Applicability
Quality management systems for organizations involved in medical-device lifecycle activities and related services.
What Changed
ISO lists the 2016 edition as published and confirmed after the 2025 systematic review.
What Did Not Change
The standard does not by itself define every customer-specific computerized-system validation activity.
Practical Impact
Use the QMS framework and applicable incorporated requirements to connect software controls with the regulated process they support.
Actions to Consider
Consult an authorized copy and record which clauses, regulatory incorporations, and local procedures apply.
Primary Source
Revision history
Version 1.2 · 12 September 2026: Terminology and source fields standardized for Version 32.