Outsourced Processes & Process Design - Interpretation of the "Outsourced Processes"

M

Marie_2007

#1
Good day to all!:bigwave:


Can anybody help me in the interpretation of the "outsourced processes" as stated in the clause 4.1 of the ISO 9001 Standard? What are examples of oursourced processes?

Another thing:

What particular clause in the ISO standard falls the "Process Design" requirements?

Thank you very much in advance.:)
 
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samer

Involved - Posts
#2
Marie said:
Good day to all!:bigwave:


Can anybody help me in the interpretation of the "outsourced processes" as stated in the clause 4.1 of the ISO 9001 Standard? What are examples of oursourced processes?

Another thing:

What particular clause in the ISO standard falls the "Process Design" requirements?

Thank you very much in advance.:)
IF you Marie Just searched well in this forum you will find a lot of threads talking about this issue,there is no need to have new issues

try this
http://elsmar.com/Forums/showthread.php?t=7487&highlight=outsourced
http://elsmar.com/Forums/showthread.php?t=13923&highlight=outsourced
and many more , you can search in this forum for mre


Good luck
 
#3
Marie said:
What are examples of oursourced processes?
Let's assume that you have no capacity for surface treatment yourself, and send your product to some external company for painting or surface plating. ISO9001:2000, clause 4.1 requires you to ensure control over such processes.

Marie said:
What particular clause in the ISO standard falls the "Process Design" requirements?
Process design? I don't see that expression in the standard. Could you elaborate a bit on what you mean? Just to avoid misunderstandings...

Good links, samer :agree1:

/Claes
 
M

Marie_2007

#4
Hi Claes!

Thanks for your reply.

Based on the result of our document review, we were asked why we excluded the whole clause of 7.3 though we stated in our manual that we do "process design"...

We are only plain manufacturing and our product designs come from our customers so what we do is we "design" our process flow.

Can we really not exclude clause 7.3?
 
#5
Marie said:
We are only plain manufacturing and our product designs come from our customers so what we do is we "design" our process flow.

Can we really not exclude clause 7.3?
Yes you can, if the prerequisites of clause 1.2 are met:

ISO9001:2000 said:
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
It is also quite common to exclude parts of 7.3, and since the question was why you excluded the whole clause, I suppose the document reviewer may be on to something that in fact is applicable to you. Was any further info given?

That said, there is a requirement to develop the processes needed for product realization, in clause 7.1 and 7.1b.

I think you need to discuss this with your registrar.

Added later: I just noticed this very similar thread: Company doesn’t design product - Exclusion of clause 7.3 Have a look.

/Claes
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#6
Re: Outsourced Processes & Process Design - Interpretation of the "Outsourced Process

Marie said:
Based on the result of our document review, we were asked why we excluded the whole clause of 7.3 though we stated in our manual that we do "process design"...
Isn't that a TS16949 thing?
 

Howard Atkins

Forum Administrator
Staff member
Admin
#8
Re: Outsourced Processes & Process Design - Interpretation of the "Outsourced Process

Marie said:
Hi Claes!

Thanks for your reply.

Based on the result of our document review, we were asked why we excluded the whole clause of 7.3 though we stated in our manual that we do "process design"...

We are only plain manufacturing and our product designs come from our customers so what we do is we "design" our process flow.

Can we really not exclude clause 7.3?
There are several aspects here.
You identified the process of "process design" as part of your QMS. As such you must relate to it in your subsequent documentation and thus you cannot then exclude it.
In ISO/TS 16949 it is not allowed to exclude "process design" as the automotive industry places a great deal of emphasis on the process.
If you look at Note 2 to clause 7.1 you will see
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
Thus your auditor is correct. You cannot exclude something that you have declared that you do.
I think process design is very important but someone got carried away with their literary ability, without understanding the meaning of the words.:bonk:
But you do design the process:agree1:
 
M

Marie_2007

#9
Hi to all!


:thanks: for all your reply. Outsourced process is now more clear to me:D ... Except for the "exclusion":bonk: because i agree with Cari that exclusion for 7.3 cannot be done only under ISO/TS16949.. but our company is seeking for ISO 9001 certification as of this time..... though we have plans pursuing TS 16949 in the near future....

Thanks again for your time. I'll get back to you as soon as we completed our audit this week.:agree1:
 
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