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ISO Standards

HDx™ DNA and FFPE Reference Standards are all manufactured within a Quality Management System which complies with the requirements of ISO 9001:2008 (Certificate Number: FM 590038) and ISO 13485:2003 (Certificate Number: MD 590039). Using a process approach to Quality Management we are able to provide specific, consistent and sustainable reference standards.

This demonstrates Horizon Diagnostics' ability and commitment to:

  • Consistently provide a product that meets both customer and regulatory requirements
  • Continue process improvement
  • Offer enhanced customer satisfaction

ISO 9001

To view our ISO 9001 certificate
Click Here


ISO 13485

To view our ISO 13485 certificate
Click Here


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