The international Quality Management Systems for the design and manufacture of medical devices can help your company stand out. Find out more!
ISO 13485:2012 or ISO 13485:2016 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.
Helps You With
quality control, risk management, legal compliance, traceability and recall, process improvement, product improvement, operational efficiency.
Please note: You can still apply for either 2012 or 2016 versions of ISO 13485. Certificates issued for 2012 version will have validity up to the end of the transition period (March 2019). Learn more about the changes to ISO 13485 here.