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Certificado nº 60148157

  • Número de Certificado
    SX 60148157
  • Certificado Titular
    SLI Sterilgut, Logistik und
    Instrumentenmanagement GmbH
    Grieskirchner Str. 42
    4600 Wels
    Austria
  • Alcance de la Certificación

    Reprocessing of medical devices
    (sse attachment for Sites included)
    Sites included:
    AEMP Braunau
    Ringstraße 60
    5280 Braunau, Austria
    Activity: Reprocessing of medical devices
    AEMP Linz
    Fadingerstraße 1
    4020 Linz, Austria
    Activity: Reprocessing of medical devices

  • Estándares cumplidos
    EN ISO 13485:2016
  • Tipo de Certificado
    QMS

    Quality Management System
    EN ISO13485 quality management standard for medical devices and related services

    The European standard EN ISO 13485 specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that constantly meet customer requirements and applicable legal requirements.

    Competent auditors analyze and evaluate the customer's quality management system. If all applicable requirements are met, its quality management system is certified according to EN ISO 13485.

    The customer's quality management system is subject to regular monitoring.

    Certified customers may use the test mark in their communication.

    Further information on this service can be found here.