What is ISO 13485

Standard ISO 13485 is an industry-specific alternative to ISO 9001 and is also based on the overall picture of business processes. ISO 13485 also in conjuction with Directive 93/42/EEC European Rat specify die requirements for a Qualitymanagement-System (QMS) for a medical devices manufacturer. The focus of the standard is on the product’s safety.
For the manufacturer, who have already gained a certification according to ISO 9001, lends itself to the certification according to ISO 13485, since the both standards extensive consistent based requirements.


Standard is divided in five main parts:Print
  • Qualitymanagement – System
  • Management requirements
  • Resource requirements
  • Product realization
  • Measurement, analyse and improvement
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