Our company designs and manufactures commercial and automotive semiconductor products. We used to maintain dual certification (ISO9001 and TS16949) for all of our manufacturing and assembly locations, but recently dropped the ISO9001 certification. My questions are as follows:
1) If we manufacture automotive and non automotive products in the same location “site”, without dedicated separation, does the TS certification eligibility apply to the entire site?
2) Can we include the non automotive design RSLs in the TS16949 certificate scope, or would we need a separate ISO9001 certificate to cover those activities?
Thank you for your question. Yes, TS 16949 requirements would apply to all of your “automotive” processes whether they produce/support only automotive products or not. This is actually the way you’d want to do it: it would be more complicated to try to have two systems for automotive and non-automotive products. If you have only one certification, the scope of your audits would have to be your whole product line, and not just your automotive products.
The answer to your second question is again related to the scope of your registration. If you are not design-responsible for the automotive side of your business there is a risk that your TS 16949 audits (internal and external) do not include your design function. If you want your design activity in scope, work with your registrar to roll it into your scope of registration. Understand that if you do it that way, your non-automotive design would be subject to all of the additional 7.3 controls listed in TS 16949. Although you should be able to cover it under one registration, It will be up to them if they want you to split it out into a separate ISO 9001 registration. The impact of that difference should be minimal.
Please let us know if you have any follow-up questions related to this answer.
Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.