ISO 13485 (Quality Management System for Medical Devices Manufacturers)

ISO 13485 is based off the ISO 9001 international standard with specific requirements to meet regulatory needs. This standard, applicable on a voluntary base, was designed in particular for medical device manufacturers; ISO 13485 addresses most or all of the quality system requirements in markets including Europe, Australia, Japan and Canada. The US Food and Drug Administration does not formally recognize ISO 13485 certification, but US Good Manufacturing Practices quality system requirements overlap with the standard in many areas. ISO 13485 is also the basis for quality system regulations in other markets such as South Korea and Brazil.

The ISO 13485 standard, officially named EN ISO 13485:2003, can be used by organizations in the design, development and production process for medical devices but also related services. It can also be used by notification bodies to meet regulatory requirements. Though replicating the format of ISO 9001, ISO 13485 switches the focus from customer satisfaction and continual improvement to standardization of regulatory requirements for medical devices manufacturers. ISO 13485 can be achieved by upgrading from ISO 9001 or as a standalone certification. Learn more about upgrading to ISO 13485 from 9001.

In order to achieve ISO 13485 certification, you must develop written policies for the following functions:

  • Document and record controls
  • Internal auditing procedures
  • Controls for non-conformance
  • Corrective and preventative actions
  • Process and design controls
  • Record retention
  • Accountability and traceability

ISO 13485 benefits

Here is what medical device manufacturers can hope to gain from having an ISO 13485 certification:

  • Access to markets that recognize or require the certification including Canada and Europe.
  • Reduce operational costs by highlighting process deficiencies and improving efficiency
  • Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints
  • Proven commitment to quality through an internationally recognized standard
  • Adds transparency to the way complaints, surveillance or product recalls are handled

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