear and measurable performance goals and methods for evaluation and improvement.
