HDx™ Reference Standards are fully characterized to guarantee the quality, specificity and consistency of each batch. The production workflow is precisely monitored and controlled, from cell line engineering (where appropriate) through to Reference Standard production. Explore the workflow diagram below to learn more about what we do at each step:
|Figure 1. Horizon’s Manufacturing and Quality Control Steps|
HDx Reference Standards are 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). This demonstrates our commitment to consistently provide a product that meets both customer and regulatory requirements.
Commentaries on use of reference standards to meet accreditation guidelines: