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Exclusions in ISO 9001:2015

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Guest user Created:   Jun 14, 2017 Last commented:   Jun 14, 2017

Exclusions in ISO 9001:2015

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Strahinja Stojanovic Jun 14, 2017

I am currently sited in Singapore which acts as the production HQ for five shoes factories based in Asia and Europe. I am trying to redraft the quality manual(currently based on 2008 ver) to conform to ISO:9001:2015. I hope to know if below requirements are justified to be excluded from the quality manual.

For 8.2 & 8.3, the justifications for exclusion are due to these processes are owned by R&D function sitting in Denmark thus my site has no control over it. For 8.5.3, we don't own any customer and external provider's properties in the factories today.

8.2 Requirements for products and service
8.3 Design and development
8.5.3 Property belonging to customer or external providers

Are these exclusions acceptable? Appreciate your insights.

Answer:

It is hard to conclude from your question whether the R&D function is part of your QMS scope or not. If yes, then it is impossible to exclude clause 8.3. If not, you need to define your relationship with the R&D section, they can be considered as your external pr ovider, so you only need to define controls of external provider and can exclude the clause 8.3.

When it comes to clause 8.2, it is not clear how this is related to R&D since these requirements are related mainly to sales process and this can hardly be excluded in your case. The clause includes identification of product requirements and review of product requirements so it is rather hard to exclude it. Justification for the exclusion can be that you only work for one customer and even in that case it is stretched. I would suggest you to keep this requirements within your QMS although I cannot say with 100% certainty since I do not have all information.

As far as clause 8.5.3 is concerned, your justification is OK, and you can exclude these requirements from your QMS.

To read more 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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Jun 14, 2017

Jun 14, 2017

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