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. Certification issued By CAS under its own responsibility, outside CAS's EGAC accreditation scope: the certificate carries the CAS mark only, not the EGAC or IAF marks, and it does not replace a notified body's assessment for CE marking.
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. The certified organisation displays the CAS certification mark; the certificate 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. The standard is referenced by the EU regulations (MDR/IVDR) and by many national health authorities.
Benefits of certification
- Referenced for medical device registration in many regulated markets
- Quality system reference required by the EU MDR/IVDR (the CE conformity assessment remains the notified body's task)
- Demonstrates compliance to customers and regulatory authorities
- Recognised by health authorities internationally
- 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?
EU MDR (2017/745) and IVDR (2017/746) require a conforming quality management system, for which ISO 13485 is the reference. CE marking, however, requires the conformity assessment of a notified body designated by a Member State: an ISO 13485 certificate issued By CAS does not replace it and is not an accredited certificate under Regulation (EC) 765/2008.
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