What is ISO 13485 2016 (Quality Management Systems for Medical Devices) standard?

The new version of the Medical Devices standard: ISO 13485 2016 was published in March 2016 in response to several globally reported medical device product failures (for example, the PIP breast implant failures). ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. 

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of ISO 13485 Standard?

  1. Increase access to more markets worldwide with certification
  2. Demonstrate that you produce safer and more effective medical devices
  3. Reduce the number of  mistakes
  4. Deliver products that constantly meet customer satisfaction
  5. Obtain superior control over its processes and control over the results
  6. Save more money by continual improvement of processes and result orientation
  7. Assist in understanding of how legal obligations and industry standards influence your organization and its customers
  8. Save more money by continual improvement of processes and result orientation
  9. Improve risk management
  10. Prove business credentials by independent accreditation against a worldwide standard



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