The Alslev-based Danish company Melitek announced that it has obtained ISO 13485:2016 certification for its Quality Management System covering sales, development and production of customised elastomer (TPE/TPO) and polymer compounds for healthcare applications.
The company said it expects the ISO 13485:2016 certification to strengthen its meliflex brand, provide further trust in its products and bring value to its customers. The new certification will not impose any changes to its products, since these are covered by the meliflex concept, which for years have incorporated key elements of ISO 13485, including full traceability, change control management, extensive line clearance, controlled operation procedures, and good documentation practices, said Melitek. The new certification covers the scope for product development that includes procedures on product risk assessment, product validation and post production surveillance, which will yield more reliable quality for new products and lower risk to products in use, said the company. As a result of achieving ISO 13485:2016 certification, Melitek said it will not renew its current ISO 9001:2008 certification when it expires.