Licensed copy of best practice compliance procedures
Club members will receive a licensed copy of the EcoDesign and Product Stewardship processes and procedures for the members own use. In addition, members will also receive examples of auditable compliance documentation which provide suitable evidence to demonstrate compliance with the standard to a certification body.
The practical integration of the processes and procedures into the New Product Design process has been tested by global medical device manufacturer Smiths Medical (www.smiths-medical.com). Smiths Medical has begun to roll out ENVIRON’s process and procedures across all sites world-wide.
Global verification, testing and certification company SGS (www.sgs.com) has reviewed the process and procedures and confirmed that there are suitable for a company to use to prepare for certification to the IEC 60601-1-9 International Standard.
The process and procedures comprise a structured series of checklists which are inserted into each stage of the new product design process. By completing the checklists the company’s design team will automatically generate the document evidence which is required to demonstrate compliance with IEC 60601-1-9.
For further information, please contact Dr Aidan Turnbull
Head of WEEE, RoHS & EcoDesign on +44 (0)1225 748420
