GDP certification is based on demonstrated compliance with the requirements of IEC/TR 62653, Guidelines for the safe use of medical products in dialysis treatment, and ISO 9001. ISO 9001 requires the establishment of a quality management system, including standardised work process and procedures, formal training programs for employees, detailed oversight and effective communication throughout the organisation. IEC/TR 62653 focuses on defining preventative measures to reduce known hazards and risks in advance of dialysis treatment. Together, these standards support efforts to develop and maintain a culture of safety within the healthcare setting, with an emphasis on continuous improvement.
Achieving TÜV SÜD’s GDP certification requires dialysis centres to establish a quality management system that meets the requirements of ISO 9001 and that also accounts for the specific requirements of IEC/TR 62653. The quality system is then audited for compliance with the requirements of both standards. GDP-certified dialysis centres are also subject to annual review and audit for continued compliance with the certification requirements.
Although TÜV SÜD’s GDP certification is voluntary, GDP certification can support efforts to achieve compliance with present and future legal and regulatory requirements. GDP certification also provides the structural and cultural framework for the development and maintenance of safe practices and procedures. Most important, GDP certification represents a clear and continued commitment to the health and safety of patients and healthcare workers.