ISO9001 Scope Exclusion Verification in a Design Company

P

Palomar

#1
My understanding is that the only exclusion allowed in the context of registration to ISO9001 standard is Product Design and Development, correct?
However, my company actually does engineering work in manufacturing / processing. The production level of manufacturing is outsourced.

Question: Under this scenario, how does ISO9001 registration of QMS be achieved?

Any insight will be appreciated.
 
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John Broomfield

Leader
Super Moderator
#2
My understanding is that the only exclusion allowed in the context of registration to ISO9001 standard is Product Design and Development, correct?
However, my company actually does engineering work in manufacturing / processing. The production level of manufacturing is outsourced.

Question: Under this scenario, how does ISO9001 registration of QMS be achieved?

Any insight will be appreciated.
Palomar,

Clause 1.2 tells you what you can exclude and still claim conformity to ISO 9001:2008.

Only parts of clause 7 can be excluded if not contrary to a customer or legal requirement.

The parts of your management system that are necessary to conform to customer requirements and comply with legal requirements cannot be excluded if you are to claim conformity of your management system to ISO 9001:2008.

As I understand the situation you describe I would not ignore your product design processes and design change control processes. Include them in the scope of your management system even if you only produce shop drawings.

John
 
M

Mallya

#4
I think u can't exclude because is part and input to your process and even if you exclude ensure that you have control/monitor outsourced processes.

Thanks

Benny
 
P

Palomar

#5
Thank you Benny for your feedback to my question.

I joined this company just recently and still in the process of understanding it from the viewpoint of QMS and registration to ISO9001.:(

With that background, my question needs some clarification. So, here it is:

This company does development work that involves Engineering experimentation & "developing" Manufacturing Processes, too. We only ship engineering samples to customers. Any parts to be sold to customers are supposed come from subcontractor(s) who do production of parts, since we are not yet in that phase of the business - It's a start up company to that degree.

Therefore, we need to include some kind of Design / Development. And, control manufacturing at subcontractors (outsourced). Not sure we are even at a point that we can initiate registration effort except for define a plan / timeline.

Please feel free to comment if I have provided more information and a better picture!

Thank you.:thanks:
Palomar
 

John Broomfield

Leader
Super Moderator
#6
Thank you Benny for your feedback to my question.

I joined this company just recently and still in the process of understanding it from the viewpoint of QMS and registration to ISO9001.:(

With that background, my question needs some clarification. So, here it is:

This company does development work that involves Engineering experimentation & "developing" Manufacturing Processes, too. We only ship engineering samples to customers. Any parts to be sold to customers are supposed come from subcontractor(s) who do production of parts, since we are not yet in that phase of the business - It's a start up company to that degree.

Therefore, we need to include some kind of Design / Development. And, control manufacturing at subcontractors (outsourced). Not sure we are even at a point that we can initiate registration effort except for define a plan / timeline.

Please feel free to comment if I have provided more information and a better picture!

Thank you.:thanks:
Palomar
Palomar,

I have tried several times to understand your:

  • Customers and what they need from your company
  • Your goods and services to satisfy the needs of your customers
  • Your essential processes to assure the quality of these goods and services

Perhaps you can explain A, B and C for all of us so we can help.

Thanks,

John
 
#7
My understanding is that the only exclusion allowed in the context of registration to ISO9001 standard is Product Design and Development, correct?
However, my company actually does engineering work in manufacturing / processing. The production level of manufacturing is outsourced.

Question: Under this scenario, how does ISO9001 registration of QMS be achieved?

Any insight will be appreciated.
If you don't have control over a specification for a product (for example changes to product specifications) you are NOT design responsible and you should exclude that requirement. Process design is NOT product design, unless you sell the process equipment and manufacturing layout you "design".
 

John Broomfield

Leader
Super Moderator
#8
Andy,

Products often comprise goods and services and customers usually do not specify the service part of the product when ordering goods.

In this case should the supplier still ignore its design processes with respect to its services?

Wikipedia refers to this as service blueprinting. Goods sold with careful attention to service quality are no longer bought as commodities based on price alone.

I know a lot of registrars would advise excluding clause 7.3 but if service design is to appear in the scope of the certification surely they should not. Or are registrars limited for any reason on what they can include in the certificate's scope statement?

I suppose one such reason could be that the registrar is not accredited for certifying management systems with service design processes. But even that reason should not cause their clients to ignore their valuable service design processes.

John
 
Last edited:
#9
"my company actually does engineering work in manufacturing / processing"

It is common for organizations to claim "design" when, in fact, they are supporting a client's product design, with their process(ing) knowledge. Unless their service is design (as you say, in their scope and, hence qms) they can't claim design responsibility - hence my questions/point about having authority over the design. The "goods and services" is getting beyond current ISO requirements, John, so we can only deal with "product" and "service" (as a product) - although the 2015 version recognizes many organizations provide the two at the same time.

Unless the OP responds it's all speculation. FWIW, it doesn't sound to me that they are design responsible:

"This company does development work that involves Engineering experimentation & "developing" Manufacturing Processes, too. We only ship engineering samples to customers. Any parts to be sold to customers are supposed come from subcontractor(s) who do production of parts, since we are not yet in that phase of the business - It's a start up company to that degree."
 
P

Palomar

#10
Thank you John. Sorry, I may have created confusion while trying to paint a better picture! So, perhaps brief answers to your questions may help.


  1. Customers and what they need from your company
There are a couple of "potential" but serious customers. They need specific part from our company. There are variations of the part, but it is one basic kind of part. An example would be bread - there are certain requirements that are given. But customers may want, say, raisin bread. They specify, how many raisins, what kind of raisins, etc. So, design is by customers, I think.

Your goods and services to satisfy the needs of your customers -
I think my example above addresses this point

Your essential processes to assure the quality of these goods and services
We do engineering experiments to come up processing that will produce the desired "bread" that meets all requirements - "basic given" and "customer specified." The product - bread - will be manufactured by our outsourced supplier.

Hope this helps.

Thank you.
 
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