Legislation & Quality

Quality standards mean quality assurance. At Gynem, we operate according to a strict set of guidelines that inform and regulate what we do and how we do it. These come both from within our organisation and without—as self imposed standards checked by regular inspection and as demanding legislation at the EU and state levels.

We are ISO certified by the technical inspection service TÜV SÜD in recognition of matching the ISO 9001 quality management standard and undergo audits every year to make certain we are up to par. With principles such as customer focus and continual improvement at its core, the ISO 9001, established by the International Organization for Standardization, ensures Gynem meets the demands of our clients and continues to improve the quality of our services.

 
TŮV

The specifics of legislation concerning assisted reproduction vary from country to country within the EU. However, a directive defining quality and safety standards for the proper handling of human tissue and cells—including eggs, sperm, and embryos—is in effect for all member states. In the Czech Republic, while the legislation pertaining to these matters takes its instruction from this directive, the law is considerably more exacting and imposes health and safety controls on nearly every aspect of a fertility clinic’s operations.

the IVF clinic award

Areas of regulation include ART procedures themselves, laboratory workspace and materials, documentation, and even air quality. Specific regulations for the protection of egg donors, recipients, and embryos are also in place. As proof of compliance with these strictures, we are licensed by the State Institute for Drug Control (SÚKL), who also audits our clinic every two years.

The foregoing factors—both internal and external—foster a culture of exceptional quality at Gynem that directly benefits our clients. Add to these the commitment and attentiveness that come with being a family-owned enterprise, and the result is a fertility clinic of a very high calibre indeed.

 
Certificate