I have a question that is a bit of a hair splitter.

My company has several corporations under the umbrella of our 'Group'. My corporation (we are an automotive OEM) utilizes the services of a test lab that is a member of another corporation which in turn is also a part of 'Group' (in fact, this lab is on the opposite coast from our factory).

Should I consider this lab to be an Internal or External asset? This matters for determination as to whether or not this lab falls under ISO/TS16949 clause 7.6.3.1 Internal Laboratory, or 7.6.3.2 External Laboratory.

Not sure if this post should go here or in the TS16949 forum, so I will place it in both.

Thanks!

Charlie

I agree, it could be a hair splitter but looking at some other questions might help. Is the lab included in YOUR quality management system documentation? Does YOUR organization determine the adequacy of the lab procedures? Do YOU control the qualifications of the lab personnel? Does your management review the related quality documents?

My opinion would be that an internal lab must be within the confines of the responsible "branch" of the "Group". I can see where there might be some discussion on it but I would think if they are truly a test lab, they are going to be certified anyway which would make the discussion moot.

Dave

We have mutliple divisions all over the country and utilize a lab at one of the divisions as an Internal Lab. We've had no audit issues with our assertion that they are an internal lab for over 7 years. We do have them included in our scope and certification and of course they have their own lab practices and scope, but because they're internal they do not have to have separate lab certification.

Thank you both for your replies, the answer seems to be that they are External in that we do NOT include them in our scope or certification.

Charlie

Thank you both for your replies, the answer seems to be that they are External in that we do NOT include them in our scope or certification.

Charlie

If you do that, then they must meet the requirements of 7.6.3.2, and other applicable requirements pertaining to suppliers.

Not sure if this post should go here or in the TS16949 forum, so I will place it in both.
FYI, I deleted the duplicate thread from 'there'. This obviously is a better forum for this question as it deals with interpretation of a TS clause.

Hello All:

I beleive the answer to the question of internal or external lab is based solely on the scope statement of the QMS. What is the scope of the quality system as stated in the certificate and in the quality manaul (or wherever the scope is documented)? I do not think this is a spliting hairs question. The idea of what is "outsourcing" and what controls need to be inplace for outsourced services is a great question. I realize that this question is based upon the lab requirements. But I beleive the general concept of outsourcing comes into play here. There is an ISO website for Technical Committee (TC) 176 that is involved in the writing of the ISO 9000 series. At this website there is a ton of info including support packages. These support packages give greater detail on certain concepts. One of the packages is about outsourcing. We all should have this website in our "favorites."

Here is the link: http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/755901/1069636/customview.html?

Finally, you may want to review the new (second edition) IATF Audit Scheme Rules for TS16949. These rules apply to registrars but they indirectly affact users of TS 16949. My memory is that in the new second edition, there is clarification as to how far away (in miles) a supporting function can be to be included in a QMS scope. This is based on my failing memory so I may be completely wrong but it is worth checking. I ordered a copy of the second edition rules but I have not received them yet. I can't understand how miles can be a factor in today's modern world but I remember reading something about this.

Also, the new rules require that supporting functions must be audited first before the main site is audited. These audits must happen within 90 days of each other.

Regards, Dirk

Hello All:

I received my copy of the IATF Audit Scheme Rules for TS16949, 2nd Edition. I do not see any reference to distance between supporting functions and the central organization. False alarm on my part.

Regards, Dirk