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Quality Control Section and Warehousing sections

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Created:   Nov 03, 2020 Last commented:   Nov 05, 2020

Quality Control Section and Warehousing sections

Our company has purchased the 13485 toolkit.  However, under the 21 sections of the ISO toolkit, we are not sure where to place our quality control SOP including SOPs QC of raw material, QC of process products and QC of finished products.  I thought the best place to put it would be under production and service.  Or do you think it would be a better idea to open a new section on it own.  Another question is regarding warehousing.  I do see the toolkit has lumped this section on the production and service section.  If we open a new section for warehousing, would this be okay?  Thank you very much!

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 05, 2020

Yes, you are right, the best place to put SOP including SOPs QC of raw material, QC of process products, and QC of finished products is under the folder Production and service.

Considering the warehouse procedure, we have in our Toolkit folder 14_Warehousing_Procedure so everything that you want to describe here, you can put it in this folder.

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Nov 03, 2020

Nov 05, 2020