ISO 9001 — Quality management systems

Also known as: ISO 9001:2015

The general quality management system standard, applicable to any organisation in any sector.

ISO 9001 ISO · current Official catalogue entry →

What it covers

scope	Requirements for a quality management system applicable to any organisation regardless of sectorVerified spec[1]
certifies	The organisation and its processesVerified spec[1]

What it means in practice

General-purpose, and therefore weaker evidence than ISO 13485 in a medical device context. A dental implant manufacturer holding ISO 9001 but not ISO 13485 would be an odd finding, because the medical device standard is the one its regulators care about. Presented on its own in implant marketing it says very little.

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Free public access is limited to a small number of lookups, which is why we do not publish bulk certificate data for this standard.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.