Internal Laboratory - Defining the Laboratory Scope - Inspection, Test, Calibration

[DJN]

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

 

[JStain - 2008]

Internal Lab

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

https://www.a2la.org/#

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.

 

[sal881vw]

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

 

[DJN]

Thanks both. That helps greatly.

 

[ralphsulser]

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

 

[bpritts]

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

 

[Hershal]

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:

https://www.iasonline.org

https://www.a2la.org

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

Hope this helps.

Hershal

 

[Hershal]

David,

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

Hershal

 

[ralphsulser]

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.

 

[Ken K]

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.