ISO 9001:2015 in Detail: Exclusions and Requirements
What requirements can you exclude from your QMS under the new ISO 9001:2015 standard?
Section 1.2 of ISO 9001:2008 states an organization may exclude or ignore product realization requirements if they cannot be applied or if implementing them does not adversely affect its ability or responsibility to meet customer and legal requirements.
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Section 4.3 of ISO 9001:2015 says –Where a requirement of this International Standard within the determined scope can be applied, then it shall be applied to the organization.– This says that once the scope of the QMS is defined, every requirement must be applied within the boundaries defined by the statement of scope.
section 4.3 and Annex A5, however, states that any requirement may be excluded if it cannot be applied. The exclusion is justified by showing that compliance would undermine the performance of the product or service.