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Calibrated equipment

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

  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
     
  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.
     
    Andy Nichols likes this.
  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?
     
  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.
     
    John C. Abnet likes this.
  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.
     
  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.
     
    Erickson Rabena likes this.
  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.
     
  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.
     
  9. tony s

    tony s Well-Known Member

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    Why do you need calibration for this kind of product?
     
  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.
     
  11. Erickson Rabena

    Erickson Rabena 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.
     

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