· Medically reviewed by Prof. Dr. Erdal Karaöz Team
ISO certification: what applies, and where
ISO standards describe management systems, not medical outcomes. We list only the standards that genuinely apply to the entities in your care pathway, and we say plainly where a standard is not held.
Standards in scope
| Standard | What it governs | Where it applies |
|---|---|---|
| ISO 9001 — Quality management systems | Documented, audited processes with defined responsibilities, records and continual improvement | Partner laboratory quality management system |
| GMP (not ISO, often confused with it) | Pharmaceutical-grade manufacturing, clean rooms, batch release | Cell manufacturing |
| ISO 15189 / ISO 17025 — laboratory competence | Testing and calibration laboratory competence | Applies to the accredited analytical laboratories used for release testing where relevant; we do not claim these on our own behalf |
| ISO 13485 — medical device QMS | Design and manufacture of medical devices | Not applicable — cell therapies are not devices |
What ISO 9001 means for a patient
ISO 9001 says nothing about whether a therapy works. Efficacy questions belong on the scientific evidence pages.
- Your pathway — intake, records review, consent, treatment, follow-up — follows a written procedure rather than improvisation.
- Records are retained and traceable, so a later clinician can reconstruct exactly what was done.
- Complaints and deviations are logged and reviewed, not handled informally.
- The system is audited by an external certification body on a recurring cycle.
Requesting the certificates
Certificate copies, including issuing body and validity dates, are provided on request during consultation. See also the certificates overview and the Ministry of Health licensing page.
Ask for the documentation
Our coordination team can share laboratory certificates, licence references and hospital accreditation details during your consultation, alongside a medical review of your own records.
Request a free medical review