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.
“ISO 9001 is by no means an easy process; My team and I needed to ensure that we followed a very prescriptive set of guidelines set out by the standard and interpreted these appropriately for our organisation. We also went above and beyond the necessary steps, incorporating additional processes to give further reassurances around our commitment. This included implementing an eQMS system, and batch-testing when we receive products, something 2San does not have a responsibility to do but we feel is an important step to ensure there hasn’t been any detrimental impact when importing products. It has been a real learning curve for the wider organisation, especially working within such a regulated area. However, the 2San team has been behind us every step of the way, being such a fluid and adaptable business has really helped the process.
“So many of our industry colleagues haven’t yet been through the process of being audited and certified. However, it brings so many benefits, including allowing us to plan changes and have processes in place for all scenarios. It could be easy to forget we work in an industry where we are potentially dealing with vulnerable people, turning to our products as the first step in their healthcare journey. One of our tests might be the first point of contact for a patient with a troubling medical issue. For us, it’s of the utmost importance we remember this always, and provide a solution in a responsible way.
“To this end – the ISO 9001 is an incredible achievement for 2San and testament to the hard work and dedication we have put in as a whole business. But it’s not the last step on our journey – and we will continue to look forward and strive towards achieving additional certifications in the future, always looking to better ourselves, improve our business, and provide an even more exceptional product.”
