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ISO 9001 exclusions

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Guest user Created:   Oct 09, 2019 Last commented:   Oct 09, 2019

ISO 9001 exclusions

I have an question with exclusions to the ISO 9001:2015. Since we do not do design and development we have been excluding this. However, when the new standard came into effect our external auditor said we can not exclude this section without replacing it. He suggested production management.
From all the readings i have been doing on-line, I havent read you need to replace not exclude.
Is this true? Can you clarify this exclusion?

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Carlos Pereira da Cruz Oct 09, 2019

I am not sure I understand what your external auditor recommends.


ISO 9001:2015 does not allow exclusions period. However, if one particular clause is not applicable within the quality management system scope you do not exclude it, you just state that it is not applicable and explain why. Please check an example in this free webinar - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/


Check also this article - What clauses can be excluded in ISO 9001:2015? - https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/

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Oct 09, 2019

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