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Design and Development (Clause 7.3) - Do you think we are involved?

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T

trainerbob

#12
#12
It would be great if more people would step up to the plate and take responsibility for Design and Development when they are involved with it along with their customers. Keep up the good work.
 
I

ivalerio

#13
#13
Re: Design and development 7.3

big jim,
nice and informative. but partial design is nowhere to be seen in the standard. i mean there should be black and white only.. i am going to discuss this with our CB:)
 
I

ivalerio

#14
#14
trainerbob,
this is one of my problems (or should i say changellenges):) . i need to push them to the limits as an MR and lead auditor:(. i have to admit the management system we have is still unmatured...
 
somashekar

somashekar

Staff member
Super Moderator
#15
#15
ivalerio said:
trainerbob,
this is one of my problems (or should i say changellenges):) . i need to push them to the limits as an MR and lead auditor:(. i have to admit the management system we have is still unmatured...
Click to expand...
I may be wrong here but just felt to share.
Not all goods and services are provided by organizations right from its inception / conceptualization until delivery.
Customer have a lot of input to give and decisions to make on the delivered goods / services. Unless we realize this in a broad business sense and stand up to take responsibility in every little task we do, this design and development will always be viewed as a devil.
If something goes wrong then its very easy to say .... 'We did not design it, and so it is the customer's or design owner's fault'. We make ourselves tiny in this vast and expanding global market if we cannot see design and development within our processes.
Having said that, there are situations where design and development are purely outside the scope and every change has to be routed outside the QMS. One must be able to see this with more clarity and make the assessment.
 
Last edited:
B

Big Jim

Super Moderator
#16
#16
Re: Design and development 7.3

ivalerio said:
big jim,
nice and informative. but partial design is nowhere to be seen in the standard. i mean there should be black and white only.. i am going to discuss this with our CB:)
Click to expand...
The idea of partial exclusions already has a precedent. I suggest that you check the TC 176 for Document ISO/TC 176/SC 2/N 524R6. TC 176 is the technical committee that wrote ISO 9001:2008 and oversees it. You can do a google search to locate their web site. The document cited above provides guidance on exclusions.

Look at example 9 in the appendix. It is about calibration. The last line states: "In conclusion, sub-clause 7.6 could not be excluded in its entirety, only in part".
 
Stijloor

Stijloor

Staff member
Super Moderator
#17
#17
Re: Design and development 7.3

Big Jim said:
The idea of partial exclusions already has a precedent. I suggest that you check the TC 176 for Document ISO/TC 176/SC 2/N 524R6. TC 176 is the technical committee that wrote ISO 9001:2008 and oversees it. You can do a google search to locate their web site. The document cited above provides guidance on exclusions.

Look at example 9 in the appendix. It is about calibration. The last line states: "In conclusion, sub-clause 7.6 could not be excluded in its entirety, only in part".
Click to expand...
Here is the link.

Stijloor.
 
I

ivalerio

#18
#18
Re: Design and development 7.3

Thanks Stijloor

Any others comments and clarifications please:)
 
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