LS CancerDiag has successfully passed through the auditing process to receive the certification according to the ISO 13485:2016 standard. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. The certificate was issued to the company by an accredited certification body in June, before the summer break.
This marks an important milestone in our journey to expand and provide DiagMMR® at a global scale and reflects our commitment to trust and quality. Our laboratory team has dedicated much time and care in implementing the quality management system (QMS) according to this demanding standard. And after passing the stage 1 audit, decided to up their game and introduce an electronic QMS to make the system more robust, future-proof, and go beyond mere compliance.
The introduction of the fully electronic QMS asked for extensive training of all staff members, particularly for those managing and administering the system. This was achieved in time to conduct the stage 2 audit, not only with the new tool implemented, but already in full auditable use. We would like to especially thank our Quality Manager, Jaana Putula who has led this incredible work over the last couple of years and brought us to the next level by establishing the extensive documentation and traceability of all laboratory work related to our flagship product DiagMMR®.
Our certified QMS is the foundation of many processes and greatly supports the company’s mission to enable an easy and accurate Lynch cancer syndrome detection or exclusion.