posted 03 February 2000 05:12 PM              

We don't really have a lab, just do dimensional measurements with a CMM. ? Lab is not a controlled area, other than the walls around it. They have procedues for what they do, but nothing as in-depth as the standarad states. Can I just refer to their measurements as inspection and testing process and say that the lab requirements do not apply to us? If I say they do not apply do I have to get a waiver from our customers, or is this between the registrar auditor and me?

posted 24 February 2000 10:03 AM               

If I have to become a lab because of one hardness tester, that is ridiculous. I will get rid of the hardness tester or use it for R&D purposes if this is the case. Is there anything else that can be done in this situation?

posted 24 February 2000 12:51 PM              

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 4.10.6.1 - 4.10.6.6, 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.
Lab requirements:

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.

posted 29 February 2000 05:20 PM            

Do I need "lab" facilities in which to "certify" my calibrated items?