2San has obtained ISO 9001 QMS certification

Suppliers of healthcare products and solutions, 2San has acquired Quality Management System Certification ISO 9001 as the company is at the forefront of its growth plans to ensure quality and regulatory compliance.

With a patient-led approach, this is a significant milestone for 2San as it enables systemic quality control across the entire supply chain.

ISO 9001 is the international standard for quality management systems, and is one of the most recognized management tools worldwide. It is specifically designed to help organizations ensure that they meet the needs of customers and other stakeholders, by creating a framework that helps ensure consistent quality in the provision of goods and/or services Is.

Working to provide a range of products specially designed to improve people’s health and wellbeing – whether through rapid self-diagnostic tests, or innovative chemical-free cleaning Through the products the Ho – 2San team has endeavored to implement quality and regulatory processes to ensure that they are delivering only the best possible solutions:

• In 2022, 2san invested in a full-time quality and regulatory team – having previously worked with several consultants – to focus primarily on in-house tests as well as implementing practices across the wider business where they are considered beneficial.
• In November 2022, the team started the process of getting ISO accreditation by completing the first stage audit by BSI.
• In February 2023, 2San implemented a new eQMS system.
• In April 2023, BSI conducts final audit and 2San is recommended for certification
• June 2023, 2San was awarded the ISO 9001 certification.

Chelsea Toews, global head of quality and regulatory, said: “The rapid self-diagnosis market boomed during the pandemic when we were all suddenly encouraged to test at home, which has catapulted this technology into widely accepted practice. Opened in At 2San, we aim to retain the knowledge invested in the meantime and take a positive step towards the future of home testing. However, as we look forward to a new era of self-testing and the doors opening for so many more, we wanted to make sure we had the quality assurance to both our customers and end-users. Be a recognized and regulated mark. Working with the highest quality standards.

“ISO 9001 is by no means an easy process; My team and I needed to make sure we followed a very instructional set of guidelines set forth by the standard and interpreted these appropriately for our organization. We also went beyond what was necessary, including additional procedures to further assure our commitment. This includes implementing an eQMS system and batch-testing when we receive products, something that is not 2San’s responsibility to do but we feel is an important step in ensuring that there is no contamination when importing products. Do not have harmful effects. It has been a real learning opportunity for the wider organization, especially working in such a regulated sector. However, the 2San team has been behind us every step of the way, having such a fluid and adaptable business has really helped with the process.

“Many of our industry partners have not yet gone through the process of being audited and certified. However, it brings a lot of benefits, including allowing us to plan for changes and implement processes for all scenarios. It can be easy to forget that we work in an industry where we are dealing with potentially vulnerable people turning to our products as the first step in their health care journey. One of our tests can be the first point of contact for a patient with a troubling medical problem. For us, it is extremely important that we always remember this, and provide solutions in a responsible manner.

“To this end – ISO 9001 is an incredible achievement for 2San and a testament to the hard work and dedication we have put in as a whole business. But this is not the last step on our journey – and we will continue to grow and strive to achieve additional certifications in the future, always striving to better ourselves, improve our business and provide even more exceptional products .