The accreditation is an international gold standard which defines quality management systems for manufacturers of medical devices.
The ISO13485 re-certification will further build on Hart Biologicals’ reputation for producing reagents to exceptionally high standards for use across the world in the treatment of cardio and vascular diseases and genetic disorders.
Carole Winton, Quality and Regulatory Affairs Manager at Hart Biologicals, said: “We have always been a quality focused company, but this new level of certification gives existing and potential customers the reassurance they need that all our systems fulfil the most stringent requirements, and that they can expect consistently high calibre manufacturing processes.
“The accreditation confirms that our manufacturing processes and safety procedures comply with European Union legislation and allows our products to bear the CE quality standard mark. But it is particularly important within our non-European markets because we are recognising more and more that customers will only work with companies that have the quality standard and carry the CE mark.”
Hart Biologicals’ processes were assessed in a number of key areas to achieve the ISO 13485 standard including infrastructure, working environment and production.