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GAP analysis and exclusions from QMS

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Guest user Created:   Sep 26, 2018 Last commented:   Sep 26, 2018

GAP analysis and exclusions from QMS

Today in this morning we have a meeting with the QMS team of which Im the leader, our main discussion today is to come up with justification on the DESIGN and Development (Clause 8.3 ISO 9001:2015) if it should be included or excluded from our QMS Scope. Since we have a list of mandatory documents already prepared waiting for approval and then to start the THIRD PHASE(Implementation phase) but our Director said that we need to conduct a second round of Gap analysis!(some thing that I have never heard before!) what I know is only Gap analysis that we have already conducted before, now is the time for Internal Audit for what I know.
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Step-by-step implementation for smaller companies.

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Iciar Sep 26, 2018

Answer:

Usually GAP analysis is conducted at the beginning of the implementation in order to know which requirements are already covered by the organization and which ones the organization still needs to comply with. That being said, you don´t need to assess another GAP analysis but you will see how your organization is doing after performing the Internal Audit.

Here you can find a free ISO 9001 GAP analysi s tool: https://advisera.com/9001academy/iso-9001-gap-analysis-tool/

Regarding the exclusion of design and development from your scope, if your organization does not do any design work, but strictly work from designs given to you by a customer, then these requirements can rightly be determined to be not applicable to your organization.

To learn more about the exclusion of design and development from the scope, you can see 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/

To learn more GAP analysis and exclusions from the scope you can see this materials:
- Book - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free on-line course - ISO 9001:2015 Foundations Course: https://training.advisera.com/course/iso-9001-foundations-course/
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Sep 26, 2018

Sep 26, 2018

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