Abstract

The 2015 standard "ISO 9001: Quality Management Systems--Requirements" contained two major revisions related to organizational context and risk-based thinking, respectively. Internal and external factors that define organizational context, environmental scanning and strategic planning should help guide the design of a Quality Management System (QMS). Implementation of a QMS should consider the interplay of the various risks an organization faces. Risk-based thinking examines the differential impacts that an individual risk can have on different processes, and how multiple risk factors impact the overall outcome of an organization's stated goals.