The design and production of external diagnostic reagents of HKLife have acquired the recognition of ISO 13485:2003 quality management system. (MD571271)
ISO13485: the full name of 2003 standard is Medical Device-quality Management System-requirements for Regulatory. This standard is made by the technical committee of SCA/TC221 medical device quality management and common requirements' standardization, which is the ISO9001 under the environment of regulations on medical devices. The ISO 9001, EN 46001, ISO 13485 are universally taken as the requirements of quality guarantee system by America, Canada and Europe.
HKLife has the first biotechnology commercial laboratory (FS56773) which acquired ISO9001:2008 recognition in Hong Kong. It also referred that HKLife has been keeping the promise since its establishment: providing the products and services with the highest quality for our customers and partners.
ISO 9001 is the most mature quality framework in the world so far, which is made by British Standard Institution (BSI)—with the leading set standard.