2San, global suppliers of high-quality innovative healthcare products and solutions, has secured the quality management system certification ISO 9001 as the company sets to ensure quality and regulatory compliance is at the forefront of its ambitious growth plans. With a patient-led approach, this is an important milestone for 2San as it enables systemic quality control throughout the supply chain.
ISO 9001 is the International Standard for Quality Management Systems, and one of the most commonly recognised management tools across the world. It has been specifically designed to help organisations ensure they meet the needs of customers and other stakeholders, by having a framework in place that helps ensure consistent quality in the provision of goods and/or services.
Working to deliver a range of products specifically designed to improve people’s health and wellbeing – be it through rapid self-diagnostic tests, or innovative chemical-free cleaning products – the 2San team have strived to implement quality and regulatory processes to ensure they are only delivering the best possible solutions:
- In 2022, 2San invested in a full-time quality and regulatory team – having previously worked with a number of consultants – primarily focusing on at-home tests, as well as rolling out practices to the wider business where they are seen as beneficial.
- In November 2022, the team kick-started the process of becoming ISO accredited, completing the first stage audit by BSI.
- In February 2023, 2San implemented a new eQMS system.
- April 2023, BSI conducted the final audit and 2San were recommended for certification
- June 2023, 2San was awarded the ISO 9001 certification.
Chelsea Tooze, Global Head of Quality & Regulatory, comments: “The rapid self-diagnostic market boomed during the pandemic at a time when we were all suddenly encouraged to test at home, which opened up this technology as a widely accepted practice. At 2San, our aim has been to retain the knowledge invested during this time and create a positive step forward for the future of at home testing. However, as we look to a new era of self-testing and the doors it opens to so many people, we wanted to make sure we have a recognised and regulated mark of quality to give both our customers and end-users the reassurance we are working with the highest quality standards.