Quality Management System (QMS)
Per our glossary, a QMS is
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
If you read our blog post regarding our definition of the three levels of compliance, a QMS is typically defined for some level two organizations and most level three organizations. Some level one organizations could benefit from standardizing company procedures like onboarding, accounting, technical system administration, etc. but having a formal SOP with formalized training is typically not needed.
From the definition of the elements of a QMS, we'll run an organization through the following checklist(s) to determine what actions need to be taken in order to comply with the regulation that govern them.