ISO 13485 2016 Handbook Published

ISO has published the handbook for ISO 13485:2016. The new document’s title is ISO 13485:2016 – Medical devices – A practical guide.

According to a description on the ISO website,, the handbook is mapped to the structure of ISO 13485:2016 and offers step-by-step guidance for medical device organizations to implement and maintain this quality management system. The handbook can also serve as reference for auditors, regulatory agencies, and certification bodies.

The handbook is available for purchase from the ISO webstore in PDF format for CHF 88.