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International Standard EN ISO 13485: 2016 specifies the requirements for a medical device quality management system used by the organization for the design and development, manufacture, installation and servicing of medical devices and the design, development and provision of related services.

ISO 13485: 2016, as a specific standard of the quality system of medical instruments, completes the SR ISO 9001: 2015 standard.

Additional requirements relate to model and process control – including environmental, special processes, traceability, record keeping, and corrective actions – that are more rigorous for the medical instruments and devices industry.

The primary objective of this international standard is to facilitate the use of harmonized regulatory requirements for medical devices within the quality management system.

The advantages of implementing and certifying the ISO 13485: 2016 standard:

  • minimizing risks and controlling them,
  • performing internal processes more efficiently and in a more transparent way,
  • meeting customer requirements as well as other stakeholders (employees, suppliers, investors), optimizing the performance of the organization in order to maintain global competitiveness,
  • create a competitive advantage and attract new customers and investors to international markets,
  • reduce non-quality costs,
  • improve the overall performance and capabilities of the organization,
  • comply with the legal provisions in force.