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Calibrated equipment

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by senior, Dec 12, 2018.

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  1. senior

    senior Member

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    Good day to all,
    Recently my company producing handryers with tap functions being audit
    regulatory body from europe.

    This auditors says i quote "Any equipemnt purchase from manufacturer must be calibrated by
    certified calibration body". Claiming that equipment manufacturer are not certified calibration body.
    Auditor also mention that any equipment sent to manufacturer fro repair must be recalibrated.

    My question is,
    Is there any standard in ISO mentioning the above statement.
    Appreciate if anyone of you could help me on this issue.
    Thank you
     
    senior, Dec 12, 2018
    #1
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @senior and welcome to the site.

    The short answer is "NO".
    You should always have the auditor reference the clause that they are writing a nonconformance against.

    In regards to calibration, first, the organization can (must) decide if it is relevant...

    7.1.5.2
    "When....a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results..."

    If the organization determines "yes" according to the previous statement, then the "method" requires...

    a)
    "...against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;..."

    What "the auditor says" is of no consequence, only what the standard (and internal stipulations) require.

    Hope this helps.

    Be well.
     
    John C. Abnet, Dec 13, 2018
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  3. BradM

    BradM Moderator Staff Member

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    Did the auditor cite anything with respect to requirements? Are there industry requirements? Any requirements with respect to purchase orders/ contracts?
     
    BradM, Dec 13, 2018
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  4. senior

    senior Member

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    Thank you John and Brad,
    I did as for the reference standard but got no reply from auditor.
    Guess i have to follow ISO standard requirements rather than following something not in standard.

    Thank you again guys.
     
    senior, Dec 14, 2018
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  5. BradM

    BradM Moderator Staff Member

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    ? What are you going to follow? Calibrate everything you see? :)

    My point is, just rolling over to auditors without some basis is not good process approach; and not good auditing.

    If you have tools/equipment that you use in your process that is important/critical, they need to be verified/calibrated.

    If an auditor makes some statement you have to do X or Y, they need to provide you a source for that observation. Otherwise, they're just giving you an opinion.
     
    BradM, Dec 14, 2018
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  6. tony s

    tony s Well-Known Member

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    Calibration does not apply to all equipment. What if I bought an "office equipment" e.g. computer or printer? If your referring to "measuring equipment" and these equipment are being used to determine conformity to product requirements, then you need to satisfy Clause 7.1.5.
     
    tony s, Dec 23, 2018
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  7. BufferMess

    BufferMess Member

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    The standard specifically requires to calibrate measuring equipment used for the conformity of products. It is not about all measuring equipment. The conditions for calibration is specified as "certain intervals" or "prior to use". You should check regulatory requirements. There might be a legal requirement for calibration of measuring equipment by a certified body before purchase or after the repair.
     
    BufferMess, Dec 28, 2018
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  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Not providing you with a reference is a problem unto itself.

    I agree with my fellow posters. I do want to also stress that you may need to be ready to defend how you identify "equipment." Was the auditor referring to taps? Taps are cutting tools. Only if a tap is being used to measure something does it need to be verified accurate according to 7.1.5. You would be well served by a list of measurement equipment, allowable error for each, frequency of calibration/verification, etc. as part of a calibration program.
     
    Jennifer Kirley, Dec 29, 2018
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  9. tony s

    tony s Well-Known Member

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    Why do you need calibration for this kind of product?
     
    tony s, Dec 30, 2018
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  10. senior

    senior Member

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    Guys, the equipment i am talking about are :
    AC Power Source / Dielectric Analyzer and Leak Testers.
    These equipments are use for testing of our products.
     
    senior, Jan 2, 2019
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  11. Neo113016

    Neo113016 Member

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    It is clear that the item that you have mentioned is a measuring equipment.

    If the auditor did not found any evidence that it is calibrated then it is a NC based on clause 7.1.5.

    I recommend you discuss this issue with your supplier and require them to take care of the calibration of equipment provided to your company.
     
    Neo113016, Jan 7, 2019
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  12. senior

    senior Member

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    Dear Erickson,
    My question is:
    We purchase the above mention equipment from supplier Extech in Taiwan.
    Auditor remark, before using these equipment we need to sent them for calibration.
    Also if we sent these equipment back to manufacturer for reset or repair, equipment need to be calibrated by calibration house.
    Is this mention anywhere in ISO9001:2015.

    Thank you
     
    senior, Jan 21, 2019
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  13. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Good day senior,

    You do not mention where you are located, but I wonder if there are local calibration service providers who can service your equipment. Meanwhile, Extech has calibration services that you can inquire about here. I wonder if they have a site near you, as they referenced NIST.

    7.1.5.2 of 9001:2015 does not require calibration/verification by the manufacturer, only that the instrument(s) be "calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information".
     
    Jennifer Kirley, Jan 21, 2019
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  14. judegu

    judegu Well-Known Member

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    I think at least, the manufacturer itself has the authority to calibrate its own product (measuring equipment), right? If they don`t, they won`t be allow to produce such type of equipment in the first place, right?
     
    judegu, Jan 22, 2019
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  15. BufferMess

    BufferMess Member

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    @senior. Your company failed to verify calibration status of the new measuring equipment. "prior to use" pretty much defines the NC...
     
    BufferMess, Jan 23, 2019
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  16. senior

    senior Member

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    Thank you guys,
    Equipment purchase from Extech comes with calibration certificate so i dont need to re-calibrate it.
    By the way i am base in Malaysia.
     
    senior, Jan 24, 2019
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  17. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Does the certificate include traceability information for the standards used to calibrate?
     
    Jennifer Kirley, Jan 24, 2019
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  18. KyleG

    KyleG Active Member

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    Should i purchase metering equipment with an ISO certification. I have 2 meters one for gloss and one for coating thickness. the 2 meters i already purchased i did not get with the certificates.
     
    KyleG, Jan 24, 2019
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  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What's this? Do you mean an accredited ISO/IEC 17025 Calibration certificate?
     
    Andy Nichols, Jan 25, 2019
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  20. KyleG

    KyleG Active Member

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    KyleG, Jan 25, 2019
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