Rigaku achieved certification by demonstrating compliance with the industry-accepted, quality management standards for the design, development, manufacture, and support of hardware and software for portable scientific instruments. Rigaku is committed to manufacturing high quality Raman analyzers for the pharmaceutical industry and the achievement of ISO certification will enable the company to continue to lead the way in delivering innovation in the field of handheld and portable Raman analyzers.
The external auditors involved in the process praised Rigaku’s methodical engineering process document highlighting its comprehensive and well developed content. They also recognized the experience and skill of the technicians, particularly their ability to work to the required engineering design standards in a timely and effective manner. The auditors also reported no majors, minors or observations regarding Rigaku’s manufacturing processes, which is an impressive achievement as this is not a common occurrence for many companies undergoing the process.
“ISO is recognized worldwide as a quality management system and I am extremely pleased with the feedback we received and am proud of the team for this achievement.” commented Pam Sheedy, Quality Assurance Manager at Rigaku Raman Technologies who oversaw the entire auditing process. “This certification marks a period of growth for Rigaku as it enables us to continue to expand our operations worldwide. We are committed to delivering innovation in new markets so more customers can benefit from the new generation in handheld Raman and receive consistent, good quality products and services to meet their material analysis requirements.”
Rigaku recently moved their ISO 9001:2008 compliant manufacturing facility to a new location in Wilmington, just outside of Boston, Massachusetts. The new scientific manufacturing space was constructed with laser lab facilities, a clean room and applications analysis space, all under one roof, enabling Rigaku to ensure excellent coordination of their manufacturing processes. By achieving certification for the new site, Rigaku has demonstrated the robust nature of its manufacturing system and its capability to transfer its operations to a new location with no disruption to production or customer care.
Being ISO accredited highlights Rigaku’s commitment to manufacturing high quality products and establishes them as a leading pioneer and innovator in Raman spectroscopy. Rigaku launched Progeny, the world’s first customizable handheld Raman analyzer for comprehensive raw material identification and chemical detection last year. With its unique 1064nm excitation laser, Progeny is able to overcome issues associated with fluorescence interference that affect other handheld Raman devices.