1. Scope
Defines the purpose and applicability of the ISO 9001:2015 standard, ensuring organizations understand how to apply it to their context to consistently provide products and services that meet customer and regulatory requirements.
2. Normative References
Lists the reference standards or documents that are indispensable for the application of ISO 9001:2015. It essentially mentions that the latest version of the standard itself contains all the information needed for implementation.
3. Terms and Definitions
Clarifies the terms and definitions applicable to the ISO 9001:2015 standard to ensure a common understanding of the key concepts among all users of the standard.
4. Context of the Organization
Requires organizations to consider both the internal and external issues that can impact their strategic objectives and the planning of the QMS. It emphasizes understanding the needs and expectations of interested parties.
5. Leadership
Focuses on top management’s role in the effectiveness of the QMS, ensuring that there is a commitment to customer focus, defining and communicating the quality policy, and assigning roles and responsibilities within the organization.
6. Planning
Addresses the requirements for planning the QMS including actions to address risks and opportunities, quality objectives and planning to achieve them, and planning of changes to the QMS.
7. Support
Covers the resources needed for the QMS, including people, infrastructure, environment for the operation of processes, monitoring and measuring resources, knowledge, competence, awareness, communication, and documented information.
8. Operation
Describes the requirements for planning, implementing, and controlling the processes needed to meet the service and product provision requirements, including design, development, production, and delivery.
9. Performance Evaluation
Details the monitoring, measurement, analysis, and evaluation requirements to ensure conformity of products and services, customer satisfaction, and the effectiveness and continual improvement of the QMS.
10. Improvement
Specifies the requirements for continual improvement of the QMS, including identifying and selecting opportunities for improvement and implementing necessary actions to meet customer requirements and enhance customer satisfaction.