Quality Policy

By providing quality products and services to laboratories and specialist and primary care physicians, ImmunoDiagnostics aims to improve the management of patients with allergic or autoimmune conditions.

To maintain ImmunoDiagnostics high standards, quality should be optimised to fulfil customer needs and expectations.

Our Quality Management System ensures that customer requirements are met and guarantees compliance with national and regional laws, regulations and standards.

The high quality of our products is secured through the Quality Management System. This established system outlines the policies and procedures necessary to improve and control various processes, ultimately leading to improved business performance.

The Quality Management System ensures compliance with national and regional regulations:

  • European Union Directive: 98/79/EC, In Vitro Diagnostics Directive – IVDD
  • USA FDA: 21 CFR Part 820, Quality Systems Regulation

Current Good Manufacturing Practices for Medical Devices & In Vitro Diagnostic Products

  • ISO13485:2016 (including requirements related to the Canadian Medical Device Regulations; CMDR)
  • ISO 14971:2012 Risk Management

Download ISO certificates for reference


As in all diagnostic testing, the diagnosis is made by the physican based on both test results and the patient history.