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Standard Issues: Does It Apply?
  • Healthcare, Manufacturing, Service

Standard Issues: Does It Apply?

Understanding exclusions and inapplicability in ISO 9001:2015

Publication:
Quality Progress
Date:
December 2020
Issue:
Volume 53 Issue 12
Pages:
pp. 70-71
Author(s):
Cressionnie, L.L. “Buddy”
Organization(s):
ASD Expertise LLC

Abstract

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.

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