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Our Mission

CGI’s mission-critical goal is to help clinical laboratories institute and maintain Quality Management Systems (QMS). We accomplish this challenging but achievable objective by emphasizing and delivering staff education, competency assessment, and by supporting world-class accreditation and certification programs. Our tools include software, information development, and other in-house products resulting from our experience, expertise, and innovation.

The last 30 years have seen CGI challenge a series of “firsts” in Japan. We were the first to bring College of American Pathologist (CAP) Accreditation services. Since that time we have seen nearly all medium and large reference laboratories become apart of the family of over 8000 globally accredited labs. We were also the first to localize CAP external proficiency testing (PT) into the Japanese language, adding hundreds of laboratories to the nearly 23,000 global CAP PT participants. We were the first to bring ISO 15189 Certification programs to Japan through TUV SUD, and later supported JAB ISO 15189 programs, and having supported some 80 laboratories gain ISO 15189 accreditation.

Then, we had the idea to create the first do-it-yourself software program, which we now call LEAP. LEAP is allowing us to vastly expand the number of laboratories we can support as well as standardize and increase the scope and quality of our services. LEAP supports both ISO 15189 and CAP Accreditation programs. It allows laboratories a step-by-step approach to both create and effectively maintain QMS.

I am continually amazed by the CGI staff as they continue to innovate our cloud based software programs into areas new and effective ways toward a fully Do-it-yourself software product – another first – and the biggest step we have ever taken toward fulfilling our mission of fully supporting laboratories in their pursuit of global quality standards.

Other firsts include the first publication dedicated to bringing global knowledge to the Japanese laboratory and in the Japanese language in the form IVD Global News. We have also localized the CAP PIP program to help anatomic pathologists prefect their craft. We were also first to bring digital learning management systems (LMS) to physicians and medical technologists before the advent of the modern internet.

I would like to offer my profound thanks to all those who have supported us as we bring new ideas – some of which probably sounded a bit crazy at the time. But, I think most would agree worked out pretty well in the end. Great thanks to the JSLM, JSP and the JAMT for their support of our mission. Thanks also to the many diagnostic manufacturers who have supported the distribution of our software solutions and sponsorships of IVD Global News. And, a special thanks to The College of American Pathologists (CAP) for your fantastic support to Japanese laboratories through all these many years. CAP is a non-profit organization whose volunteer inspectors sacrifice their time and knowledge to help laboratories around the globe.

The future is looking bright for laboratory medicine in Japan, and I hope that CGI can continue to be a small part in helping to foster quality management systems toward global best practices and contribute to the highest possible patient outcomes.


Yours truly,



Mark A. Colby

Founder and CEO