Abingdon Health is committed to developing and manufacturing high quality, reliable rapid tests for all partners and industries.
We demonstrate this by working within recognised quality standards.
Abingdon Health operates under an effective Quality Management System in accordance with ISO 13485 and ISO 9001, both of which are managed by our in-house QARA team and regularly audited by an independent organisation.
Our company, including best in class LFT manufacturing facilities, also works in accordance with IVDD 98/79/EC, IVDR 2017/746, FDA 21CFR829 and GMP 21CFR820. In addition, our facilities have medical device establishment registration with the FDA and MHRA.
Certifications
These certifications are evidence of our adherence to internationally recognised quality standards.
Quality Policy
Abingdon Health’s mission is to improve life by making rapid tests accessible to all. Abingdon’s core proposition is the provision of technology-enabled lateral flow contract services to customers across a wide range of industries. Our contract services include lateral flow development, lateral flow manufacturing and related services such as regulatory and commercial support. We also develop and commercialise our own lateral flow tests primarily under the Pocket Diagnostic (b2b) and Abingdon Simply Test (b2c) brands. We are committed to providing our customers with products and services that meet or exceed their expectations for safety, quality and reliability.
Our values provide a framework that supports decision-making across our business and are as follows:
- People Focused: we want to enrich the lives of our team, clients and customers
- Progressive: we are committed to innovation and collaboration; now and always
- Empowering: giving our experts the freedom and confidence to put their best foot forwards
- Passionate: believing fervently in the difference our work can make in the World
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 9001:2015, ISO 13485:2016, as well as conformity with FDA 21 CFR Part 820, the IVD Directive (98/79/EC), the IVD Regulation (2017/746) and Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) 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 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 quarterly reviews to ensure the highest standards of Quality management are maintained.
A full signed copy of our Quality Policy (QMP212) is available on request. For further information relating to our quality standards please contact our QARA team at +44 (0) 1904 406050 or [email protected].
