Exclusion of 8.3 Design and Development for Design Companies

kensonic_qmr

Starting to get Involved
#1
If a company designs the products for their clients, is it possible that you can exclude the clause 8.3 Design and Development? My logic is the following:

1. Their design and development activities are actually under 8.5 since its their actual products/services.
2. The clause 8.3 is pertaining to design and development of their own product/services, since they are not designing their own products/services, this clause can be excluded.

Please correct me if I'm wrong with this. I'm current helping a friend with their implementation of the standard. This is the only part where I'm not sure if my interpretation is correct.
 
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#2
If a company designs the products for their clients, is it possible that you can exclude the clause 8.3 Design and Development?
No.

1. Their design and development activities are actually under 8.5 since its their actual products/services.
2. The clause 8.3 is pertaining to design and development of their own product/services, since they are not designing their own products/services, this clause can be excluded.
1) 8.5 is not a replacement for 8.3 - they have different roles and purposes.
2) 8.3 does not anywhere limit its definition to only one's own products/services, that I can see.
 

kensonic_qmr

Starting to get Involved
#4
No. I could see a strictly design company excluding 8.5 though.
Thank you for the response. :)

I see. I was thinking about this as well. If 8.3 Design and Development is not excluded (it's understandable since they have design activities), I'm thinking that maybe 8.5 can be excluded since most of the control in design is under 8.3 already. But I'm hesitating to exclude 8.5 because it's a very rare case.
 

kensonic_qmr

Starting to get Involved
#5
No.



1) 8.5 is not a replacement for 8.3 - they have different roles and purposes.
2) 8.3 does not anywhere limit its definition to only one's own products/services, that I can see.

Thank you Sir for the reply.

As I can see, it seems like 8.3 should not be excluded from their QMS because they have design and development process. It just happens that it is also their operation. I guess both 8.3 and 8.5 is applicable to their operation. Thank you very much.
 
#6
1. Their design and development activities are actually under 8.5 since its their actual products/services.
2. The clause 8.3 is pertaining to design and development of their own product/services, since they are not designing their own products/services, this clause can be excluded.
This is actually how the earlier versions of ISO 9001 were applied to design houses in 1987 and 1994 editions, although the design AND production clauses were used.
I’d suggest there’s some benefit still, today, in doing that.
 
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