Clauses in ISO 9001:2015 Quality Management System

ISO 9001:2015 is structured around several clauses, each addressing different aspects of quality management. The main clauses in ISO 9001:2015 are as follows:

1. Scope: This clause defines the scope of the quality management system (QMS), specifying the boundaries and applicability of the standard within the organization.

2. Normative References: This clause lists any external documents referenced in the standard that are necessary for its application.

3. Terms and Definitions: This clause provides definitions for key terms used throughout the standard to ensure consistent interpretation and understanding.

4. Context of the Organization: This clause requires organizations to determine the internal and external factors that may affect their QMS and to understand the needs and expectations of interested parties.

5. Leadership: This clause emphasizes the importance of leadership and commitment in establishing and maintaining the QMS, including roles, responsibilities, and promoting a quality culture.

6. Planning: This clause focuses on the organization's commitment to addressing risks and opportunities, setting quality objectives, and planning actions to achieve them.

7. Support: This clause addresses resource management, including providing the necessary resources, competence, awareness, communication, and documented information to support the operation of the QMS.

8. Operation: This clause covers the execution of planned processes, including operational planning and control, product/service provision, and the management of external providers.

9. Performance Evaluation: This clause emphasizes the importance of monitoring, measuring, analyzing, and evaluating performance against quality objectives, requirements, and the effectiveness of the QMS.

10. Improvement: This clause focuses on continually improving the suitability, adequacy, and effectiveness of the QMS through corrective actions, preventive actions, and management reviews.

Each clause contributes to the overall framework of ISO 9001:2015, providing guidance for organizations to establish, implement, maintain, and continually improve their quality management systems. This standard helps organizations enhance customer satisfaction, meet regulatory requirements, and achieve continual improvement in their processes and products/services.