Our policy is to maintain compliance with all applicable worldwide regulations as well as sustain profitable growth by consistently delivering quality products and services that will meet and /or anticipate the needs of the global scientific and transplant communities.

The implementation of a pro-active quality management system based on continuous process improvement will ensure that quality is the fundamental value that is "built" into every process and product.

The Quality Management System of One Lambda Incorporated has been assessed and approved against quality assurance management systems standard: 

EN ISO 13485:2003 

The Quality Management System is applicable to the Design, Manufacturing and Distribution of In Vitro Diagnostic assays and reagents for the determination of HLA tissue groups.  

Download ISO 13485 certificate.

Download CMDCAS certificate.