Udenco SRO acquires ISO13485

After having acquired the quality norm ISO15189, Udenco SRO was assigned the ISO13485 norm. This is an independent norm but is usually (as is the case at Udenco) combined with ISO9001.

ISO13485 is a qualitative norm regarding introduction and management of a quality system that meets the generic European standard.

ISO13485 focuses on

  • the awareness and executive strength that requirements stated by law are a management responsibility
  • guaranteeing control on the working environment and product safety
  • risk management activities and design activities during development
  • specific requirements regarding inspection and traceability of implants
  • specific requirement regarding documenting and validating processes for sterile medical appliances
  • specific requirement regarding verification of effective of correcting and preventive measures.

By working with ISO13485 we contribute to a uniform European system of quality control.

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