Samenvatting

This report is compiled to evaluate and optimise the current purchase and traceability process of MR Production & Service and presents recommendations on how the organisation should design documentation for its Quality Management System regarding purchasing and traceability to meet the standards of ISO 13485 by the end of 2017. The purpose of this research is to set up the documentation in a way it can be implemented and it will still be applicable when the organisation has grown tenfold. Based on the theory of Greiner, the organisation is in its Pioneer Phase and growing towards a Leadership Crisis where professional management is needed.