I know R&D center need be considered as a remote location and supporting function of a manufacturing plant.
There are two solutions:
1. establish a independ quality management system in R&D center, such as quality manual, procedures, WIs
and identify the interfact between R&D center and plant for well control
2. use plant's QMS, such as same quality manual, some same procedures&WIs, and cerate some indenpend procedures

What is the right way to make sure R&D center pass TS2 certification? please give your suggestion!

In addition, if the first way, how can we describe the QMS scope of R&D center? especially for 7.4&7.5? no manufacturing? no purchasing?

I know R&D center need be considered as a remote location and supporting function of a manufacturing plant.
It does not "need" to be a remote location, so I'm assuming yours is. Just align the procedures. I wouldn't recommend a separate registration for the R&D facility alone. That route would probably be more expensive.

thanks for your reply!
Then the R&D center as plant's supporting function, how can establish QMS as per TS2?
Maybe the center will be the supporting function as other plants

Typically R&D is a 'support' function'.

You comply with applicable parts of TS 16949. For example, if you do not purchase anything and the company purchasing procedure is adequate, then that's all you need. Often I do see R&D with unique purchasing procedures because production material purchasing (like office materials purchasing) is typically different than purchasing for R&D.

What you first have to do is map all the locations and what documents they have and see how they integrate. I call it document mapping.pdf (http://elsmar.com/pdf_files/Doc_map_B.pdf).

In the applicability text in the ISO TS 16949 ( Page numbered 1 ) the following can be found on the subject:

Quote:
This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.

Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to this Technical Specification.
Unquote

The last part makes is rather clear I hope.

Best regards,

Antoine

OK, thanks very much, Marc.
I will describe applicable parts of TS2 requirements in R&D center, and prepare a independ quality manual and enough procedures for it.
Some elements, such as 7.4, 7.5, are not applicable for R^D center, the QMS scope will be described in quality manual.

There shouldn't be a need for a separate quality manual. Just applicable procedures which map to the 'main' company procedures.

R&D is a support function, just like purchasing or maintenance. These support functions don't write their own QMS manuals, they write appropriate procedures which are tied together by the company's QMS manual. R&D is no different.

I know R&D center need be considered as a remote location and supporting function of a manufacturing plant.
There are two solutions:
1. establish a independ quality management system in R&D center, such as quality manual, procedures, WIs
and identify the interfact between R&D center and plant for well control
2. use plant's QMS, such as same quality manual, some same procedures&WIs, and cerate some indenpend procedures

What is the right way to make sure R&D center pass TS2 certification? please give your suggestion!

A remote location (Design, R&D, Sales) cannot achieve separate TS certification, unles it also is a manufacturing site. Otherwise, it can be certified with the manufacturing site on their certificate.

If you wish, you are permitted to get an ISO 9001 cert, which some corporate locations opt for.

Just to clarify, is this the organization which does the product design and development function? I know of companies who have a 'research' function who do R & D, but the result of their work is the product 'solution' which is then passed on to the (product) 'Design and Development' organization. In my experience, the research type of function isn't necessarily required to be considered under the qms, since the very nature of their work is not entirely systemmatic or consistent.:rolleyes:

Leon Song, could you clarify for us which type of R & D organization you are describing? You may not need to do anything for inclusion in the qms........

Andy

OK，we do product design and development, the plant just do product application as customer requirements. R&D center is located out of the plant. As you know, we want R&D center as a supporting function to show on plant's certificate. We do know R&D center can't gain independ registration of TS16949, so we must select a plant to do this, as its supporting function.

Then we need do something to make sure R&D center pass the TS16949 audit as supporting function. But we don't very clearly know how to establish a QMS in the R&D center, to meet TS16949 requirements.

OK，we do product design and development, the plant just do product application as customer requirements. R&D center is located out of the plant. As you know, we want R&D center as a supporting function to show on plant's certificate. We do know R&D center can't gain independ registration of TS16949, so we must select a plant to do this, as its supporting function.

Then we need do something to make sure R&D center pass the TS16949 audit as supporting function. But we don't very clearly know how to establish a QMS in the R&D center, to meet TS16949 requirements.


You are on the correct track. Now, define those processes the R&D location performs, and define them per the requirements in cl 4.1. You can follow the same format the plant uses.

Basically, think of yourself as if you were located in a corner of their building, but a separate department. Design your qms around that example.

If you also do document control and internal audits, and other things the manufacturing plant does, consider using their same procedures for these processes if you can. If not, begin with their procedures and modify as needed to suit your needs.

In this way you will be as similar to the palnt as you can, but still meet your needs.