ISO 9001:2015

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

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

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

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

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

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

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