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ISO Certificate Roche CustomBiotech in Penzberg, Germany

In 2011 the CustomBiotech Quality Management System (QMS) was switched from ISO 9001 to ISO 13485certification. This international standard requires an organization to consistently meet customer and regulatory requirements specifically applied to the in-vitro diagnostic and medical device industry.

CustomBiotech raw material and final kit production follows:

  • Detailed documentation (SOPs, central documentation)
  • Batch records with full traceability of all parameters
  • Independent QC and QA departments
  • Change control procedures
  • Complaint handling procedures
  • Education and training programs
  • Supplier evaluation programs
  • Maintenance and calibration programs

ISO 13485:2016 certificate

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