QMS
A Quality Management System (QMS) is a formalized framework of policies, processes, and software tools that documents how an organization ensures product and process quality, manages nonconformances, executes corrective and preventive actions, and demonstrates regulatory compliance. Software QMS platforms (Veeva Vault QMS, MasterControl, ETQ Reliance) automate the workflows for document control, CAPA management, audit management, and regulatory submission.
Why it matters
In regulated industries, a QMS is not optional — it is a regulatory requirement. ISO 9001, ISO 13485, IATF 16949, and AS9100 all mandate a formal quality management system. The QMS is the mechanism by which quality events are captured, investigated, and resolved in a way that is defensible under audit. Without it, quality management is informal and unauditable.
External References
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Cite this definition
Finocchiaro, Michael. “QMS.” DemystifyingPLM PLM Glossary, 2026, https://www.demystifyingplm.com/glossary/qms