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Laborscope and evidence that the measuring devices have been calibrated

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by JohnDoe, May 18, 2018.

  1. JohnDoe

    JohnDoe New Member

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    Hello.
    I am rather new in the ISO topics. We are implementing ISO 9001:2015 at the moment.
    Can someone please give me an answer do I need the accreditation of the house which calibrated the measuring devices for the ISO 9001, or is this only a part of the IATF 16949?

    Secondary, if we decide to calibrate the measuring devices by ourselves, what grade of etalons must be used. Must it be etalon of the 0th grade, or does grade 1 apply aswell?

    Do we in this case need a document for each and every measuring device, or is it enough to state the list of calibrated dates and next calibration date in an table?

    Thx in advance.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome to the forum and to ISO 9001:2015. To answer your first question, "do I need the accreditation of the calibration house", the answer is - according to ISO 9001, then "no". In practice, however, if you want to be confident in the calibrations performed, the answer may well be "yes". An unaccredited lab is less likely to provide an accurate calibration result and you'd have to do more work in understanding WHAT they do. If you don't know calibration and what labs do, then you'll have problems.

    The grade of equipment (Etalon is a brand name, not a device type) used for calibration is up to you, and is dependent on what precision of measurement.

    For any equipment used to measure/test product (and some process measurements sometimes) you need to have comprehensive records - not just a list of dates.

    I'd suggest you find a source of help (a consultant who knows calibration/verification processes)
     
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  3. tony s

    tony s Well-Known Member

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    For ISO 9001, not necessary. For IATF 16949, the external laboratory must be accredited to ISO/IEC 17025 or national equivalent.
    If ISO 9001 requires an organization to retain documented information (1) as evidence of fitness and purpose of the measuring resources and (2) when measurement traceability is a requirement, IMHO, you will need to keep calibration records of each measuring equipment.