HACCP

EN46001 indicates that a company’s internal systems and products consistently achieve a uniform, high quality specification. Cozart received accreditation following an intensive, two-day audit by an independent British Standards Institution (BSI) representative at Cozart’s premises. Once a company has received EN46001 accreditation, completed the necessary technical files and notified the Medical Device Agency it can CE mark its products.
‘We are delighted to have received this prestigious certificate’ commented Dr Roberto Liddi, Cozart Quality Assurance & Regulatory Affairs Manager. ‘EN46001 is specific to the manufacture of medical devices and demands additional, tougher, requirements compared with ISO9001:1994, which we were awarded in early 1999. Quality is a priority issue for Cozart and we have invested considerable time and effort into achieving this milestone in just eight months.’
EN46001 was developed by the medical device industry in Europe and it is administered by the BSI, a world leader in standards and quality management. It is an extension of the existing Quality System, ISO9001:1994 which covers a company’s internal systems, whereas EN46001 also encompasses product quality.