Abstract

ISO 9001:2008, the international quality management system (QMS) standard, has been in use for many years and the more than one million certified organizations that abide by it are understandably wary of the impending change to ISO 9000:2015. The reality, however, is that the changes that have been implemented are designed to improve organizational QMSs by addressing the growing need for risk-based thinking. Risk-based thinking means that when an organization decides to change something, there are choices, consequences, opportunities and, of course, risk. It encompasses the varying acceptable degrees in which organizations choose (or don't choose) to manage risk. Because a QMS touches virtually every part of an organization, applying risk-based thinking allows organizations of any size to assess the value of its decision-making and makes higher level management less about giving direction and more about being an integral part of the decision-making process. Understanding risk means understanding one's organization. Risk-based thinking is simply the understanding of uncertainty and requiring that this consideration be part of formal and auditable processes will only enrich and improve overall quality and corporate objectives.