An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, technical requirements for:

adequacy of the laboratory procedures,
competency of the laboratory personnel,
testing of the product,
capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN,) and,
review of the related records.

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

:thanx: I'm having trouble understand what all the above means in plain English. Can someone expound on the content above a little bit for me? Thanks!!

An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, technical requirements for:

adequacy of the laboratory procedures,
competency of the laboratory personnel,
testing of the product,
capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN,) and,
review of the related records.

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


Let's take one step at a time - you need a written Scope. This should include all the various tests you do in the in-house lab and it should be included in your Quality Manual. I am attaching a copy of ours as an example. This is only an example.

Next, your documentation needs to establish the requirements for the list you provided. In other words, how do you verify the adequacy of your procedures etc.? How do you verify the competency of your lab personnel? The same with the rest of your list.

Lastly, the note means if you are accredited by A2La, LAB, or another recognized accreditation body that would demonstrate that you meet the requirements but you are not required to be accredited.

Dave

That helps.. and thanks for the example. I'll get some folks working on it here.

but you are not required to be accredited.


Unless you supply certain product to GM.

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.

Ken - Could you please let me have a source for your quote. I haven't seen anything from GM that allows accreditation to IEC Guide 25 since the old 2pCP allowance. The "Registration to QS9000 is not ..." statement looks as though it came from a QS-9000 era document. If this were the case, I would think it applies to testing done by external labs, not in-house labs testing the performance of their own process. Any clarification you can give will be appreciated.

Thanks

Dave

Ken - Could you please let me have a source for your quote. I haven't seen anything from GM that allows accreditation to IEC Guide 25 since the old 2pCP allowance. The "Registration to QS9000 is not ..." statement looks as though it came from a QS-9000 era document. If this were the case, I would think it applies to testing done by external labs, not in-house labs testing the performance of their own process. Any clarification you can give will be appreciated.

Thanks

Dave

According to GM Customer Specifics - ISO/TS 16949 December 2003 available here
http://www.iaob.org/forms/GMCustomerSpecificsISO_TS%20December2003fnl.pdf

3.1 Accredited Laboratory
Accredited Laboratory is one that has been reviewed and approved by a nationally-recognized accreditation body, or as an alternative a customer recognized accreditation body, conforming to ISO/IEC Guide 58 for calibration or test laboratory accreditation to ISO/IEC Guide 17025, or national equivalent. NOTE: The above definition also applies to the QS-9000 reference manuals currently in effect.

Searching the document this is the only use of the word laboratory
It would appear that for GM you need to have 17025

Dave, the quote is copied from GM2616M. It is also listed in other GM specs.

As you know, Guide 25 and GP-10 are long gone. ISO 17025 replaced them.

Believe me, it applies to internal labs. Joe Bransky made that clear at the TS rollout meetings. The only reason we are accredited is because the GM Interiors Group would not accept our lab test data included in PPAP submissions. Other divisions within GM are also moving towards the same requirements.

The GM Customer Specific Requirements called out in QS9000, under Evaluation and Accreditation of Supplier Test Facilities states; "Some GM divisions may require laboratory accreditation of supplier lab facilities".

Ken & Howard - Thanks for the clarification.

Dave

Dave, one more interesting move by Chrysler concerning internal labs.

One of their Material Standards was PS-8965 which states;

1.1 Purpose

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.

Additional requirements and information may be required for determining
compliance depending upon the specific character of the task of the testing
laboratory.

As used herein, a testing laboratory refers to the facility which is operated at
or from a specifically designated location, and is identified by a Chrysler
Motor's Vendor Code.

1.1.1 Purpose of this Standard

This standard describes the requirements of a manufacturing facility whose
testing laboratory is submitting fabric samples and test specimen/test data
folder(s) in consideration for material source approval by the Organic
Materials Engineering Department, Engineering Office, Chrysler Corporation.


Latest revision to the standard;


ORGANIC MATERIALS ENGINEERING SUPPLIER TESTING ACTION PROTOCOL


SUPERSEDED BY ISO 17025


A look into the future......? :rolleyes:

I found the letter that was originally sent by GM to its suppliers.

Hmmm - Now I'm back to confused. The two items you illustrated were specifically for material testing per a given spec. These are normally done by an outside lab because of the specific testing requirements. Neither of the documents addresses the accreditation of an internal lab used to verify performance of a process to a spec. An example I will site would be GM6175M which is done internally while the lab certification of the technical properties of the material are done (initially or annually) by an accredited outside lab. All the materials we use here must be certified to the end user via PPAP and material approval. Those certs must be done by an accredited outside lab but once the approval is made, in-house performance testing to verify compliance needs no such accreditation.

There are two distinct requirements for labs, subcontracted (external) and internal. The GM document clarifies the term "Accredited" for use with 16949 but does not change any of the requirements. It simply shows what they consider to constitute "accredited". An internal lab still has to meet the requirements stated in 16949 but there is no requirement there for the internal lab to be accredited. It does allow for an internal with accreditation to use that accreditation as a demonstration of conformity.

If anyone else would like to jump in on this one, I would be thankful for the input.

Dave