Paul Batalden, M.D., professor at The Dartmouth Institute for Health Policy and Clinical Practice, once said, “Every system is perfectly designed to get the results it gets.” This idea seems applicable to any system of human design. Phrased slightly differently using ISO 9001 parlance, “Every system is perfectly designed for its outputs.”

A quality management system (QMS) is a system of processes working together to achieve the objective of customer satisfaction. This objective is achieved when the system outputs quality product or services as expected by customers. Using a process approach, a QMS is designed to continually improve processing. It starts with defining the processes needed by the system. These are known as value-chain processes or core processes. Each plays a part in outputting quality product and is central to what an organization does in order to make a profit.

Each process needed for a QMS has some kind of procedural support. Procedures specify how processes should be carried out, providing a foundation for consistency in processing. A written procedure provides stability to core processes by documenting how management wants those processes to be performed.

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