ISO 9001 Design & Development - 7.3.4 Review, 7.3.5 Verify, 7.3.6 Validate

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S

sal881vw

#22
Kindly note also the following definition found in ISO 9000 – 2000 QMS Guidelines and vocabulary
3.4.1
process set of interrelated or interacting activities which transforms inputs into outputs
NOTE 1 Inputs to a process are generally outputs of other processes.
NOTE 2 Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to add value.
NOTE 3 A process where the conformity (3.6.1) of the resulting product (3.4.2) cannot be readily or economically verified is frequently referred to as a “special process”.

From a search that I have made it results that NADCAP lists welding as a special process but maybe that is another case.

I hope to have been of some help.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#25
Where is that requirement found? I can't find that in ISO 9001:2008.
That part that talks about the product having to comply with regulatory requirements, applicable codes and those pesky customer requirements.

Anyone who knows a little about critical welding knows that product integrity requires process validation, which comprises, as a minimum, approved WPS's, approved personnel, process conformance to specs, calibrated instrumentation in process equipment, and the same concerns for the typical NDT processes that follow suit.
 

Big Jim

Super Moderator
#26
That part that talks about the product having to comply with regulatory requirements, applicable codes and those pesky customer requirements.

Anyone who knows a little about critical welding knows that product integrity requires process validation, which comprises, as a minimum, approved WPS's, approved personnel, process conformance to specs, calibrated instrumentation in process equipment, and the same concerns for the typical NDT processes that follow suit.
So it is not part of ISO 9001:2008 unless those other factors apply?
 
S

sal881vw

#27
Nice except you're using a reference that was replaced 5 years ago
it was not replaced 5 years ago........ISO 9000-2005 still shows the same clause and the same text.....a simple search will suffice this.....just email me if you need any help.
 
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C

ccochran

#29
Champlain, thanks for your kind feedback. I appreciate it. With the approaching publication of ISO 9001:2015, I'm hoping to get inspired again to write about quality...
 
M

Mike_H

#30
We are a subsidiary company in Australia, out parent company is in USA who hold Design Authority (that pesky ITAR...) for pretty much all engineering design we built to. They hold AS9100 and follow their own D&D, Configuration processes etc.. We are, in effect, subcontractors for engineering design and satisfy their SOW requirements (when they stop changing their minds) in the form of engineering technical data packages that we eventually manufacture to.

1. When developing processes for D&D and Config Management, is it enough to "point" to their QMS or do local processes need to contain a subset of theirs to some degree?

2. Control of D&D Changes AS9100 Sect 7.3.7: Is this applicable to any stage of D&D activity, or is it more geared to change control after final design is approved (aka revision control) ? I ask this because of reference to "...product already delivered" , which only makes sense if the D&D is complete and product is actually being manufactured against that design.

Bit confused here...
 
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