To define the QMS scope according to ISO 9001:

- Start by understanding the organization's context and the requirements of relevant interested parties.

- Identify the products and services offered, considering the internal and external factors that affect the organization.

- Determine the boundaries and applicability of the QMS, ensuring it addresses all relevant statutory, regulatory, and contractual requirements.

- Document the scope clearly, explaining any exclusions from the QMS standards and their justification, ensuring they do not affect the organization's ability or responsibility to ensure conformity of products and services.