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.
The ISO 13485: 2016 standard, as a specific standard of the medical instrument quality system, 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 to 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.
Advantages of implementing and certifying ISO 13485: 2016:
- risk minimization and control;
- streamlining internal processes more efficiently and in a more transparent way;
- meeting the requirements of customers, as well as other stakeholders (employees, suppliers, investors);
- optimizing the organization’s performance to maintain global competitiveness;
- creating a competitive advantage and attracting new customers and investors to international markets;
- reducing non-quality costs;
- improving the overall performance and capabilities of the organization;
- compliance with the legal provisions in force.