Hamimi Abdul Razak, Izatul; Kamaruddin, Shahrul; Abdul … - In: The TQM Journal 21 (2009) 1, pp. 6-19
:2003 – “Medical Devices – Quality Management System – Requirements for Regulatory Purposes” – in the perspective of medical device … to ISO 9001:2000 quality management systems. Design/methodology/approach – Literature research and comparative analysis … of medical devices that are being produced. For this reason risk management is an essential process that needs to be …