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There are many internal and external issues involved in running a business – Remember that for the QMS you only need to consider the issues that are relevant and that affect your ability to achieve the intended results of the QMS. To fully understand the organization and its context, your company determines the external and internal issues that are relevant to the QMS. To completely understand the needs and expectations of interested parties, you must identify the relevant interested parties, determine, monitors and reviews the requirements that are relevant to the QMS. Their expectations and needs and the impact or potential impact on the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements are considered. To determine and establish the scope of the QMS, Your Company determines the boundaries and applicability of the QMS and considers the external and internal issues, the requirements of relevant interested parties, the requirements that can be applied, and the products and services of your company. To establish, implement, maintain and improve the QMS, Your Company determines the processes needed and their interaction and application throughout the company. This process approach provides for the management of the quality system and its processes through the application of a “Plan-Do-Check-Act” continual improvement methodology, and a focus on “Risk-Based-Thinking” that lead to the prevention of undesirable outcomes.