This upgrade from the well-established ISO 13485:2003 system followed assessment from LRQA, with an effective date of December 2017.
ISO 13485:2016 was published in March 2016, and Team worked to implement the changes as soon as possible. Team has achieved certification well before the transition deadline, and ahead of others in the industry, as part of their commitment to robust and rigorous processes at every stage of the product development lifecycle.
Achieving certification to the new standard is testament to the continuous improvement of Team's quality systems, and to the fulfilment of client expectations in the highly regulated medical sector. The new standard requires considering risk-based approaches to support quality management activities.
Hannah Murfet, Team’s Quality Assurance Manager, explains “Team has had a certified quality management system since the late 90’s and certification to ISO 13485 since 2006, but the 2016 version prompted us to re-evaluate our systems. We started this evaluation as early as possible and adopted a risk-based approach, allowing us to prioritise and focus on what matters most to our clients and the products. It is fantastic to have achieved ISO 13485:2016 so far ahead of the transition period.”