Questions and answers about ISO 13485

Marcela Ivankovich

What is ISO 13485?

This is the standard that establishes good manufacturing practices for companies or establishments that are dedicated to manufacturing medical devices, which are used in medical practice; These include: electromedical equipment, implants, prostheses, clinical diagnostic kits, among others.

What does this standard set?

The international standard ISO 13485 specifies the requirements that a quality management system must meet for the design, development, production, installation and service of medical devices as well as for the provision of related services. It is especially based on the structure of ISO 9001, but includes some requirements in particular for medical devices, such as risk analysis, sterile manufacturing and traceability, while excluding other requirements of ISO 9001 that are not necessary.

Who can be certified under this standard?

In general, any company or organization dedicated to manufacturing medical devices or providing related services:

  • Health products manufacturers
  • Distributors of medical devices
  • Technical assistance services for medical devices
  • Electromedicine Services
  • Clinical Engineering of the Hospital
  • Hospital Sterilization Centers

What advantages can a company that has this certification receive?

This standard is the most accepted within its area at an international level and therefore, companies or organizations that have it can see advantages such as:

  • Demonstrate that the company has the capacity to provide medical devices that meet the demands of its customers and the applicable regulatory requirements.
  • Enjoy a certified quality system with the assurance that it meets the legislative requirements of any market worldwide.
  • Establish robust development, manufacturing, distribution and control processes that increase efficiency while reducing costs.
  • This standard also helps to monitor the supply chain so that companies can always keep control of it.

What is the relationship between ISO 13485 and other standards?

ISO 13485 is partially consistent with ISO 13485: 2003 and ISO 9001: 2008. It also relates to ISO 14969: 2005, which provides guidance for the application of the requirements to quality management systems contained in ISO 13485: 2003 and with ISO 14971: 2007 that specifies a procedure by which a manufacturer can Identify hazards associated with medical devices and their accessories.

In addition, ISO 13485 has been adopted by the European Committee for Standardization and is harmonized with respect to European medical device directives 93/42 / EEC, 90/385 / EEC and 98/79 / EC.


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