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Certification mark for Good Dialysis Practice

Certification mark for Good Dialysis Practice

Scope:

The certification mark applies to dialysis centres.

Basis of certification:

The certification mark is based on the ISO 9001 standard and, if requested by the customer, the ISO 14001 standard. In addition, the International Technical Report IEC 62653 “Guideline for safe operation of medical equipment used for haemodialysis treatments” is applied. Given this, the award of the certification mark covers assessment of the quality management system (QMS) and preventive safety measures.

Key words of the certification mark:

 

  • Good Dialysis Practice
    Dialysis centres throughout Europe use the “Good Dialysis Practice” certification mark to demonstrate the quality and safety of their facilities to their patients.

    The certification mark is awarded to the dialysis centre following the successful completion of a management system and safety audit. The audit is based on the following requirements.
  • IEC 62653
    The International Technical Report IEC 62653 provides the basis of the TÜV SÜD “Good Dialysis Practice” certification mark.

    The technical report regulates various aspects including prevention of patient risks that are not recognised by the dialysis equipment, regular monitoring and testing of patient and equipment during treatment, instruction of users in the safe handling of medical devices and monitoring, operation and maintenance of dialysis equipment and water-treatment systems.

    It also covers subjects such as the compatibility of medical devices (disposable items and equipment), electrical safety requirements, hygiene guidelines for dialysis treatment and operation of equipment, and compliance with legal requirements.
  • ISO 14001
    The ISO 14001 standard forms the basis for the establishment, introduction, surveillance and continual improvement of environmental management systems.

    The overarching objective is to promote environmental protection and reduce environmental pollution in line with economic, social and political requirements. Compliance with the ISO 14001 requirements is available to customers as an additional option.
  • ISO 9001
    The quality-system requirements set forth in the ISO 9001 ”Quality management systems – requirements” standard define the framework for establishing the criteria for a functioning and effective safety culture.

    Compliance with the requirements of ISO 9001 is essential for the award of the “Good Dialysis Practice” certification mark.

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