What is QMS?

A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements, thereby improving its effectiveness and efficiency on a continuous basis.

ISO 9001:2015, the international standard specifying requirements for quality management systems, is the most prominent approach to quality management systems.

A QMS handles the following essential records:

  • Complaints
  • Investigations
  • CAPA
  • Action Items
  • Change Control
  • Root Cause Analysis
  • Effectiveness Checks
  • Risk Analysis
  • Audits
  • Findings and Observations
  • Training Management
  • Controlled Documents