ISO 9001:2015, 4.1

The first requirements clause of ISO/DIS 9001:2015, clause 4, Context of the Organization, has four sub-clauses:

4. Context of the Organization
4.1 Understanding the Organization and its Context
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Determining the Scope of the Quality Management System
4.4 Quality Management System and its Processes

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.1 and highlights the changes from ISO 9001:2008. The other articles in this newsletter describe clauses 4.2, 4.3, and 4.4.

4.1 Understanding the Organization and its Context

Determine the external and internal issues that:

  • are relevant to the organization’s purpose and strategic direction
  • and affect its ability to achieve the intended results of its system

Monitor and review the information about these issues.

Note 1: Consider external issues arising from legal, technological, competitive, market, cultural, social, and economic environments (local, regional, national, or international).

Note 2: Consider internal issues related to organizational values, culture, knowledge, and performance.

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


  • This is a new requirement on the context of the organization.
  • The Notes provide examples of external and internal issues.
  • Your organization may already monitor and review these issues.
  • Auditors will look for evidence of issue monitoring and reviews