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How can I justify excluding the R&D group and the design and development clause?

O

ochem

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#1
#1
This new company I recently started at has me implementing ISO 9001. They have an R&D group in the parent company, and one of their IP holding sub companies wants the ISO certification to open up new markets. R&D is clearly doing design and development of new products, not only for the sub company in question, but other product development as well. In my previous place of employment, it was a similar setup, R&D at corporate headquarters, chemical plant in different state. That place was able to exclude design and development, and I could never get the answer on how they managed that.

How can I justify excluding the R&D group and the design and development clause at the new company? My thought was to treat it as an externally provided resource. They have very good controls and record keeping, but the head of R&D absolutely does not want to be under the ISO cert. Ideas?
 
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Pjservan

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#2
#2
It sounds like your site does not do Design. You are allow to explain that in the scope of your system and explain why requirements related to product design do not apply to you. This is permissible under ISO 9001. In your case you are trying to certified the manufacturing site and not the whole corporation.
 
John Broomfield

John Broomfield

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#3
#3
The answer lies in your scope statement.

Write it so it does not include design of your products.

You may however find that your organization continues to design its services.
 
Sidney Vianna

Sidney Vianna

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#4
#4
ochem said:
Ideas?
Click to expand...
In this day and age of commoditization and trivialization of certificates, you will find no shortage of CB's fighting for your business and none will object to the idea of certifying the manufacturing operation, "ignoring" one of the most critical processes, in terms of product regulatory compliance, product safety and risk mitigation: product design and development.

You do what you can, but an organization leadership that allows products to be designed in the absence of well structured D&D process is doing a terrible job of managing risks. So, be aware.
 
John Broomfield

John Broomfield

Staff member
Super Moderator
#5
#5
ochem,

Sidney makes a very good point.

The top manager of the parent company would be well advised to require R&D to conform to the standard too.

Meanwhile, what do your customers expect?

John
 
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