ISO 9001:2015, 4.3

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.3 and highlights the changes from ISO 9001:2008.

4.3 Determining the Scope of the Quality Management System

Determine the boundaries and applicability of the system to establish its scope.

When determining the scope, consider:

  • External and internal issues (see 4.1)
  • Requirements of interested parties (see 4.2)
  • Products and services of organization

Apply the requirements of ISO 9001 when they can be applied within the scope.

If an organization can’t apply a requirement, this must not affect its ability or responsibility to ensure conformity of products and services.

Maintain and make available the scope as documented information stating:

  • Products and services covered by the system
  • Justification for any instance where ISO 9001 requirements cannot be applied

Further changes may be introduced in the FDIS version, as well as, in the final published version of the ISO 9001:2015 standard.

Changes:

  • This clause 4.3 replaces the need for old clause 1.2, Application.
  • Specifying the scope of the system is not a new requirement.
  • Adds to consider issues, interested parties, and products and services.
  • Exclusions are no longer limited to old clause 7, Product Realization.
  • See the new Annex A.5 for more on the applicability of requirements.