Are Hertility’s At-Home Tests accurate?

Our lab is UKAS accredited (ISO 15189:2022) for capillary and venous blood sampling and was the first UK lab to attain this level of accreditation. It leads the UK in the capillary testing specialisation having published widely on the subject, it maintains the highest form of internal and external regulations. Our hormone & fertility test kits are CE-marked for IVDR use and MHRA registered, we adhere to strict testing policies to uphold our compliance.

At our laboratory, we maintain the highest standards of quality and compliance through a range of accreditations and certifications. These include:

• CQC Registration: We are registered with the Care Quality Commission (CQC), the independent regulator of health and social care services in England. This registration demonstrates our adherence to essential standards of quality and safety in providing healthcare services, including hormone and fertility testing. Specifically, we are registered for diagnostic and screening procedures and the treatment of disease, disorder, or injury, ensuring compliance with the quality and safety standards set by the regulatory authority.
• ISO 9001:2015 Our partner laboratory is certified to ISO 9001:2015, the international standard for quality management systems (QMS). This certification signifies our partner laboratory’s commitment to maintaining effective quality management processes to consistently deliver products and services that meet our customer and regulatory requirements.
• ISO 27001:2022 Certification: Our partner laboratory holds ISO 27001:2012 certification for information security management systems (ISMS). This certification highlights our partner laboratory’s dedication to managing and protecting sensitive information, including data related to our hormone and fertility tests, ensuring confidentiality, integrity, and availability.
• ISO 15189:2022 Accreditation: Our partner laboratory is accredited to ISO 15189:2022, the international standard for medical laboratories. This accreditation demonstrates our partner laboratory’s technical competence in providing testing and calibration services, ensuring the accuracy and reliability of our hormone and fertility tests through standardised processes and procedures.