It includes a commitment to comply with the legislation applicable to ORTHOAPNEA’s products and services, to comply with the requirements of the UNE-EN ISO 13485: 2016 and regulatory standards and to maintain the effectiveness of the QMS.
Provides a framework for establishing and reviewing quality objectives.
It is communicated and understood within the organization.
It is reviewed for its continued suitability.
ORTHOAPNEA, trusts that the development of the Quality Management System and its use in an appropriate way will translate into a valuable tool for the achievement of business objectives, since as its premises it must serve to increase our effectiveness, our efficiency and thus improve continuously, increasing in the same way the degree of satisfaction of our clients.
For this reason, this Quality Policy will be linked to the evolution of our activities and the exercise of our functions, assuming that their optimal performance must be promoted and ensured thanks to the planning of quality objectives and the execution of actions. programmed to achieve this, from these lines I undertake to provide the resources provided for them and to monitor the progress of said plans, which will be communicated annually together with this QUALITY POLICY, so that the entire organization is aware of the themselves and collaborate to the best of your ability and responsibilities.
The OrthoApnea company designs, markets and distributes the ORTHOAPNEA KIT, which contains the essential elements for the fabrication of the final device by the prosthetist. These elements that are part of the KIT ORTHOAPNEA product are Class I medical devices. These plans will be reviewed by management in the annual review that management will carry out on the effectiveness of the system and the degree of customer satisfaction.
Date: February 16, 2015
Signed: OrthoApnea address