ISO 13485: Medical-Device Quality Systems and Certification Scope
ISO 13485 specifies requirements for a quality management system in the medical-device field. Its focus is how an organisation manages relevant processes; a certificate against the standard is not a universal product approval. Start with the organisational scope ISO's publication record identifies ISO 13485:2016 as the current edition, reviewed and confirmed in 2025. Organisations involved in device design, production, installation, servicing and related supply activities can have relevant responsibilities within its scope. Define which activities, sites and services the organisation's system covers. Then connect procedures and records to the work actually performed. A supplier carrying out a limited activity should not imply that its certificate covers the entire device lifecycle. Three things to check in a certification claim The organisation and locations named on the certificate. The activities and scope covered by the assessment. The applicable standard, certificate statu...