TS16949 - 7.3 Design and Development Exclusions for a Service Company


Starting to get Involved
My first post - I hope I have placed it within the correct area.

The company that I work for has 4 UK based sites, and 4 international stockists. All are covered by a blanket group certification of ISO9001 & ISO 14001.

The site that I work at want to go for TS16949, as they primarily deal with automotive customers. Our basic work is;
Diagnosing and rectifying vehicle fuelling and electrical faults;starter motors, alternators, compressors, turbochargers, diesel injector pumps, injectors and wiper motors.
We do not design any product. We only rework/rectify vehicle electrical systems.

In it states The organization shall use a multidisciplinary approach to prepare for product realization, including
- development/finalization and monitoring of special characteristics
- development and review of FMEAs, including actions to reduce potential risks, and
- development and review of control plans.

We do not have FMEAs, nor development/finalization and monitoring of special characteristics. (We do however use Control plans.)

Therefore, how could we satisfy TS16949 within clause 7.3 Design and development, or will we be allowed to have section 7.3 omitted from our assessment?
Your help would be appreciated.


to start with, your Quality team (or Quality person) should have a very thorough look at your organisation and go through the TS with a fine toothcomb to check if there are any clauses that do not apply.
After identifying them (and double and triple- checking the facts), your Quality Manual should list those exclusions to TS clauses that do not apply to your site. this is then reflected in your internal audits (your plan will mirror the applicable / non-applicable clauses).
This should also be pointed out to your TS external auditor before they come over to audit your site.
Hope this helps to set you on your way.


Starting to get Involved
We actually "remanufacture" parts.
Our customers...OEM's and vehicle service companies, will send us fuel pumps, vehicle starter motors, alternators, compressors, turbochargers, diesel injector pumps, injectors and wiper motors, which have fuelling and electrical faults.
We strip them down, and using genuine automotive parts, repair / rework them, and then return them to the customer.
In this respect, as "re-manufacturers", are we eligible to apply for TS16949?


Trusted Information Resource
The Technical spec is applicable to sites of the organizations where customer specified parts, for production and/or service, are manufactured as per ISO TS 1.1 clause.

Suggestion is to contact your CB for this and explain.

Was this a request of one of your automotive Customers?

To come back to your previous question, ISO TS states that you cannot exclude manufacturing process design and development, whuole you can only exclude 7.3product design and development whether you do not design.
Said that, you should have a process FMEA based upon your process flow from incoming to shippinh through production.
Hope this helps:bigwave:


Is your TS certification independent from the main manufacturing site?
Our office does only Sales & Distribution, we have our own QMS (maintained in blood sweat and tea by yours truly) and we get audited every year but our certificate is part of the overall TS one. We're listed as a 'supporting location'.
Maybe this could work for your site too.


Starting to get Involved
All of our group is covered by a blanket group certification of ISO9001 & ISO 14001.
4 UK sites, 4 international stockists.
It is the wish of our MD for our individual site to become certified to TS16949, and remain covered by the blanket ISO14001.
We would need our own QMS to TS16949 for this.
We remanufacture automotive electrical equipment. Components that have failed the end user, or on line at an OEM, are sent to us to be stripped down & remanufactured. Not repaired.
All the "design" element has been covered by the original OEM. Hence my initial question - as we do not "design" anything, can we remove the 7.3 Design and Development section from our Manual, and place it within an exclusion?

**EDIT I have just had a meeting with a CB who has told me that we can place 7.3 Design and Development into our exclusions. :)
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Upgrading your QMS from ISO to TS is not such a big deal, it's just a bit more prescriptive (spare a quiet thought for us under VDA which is so prescriptive I'm amazed they haven't put down what colour the Auditor's underwear should be on audit day).

Go through the whole TS with a fine toothcomb and analyze the effect each of the clauses has on your site. If it doesn't apply - and you can justify it, list it in your QMS with the explanation.
Also, make sure you declare your scope in the QMS as 'remanufacturing' and clearly state that the responsiblity for design is with your HQ. Belt and braces method.

Good luck
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