ISO 13485:2016 — Medical Devices QMS
The international standard for quality management systems in the medical devices industry — demonstrating the ability to consistently provide safe, effective medical devices and related services.
Standard
ISO 13485:2016
Service type
By CAS
Issued under
CAS — own authority
Standards & technical basis
Certified standard
ISO 13485:2016
Certification-body competence
ISO/IEC 17021-1:2015
CAS certifies to the general requirements of ISO/IEC 17021-1:2015; no scheme-specific ISO/IEC 17021 competence part is published for this standard.
Mark & recognition
Issued by CAS under its own authority — carries the CAS mark and does not bear the EGAC or IAF marks.
What it is
ISO 13485:2016 specifies requirements for a Quality Management System specific to the medical devices industry. It is used by manufacturers and related service providers throughout the supply chain to demonstrate their ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements.
Who needs it
Medical device manufacturers, distributors, importers, exporters, and service providers in the medical device supply chain. Required for CE marking (EU MDR), FDA registration, and many national health authority approvals.
Benefits of certification
- Required for medical device registration in many regulated markets
- Prerequisite for CE marking under EU MDR and IVDR
- Demonstrates compliance to customers and regulatory authorities
- Internationally recognised by health authorities globally
- Foundation for regulatory submissions and market access
- Strengthens risk management and post-market surveillance processes
Frequently asked questions
Common questions
Is ISO 13485 the same as ISO 9001?
No. ISO 13485 is specific to medical devices and has additional requirements relating to regulatory compliance, risk management, and sterile manufacturing. It is based on ISO 9001 principles but goes further.
Is ISO 13485 required for CE marking?
Yes. EU MDR (2017/745) and IVDR (2017/746) require ISO 13485 certification as a prerequisite for CE marking of medical devices.
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