ISO14001 certification requirements

ISO 14001 certification bodies are increasingly requiring medical device manufacturers to show how they are addressing EcoDesign and product stewardship in their ISO 14001 environmental management systems. Clause 4.3.1 of ISO 14001 (2004) requires medical device manufacturers to establish, implement and maintain procedures to:

“identify the environmental aspects of its activities, products and services within the defined scope of the environmental management system that it can control and those that it can influence taking account of planned or new developments, or new or modified activities, products and services.”

ISO 14001 certification bodies are increasingly requiring medical device manufacturers to provide evidence of how the environmental impacts of their products are being assessed, controlled and reduced through the EMS.

For further information, please contact Dr Aidan Turnbull
Head of WEEE, RoHS & EcoDesign on +44 (0)1225 748420