As stated in ISO 9001:2015 Annex Table A.1, the term "exclusions" is no longer used in the standard. Instead, you must determine which requirements don't apply to your organization's quality management system (QMS) based on the organization's size, complexity, management model, activities, and risks and opportunities.The requirements for applicability are stated in Clause 4.3-Determining the scope of the quality management system, "which defines conditions under which an organization can decide that a requirement cannot be applied to any of the processes within the scope of its quality management system. The organization can only decide that a requirement is not applicable if its decision will not result in failure to achieve conformity of products and services."
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