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Related Topic Tags
7.3 - design and development, 7.5.1 - control of production & service provision, 7.5.2 - validation of processes, design and development, design engineering company, iso 9001 - quality management systems
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  #1  
Old 19th July 2012, 05:22 AM
armani armani is offline
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Question Auditing Design Organization - Auditor has to audit 7.3 and 7.5.1 / 7.5.2 separately?

I was never very clear about one thing - at a certification audit for an organization performing "only" design activities, auditor has to audit separately both 7.3 and 7.5.1 / 7.5.2 clauses?
What can be asked - or rather found, that' interesting to me - at 7.5 apart from what found at 7.3?

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Old 19th July 2012, 09:26 AM
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Re: Auditing Design Organization - Auditor has to audit 7.3 and 7.5.1 / 7.5.2 separat

For a pure design organization they do appear to run together. The difference maybe subtle (or even no existent) in your processes.

I like to take a step back and think of 7.3 as the process for designing the product, and 7.5 as the process for providing the final design (production) to your customer.

7.3 controls what you do in your organization to design the product and the controls in place to ensure the design integrity.

7.5.1 would control the processes that your organization performs to prepare it for the presentation to the customer.

Hope it makes sense!
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Old 19th July 2012, 10:38 AM
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Re: Auditing Design Organization - Auditor has to audit 7.3 and 7.5.1 / 7.5.2 separat

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7.5.1 would control the processes that your organization performs to prepare it for the presentation to the customer.

Hope it makes sense!
I'm not sure about what u mean with "prepare it for presentation"??
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Old 20th July 2012, 12:54 AM
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Re: Auditing Design Organization - Auditor has to audit 7.3 and 7.5.1 / 7.5.2 separat

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I'm not sure about what u mean with "prepare it for presentation"??
Probably means everything up to delivering (ie, handing over) to the customer.
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Old 20th July 2012, 12:45 PM
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Re: Auditing Design Organization - Auditor has to audit 7.3 and 7.5.1 / 7.5.2 separat

When auditing using the Process Approach, hopefully the processes are being audited and not each clause of the standard.

I think you need to think about a clear definition of what your product is. And then once you have a very clear definition of your product, spend some time thinking about the meaning of each clause of 9001.

7.3 is how you design your product. How do you design the thing that you provide to your customers.

7.5.1 is about how you turn that product design into the thing that is delivered to your customer (including the actual delivery of the thing).
Thank You to vanputten for your informative Post and/or Attachment!
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Old 20th July 2012, 12:54 PM
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Re: Auditing Design Organization - Auditor has to audit 7.3 and 7.5.1 / 7.5.2 separat

Quote:
In Reply to Parent Post by armani View Post

I was never very clear about one thing - at a certification audit for an organization performing "only" design activities, auditor has to audit separately both 7.3 and 7.5.1 / 7.5.2 clauses?
What can be asked - or rather found, that' interesting to me - at 7.5 apart from what found at 7.3?
First, you look at auditing the processes and then to fit them into a clause is no big deal.
For an organization performing "only" design activities, for 7.3 the addressing has to be towards how designs are designed and developed.
for the 7.5 the addressing has to be towards a design and development delivery.
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