ISO 13485:2016 Confirmed – No Revision for Now!
ISO 13485:2016 has officially been confirmed for another five years, meaning it will remain unchanged until the next systematic review.
The current focus now shifts to the revision of the ISO 13485 Handbook, which will be published as ISO/TS 23485.
🔗 Sources & further reading:
📄 ISO 13485 Status: https://lnkd.in/drSUb8vG
📘 ISO/TS 23845: https://lnkd.in/d_J8XtTC
📚 ISO document types explained: https://lnkd.in/dbM-QSDV