Guide
ISO 13485 in 2026: what's changing and what isn't
The biggest ISO 13485 change for many manufacturers in 2026 is not a new edition of the standard — it is that the FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, incorporates ISO 13485:2016 by reference. At the same time, work on revising the standard itself is under way.
Where things stand
Four facts to plan around
ISO 13485:2016 is still the current edition
Certificates, MDSAP audits and the FDA QMSR all reference the 2016 edition. Plan against it until a new edition is formally published.
The QMSR is in force
US manufacturers are now inspected against ISO 13485:2016 plus FDA-specific requirements, replacing most of the old Part 820 text.
A revision is being developed
ISO's technical committee for medical device quality management is working on a revision. Content and dates are not final — treat drafts as direction, not requirements.
Transitions come with a period
When ISO publishes a new edition, certification bodies and regulators normally set a transition period. There is no need to rewrite your QMS against a draft.
What to do now
Actions that pay off either way
- 1Map procedures and records to ISO 13485:2016 clauses — the QMSR requires it and it makes any future revision easier.
- 2Strengthen risk-based thinking across supplier control, validation, complaints and change control.
- 3Keep document, training and CAPA records clause-traceable and consistently named.
- 4Watch ISO and your certification body for the published edition and its transition timeline.
Where Qevatrix fits
A clause-aware QMS
QualityOS models document control, CAPA, complaints, suppliers, training and audits against ISO 13485, with Part 11 e-signatures and an append-only audit trail, so re-baselining is mapping work rather than a migration.
More guides
See all guidesQualityOS
FDA QMSR transition guide
What changes as 21 CFR Part 820 aligns with ISO 13485:2016, and how to prepare your quality system.
QualityOS
Medical device quality management system
The processes a device QMS needs, how they connect, and a practical order to build them in.
QualityOS
Design controls
User needs, inputs, outputs, verification, validation and the design history file, in plain terms.
This guide is an orientation, not regulatory advice. Confirm the status of any ISO 13485 revision with ISO or your certification body, and QMSR requirements with the FDA's published rule.