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ISO 9001 with ISO17025 lab?

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Kishnu, Jun 9, 2017.

  1. Kishnu

    Kishnu New Member

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    good day,
    we are manufacturers of hand held meters and currently undergoing our upgrade from iso9001:2008 to 2015.

    however I would like to ask that since we have a service department and laboratory, would it be nessecary to have the lab certified to ISO17025? Would it not be a conflict of interested to have an 'independant' body within the same organization as the manufacturer?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Firstly, it's your choice - based on an understanding of those topics of consideration in the "Context of the Organization", plus commercial considerations - but not mentioned in ISO 9001:2015, so not a requirement. Are far as conflict, then in fact, such arrangements are common, at least in my experience.
     
  3. Kishnu

    Kishnu New Member

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    Thanks for your feedback! just so I could get this figured out.. so for instance during manufacturing, calibration and test will fall under its ISO9001 system. However if a customer returns their instrument for repairs/re-calibration or their annual calibration schedule, it will go under the service department, which has yet been incorporated into the ISO9001 system. In this instance it would be the better option to assume the laboratory as a seperate entity and have it certified to ISO17025?
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Well, to be honest, I'd have to understand more of your business "model" before I can answer fully. Here's some thing to consider:

    • Does your customer expect/demand accredited calibration results? (Labs are "accredited" to 17025, not certified)
    • Does the lab also do the final product testing before shipment of the new product?
     
    Jennifer Kirley likes this.
  5. Kishnu

    Kishnu New Member

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    Hi Phoenix, hope the weekend was good! :)
    Basically we are a company that manufacturs hand held meters and part of the manufacturing process is to calibrate these meters before being sold. With it comes a standard calibration cert and its traceable to several bodies, hence the paper trail is there for this.
    Less than a year ago we set up the Service department, whereby customers from all over gets to send us their meters (the same as manufactured) to get their annual calibration done or repairs, be it bodywork or electronics. These are done by the same guys from manufacturing and the issuance of the calibration certs are the same as of brand new meters. The procedures are exact same that of new manufacturing, just a re-do of the same.

    And now since our business are growing, a few companies have approached us to be our service agents to cater the region they are in and it got us wondering, should we adopt 17025 for our own Service department?Is it either by practice or getting it certified? and should we have to have it in order to demand these companies to adopt themselves before we allow them to carry out the repairs for us?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If the question is simply "Should our labs be ISO/IEC 17025 Accredited?" then that is a question for your top management to decide on whether the effort and cost has any benefit. Should the lab who does the initial testing and calibration etc comply with ISO/IEC 17025 requirements (without the accreditation), then I'd suggest that this rigor is very useful to understand the condition the product was shipped, such that if/when it returns for calibration, that baseline is very helpful to know.
     
  7. Kishnu

    Kishnu New Member

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    Thank you Andy for your advice! I'll look into this in more detail and get back to you if any other questions arises
     
    Andy Nichols likes this.