Manufacturing Unit Ready for ISO 13485:2003 Certification
The Manufacturing Unit at the Hospital is ready for ISO 13485:2003 Certification by the Kenya Bureau of Standards (KEBS) for the Intravenous Fluids.The Unit will receive the Certificate on 22nd August, 2012 as the institution is re-certified for ISO 9001:2008, Quality Management System.
The ISO Standard will among other things ensure safety of Medical Devices while operating efficiently, achieving customer satisfaction and harmonizing regulatory requirements for medical devices.
While making a presentation during the weekly Continuous Professional Development (CPD) session on August 14, 2012, an officer in the Unit, Mr. Bunyasi Steve said the Standard puts emphasis on processes for manufacture of medical devices.
The Standard further governs any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) such as: diagnosis, prevention, monitoring, treatment or alleviation of disease.
Others are; monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, and disinfection of medical devices.
ISO is an International Agency consisting of 157 members countries including Kenya. It was formed in 1947 and is based in Geneva, Switzerland.ISO has developed about 17000 international Standards to date to foster increased trade of products and services.