We are a small stamper working toward registration in October. We do work for a customer who is requiring registration do to their TS requirement. We have other customers who have no requirements. THey make chicken feeders or something of the sort. They have no inspection guidlines at all and do not wish to set any up. We do not have any design data or tolerances from them. All we do is set the blank in the die and roll the press throw it in the basket and ship them when we are done a few times a year. If the balnk is not the right size (which does happen frequently) we toss it in the scrap barrel. Size is set in a previous process before we get the steel blanks. Can we exclude this customer and their product from our registration?
Mark

It sounds like you have internal requirements for the products and the customer orders a generic product. Therefore, the customer requirements are already set.

It sounds like you have internal requirements for the products and the customer orders a generic product. Therefore, the customer requirements are already set.
I am sorry what do you mean? I feel like I am talking to my wife and only got part of what needed to be said for it to make sense to me. :bonk:
Mark

We are a small stamper working toward registration in October. We do work for a customer who is requiring registration do to their TS requirement. We have other customers who have no requirements. THey make chicken feeders or something of the sort. They have no inspection guidlines at all and do not wish to set any up. We do not have any design data or tolerances from them. All we do is set the blank in the die and roll the press throw it in the basket and ship them when we are done a few times a year. If the balnk is not the right size (which does happen frequently) we toss it in the scrap barrel. Size is set in a previous process before we get the steel blanks. Can we exclude this customer and their product from our registration?
Mark The only exclusions that you are allowed are in clause 7. Now, that being said, maybe the term you want to use is not exclude. There are ways to justify i.e. in 7.4.1 The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. So, if you can live with the scrap cost or you pass it back to the supplier when you find it and the final product is not affected, you don't have to verify the purchased product.

You cannot exclude customers. TS 16949 In "Determination of Requirements Related To The Product", Clause 7.2.1b states "requirements not stated by the customer but necessary for specified or intended use, where known." That you have said sound that you are meeting these requirements and you should document this in your system either via the order process or the product realization process.

How do you know a blank is the wrong size? What material is required? How do you know? What quantity do you build? Why?

Your customer has requirements; price, quantity, delviery schedule, material, etc. You are not scraping parts for no reason. What about burrs (safety)?

It seems to me you are thinking too critically about customer requirements. You have requirements otherwise you would not dedicate press and operator time to stamping parts that no one wants.

Regards, Dirk

By the way, Mark. Your customer can require you to be ISO 9001:2000 certified but not TS 16949. They can require the you to conform to TS 16949 but you are not required to be TS 16949 certified.

Also, you can ask them to exclude you from the requirement of ISO 9001:2000 certification. You have to make a case as to why they should exclude you from this requriement. At least that is my understanding of clause 7.4.1.2 of TS 16949 which is what is driving your customer.

Regards, Dirk

Seems like Mark has one customer that is TS and is requiring its suppliers to be ISO 9001 and one supplier that doesn't give a rat's *** about ISO 9001. So why can't Mark's ISO 9001(not TS16949) system be tailored to Mark's organization's and customers' needs. Now I am assuming the non TS customer supplies the blanks that are sometimes NC and the blanks are inspected just prior to being used by the operator of the press when he inserts the blank in the press. A Cost-Benefit Analysis might indicate that a separate inspection operation is not cost effective. How is that for an argument?

Mark:

You may be able to limit the Scope of your ISO 9001 registration to only Automotive Products to a list of product types that somehow excludes this customer's products.

You may want to look at this guidance.
N524 - Guidance on ISO 9001:2000 Sub-clause 1.2 'Application' (http://isotc176sc2.elysium-ltd.net/1.2Application.doc)

Seems like Mark has one customer that is TS and is requiring its suppliers to be ISO 9001 and one supplier that doesn't give a rat's *** about ISO 9001. So why can't Mark's ISO 9001(not TS16949) system be tailored to Mark's organization's and customers' needs. Now I am assuming the non TS customer supplies the blanks that are sometimes NC and the blanks are inspected just prior to being used by the operator of the press when he inserts the blank in the press. A Cost-Benefit Analysis might indicate that a separate inspection operation is not cost effective. How is that for an argument?
Al and others,
thanks for the input. Maybe I should not use exclude to define what I want to do. Maybe I can just limit which customers we are applying the QMS to. The customer with the plate does not care what happens no saftey requirements no handling requirements they drop of and when we are done they pick it up. The company owns the tools and has been using the same tooling since the early 70s. Our company stores the dies and runs the parts as fill in work when needed by the customer. Aside from shippers there is no other documentation on this job ever. If a punch or die steel become worn we call the customer and they have us fix it.
I was thinking that in my scope I could say something like,

Scope
The quality system described within this manual defines "our" quality policy and its procedures as related to the development and production of small to midsize stampings and minor assemblies of all "our" customers except "xyz Co.". The manual as written addresses the requirements of ISO9001-2000 except for the exclusions listed below.

Exclusions
"We" are not design responsible nor do "we" provide service as described in the ISO 9001-2000 Standard.
Do you think this will work.

