Supplier & internal audits


  • Complete compliance audit according to ISO 9001 / ISO 13485 standards and QSR
  • Initial supplier qualification audit during design phase
  • Supplier audits in the view of Quality Management System requirements
  • Manufacturing audits to evaluate the performance of a given supply chain
  • Development of supply agreements and quality agreements
  • Specific audits such as :

• process audit to evaluate manufacturing
• process to specifications and good practices
• process validation audit according to IQ/OQ/PQ
• cleanliness and reprocessing audits

  • Medidee is in position to execute an audit anyplace on the planet within 10 days.