ABSTRACT
A traditional quality management system will consist of a quality policy, quality manual, procedures, work instructions, guidance and forms to create records. It follows the traditional document-centric format for any part of a business management system. The 2015 version of the International Organization for Standardization 9001 standard has even permitted doing away with quality management documents, such as manuals and written procedures, leaving it to auditors to assess consistency from evidence gleaned by discussion and observation. One key aspect to management systems in high-risk industries is the quality assurance graded approach that aims to avoid an overly prescriptive system, given the propensity to add layers of very detailed documents within the system. The graded approach will also support the effective use of quality assurance resources, by prioritising activities requiring greater quality management oversight and scrutiny. Developing key performance indicators from the people, process, materials and machine metrics allows the management system to be measured and improved.