Mark,

It sounds like everyone else has covered the items that I was referring to. If your organization receives an order from the customer and the order requirements are communicated throughout the organization:

what and how much is to be produced?
when does the product need to be produced?
when is it to be delivered?
what are the packaging requirements?
what are the requirements for conformity?

then you have defined customer requirements. You simply need to document how these requirements are communicated throughout the organization.

We accomplish these tasks by using sales orders, job travelers, product specifications and a shipping/receiving schedule and any required inspection documentation. The use of all documentation is defined in either the operational procedure or work instruction for the individual task.


Remember to keep it simple!! If you are producing product that your customer is happy with then chances are you already have procedures (documented or undocumented) in place to ensure conformity to requirements.

Maybe instead of specifically excluding them in your scope, you could simply define the process their products go through as separate from the other processes you have? (i.e.: "Process for Company XYZ Product"...)

Maybe instead of specifically excluding them in your scope, you could simply define the process their products go through as separate from the other processes you have? (i.e.: "Process for Company XYZ Product"...)
I understand what you are saying but what I am trying to do is bring all Items manufactured and their associated processes into some sort of statistical control. With the product from this particular customer we have control over so few of the variables that it would become a nightmare. If there is a way I want to keep this "side job" from being an issue we get minor or major NCs for durring audit season. It would be better if we are able to keep them out of our main business operations.

So keep it as a side job. If you think is that the process and customer are in control and is not put the over all system at risk.....then keep it quiet from the auditors.

We use product specifications to identify each task that is to be performed on an item. If a product does not require inspection because the customer does not want it, we simply state no inspection required in the product specification. Perhaps you could handle your issue in the same manner.

Ok instead of specifically excluding them how about just not including them in our scope. Would that work? What if we said that our system only applied to our automotive and potential appliance and furniture customers?
Mark

I have never heard of the system not being applied to all customers.

IMHO: I think that the key here is to show that you are meeting their requirements (as minimal as they are, you are meeting them). You must have some idea as to what they want or you would not be able to supply them with product.

Mark,

If it's just a certain set of product line(s) ou sell to this one customer, include ONLY that product line(s) in the scope of your registration. Depending on how your customer base is and your product line, this will take care of excluding your other customers and satisfy the one requiring registration. If it's a generic product that many others get, it won't hurt anything to have itin the scope.

Ok instead of specifically excluding them how about just not including them in our scope. Would that work? What if we said that our system only applied to our automotive and potential appliance and furniture customers?
Mark

Hi Mark - see post #9 of this thread. Al provided a link to the guidance document on application. I just pulled out my copy to peruse, see section 3 - Application of ISO9001:2000: "However, even when an organization includes all its products in the scope of its QMS..."

That's as far as I got - gotta run - lunch time - but this statement leads me to believe that you can exclude a product from your scope. As usual - my advice is to contact your registrar's technical function.

I looked at the following, and there may be a way to exclude the historical customer with a "just stamp and ship" criteria. I think that since your company does have a long established history with this customer, then it should be sufficient evidence that ISO type systems are not applicable to this product line. But as it states below then ISO 9001/TS16949 cannot be claimed for this type product. But, then again you may find a way to include their basic requirements in the ISO9001 portion by establishing specifications and obtain a customer sign off. However, top management may not want to go through all this because they do have a history with this customer, and probably profitable at that. Hope this is at least some help in providing possible alternatives.

1 Scope
1.2 Application
ISO 9001:2000, Quality management systems — Requirements
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
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.
The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.
Permitted exclusions do not include manufacturing process design.

I looked at the following...

The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.
Permitted exclusions do not include manufacturing process design.

Is that from TS16949?

Is that from TS16949?

Cari, Yes I copied it direct from ISO/TS16949:2002(E) and pasted it in.

Ahh - I didn't see that last part in ISO9001:2000 and wondered. ISO does not limit the exclusion to only 7.3.

Mark - did you get a chance to read through 524R2? Did it help?

Ahh - I didn't see that last part in ISO9001:2000 and wondered. ISO does not limit the exclusion to only 7.3.

Mark - did you get a chance to read through 524R2? Did it help?
I read through it twice and did not see what you quoted in it. I was in a hurry though so maybe I just missed it.

Mark

Krap - it's up to rev.4 - I was reading rev.2 and that isn't there anymore.

How about pg 3, section 3, second paragraph: "Any publicly available documents, promoting conformance to ISO9001:2000, should clearly state the scope of the QMS in a way that will not mislead customers and end users. This should ensure that the necessary information is available for the user to determine which categories of product and product realization processes are included." (bolded text is my doing)

Mark:

You may be able to limit the Scope of your ISO 9001 registration to only Automotive Products to a list of product types that somehow excludes this customer's products.

You may want to look at this guidance.
N524 - Guidance on ISO 9001:2000 Sub-clause 1.2 'Application' (http://isotc176sc2.elysium-ltd.net/1.2Application.doc)
Al,
I do not know why I did not notice the underlined portion earlier. :tunnel: I am waiting to hear back from the entela tech person on if this is okay in their opinion (per Cari Spears suggestion).
:thanks: all.
Mark