ISO 15189 knowledge hub
[Ideagen Quality Management] has allowed us to gain accreditation for ISO 15189 and maintain that, particularly over the pandemic.
What is ISO 15189 and why is it so important?
ISO 15189 is the international standard for medical laboratories, specifying the standards for quality and competence. It is a globally recognized accreditation that demonstrates your commitment to the reliability, competence, integrity, and overall quality of your lab’s practices.
Additionally, as labs all over the world increasingly look to standardize their practices to enable better data sharing and more informed decision-making, many see ISO accreditation as a vital step towards globally consistent data.
Royal Wolverhampton NHS Trust
Experienced users of Ideagen Quality Management since 2004, Ideagen software is vital to Royal Wolverhampton NHS Trust’s Pathology department. It has helped the trust and its hard-working staff to simplify the tasks associated with its compliance efforts. This includes achieving and maintaining compliance to ISO 15189 and meeting strict criteria from regulatory bodies such as MHRA, HTA, CQC, and HSE. Ideagen also provided a validation pack through their partnership with CompliancePath, greatly reducing the time taken to validate the system unguided.
The main benefit from the pack was the huge savings in time which would have been spent validating the system ourselves. We also saved on associated staffing costs that would have been incurred, which is often forgotten about.
Video success story
Spire healthcare meet ISO15189 with Ideagen Quality Management
Watch our case study about Spire Healthcare’s experience with using Ideagen Quality Management to manage quality and support their processes in order to meet ISO 15189.
More useful reading
7 regulatory changes in life sciences and what you should do to prepare
This blog breaks down 7 regulatory changes in life sciences for 2023 and what action you should be taking to be resilient in a changing regulatory environment.Read more
Request an ISO 15189 software demo
Want to see our software solution for meeting all the requirements outlined in ISO 15189 in action? Request a demo with our team today.