Hamimi Abdul Razak, Izatul; Kamaruddin, Shahrul; Abdul … - In: The TQM Journal 21 (2009) 1, pp. 6-19
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...