A Quality Management System (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction (ISO9001:2015). It is expressed as the organisational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it.
A QMS process is an element of an organizational QMS. The ISO 9001:2000 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes
Examples of such processes include:
- order processes
- production plans
- product/ service/ process measurements to comply with specific requirements e.g. statistical process control and measurement systems analysis
- calibrations
- internal audits
- corrective actions
- preventive actions
- identification, labeling and control of non-conforming products to prevent its inadvertent use, delivery or processing,
- purchasing and related processes such as supplier selection and monitoring.
ISO9001 requires that the performance of these processes be measured, analyzed and continually improved, and the results of this form an input into the management review process.
The term “Quality Management System” and the initialism “QMS” were invented in 1991 by Ken Croucher, a British management consultant working on designing and implementing a generic model of a QMS within the IT industry.
