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 purpose of this study is to investigate the presence of quality assurance, risk management, and audit practices at the municipal, provincial and federal levels of law enforcement in Canada. Based on open‐ended interviews and surveys with management of law enforcement agencies,...

Purpose The purpose of this paper is to theorize and prioritize the main categories of risk sources for the European manufacturing small- and medium-sized enterprises (SMEs) in accordance with the International Organization for Standardization (ISO) 9001:2015 requirement “risk based...

Purpose – The purpose of this paper is to focus on developing a knowledge-based engineering (KBE) approach to recycle the knowledge accrued in an industrial organization for the mitigation of unwanted events due to human error. The recycling of the accrued knowledge is vital in mitigating the...

Purpose – The purpose of this paper is to examine the field of risk management in relation to the connection to quality management. It poses and attempts to answer three questions. What can quality teach risk management? What can risk management teach quality? What must both risk and quality...