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Calibration (Internal V. External)- Clause 7.1.5.2

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Suraiya Ramkissoon, Jun 11, 2019.

  1. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    Hi Everyone,

    I'm implementing ISO 9001:2015 (with the aim for certification) at a company that sells automotive batteries. We offer 18 months warranty for our batteries.

    Part of the warranty process is validation of battery which we use a hydrometer and a multimeter to test.

    Therefore I am telling the manager that these devices need to be calibrated according to 7.1.5.2.

    For us to calibrate these devices we would need to send it to another country.

    I do not have a technical background in calibration, so I was wondering if we can calibrate our hydrometer internally (developing a test method with the related retained documented information) using the steps in the link below?

    https://www.wikihow.com/Calibrate-a-Hydrometer#Calibrating_a_Hydrometer_sub

    Feedback appreciated, calibration is not my area of expertise at all.

    Suraiya.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Calibration is one option. ISO 9001 also allows for verification and that may be the option you should choose. A multimeter can be checked against a standard like a couple of standard voltage cells (Weston Cell) or a calibrator. For the hydrometer it's the same thing. It's simply a check by comparison - which in basic terms is a verification.
     
  3. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It is true that ISO 9001:2015 does not require professional calibration. A sound method with traceable standards and documentation should be adequate.
     
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  4. tony s

    tony s Well-Known Member

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    How much will it cost your organization to send your measuring equipment to another country for calibration? How frequent are you going to calibrate them? Yearly? Is it more practical to buy a new one yearly? Have you experienced before a customer-returned product due to inaccurate measurement results? Will there be significant differences in the results between external calibration and internal verification? If there are differences in the results, will these affect product quality? Will these affect your organization's and customers' confidence in the validity of measurement results?

    I believe, these are the questions that you may need to consider before deciding to go for external calibration or internal verification.
     
  5. Golfman25

    Golfman25 Well-Known Member

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    I would follow Andy's approach. Then only when it can't be verified, you'll need to calibrate or replace.
     
  6. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    Thanks for the feedback everyone, I'll pitch the questions out to the management team so we can decide on a way forward.
     
  7. Qualmx

    Qualmx Well-Known Member

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    Jenni
    What do you mean with proffesional calibration?
    Thanks
     
  8. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Suraiya Ramkissoon ;
    Please forgive me for picking on your terminology, but the use of "validation" (as you used in your sentence above), vs. "verification", is somewhat more than semantical. In context of what you are describing , your organization is "verifying" that the product is within specification. You are not "validating" that the design meets its intended purpose. Unless the topic is "design", the term validation is generally not applicable and can potentially cause exposure beyond the presumed scope of your organization. Food for thought.

    Be well.
     
  9. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Calibration by a contracted service provider versus done in-house.
     
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    FWIW - calibration is often performed internally by a competent lab. It's not always necessary to go to an outside provider (even IATF 16949 recognizes this) and hence obtain a meaningful result. Of course, some technologies are only (commercially) justified by a commercial lab, but a voltage check could be done very satisfactorily by an internal person.
     
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  11. Miner

    Miner Moderator Staff Member

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    You can purchase specific gravity standards with which to verify your hydrometer. However, depending on the type of hydrometer you have, some have no moving parts, are not susceptible to wear, could be visually checked for damage and simply replaced at relatively long intervals.
     
  12. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    thanks! that actually reminds me, I think I need to justify exclusion of 8.5.1.(f) as we do not design. I already noted 8.3 to be excluded.
     
  13. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Suraiya Ramkissoon

    Please note that 8.5.1(f) is not (necessarily) speaking about product design. What 8.5.1(f) is speaking of , is the providing assurance that output (generally product) is good even if there is no way to physically check (verify) that the product is good. For example, if you make a product for which conformance to requirements cannot be checked, then you are required to validate that the process will achieve its intended outcome. i.e. Show through objective evidence (statistics, etc..) that the PROCESS will indeed make good product. (i.e.confirm that the PROCESS design will achieve its intended outcome.)

    It may indeed be true that 8.5.1(f) does not apply to your organization (it generally does not apply to most typical manufacturing organizations), however, I wanted to ensure you understood its actual meaning.

    Hope this helps.

    Be well.
     
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  14. tony s

    tony s Well-Known Member

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    Clause 8.5.1f is intended for "special processes". ISO 9000:2015 defined this kind of process in section 3.4.1 in Note 5 as: "a process where the conformity of the resulting output cannot be readily or economically validated". There are products that need to undergo destructive testing to be able to demonstrate conformity to specifications. A simple inspection will not be enough to determine conformity to specifications.

    Inspection is a form of verification, while test is a form of validation. ISO 9000:2015 defines both as :

    Verification - confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. NOTE: The objective evidence needed for a verification can be the result of an inspection...

    Validation - confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. NOTE: The objective evidence needed for a validation is the result of a test...
     
  15. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    John C. Abnet likes this.

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