By Joana dos Guimarães Sá

The scope of the quality management system is determined by the organization and defines the boundaries of the QMS; the products, services, and process included; and the interfaces of the system with other relevant interested parties—either internal or external.

Analyzing the determined scope is one of the most relevant activities for an auditor as it will strongly impact either the scope of the audit (and the subsequent planning of the audit), the scope of a certificate (in the case of a third-party audit), and any communication to customers and other relevant external interested parties.

Alongside the scope definition, the organization must determine the need to consider any requirement of ISO 9001:2015 as non applicable and provide a clear justification. The concept of non applicability is different from the allowed exclusions in previous versions of ISO 9001 and poses different challenges to organizations and auditors. Given the broad applicability of ISO 9001:2015 to all organizations in all sectors and different contexts, it is difficult to define a simple decision criteria.

This presentation will explore the factors to consider as well as examples of good and bad practices.