Robust quality systems and ISO certifications ensure that the products we produce for you will meet or exceed your customers’ expectations.
Quality is the foundation of our business. Every point in the production process is critical to ensuring that your product is delivered with the exact specifications you require. Our ISO13485, 9001, 14001, CMDCAS, FDA Facility Registration and OHSAS 1801 certifications guarantee that your finished product will always meet high quality standards and responsible manufacturing requirements.
Quality management systems and precise manufacturing ensure lot-to-lot consistency. Accurate release analysis helps you formulate your final product – without the need to perform incoming testing. All of the products we manufacture are tested by highly-trained Quality Control analysts before being released to you by our Quality Assurance Department.
We have company-wide Continuous Improvement programs such as Lean Six Sigma which relies on a collaborative team effort to improve performance by systematically removing waste and reducing variation. This leads to improved quality of our products and a more efficient and safe manufacturing environment.
Lab managers and med techs value SEKISUI Diagnostics products – from the higher-than-normal sensitivity of our Ultra Strep A Test* and our trailblazing leadership in HDL/LDL testing to the breadth of our infectious disease expertise and the market-leading position of our Mono rapid diagnostic test in the U.S.
Our product lines include: