Standard Issues: Does It Apply?
Understanding exclusions and inapplicability in ISO 9001:2015
- Quality Progress
- December 2020
- Volume 53 Issue 12
- pp. 70-71
- Cressionnie, L.L. “Buddy”
- ASD Expertise LLC
One change in ISO 9001:2015 that did not get much notice was related to how exclusions were handled. Previously, exclusions—clauses or requirements organizations could deem inapplicable to their quality management system (QMS) with justification—applied only to product realization requirements. The 2015 revision allowed inapplicability to be applied across all sections of the QMS standard, as long as the organization can justify that inapplicability.