This is from the AIAG website, and is guiding our compliance development (i.e scope statement, generic operations manual, operator qualifications):
Labs and Calibration
4.10.6 - Requirements for an In-House Laboratory
Compliance to ISO Guide 25 is not required per se
Compliance to QS-9000 Requirements, including 184.108.40.206 - 220.127.116.11, is required
What is a lab? A facility, a building, a special room, a designated area, etc., that facilitates (makes possible) an activity where testing is done.
What isn't a lab? Places where testing occurs as a part of a process, which are within the parameters of that process. In other words, if testing is adequately controlled by in-process testing and inspection, and the items to be tested are not taken out of the process to a "facility," the in-house laboratory requirement does not apply.
Scope - answers the questions:
-What is the reason for the activity?
-What are the elements/rules/laws/procedures that will be included in the activity?
-Who or what is affected by the activity?
More specifically, the definition from QS-9000: A quality record (see 4.16) containing the following:
1) the specific tests, evaluations and calibrations a supplier laboratory has the ability and competency to perform,
2) a list of the equipment used to perform the above,
3) a list of the methods and standards to which it performs the above.
Lab personnel - professional judgments require theoretical and practical experience.
Test samples - must be retained and/or disposed of by procedures.
Environment controls - must be adequate.
Methods - must meet the needs of the customer and meet current standards. The lab must verify its capability to perform to standard specifications.
Statistics - must be appropriate to the work done.