Excluding design and development
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Answer:
If the organization does not have design and development process within scope of the QMS, it can exclude the clause 8.3 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 exclusions.
You should also consider excluding clause 7.1.5 because I assume you do not use monitoring and measuring equipment in your processes. For more information about exclusions in ISO 9001:2015, see: 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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Apr 08, 2017