ReoCell Clinic Has Successfully Achieved ISO 9001:2015 Certification

ReoCell Clinic has successfully obtained certification of its Quality Management System in accordance with the international ISO 9001:2015 standard, confirming that the clinic’s internal processes comply with globally recognized requirements for quality management in the provision of medical services.

What ISO 9001:2015 Certification Means

ISO 9001:2015 is an internationally recognized standard that regulates:

• a systematic approach to quality management,
• transparency and control of internal processes,
• a strong focus on patient safety and consistent clinical outcomes,
• continuous improvement and risk management.

For a medical center working in innovative fields—particularly cellular therapy—the implementation of ISO standards is a fundamental prerequisite for responsible, sustainable, and long-term clinical practice.

Scope of ReoCell’s Clinic Quality Management System

At ReoCell Clinic, ISO 9001:2015 certification covers key departments and processes, including:

• administrative operations,
• diagnostic and therapeutic units,
• infection control systems,
• the activities of the head nursing service,
• scientific and clinical practice activities.

This means that quality at ReoCell is not a separate function, but a comprehensively structured system that encompasses the entire patient journey—from the first contact to clinical follow-up and internal quality control.

International Recognition and Ongoing Compliance

The certification was conducted by a conformity assessment body accredited within international recognition systems (IAF, European Accreditation). Compliance with the quality management system requirements is ensured through regular surveillance audits, guaranteeing that the standard is actively implemented and maintained in daily clinical practice rather than remaining a formal designation.

What This Means for Our Patients and Partners

For patients of ReoCell Clinic, ISO 9001:2015 certification ensures:

• consistent and reliable quality of medical services,
• clearly structured clinical and administrative processes,
• enhanced safety and quality control,
• compliance with international standards for medical centers.

For partners and the professional medical community, it serves as confirmation that ReoCell:

• operates in accordance with transparent and reproducible standards,
• is prepared for international collaboration,
• integrates innovation within a robust and systematic quality management framework.

Quality as the Foundation of Innovative Medicine

We believe that innovation in medicine has true value only when implemented within a controlled, standardized, and responsible system. ISO 9001:2015 certification represents another important step in ReoCell Clinic’s commitment to the development of modern, evidence-based, and safe medicine in Ukraine.

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