Quality Policy

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FASTinov, S.A is comitted to improving healthcare by providing high quality, safe and effective in vitro diagnostic medical devices (IVD), with a specialization in antimicrobial susceptibility testing devices. The organization strives to consistently meet and exceed the expectations of its clients.

This commitment will be achieved through:

  • Managing the organization processes by setting clear quality objectives and defining responsibilities for their fulfillment.
  • Establishing, applying, maintaining, and continually imroving the effectiveness of the Quality Management System according to EN ISO 13485:2016 and applicable legal or regulatory requirements at local and European levels.
  • Determining criteria and methods to ensure effective operation and control of processes and implementing actions as necessary to achieve planned results.
  • 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 devices.
  • Embracing new technologies and commiting to the continuous education and development of employees.
  • Managing IVD devices to uphold the highest standards of safety.
  • Carefully selecting suppliers and subcontractors to ensure quality.
  • Ensuring that any outsourced processes affecting product conformity meet required standards.
  • Enhancing the quality of IVDs, and update them according the needs, to exceed customer expectations and satisfaction.
  • Commitment to quality in every aspect of business processes.
  • Ensuring the availability of resources and information necessary to support and monitor all company processes.
  • Making continuous improvements to processes and products through ongoing monitoring, measurement, and analysis.
  • Ensuring that the quality policy and procedures accurately reflect the company's operations and reality.
  • Promoting an understanding among all staff of how their roles contribute to the overall workflow and quality at FASTinov, S.A.