Certifications and Accreditations
Gennet clinics meet strict international and Czech standards for the quality of healthcare. We hold important certifications and are also a specialised accredited workplace of the Ministry of Health of the Czech Republic.
All our workplaces are regularly inspected and meet high requirements for expertise, impartiality, safety and the standard of technological equipment.
Thanks to our long standing experience, transparent procedures and consistent compliance with all regulatory requirements, our medical laboratories are among highly trusted and independent workplaces whose results patients and healthcare professionals can rely on.
Quality Management System Certification
Our clinics have implemented a quality management system according to ISO 9001, focused on systematic process management, improving the quality of care provided and patient safety.
The system is regularly audited by an independent certification body and continuously developed in line with current requirements for healthcare quality and safety.
Standard: EN ISO 9001:2015
Certification body: TÜV NORD Czech, s.r.o.
Validity: 16 September 2025 to 15 September 2028
What This Means for Patients
The certification confirms that:
- We have a systematic approach to service quality in place
- The quality of the services provided is regularly monitored and evaluated
- Internal and external audits focused on safety and quality of care are carried out
- We actively work on the continuous improvement of all processes
Scope of Certification
The certification covers the provision of specialised healthcare in:
- Reproductive medicine and urology
- Gynaecology and obstetrics
- Medical genetics and fetal medicine
- Allergology and clinical immunology
- Medical laboratory activities
Certificate PDF available for download
ISO 9001 Certificate
👉 The certification covers multiple workplaces in Prague and Liberec.
Accreditation of Medical Laboratories
Our laboratories meet internationally recognised standards for medical laboratories. These standards ensure a high level of result accuracy and professional competence of the staff.
Accreditation authority: Czech Accreditation Institute, o.p.s.
Standard: ČSN EN ISO 15189 ed. 3:2023
Accreditation number: 631/2025
Valid until: 28 March 2027
What This Means for Patients
The accreditation confirms that our laboratories:
- Meet the highest standards for medical laboratory diagnostics
- Provide accurate and reliable results
- Work according to internationally recognised methods and procedures
- Are regularly inspected by an independent accreditation body
Scope of Accreditation
Genetic laboratories
- Molecular genetic testing
- Cytogenetic testing
- Preimplantation genetic testing of embryos
Embryology laboratories
- Semen analysis
Immunology laboratory
- Testing in the fields of immunology and allergology
Accreditation certificate PDF available for download
The accreditation applies to several specialised laboratories in Prague and Liberec.
Accreditation certificate PDF available for download
👉 The accreditation applies to several specialised laboratories in Prague and Liberec.
Accreditation by the Ministry of Health of the Czech Republic
Gennet clinics are a specialised accredited workplace of the Ministry of Health of the Czech Republic in the fields of allergology and clinical immunology, reproductive medicine, clinical embryology, medical genetics and clinical genetics.
This accreditation confirms the high professional standard of the workplace and also enables the training of healthcare specialists in these fields.
PDF Documentation (issued in Czech)
In-house IVD (IVDR)
In accordance with the requirements of Regulation (EU) 2017/746, IVDR, we publish a declaration for in vitro diagnostic medical devices developed and used within our healthcare facility on an in house basis.
These methods are used exclusively for internal diagnostics and meet the requirements for quality, safety and professional accuracy.
Below you can find the current declaration pursuant to Article 5, paragraph 5 of the IVDR.
PDF available for download (The original certificate is issued in Czech)
Healthcare Facility Declaration on IVDR
State Institute for Drug Control
Authorisation to Operate a Tissue Establishment
Gennet clinics hold an authorisation to operate a tissue establishment issued by the State Institute for Drug Control.
This authorisation applies to the operation of all our assisted reproduction, IVF, clinics and confirms compliance with strict legislative, technical and personnel requirements for handling human tissues and cells, including ensuring their traceability and safety through an established quality system.
Decision on the Authorisation to Operate a Tissue Establishment and Diagnostic Laboratory
The original certificate is issued in Czech
Annual Report of the Tissue Establishment
In accordance with applicable legislation, we prepare an annual report of the tissue establishment, which is submitted to the State Institute for Drug Control.
This report summarises the activities of our workplaces in the area of handling tissues and cells and serves to verify compliance with all requirements for quality, safety and traceability.
Annual Report of the Tissue Establishment
The original certificate is issued in Czech
Frequently Asked Questions
What does ISO certification of a clinic mean?
ISO certification confirms that the clinic has an established quality management system and regularly undergoes independent audits.
What is accreditation according to ISO 15189?
It is a specific standard for medical laboratories that guarantees the accuracy of results and professional competence.
Are these certifications mandatory?
Not all of them, but obtaining them means that the workplace meets standards higher than the basic minimum.
How can I recognise a high quality IVF clinic?
Key indicators include accreditations, an experienced team and transparency of results.