Knowledge · ISO 13485
ISO 13485:2016 — the QM system for medical devices
What the standard demands, whom it concerns and what a certified QM system must deliver.
ISO 13485:2016 is the internationally valid standard for quality management systems in the medical device industry. It defines requirements for development, production, storage, distribution and post-market support of medical devices — and is the basis for conformity assessment under EU MDR. Our own QMS under ISO 13485:2016 is currently being established; certification has been initiated.
Core chapters
- Ch. 4: QM system and documentation
- Ch. 5: Management responsibility, policy, roles
- Ch. 6: Resources, infrastructure, work environment
- Ch. 7: Product realisation — planning, development, purchasing, production, validation
- Ch. 8: Evaluation, analysis, improvement — incl. CAPA
Differences from ISO 9001
ISO 13485 is more regulation-oriented: documentation duties are tighter, risk management under ISO 14971 is anchored, traceability and document control are stricter.
Certification and validity
Certification is performed by accredited bodies; certificates run three years with annual surveillance audits.
Frequently asked questions
Does ISO 13485 also apply to contract manufacturers?
Yes, as soon as they manufacture parts of medical devices: suppliers and contract manufacturers fall within scope where their share affects conformity. INOPREX requires this in supplier qualification.
Is INOPREX certified?
Not yet. The QMS under ISO 13485:2016 is currently being established; certification has been initiated. We share the current status transparently within the project.
Applied to your project
We apply these rules directly to your project — from classification to market access. First assessment within two working days.