The Fly in the Ointment - ISO 13485:2016


For those of you whose organization has a Quality Management System (QMS) and an Environmental Management System (EMS), the act of integrating both systems into one can prove difficult. When ISO 14001:2015 was released, a sign of relief was heard around the world when it was discovered it followed the same High Level Structure (HLS) as ISO 9001:2015. But now, companies who have both ISO 9001 and ISO 13485 are facing pressure, and the unknown, in making it all work together.

ISO 13485:2016 is Here
ISO 13485:2016, which represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices, was released in February 2016. TAKE NOTE: This recently released standard isn’t following HLS. Instead, ISO 13485:2016 is following the same eight clauses it had in the past. A theory to explain this revolves around the idea that the HLS was incompatible with their attempt to focus on regulatory requirements.

Standards Integration
So, what is the impact on organizations with registrations to both ISO 9001 and ISO 13485? First, you will need to figure out how to integrate the various requirements and formatting of standards together. This might be a significant issue, especially if documents are numbered to match the standard.

FOR EXAMPLE: In ISO 9001:2015, purchasing (called ‘Externally Provided Processes, Products and Services’) is located in clause 8.4, whereas ISO 13485:2016 has it in clause 7.4. It leaves you wondering which number you choose.

Most of the changes from ISO 13485:2003 to ISO 13485:2016 include additional requirements to keep up with increasing governmental and regulatory requirements. Just like ISO 9001:2015, ISO 13485:2016 has an increased amount of change management activities, an understandable alteration since change always increases the risk of variation being introduced into the process. This variation is the cause of nonconformity.

Expanded Risk Management
Risk management has always been a requirement of ISO 13485, but it’s expanding. Now, in both corrective actions and preventive actions, there is a requirement to verify the action does not have any adverse effects. Another example is in clause 8.2.1 ‘Feedback’ where ISO 13485:2016 adds a requirement to use feedback in the risk management process.

Overall, adapting to the updated standard will not be a major issue if you are registered to ISO 13485 alone. Transitioning will be considerably more complex if integrating both ISO 9001 and ISO 13485. The good news is the Michigan Manufacturing Technology Center can assist in achieving the transition with minimal agony. Let the experts of the Michigan Manufacturing Technology Center assist you. To speak to a Quality Solutions Expert, call 888.414.6682 or email

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Categories: environment, Quality Management