January 2018 Haemokinesis gains ISO 13485:2016 certification
Haemokinesis is proud to announce that the company has been awarded ISO13485:2016 certification. It recognises the dedicated work across the company to achieve this internationally recognised standard. Haemokinesis designs, manufactures and supports hardware and consumables used in Immunohaematology laboratories. It also distributes a range of immunohaematology products imported from overseas to Australian and New Zealand Transfusion laboratories.
To quote from the International Organization for Standardization
“ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).”