Demonstrate compliance with IEC/TR 62653 and ISO 9001 to ensure the safe use of medical products in dialysis treatment
TÜV SÜD’s Good Dialysis Practices (GDP) certification program is a voluntary certification scheme that assesses quality management and preventative safety measures at dialysis centers and clinics involved in treating patients with renal insufficiency. More than 600 dialysis centers throughout the European Union (EU), Turkey, and South Africa, employing more than 12,500 medical professionals, have already achieved TÜV SÜD’s GDP certification.
GDP certifications 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 standardized work processes and procedures, formal training programs for employees, detailed oversight, and effective communication throughout the organization. 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, which emphasizes continuous improvement.
Achieving TÜV SÜD’s GDP certification requires dialysis centers to establish a quality management system that meets the requirements of ISO 9001 that also accounts for the specifics of IEC/TR 62653. Then the quality system is audited for compliance with the requirements of both standards. GDP-certified dialysis centers 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 achieving 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.
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