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.
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:
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 406080 or [email protected].