How to Define the scope of iso 9001 certification?

Defining the scope of ISO 9001 certification is an important step in implementing a quality management system. The scope statement defines the boundaries of your quality management system and specifies what is included and excluded from the certification. Here are some steps to define the scope of ISO 9001 certification:

  • Identify the organization's objectives and goals: The first step is to understand the organization's objectives and goals, including the products or services it provides, the markets it serves, and the customers it targets.
  • Identify the processes: Identify the processes within the organization that are involved in delivering the products or services, such as design, production, delivery, customer service, and so on.
  • Define the boundaries: Define the boundaries of your quality management system. This includes specifying the products or services covered by the quality management system, the locations, facilities, and processes included, and any exclusions from the certification.
  • Consider external factors: Consider any external factors that may impact the scope of your quality management system. This may include regulatory requirements, customer requirements, or any other factors that may affect the quality of your products or services.
  • Consult with stakeholders: Consult with stakeholders, such as customers, employees, and suppliers, to ensure that the scope statement accurately reflects the organization's objectives and goals and meets their needs and expectations.
  • Document the scope statement: Document the scope statement in the quality manual, along with the processes, policies, and procedures required to meet the ISO 9001 standard.

By following these steps, you can define the scope of your ISO 9001 certification and ensure that your quality management system meets the requirements of the standard. Remember that the scope statement should be reviewed regularly and updated as needed to reflect changes in the organization's objectives or external factors that may impact the quality management system.

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