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ISO 9001:2015 Exclusions and Requirements

What requirements can you exclude from your QMS under the new ISO 9001:2015 standard?

Clause 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, also 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.

For example, if you do not design and develop products and services, you would want to state within your QMS scope that the design and development clause 8.3 of the ISO 9001:2015 requirements is excluded from your QMS.

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