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Exclusions in ISO 9001:2015

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Guest user Created:   Jun 12, 2018 Last commented:   Jun 12, 2018

Exclusions in ISO 9001:2015

I want to ask a question or consult, if a company manufactures something under the variables established by the client. Do you think you should exclude the product development point?
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ISO 9001 DOCUMENTATION TOOLKIT

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Iciar Gallo Jun 12, 2018
If the organization does not perform any design and development process within the QMS, the clause 8.3 of design and development of products can be excluded from the scope. When excluding clauses of the standard, you need to document the exclusions in the document about the scope of the QMS and provide justification for those exclusions.
To learn more about exclusions in ISO 9001:2015, see this article - What clauses can be excluded in ISO 9001:2015https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/
These materials can also help you with the implementation of ISO 9001:2015:
- 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://training.advisera.com/course/iso-9001-foundations-course/
- Conformio - Compliance tool: https://advisera.com/conformio/
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