ISO 13485 is an ISO standard, published in 2003, which represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It is the quality management standard specifically designed for organizations that provide medical devices or related services to ensure that customer requirements and regulations are consistently met.

This standard incorporates additional requirements to comply with the legal requirements of the sector, in aspects such as: design, control of records, critical processes, traceability, sterilization processes, or risk management.

The certification according to this standard is applicable to all organizations of any sector that intervene during the life of a medical device in the design, manufacture, packaging, packaging, drafting and / or translation of manuals. 


ISO 13485 promotes harmonization with regulatory requirements for medical device manufacturers on an international scale and incorporates many of the principles of quality management and provides the benefits of an ISO 9001 quality management system, which include: 

  • It increases the Organization's reputation towards clients and authorities.

  • Positive impact on the quality of processes and products.

  • It is an advantage compared to competitors in new markets, both domestic and international.

  • Assurance of control and compliance with applicable legal and regulatory requirements.

  • It establishes a regulatory framework conducive to guarantee the quality of health products.

  • Helps to minimize and manage risks of the organization throughout the realization of the product or service delivery.

  • Reduced operational costs, through continuous process improvement and resulting operational efficiency.

  • Improved risk management, through greater consistency and traceability of products and the use of risk management techniques.