ISO 13485 — Quality management systems for medical devices

Also known as: ISO 13485:2016

The quality management system standard for organisations that design and manufacture medical devices, covering design control, traceability, complaint handling and corrective action.

ISO 13485 ISO · current Official catalogue entry →

What it covers

scope	Requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices meeting customer and regulatory requirementsVerified spec[1]
certifies	The organisation and its processesVerified spec[1]Not the individual product
verifiability	Accredited certificates are searchable via IAF CertSearch, which limits free public verification to a small number of lookupsVerified spec[2]

What it means in practice

This is the certificate most often presented as though it said something about an implant, and it does not. ISO 13485 certifies that a company runs a controlled quality management system — that production is documented, that a defective batch can be traced, that complaints are investigated. That is genuinely worth having, and its absence would be a red flag. But it is a statement about the organisation, not about whether a particular implant design performs well clinically. A company can hold an impeccable ISO 13485 certificate and make an unremarkable implant. Note also that ISO itself does not issue these certificates: independent certification bodies do, accredited in turn by national accreditation bodies.

Checking a company's certificate

ISO does not hold a register of certified companies — certificates are issued by independent certification bodies. Accredited certificates can be looked up in IAF CertSearch, the International Accreditation Forum's global database, which shows the certificate status, scope, certified sites, the issuing body and its accreditation body.

Free public access is limited to a small number of lookups, which is why we do not publish bulk certificate data for this standard. Where a manufacturer publishes its own certificate we record that as a manufacturer statement, clearly labelled, rather than as something we independently verified.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]ISO — Online Browsing Platform and standards catalogue — International Organization for Standardization. Accessed 2026-07-22.
[2]IAF CertSearch — global database of accredited management system certifications — International Accreditation Forum. Accessed 2026-07-22.