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
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