Quality management system auditing and ISO 19011: Fundamentals for future standardization of the method

Auditing is used to assess whether the requirements laid down in standards are being met. This paper studies the process of auditing quality management systems (QMS) to enhance our understanding of the process and develop a systematic approach. We focus on the information gathering and judgement parts of it. We compare the scarce literature about QMS auditing with the management system auditing standards ISO 19011 and ISO/IEC 17021-1. We incorporate insights from philosophical literature to develop a process model regarding the main steps of reliable auditing: observing reality; recalling memory and understanding the observed reality; contemplating and understanding abstract objects; expressing what is understood; judging: comparing what is understood and concluding about fulfilment of a requirement; and expressing the judgement. The methods described in these two standards are insufficient. Future researchers can use our model in developing theory on conformity assessment. The International Organization for Standardization (ISO) may use it to improve its conformity assessment standards.