| Context of the organization: There is no text without a context. Context of the Organization involves understanding all the relevant factors impacting an organization's ability to achieve its objectives. | - Document Management
- Change Management
- Audit Management
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| Leadership: Leadership enables the QMS, fixing accountability on top management for the QMS's effectiveness. Leaders create vision and values, ensuring coherence throughout the organization. | - Document Management
- Change Management
- Audit Management
- Training Management
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| Planning: Planning sets clear quality objectives. It determines the action required to achieve the set objectives by allocating necessary resources to support the QMS. | - Document Management
- Change Management
- Audit Management
- Risk Management
- CAPA Management
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| Support: Providing the necessary resources, including personnel, infrastructure, and information to enable the QMS to function effectively is crucial. | - Document Management
- Change Management
- Audit Management
- Training Management
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| Operation: This element focuses on executing planned processes, ensuring products and services meet quality requirements, and maintaining process control. | - Document Management
- Change Management
- Audit Management
- Training Management
- NC Management
- CAPA Management
- Complaints Management
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| Performance evaluation: Regular evaluation of the QMS's performance by monitoring, measuring, and analyzing results helps an organization in tracking progress and identifying areas for improvement. | - Document Management
- Change Management
- Audit Management
- Training Management
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| Improvement: Continuous improvement is central to ISO 9001:2015, with organizations encouraged to identify opportunities for enhancement and implement changes to increase efficiency and effectiveness. | - Document Management
- Change Management
- CAPA Management
- NC Management
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