Purpose – The purpose of this paper is to provide an understanding on implementation and operation of ISO 13485:2003 – “Medical Devices – Quality Management System – Requirements for Regulatory Purposes” – in the perspective of medical device industries in Malaysia. The study is...

Purpose – The paper aims to introduce a model for measuring individual performance named Workforce Competency Model (WFCM). Notable aspects of the model including its validation/verification are explored and presented by means of a case study. Design/methodology/approach – The model is...