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  • 证书号 60148157

    • 证书号码
      SX 60148157
    • 证书持有人
      SLI Sterilgut, Logistik und
      Instrumentenmanagement GmbH
      Grieskirchner Str. 42
      4600 Wels
      奥地利
    • 范围

      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

    • 测试标准
      EN ISO 13485:2016
    • 证书类型
      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.