4.1 Understand your organization and its unique context | • Identify and understand your organization's context.• Identify and understand your organization's context before you establish its quality management system (QMS).• Consider the external issues that are relevant to your organization's purpose and strategic direction and think about the influence these issues could have on its QMS and the results it intends to achieve.• Consider the internal issues that are relevant to your organization's purpose and strategic direction and think about the influence these issues could have on its QMS and the results it intends to achieve.• Monitor information about your organization's context. • Consider the impact changes in context could have on your organization's quality management system (QMS). | 4.2 Clarify the needs and expectations of interested parties | • Identify the parties who affect or could affect your QMS. • Consider how interested parties affect or could affect your ability to provide products and services that meet customer requirements. • Consider how interested parties affect or could affect your ability to provide products and services that meet statutory and regulatory requirements.• Clarify and understand their unique needs and expectations.• Monitor and review information about your interested parties. | 4.3 Define the scope of your quality management system | • Clarify boundaries and think about what your QMS should apply to. • Use boundary and applicability information to define your scope. • Consider your organization's context when you define your scope.• Document the scope of your quality management system (QMS). • Use your scope document to describe the boundaries of your organization's QMS and to explain what it applies to.• Use your scope document to identify and describe the products and services that will be