Company doesn?t design product - Exclusion of clause 7.3

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darkafar

#1
Company doesn’t design product - Exclusion of clause 7.3

My company doesn’t design product. In the industry my company belongs to, the process are more or less similar, and the technical department modifies the process a little to suit our need when a new order comes. Do you think it is a good idea to exclude clause 7.3 entirely when implementing the ISO9001:2000 system?
 
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samer

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#2
Re: Company doesn’t design product - Exclusion of clause 7.3

darkafar said:
My company doesn’t design product. In the industry my company belongs to, the process are more or less similar, and the technical department modifies the process a little to suit our need when a new order comes. Do you think it is a good idea to exclude clause 7.3 entirely when implementing the ISO9001:2000 system?
modify a process a little?this is not clear , but any change to a design should always be conidered as a new design activity .so you cant exclude 7.3

this would depends on the nature of change .......

Samer
 
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Antonio Vieira

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#3
Re: Company doesn’t design product - Exclusion of clause 7.3

As a friend of mine uses to say:
In the limit all organizations have Design!
The exclusion of 7.3 is a good idea if you want to have less work in implementing your QMS, but I can assure you that it a good tool in order to know much better how your company really produces things.
If you need fats registration, you can always exclude 7.3, and do it next year, it’s also a good idea!
 
D

darkafar

#4
Re: Company doesn’t design product - Exclusion of clause 7.3

I tried to exclude clause 7.3. But the auditor still audited the design process in a much more simplified way. He used clause 7.1.
 

Sidney Vianna

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#5
Re: Company doesn’t design product - Exclusion of clause 7.3

António Vieira said:
If you need fats registration, you can always exclude 7.3, and do it next year, it’s also a good idea!
This contravenes the intent of ISO 9001 and the IAF Guidance to the Accreditation and Certification Sector. If an organization is responsible for the design of the product, you can not disregard clause 7.3.
 

samer

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#6
Re: Company doesn’t design product - Exclusion of clause 7.3

darkafar said:
I tried to exclude clause 7.3. But the auditor still audited the design process in a much more simplified way. He used clause 7.1.
that means the change you apply to the design was not considered as a design change, this is as if you change the packaging of a product, am I right ?

if you mention yr case in details that would be better...you are talking in general about a special case!!!
and as Sidney mentioned :agree1: ,if you have A design activity ,then you cant exculde it from yr system.

Samer
 
T

triner

#7
Re: Company doesn’t design product - Exclusion of clause 7.3

The key question to ask is "Who has design responsibility?" At the end of the day, if the part fails due to a design flaw, who is going to be held responsible? We produce castings for the automotive industry. We may suggest changes in design to make the part more castable or improve soundness, but it is the OEM's design engineer who ultimately takes responsibility.

For this reason, we are allowed to take exception to clause 7.3
 

Antonio Vieira

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#8
Re: Company doesn’t design product - Exclusion of clause 7.3

Sidney Vianna said:
This contravenes the intent of ISO 9001 and the IAF Guidance to the Accreditation and Certification Sector. If an organization is responsible for the design of the product, you can not disregard clause 7.3.
Sidney, you are absolutely right.
In my opinion there are few organizations that really could exclude 7.3 from their QMS.
But some registrars sometimes, when in grey areas, allow companies to exclude 7.3 when in fact they have some way of making their products/services that it’s made by their own knowledge – design.
For those organizations that are in this frontier, if they want a fast registration, my advice is exclude 7.3 in the first year.
As a consultant I always include 7.3 in every QMS. All organizations have somehow something they create. :truce:
 
Q

Qualiman

#9
Re: Company doesn’t design product - Exclusion of clause 7.3

Darkafar:

Nobody knows better a company than the company by itself. If you are not responsible for design you could exclude it.

But a question, Has your QMS a ISO 9001 or TS 16949 scheme?

In the first case you are allowed to exclude (Clause 1.2) any section of clause 7.0 , with the only condition that the exclusion will no affect the ability of your QMS to give your customer the agreed quality.

In the second case(TS) you are limited to make exclusion ONLY in clause 7.3, if you are not responsible for PRODUCT design, but YOU WILL NEVER COULD EXCLUDE PROCESS DESIGN.

Qualiman
 
S

suziwann

#10
Re: Company doesn’t design product - Exclusion of clause 7.3

My old company designed product at one site and manufactured it at another.
The site at which the product was manufactured, totally excluded any design clauses from it's QS.

These were medical devices made in the UK and supplied to the US.
 
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