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7.1.5 Monitoring and measuring resources

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by John1987, Nov 4, 2022.

  1. John1987

    John1987 New Member

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    Are hand tool such as wire stripper and crimpers required to be calibrated?
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @John1987 and welcome to the site.

    I know of no "wire stripper" nor "crimpers" that are a Monitoring nor measuring resource.

    Unless the tools you describe are not as I understand/am familiar with simple strippers and crimpers, then no.

    (Reminder. ISO 9001 does not "require" that any equipment be "calibrated" . The organization determines if the equipment is "essential to ...validity of results..." That equipment can then either be "verified" and/or "calibrated". )

    Hope this helps.
    Be well.
     
  3. John1987

    John1987 New Member

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  4. John C. Abnet

    John C. Abnet Well-Known Member

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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    As @John C. Abnet states, these tools measure nothing. It is common, however, for 3rd Party auditors to ask such a thing, because crimpers are frequently “set” to a block which is the optimal size/shape for a crimp. Is that why you asked?
     
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Hello John1987,

    ISO 9001:2015 focuses on product quality so the calibration requirements usually focus on final inspection. In-process inspections are valuable for Cost-Of-Poor-Quality (COPQ) control, but this is not included in ISO 9001:2015 requirements unless you have done so under that standard. I hope this makes sense.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I don’t agree with these statements at all. Calibration - if required - applies at whatever point in the process a measurement must be taken to assure accurate results. Further processing may “hide”, the product at final, so that an inspection at that point is impossible. It really worries me when people make such suggestions about what ISO “suggests”.
     
    RonR Quality Pro likes this.
  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I am not fully comfortable with it either, as I would prefer keeping vigilance of instruments' accuracy for Good Manufacturing Practices purposes.

    But I will now quote ISO 9002:2016:
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I give up. I’m not equipped for this.
     
  10. tony s

    tony s Well-Known Member

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    Since the title of the thread is "7.1.5 Monitoring and measuring resources" and within the ISO 9001:2015 discussions, @John1987 is asking a question expecting an answer with the ISO 9001 perspective.

    IMHO, to determine whether calibration is required for a measuring equipment (as per 7.1.5), the following should be considered:
    1. What is the product?
    2. How will you know if the product conforms to requirements?
    3. Do you need measuring equipment to verify conformity of the product to requirements? (see 7.1.5.1 1st sentence)
    4. Do you need to have confidence (or is there a requirement) that the measured values of your measuring equipment are identical to measured values of national/international measurement standards? (see 7.1.5.2 1st sentence and letter a) sentence)
    5. If you answered Yes to both questions 3 and 4, then your measuring equipment needs to be calibrated or verified.
    If the wire stripper and crimpers function like the measuring equipment mentioned in questions 3 and 4, then you have to consider number 5.
     
    Last edited: Nov 6, 2022
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    They don’t.
     
  12. Bev D

    Bev D Moderator Staff Member

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    Wire strippers and crimpers ‘measure’ things just like the ID of a hole measures the OD of a round thing that goes into it…they don’t.

    Perhaps their dimensions are critical to ensuring that the wire is stripped of insulation but doesn’t take out some of the wires: so measure the stripper settings to ensure they are within the necessary tolerances and measure the tolerances on the insulation and the wire bundle. Those measuring things might require calibration if there is no other way to reliably measure the output of the product. Which in the case of a wire is it’s conductivity (or resistance), amperage rating, and strength to resist an open circuit or intermittent open circuit, etc.
    Same, Same with the crimpers.