Quality Management System

Our quality management system was established in 2013 for the design, development, manufacturing and distribution of HDx™ Reference Standards to ensure the traceability required. The current standards of ISO 9001:2008 and ISO 13485:2003/2012 are held.

Our quality management system has continued to evolve to facilitate changes in requirements and incorporate opportunities for improvement. Processes are established to manage the supply chain from raw material procurement to manufacturing to distribution of finished product.

Custom and OEM orders are managed according to project requirements. Any differences are managed according to standard processes wherever possible or through novel development outside of scope where necessary in order to fulfil customer requirements.

You can view the pdf versions of the key documents associated with our quality management system below:

Quality Fact Sheet ISO 9001 Certificate ISO 13485 Certificate Quality Policy
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