SAFETY & QUALITY IN THE DIAGNOSTIC DIVISION
Supplier controls

The Diagnostic Division defines requirements to assess, approve and monitor suppliers, and classifies them according to their importance in the production process. Results are documented in a supplier evaluation registry, and potential new suppliers are accepted or rejected depending on the results of this analysis.

To ensure quality compliance at all times, Grifols re-evaluates its quality system and standards for key suppliers every three years, and every five years in the case of important suppliers. The division also regularly evaluates its quality markers.

Main Relevant Regulations
  • Code of Federal Regulations (CFR): 21CFR sec 820.50 “Purchasing controls”
  • ISO 13485:2016 Sc. 7.4.1 “Purchasing process”
Safety and control
standards IN PRODUCTION

The Diagnostic Division ensures the safety, efficacy and quality of its products through a range of production, quality and R+D+i management processes.

The division also implements project-management techniques, agile software development, GMP, automation, continuous improvements and ongoing validation of its integrated IT systems. Moreover, the division’s employees take part in continuous training initiatives to reinforce their technical skills.

Main Relevant Regulations
  • EN ISO 14971:2012
  • Code of Federal Regulations (CFR): 21CFR820 “Quality System Regulation”
  • Code of Federal Regulations (CFR): 21CFR600 “Biological Products: General”
  • ISO 13485:2016 “Medical devices – Quality management systems – Requirements for regulatory purposes”
  • Regulations under the Medical Device Single Audit Program (MDSAP)
  • ISO 14971 “Medical devices – Application of risk management to medical devices”
  • IEC 62304:2006 “Medical devices software – Software life cycle processes”
Product licenses

The production, marketing and sale of Diagnostic Division products are registered with relevant authorities in applicable countries.

Main Relevant Regulations
  • Local country-specific regulations