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Quality Standards

Abingdon Health is committed to customer satisfaction, whether that be developing a test(s) for our own product line or for a commercial partner. One of the ways we demonstrate this is by working within recognised quality standards.

Abingdon Health can confirm that it operates under an effective Quality Management System for both ISO 13485 and ISO 9001, both of which are regularly audited by an independent organisation.

The recent achievement of the revised ISO 9001:2015 and ISO 13485:2016 certifications endorses Abingdon Health’s commitment to maintaining a compliant QMS.

Abingdon Health’s manufacturing facilities operate in accordance with GMP 21CFR820, the requirements of the U.S. Food and Drug Administration (FDA), for the design, development, and manufacture of lateral flow devices, and device readers for in vitro diagnostic medical use.


These certifications are evidence that we adhere to internationally recognised quality standards. Read on to learn about each of the standards which we comply with.

ISO 13485:2016 – an ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices and related services that consistently meet customer and applicable regulatory requirements.

Certificate: click here


ISO 9001:2015 –an ISO standard that demonstrates a structured approach to quality management, to ensure that a company meets the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service, regardless of its type or size, or the products and services it provides.

Certificate: click here


Good Manufacturing Practice (GMP) – GMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

Quality Policy

Abingdon Health is committed to providing its customers and regulatory authorities with products and services that meet or exceed their expectations for safety, quality and reliability.

Our commitment to Quality underpins all aspects of our business processes as well as being one of the key building blocks of the company, alongside ‘Customer’, ‘People’ and ‘Collaboration’.

We achieve this by:

  • Complying with the relevant regulations and standards including ISO 13485:2016, ISO 9001:2015 and 21 CFR 820 FDA Quality System Regulations.
  • Evaluating and continually measuring Business Management processes and their effectiveness; enabling all personnel to deliver products and services that meet agreed quality standards, regulatory and customer requirements.
  • Ensuring Abingdon Health personnel are aware of, and have a clear understanding of, their responsibility to comply with the Quality Management System and its processes, as a well as regulatory requirements, to meet Quality and Company Objectives and achieve continual improvement of products and services.
  • Demonstrate leadership and commitment with respect to the Quality Management System by promoting the use of the process led approach and risk-based thinking.
  • Continue to nurture the company building blocks: ‘Customer’, ‘Quality’ ‘People’ and ‘Collaboration’ which form the foundations of the Company’s culture and are key areas of focus across all functions of the business.

Abingdon Health maintains its Quality Management System through a process of continual improvement supported by annual reviews to ensure the highest standards of Quality management are maintained.

For further information relating to our quality standards please contact us on+44 (0) 1904 406082 or [email protected].

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See how we utilise our quality management and regulatory expertise to manufacture tests for a range of markets.