ISO/TS Exclusions

Manufacturing, inspection, exclusions


I have a question regarding exclusions from the ISO/TS standards.

The majority of our business is the design and manufacture of enclosure hardware.  Recently though, a small portion of our business has become the sole North American Distributor for an Italian company. Their product lines are similar to ours. However, we procure their products and simply resell/distribute to their customers stateside, to Canada and Mexico. We do not have Design or Process Control for these items; they are pass-through product.

Therefore, my question is related to permissible exclusions from the ISO standard. Should we seek exclusions regarding certain clauses of Clause 7 of the standard, for this certain “supplier”, and/or for certain product groups that are sold on their behalf?

Response (Answered by Bud Salsbury):

At first, your question seemed relatively uncomplicated and I am inclined to say that you can simply sell or provide the products in question with a disclaimer or something identifying the fact that your company is not the designer/manufacturer of the product.  My company occasionally has purchased parts inserted into or added to the products made. Like bushings or threaded inserts, etc. We don’t have to add anything to our QMS for those as long as those items meet regulatory and statutory requirements.

However, I should mention, the standards make it clear that exclusions are permissible if “such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.”

Therefore, stepping away from the initial ‘simple’ answer, I would say that such exclusions would not be permissible. This is due to the fact that your organization is ultimately responsible for meeting customer requirements. Although you do not design or manufacture that specific product, you provide, and are responsible for what the customer requests.

You are also responsible for seeing to it that the OEM is meeting customer as well as any statutory or regulatory requirements. This would be of particular importance if these are electrical enclosures or intended for hazardous services, such as NEMA 7 (explosion proof enclosures).

Since you already design and manufacture your own products and have the Clause 7 included in your QMS, it would be counterproductive to add more documentation to exclude what you have mentioned. It would be wise to notify customers up-front, in the sales/purchase order process, that the product you are distributing is from a separate company.

Thanks much for this good question.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Follow Up Questions:

• IF there were permissible exclusions allowed, WHO would need to ‘approve’ these or ‘allow’ them to be exclusions?  Would that be the registrar or someone else?

• IF there were permissible exclusions, would it be stated/depicted on the actual Certificate as such or only noted in the quality manual, for example?

• IF there were permissible exclusions, would it be an exclusion of the ISO CLAUSE?  And/or PRODUCT?  And/or  SUPPLIER?

• Currently we list “the design and manufacture…” in our scope.  Would we need to revise the scope to include ‘distribution’?

Response (Answered by Denis Devos):

Thank you very much for your question and your follow up.

In further response to your original question – if you are in the automotive industry, you will still be obligated to provide a Level 3 PPAP (as a default) to your customer for the product you are purchasing and reselling; whether you are design and process responsible or not.

Permissible exclusions are only granted for Clause 7.3 Product Design.  Per TS 16949, you cannot be excluded from the requirements of Clause 6.3 related to process design.    You can declare this exclusion yourself in your Quality Manual and your registrar will validate your claim during your registration audit.   The exclusion will appear on your registration certificate.  You can only be excluded from Clause 7.3 Product Design, (not process design).

Under TS 16949, you cannot exclude products from your registration if they are being sold to the automotive industry.   Sometimes, a registrar will permit only a portion of your business to be registered and that would be reflected in the scope on your certificate:  Check with your registrar.   You cannot be exempted from any requirements related to supplier management, such as Clause 7.4.

Yes, you will likely have to include “distribution” in the scope of your registration; check with your registrar.

I hope this sufficiently answers your follow-up questions and you find this advice helpful.  If you need anything further, please don’t hesitate to contact us.

Best Regards,

Denis J. Devos, P.Eng
ASQ Fellow
Devos Associates Inc.
London Ontario