ISO 13485:2016

What is the ISO 13485 Standard?

ISO 13485 is an international standard that specifies requirements for regulatory purposes for medical device manufacturers. It provides a framework for companies to meet their customer and regulatory requirements. It is becoming widely accepted as the international standard to address medical device requirements around the world. While it remains a standalone document, ISO 13485 is generally harmonized with ISO 9001.

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 requirements and regulatory requirements applicable to medical devices and related services.

It includes some particular requirements for medical devices with emphasis on:

  • The promotion and awareness of regulatory requirements as a management responsibility.
  • Controls in the work environment to ensure product safety.
  • Focus on risk management activities and design transfer activities during product development.
  • Specific requirements for inspection and traceability for implantable devices
  • Specific requirements for documentation and validation of processes for sterile medical devices.
  • Specific requirements for verification of the effectiveness of corrective and preventive actions.

Key Benefits

  • Minimise mistakes
  • Cost reduction
  • Increased customer satisfaction
  • Sales and marketing advantages
  • Continuous improvement
  • Greater control over processes and internal systems
  • Access new markets and clients
  • Industry best practise
  • Happier staff and contractors
  • Demonstrates your commitment to quality