Understanding Exclusions & Non-Applicable Clauses in ISO 9001

Not every requirement in ISO 9001 fits every organization, but deciding what doesn’t apply is one of the most commonly misunderstood parts of building a quality management system. In this webinar, Joe Krolikowski breaks down how organizations can correctly identify and justify requirements that do not apply to their operations.

The session explains how the concept has changed from the older “exclusions” approach of ISO 9001:2008 to the current standard’s framework under Clause 4.3, where organizations define the scope of their QMS and must justify any requirement they determine does not apply. Joe covers the key condition that governs these decisions: a requirement can only be considered not applicable if it does not affect the organization’s ability to ensure product and service conformity or enhance customer satisfaction.

Attendees will learn which clauses are most often cited as not applicable, such as design and development, customer property, or monitoring and measuring resources, along with how to document a clear, defensible justification. The webinar also highlights common mistakes that lead to audit findings, helping organizations approach certification audits with confidence and keep their QMS scope accurate and credible.

Ideal for quality managers, management representatives, and anyone preparing for ISO 9001 certification or recertification.

Presented By:

Joseph Krolikowski
PJR QMS & ABMS Program Manager