Scope and Exclusion of 7.3 - No Product Design - Multidisciplinary Approach



My company does not design product, am I correct in the assumption that we can exclude 7.3.1 from TS16949 but not the the mutidisciplinary approach,and more in particular 7.3.2. design and development inputs? Would 7.3.2 design than refer to the tools and machines to make the product?

Jimmy Olson

If your company does not design product than you can exclude all of 7.3 instead of limiting yourself to portions of it. Just put something in your manual that indicates you are excluding 7.3 and the reason and justification why.


no inputs or ouputs -manufacturing process

Well that is good news. Thank you I thought I would at least have to document those requiremnts for the manufacturing process. It seems to be that the tool design and the station in which they are put in the press would have to be part of the design concept.
Would I have to document these requirments at another section?

Don Wood - 2011

Permissible Exlcusions - Clause 7.3

Iday, take a good look at clause 1.2 of TS 16949:2002 (TS2) and the "IATF Guidance to ISO/TS 16949:2002", clause 7.3. The only clauses that can be excluded in their entirety is (Product design input) and (Product design output). All the other requirements of clause 7.3 are applicable to the design and development of an organization's manufacturing process. This includes 7.3.2 (Design and development inputs) and 7.3.3 (Design and development outputs), where the expectation is that one should substitute "Process" for "Product" in the ISO clauses.

Manufacturing process design CANNOT be excluded. This is clearly spelled out in clause 1.2 of TS2, and emphasized in the note under clause 7.3. Tool design cannot be excluded either, as tooling design clearly has a significant impact on the manufacturing process.

Take heart though - documented procedures are NOT required, but you are expected to comply with your customer's requirements for quality planning and product approval.

Hope this helps, and good luck on your transition efforts!
Don Wood
Deosil Management
Licensed Plexus Trainer/ ISO/TS 16949:2002 CB Auditor Examiner
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