What is a Quality Management System (QMS)?

Quality Management System Definition

A quality management system (QMS) is a formal system used to document, track, approve, and adhere to policies, procedures, regulations, and processes. The international standard, ISO 9001:2015, specifies requirements for a quality management system. “QMS” is often used to describe the ISO 9001 standard, but it actually refers to the entirety of the system. Having comprehensive QMS systems in place enables companies to design, produce, and deliver safe and effective products and medical devices by complying with a variety of regulations (e.g., FDA, ISO, EU MDR). This ultimately helps manufacturing companies prevent quality mistakes, cost overruns, and non-conformances by using a single, secure system for all internal teams and their supply chain partners.