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テュフズードの適正透析規格(GDP)認証 (英語)

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TÜV SÜD’s Good Dialysis Practices (GDP) certification program is a voluntary certification scheme that assesses quality management and preventative safety measures at dialysis centres and clinics involved in the treatment of patients with renal insufficiency. More than 600 dialysis centres throughout the European Union (EU), Turkey and South Africa, employing more than 12,500 medical professionals, have already achieved TÜV SÜD’s GDP certification.

TÜV SÜD’s Good Dialysis Practices (GDP) Certification

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.

Why choose TÜV SÜD

  • Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Department, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
  • Quality system certification and auditing expertise - TÜV SÜD is an accredited conformity assessment body (CAB) for a number of quality management systems standards, and can conduct audits and factory inspections as required under these standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
  • Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
  • Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations. 

Your benefits at a glance

  • Improved practices and procedure - Achieving GPD certification requires the implementation of quality management and risk management systems, leading to improved practices and procedures, greater service consistency and increased profitability.
  • Increased safety for patients and workers - Improved practices and procedures also increase safety for patients and healthcare workers by creating a culture of safety and an emphasis on continuous improvement.
  • Compliance with current and future legal requirements - Although TÜV SÜD GDP certification is voluntary, certification can support efforts to meet current and future legal and regulatory requirements.
  • Reduced legal exposure - GDP certification is a clear demonstration of commitment to safe practices and procedures, which can mitigate judgments or penalties in legal or civil actions.
  • Better market distinction - TÜV SÜD GDP certification can provide important service differentiation in a competitive marketplace.

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