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Exclusions in the scope of the QMS

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Guest user Created:   Nov 21, 2018 Last commented:   Nov 21, 2018

Exclusions in the scope of the QMS

I have a question in relation to 03_Quality_Manual and specifically section 2.1 Exclusions. From by research it appears that this section only applies in the case that ISO 9001:2015 has been implemented? Such that, if ISO 9001 has not been implemented there are no relevant exclusions. Can you please confirm this is correct.
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ISO 9001 SCOPE OF THE QUALITY MANAGEMENT SYSTEM

Define the scope of the QMS and its boundaries.

ISO 9001 SCOPE OF THE QUALITY MANAGEMENT SYSTEM

Define the scope of the QMS and its boundaries.

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Iciar Nov 21, 2018

Answer:

Exclusions doesn´t apply when the standard has been already implemented. In fact one of the first steps when implementing ISO 9001:2015 is determining the scope of the organization and when defining the scope of your QMS you should also determine if any exclusions apply and justify them. For instance, if a company doesn´t do any design work, but it uses designs already given by a customer, you can say that this requirement doesn´t apply to your organization.

These materials can help you to better understand exclusions in the scope of ISO 9001:2015
- 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/
- Articl e: https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- Book - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/

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Nov 21, 2018

Nov 21, 2018

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