The ISO 13485:2003 Standard relates to quality management systems in the respect of medical devices, including In Vitro diagnostic. The standard can be applied by organizations for the design, development, manufacture, installation and servicing of medical devices as well as for the design, development and provision of related services.

The current revision of ISO 13485:2003 replicates the format of ISO 9001:2008 standard and the clause numbering is aligned between these two standards, which is convenient for users. Moreover, similarly to the case with ISO 9001:2008, if Section 7 requirements cannot be fulfilled due to specific character of the organization and its products, these requirements can be deemed to be exclusions.

Technical Report ISO/TR 14969:2004 was issued as Guidance on the application of ISO 13485:2003. It contains guidance for the development, implementation and maintenance of quality management system compliance with the requirements of ISO 13485:2003.

Within the last few years ISO 13485:2003 standard has become a popular instrument used to build management system able to comply with the majority of regulatory documents in respect of medical devices, including European, Canadian (SOR 98-282 Regulations), Australian (TGA), Japanese (GMP).


  • opportunity to export many kinds of medical devices to the European Union countries;
  • high level of harmonization with other international standards, such as ISO 9001 and GMP, which simplifies the development of integrated management systems;
  • image improvement of the organization, demonstrating commitment to the requirements of international standards, best practices and products quality, and compliance with applicable statutory and regulatory requirements;
  • provision of economic stability of the organization on the existing market of medical devices manufacturers and opportunity to enter new distribution markets;
  • increase of the products’ commercial value through higher consumer confidence and therefore increase in sales;
  • products quality improvement;
  • contributes to successful participation in tenders, contests for organizations’ products delivery;

clear alignment of the organization’s business processes, efficient allocation of internal resources, personnel responsibilities and authorities within the frameworks of current management system.

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