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 implementation, this standard has placed great emphasis on documentation requirements which are more prescriptive in insisting on the …