usMIMA S.L. ‘s objective is to consolidate in the markets in which it operates, offering products that fully satisfy customers’ needs, both in terms of quality of medical devices and service.
For this, the company has decided to establish a Quality Policy, which through a robust Quality Management System for Sanitary Products, provides the company with the ability to work correctly and satisfactorily, continuously improving the various processes defined in usMIMA SL. according to the activities carried out, assuming that optimal performance of these must be promoted and sought with the planning of quality objectives, optimizing the development of the functions of the company and of all the agents involved, applying an approach based on risk and the opportunities of each of the processes.
To achieve these objectives, the company’s action and strategy are based on the following principles and commitments:
· Understand and meet customer needs, requirements, and expectations.
· Guarantee excellence in the quality of execution of the manufactured products.
· Understand and comply with contractual obligations.
· Maintain an effective Quality Management System.
· Ensure compliance with applicable legal and regulatory requirements.
· Establishment of quality objectives.
· Apply the philosophy of continuous improvement.
· Apply an approach based on risks and opportunities.
The General Management assumes the responsibility of defining, implementing, and maintaining this Quality Policy. For which, it has based the QUALITY MANUAL and its Quality Management System in accordance with the requirements of:
· The standards, UNE-EN-ISO 13485, UNE-EN-ISO 14971, UNE-EN 62304, IEC 60601, ISO 10993, ISO 19011, Machinery Directive 2006/42/EC, LOPD, RoHS Directive, AEMPS/CTI-PS, EN-ISO 15223-1, EN-ISO 980, EN-ISO 1041, MEDDEV Guidelines, UL 94.
· Medical Device Regulation (EU) 2017/745.
· FDA, FY2018 MDUFA.
The effectiveness of usMIMA’s Quality Management System depends on the unconditional support of all our employees. The staff must make their concern for Quality, understanding the importance of the task they perform and that the sum of all of them makes the achievement of the objectives possible.
The Quality Director is under the direct supervision of the General Management of the Company, to be totally independent from the other departments or people involved in the production process. The access, of the Quality Director, to the managerial spheres will allow to suggest the implementation of as many procedures, reviews, or Corrective Actions as deemed necessary to comply with the Quality Management System.
The Quality Department is empowered to stop any activity that is not carried out as defined in the Quality Management System.
The General Management establishes the necessary measures to ensure the dissemination of the Quality Policy in all areas of the Company, committing itself to be understood, applied, reviewed, and updated.
The General Management defines the specific objectives of the company and the key elements to comply with what is defined in the Quality policy, awarding each department the necessary authority and responsibility, putting at its disposal the possible human, technical and economic resources for the Accomplishment of the goals.