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Taking an Exception to Clause 7.3 in ISO 9001 and ISO 13485

#1
I have a question about taking an exception to clause 7.3 in ISO9001 & ISO 13485. We are a contract molding manufacturer who also builds tools for molded products. Our company is divided into two divisions (Tool building & Molding) The tooling side will build and design tools for customers but we do not design the final product. The molding side uses the tools to mold the product.

We were told we could not take an exception to 7.3 design and development for the tooling side because we "design" the tool itself. However, the tool is not the final product as defined. I believe we should take an exception. Emails to ANAB have gone unanswered.

Does anybody have an opinion or maybe have gone through this issue? As it stands now, we are going to continue with our exception to 7.3 but adding it will be a tremendous amount of extra work.
 

Sidney Vianna

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#2
Re: Taking an Exception to 7.3

If your scope of certification includes tooling, that would be (one of) your final products. So, you could not take exception to 7.3.

If your scope of certification relates only to the molding of parts, the exclusion would be acceptable, since you don't design the products you make for the customers.

You need to have that clarification confirmed with your chosen CB. ANAB is not going to interfere with the discussion that needs to happen between your and your CB.
 
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