ISO 13485:2016 Quality Management Systems for Medical Devices

The ISO 13485:2016 standard has been published.

The world’s most recognized quality management system standard for the medical device industry has been revised for the first time since 2003.

The standard provides manufacturers, designers, and suppliers to the medical device industry with an updated framework necessary to demonstrate compliance to regulatory requirements, mitigate risks, and ensure best practices are taken for quality, safety, and sustainability. 

Some key changes to the ISO 13485 standard include:

  • Expanded requirements for risk management and process based decision making
  • Increased attention on processes through the supply chain
  • Explicit requirements for software validation
  • Increased alignment of global regulatory requirements

ISO 13485:2016 focuses on what the manufacturer does to deliver safe and effective medical devices. The revision places more emphasis on risk-based thinking and decision-making while also offering stronger intra-operability between the clauses and requirements. Well-known medical quality management programs like the Medical Device Single Audit Program (MDSAP) and the Canadian Medical Devices Conformity Assessment System (CMDCAS) recognize and use ISO 13485:2016 as a framework. 

ISO 13485:2016 was published February 25, 2016. Current ISO 13485:2003 clients will have three years to transition to the new standard. To prepare for the February 28, 2019 transition deadline, Intertek will be hosting a number of information sessions, webinars, and Intertek Academy training courses to help you and your organization prepare for the change.


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