Supplier has different ISO 9001 certification scope and TS 16949 certification scope

[cheahga]

Hi Cover Experts,

Recently during an audit with our purchasing dept, I noticed that one of the supplier certification information as below:
Supplier A - ISO 9001: 2000 & ISO/ TS 16949: 2002 certified.

The certification scope for their ISO 9001: 2000 is
Design & manufacturing of bonding wire

While, their ISO/ TS 16949: 2002 certification scope is
Manufacturing with permissible exclusion
7.3 Product Design Activities

When I asked on the reason why these two certification scopes are different; the reason given as below:

The design exclusion for TS16949 is more stringent than ISO 9000. As we are not design responsible for our Automotive Customers, it is not allowable to include design in the scope. In ISO 9000, in-house product development for general market can be termed as design in the scope.

We are semiconductor supplier to automotive supply chain & big three. We have not asked them to exclude the product design before.

Is this true and is it allowable? This is the first time I've ever seen this kind of issue, would the cover expects please advise us?

thanks in advance

 

[dbzman]

splitting hairs

Sounds like they are splitting hairs.

We had the same problem here. I had a discussion with our corporate office about whether we need to have both an ISO cert and a TS cert since we do work for a few automotive customers (2nd and 3rd tier).
They said that we only needed TS since it included ISO.
When we discussed the exclusions they had us exclude all section but 7.3,2,2 and 7.3.2.3 and 7.3.3.2 since they used the term “process”. Section 7.3.2.3 dealt with special characteristics.

I couldn’t understand this reasoning. I believe that section 7.3 would be hard to exempt from for a lot of industry, including the service industry.

I don’t see where TS is more stringent then ISO. IT is more extensive. It adds to ISO. If it is applicable in ISO, it’s applicable in TS.

 

[ralphsulser]

I can understand the different scopes for ISO9001 and TS16949.
TS16949 is for their supply of automotive parts only, excluding product design.
ISO9001 for the general market, not including automotive, for which they have design inputs.
Not a problem, a lot of companies manufacture products for both markets.

 

[Howard Atkins]

I can understand the different scopes for ISO9001 and TS16949.
TS16949 is for their supply of automotive parts only, excluding product design.
ISO9001 for the general market, not including automotive, for which they have design inputs.
Not a problem, a lot of companies manufacture products for both markets.

Exactly, in a lot of cases the ISO9001 scope will exclude 7.3 completely as there is no requirement for process design.
Design responsibility is a very important area, it can involve enormous costs if there is a problem. In automotive you do not want any one to think that you are in the area of being design responsible if you are not

 

[Cari Spears]

We are semiconductor supplier to automotive supply chain & big three. We have not asked them to exclude the product design before.

You don't get to ask them to exclude or include anything. They cannot include design for TS if they aren't design responsible for automotive products - and just because they don't design their automotive products does not mean that they aren't free to be design responsible for other markets.

In automotive you do not want any one to think that you are in the area of being design responsible if you are not

Exactly.

 

[Howard Atkins]

In automotive you do not want any one to think that you are in the area of being design responsible if you are not

Despite this I have seen arguments with TS auditors who claim that if you produce your own drawings then you are designing the part. When it was said that there is no way in which a DFMEA could be performed the auditor claimed that there should be a DFMEA of one line saying that the riskas are that the part would not be validated and the action was for the customer.
He refused to see the difference between designing the process and designing the part. (No comments on go to his boss etc please)
Design responsible is a contractual issue and part of the order.
Has anyone else had this sort of experience?

 

[dbzman]

Confusion

We have had a lot of discussion with our corporate headquarters over this topic.

We just sent in our level one Quality Manual. He stated that we excluded too much of 7.3.

Example:

We exempted out of 7.3.2 and 7.3.2.1 but addressed 7.3.2.2 and 7.3.2.3. The main reason for this is the usage of “Product” and “Process”.

This is how our corporate head quarters said it should be. I disagreed with them I agreed with the auditor.

Our auditor had a problem with us since 7.3.2.2 is a subsection of 7.3.2 how can we exempt from 7.3.2. If 7.3.2.2 is applicable then 7.3.2 is also.

It seems to me that the AIAG is going to have to come out with a clarification on what they actual mean by “Product”. Can it also be a process?

If we design the process that makes the part that is designed by someone else then are we performing design of service?

This is going to haunt us until we get a clarification.

 

[SilverHawk]

Perhaps "cheahga" can explain further that whether the certificates are issued from the same or different CB and whether both the audit were conducted at the same time or at different period of time. This may clear up a few concerns.

Obviously, at time, product design may from from the OEM as for TS as explained by "ralphsulser" and not required to seek product design activities but only process design activities.

 

[Barahir]

I think you can only take an exemption to 7.3.2 (and likewise to 7.3.3, 7.3.4, 7.3.5 and 7.3.6) as they relate to product.

Since the main part of 7.3.2 (the ISO 9K portion) does not specify either product or process, but lists design inputs, an automotive manufacturer going for TS who does not do product design would have to both exclude and include it (take the exclusion as it relates to product/services, but include it as it relates to processes).


Our company doesn't do product design, and currently what our Scope for the Quality Manual lists this as our exclusions (note that this is not yet audited by a registrar):

Middletown Tube Works, Inc. is a non-product design function company, and therefore excludes from the scope of it's Quality Management System the following clauses (and their subclauses) of ISO/TS-16949:2002:

7.3 - Design and development*

*Exclusions are taken on these clauses only as they relate to product design and development. These clauses are included and addressed within the Quality Management System as/if they relate to manufacturing process design and development and/or the verfication and validation of customer-designed product.

​

That's what I've got anyway. In 1.2 it says:

"The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is responsible not for product design and development."

​

So what I wrote above covers that.

 

[cheahga]

Perhaps "cheahga" can explain further that whether the certificates are issued from the same or different CB and whether both the audit were conducted at the same time or at different period of time. This may clear up a few concerns.

Obviously, at time, product design may from from the OEM as for TS as explained by "ralphsulser" and not required to seek product design activities but only process design activities.

Hi All,

Thanks for all the comments.

The supplier supply only a single product which can go to automotive or general market as the product is generic.

CB is the same for both certification at the same site. ISO 9001 & TS were audited at the same time with ISO 9001 upgraded from ISO 9001 since certified in 1997.

Hope this can clear out the doubt.