Quality Policy
At Nanodecaldx, S.L., we are committed to establishing ourselves as a benchmark for excellence in the in vitro diagnostic industry, with a focus on respiratory diseases. Our innovative solutions offer new methods for analyzing respiratory samples with user-friendly devices that can be easily integrated into any healthcare setting. Our technology provides accurate and timely information, enabling healthcare professionals to make informed decisions for the treatment of respiratory conditions more effectively.
This commitment will be achieved through:
- Implementing, maintaining, and continuously improving the effectiveness of the Quality Management System according to EN ISO 13485:2016 and applicable legal and regulatory requirements.
- Managing the operations effectively by setting clear quality objectives and defining responsibilities for their fulfillment.
- Advancing patient care through providing accurate diagnostic devices and customer support, with an emphasis on the continuous enhancement of customer satisfaction.
- Embracing new technologies and committing to the continuous education of employees.
- Ensuring patient safety through rigorous risk management and compliance with the in vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, as well as assuring the quality of its devices.
- Determining criteria and methods to ensure effective operation and control of processes and implementing actions as necessary to achieve planned results.
- Ensuring the availability of resources and information necessary to support and monitor all company processes.
- Managing devices to maintain the highest standards of safety.
- Carefully selecting suppliers and subcontractors to ensure quality.
- Ensuring that any outsourced processes affecting product conformity meet required standards.
- Commitment to enhance the quality of its devices to exceed customer expectations.
- Commitment to quality in every aspect of business processes.
- Making continuous improvement a part of every day and every job, through ongoing monitoring, measurement, and analysis.
- Ensuring that the quality policy and procedures accurately reflect the operations and reality of the company.
- Promoting an understanding among all staff of how their roles contribute to the overall workflow and quality at Nanodecaldx S.L.