I have been asked to write the procedure on the Internal Laboratory, but am confused. The standard says that the Lab shall have a defined scope the includes its capability to perform the required inspection, test or calibration services. Question is, how do I define that scope? What evidence would I need to supply?
Any help or guidance appreciated.

David

If I understand you correctly, they want you to define what your capable of doing. Here's a link to some examples:

http://www.a2la2.net/

This is a bit more involved, however it will give you a place to start. I've seen them as simple a a spread sheet to as complex as a Power Point Presentation.

Hello DJN,

I think something like this will fit the scope..........
This technical, QMS......whatever, defines the technique used to carry out tests, calibrations........ using standard and in house methods.


You can also find valuable information by searching the web for ISO/IEC 17025

Good luck

Thanks both. That helps greatly.

Dave, I have attached one of ours which be be helpful for you to see how we put it together. Hope this helps

David:

The format provided by Ralph is absolutely on target.

With regard to evidence, you need to consider:

A. the written procedures (either standards or your own internal) on how
to do the procedure

B. Evidence of qualification. How do you determine that your internal
procedures work? Could be confirming a test using a 3rd party to repeat a
test as an audit
check, for example.
C. Most auditors also have special focus on training of those doing the
testing. Have your training records up to date!

Best regards,
Brad

I have been asked to write the procedure on the Internal Laboratory, but am confused. The standard says that the Lab shall have a defined scope the includes its capability to perform the required inspection, test or calibration services. Question is, how do I define that scope? What evidence would I need to supply?
Any help or guidance appreciated.

David

David,

The scope provided by Ralph is good, and for an internal lab may be sufficient.

I am a bit fuzzy whether TS-16949 requires internal labs to be accredited however. Your external providers are required to be accredited to ISO/IEC 17025 so I am given to understand.

If accreditation of internal labs is required, then the scope needs more work. Places to go to look at scopes for either calibration or testing include three of the accrediting bodies that offer accreditation to ISO/IEC 17025:

http://www.iasonline.org

http://www.a2la.org

http://ts.nist.gov/htdocs/210/214/214.htm

Hope this helps.

Hershal

David,

If you need additional help, contact me off-line.

Hershal

My understanding at this time is that Internal Labs (ours at least) does not require accrediation. However, you are correct about external labs needing it.

If your company supplies product to GM, your internal lab needs to be ISO 17025 accredited.

They are currently upgrading their specs to read:

3.1 General Requirements. Testing is to be performed
by a laboratory accredited or audited, by
a third party organization recognized by GM, to
ISO 17025/IEC Guide 25 or GM GP-10. Include a
Scope of Accreditation or a Scope of Activity with the
test data. Registration to QS9000 is not a substitute
for lab accreditation.

Since GP-10 is no longer praticed by GM, your only choice is accreditation.

Ken,

I have not heard about these changes yet. Thanks.

Do you know if this also applies to the Inspection lab. Our Testing laboratory is in compliance with their new requirements, however our inspection lab is not and we are not planning to.

Cindy

Ken,

Where is this change officially documented? Is it a customer specific requirement to TS, or somewhere else?

Tom

If your company supplies product to GM, your internal lab needs to be ISO 17025 accredited.

They are currently upgrading their specs to read:

3.1 General Requirements. Testing is to be performed
by a laboratory accredited or audited, by
a third party organization recognized by GM, to
ISO 17025/IEC Guide 25 or GM GP-10. Include a
Scope of Accreditation or a Scope of Activity with the
test data. Registration to QS9000 is not a substitute
for lab accreditation.

Since GP-10 is no longer praticed by GM, your only choice is accreditation.


This doesn't make much sense to me. I would like to see something official if it is available. Why would GM require accreditation for testing done in-house as a process control? Certainly, if you were sending something out for testing or if you were testing work done by others your lab would need to be accredited but where is the need for in-house testing of your own product? Is this supposed to apply to calibration as well? I don't think GM would "upgrade" their requirement to include GP-10 if GP-10 were no longer available.

I don't mean to sound argumentative on this but is it possible you are quoting the existing GM requirement for "outside" testing labs? If this is in fact a mandate of GM, TS16949 is falling apart faster than it can be put into place. 7.6.3.1 Internal Laboratory - Note states - Accreditation to 17025 may be used to demonstrate supplier in-house lab conformity to this requirement but it is not mandatory (lit.).

Thanks for anything further you can provide.

Dave

Tom, the changes are in the material specifications. The Interior Systems Group at GM made ISO17025 accreditation for internal labs mandatory if you supply them product.

We found this out when GM refused test data listed in PPAP generated from our lab even though we were GP10 certified in the past.

Even though Ford and DCX said at the TS16949 rollout meetings they would not require internal labs to become accredited, DCX recently superceded PS-8965 with ISO17025. My guess is accreditation will become mandatory for internal labs in the near future for both.

Ken,

I have not heard about these changes yet. Thanks.

Do you know if this also applies to the Inspection lab. Our Testing laboratory is in compliance with their new requirements, however our inspection lab is not and we are not planning to.

Cindy

The definition of Laboratory in Ts is (3.1.4)
"laboratory
facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional,physical, electrical or reliability testing"

This would tend to mean to me that even in process measurements or incoming inspection are in fact laboratory processes.
This seems to me to be harsh, and would require compliance to 7.6.3.1.

Despite this in clause 8.2.4.1 where a layout and functional testing is required as this is not in process does this need to be performed by a defined internal lab.


Any one any input. :confused:

I have the same opportunity. We have a test quality area whete our pieces are analyzed, however is not located in a special area. We located it on the 2nd floor of our installation only for space reasons and maybe in the future we will move near to production floor.
Auditor says that is an laboratory....we think that is like the other inspections that we have on the floor during the process...

Somebody can definy or clary what means "Facility" for TS ?

Facility...is a special area?...
Tks in advance

Ken K is right of course, but if you are not GM supplier you dont need accreditation of your internal Lab.

"NOTE: Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this requirement but is not mandatory.
(7.6.3.1)

Qualiman

I have the same opportunity. We have a test quality area whete our pieces are analyzed, however is not located in a special area. We located it on the 2nd floor of our installation only for space reasons and maybe in the future we will move near to production floor.
Auditor says that is an laboratory....we think that is like the other inspections that we have on the floor during the process...

Somebody can definy or clary what means "Facility" for TS ?

Facility...is a special area?...
Tks in advance

Some questions that may help you include:

What exactly is performed in this area? Is that different than what is performed on the production floor? Is there special test equipment or controlled conditions in the special area that may be different than on the production floor?

If the answers indicate that there is special equipment or extra controls, then it can be considered a laboratory.

For your accreditation, I recommend contacting EMA (Mexico's accrediting body) before you contact a U.S. based accrediting body.

Hope this helps.

Hershal

but if you are not GM supplier you dont need accreditation of your internal Lab.

Actually, I have a feeling that might change. Do any of you DCX suppliers remember PS-8965? (Supplier Testing Action Protocol) We used it in the very early 90's for;

The purpose of this standard is to set forth the general requirements with which a testing laboratory shall comply if it is to be recognized as a technically competent source for which submissions of fabric samples and test specimen/test data folders will be considered for material source approval by the Organic Materials Engineering Department, Engineering Office, Chrysler Corporation.



It has been superceded by ISO17025 :rolleyes: