Omega Diagnostics awarded ISO compliance
Medical diagnostics company Omega announced on Thursday that its fully owned Indian subsidiary, Omega Dx Asia, has received certificates of accreditation from BSI confirming its Quality Management System is compliant with the ISO 9001:2008 and ISO 13485:2003 standards.
The AIM-traded firm said the accreditation covers the manufacturing facility in Pune and ensures that product originating from this site is designed, manufactured and supplied to internationally recognised quality standards.
It said the milestone is an important prerequisite for CE-Marking the malaria and pregnancy tests produced at the site.
CE-Marking is still expected to be achieved by the end of the current financial year, the board said.
The board added that accreditation also means that products can be supplied for the Indian domestic market with immediate effect, and said the first commercial sale of one of the company's malaria tests has now been achieved.
“We are pleased to have reached this milestone on schedule and look forward to generating a return from the investment to date in this facility,” said CEO Andrew Shepherd.