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Document control - what is mandatory to be controlled?

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by Lorin B., Jul 22, 2022.

  1. Lorin B.

    Lorin B. New Member

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    Hey everyone,

    i have a question regarding document control. Are there specifications that regulate which documents must be controlled? I am aware that internally used documents must be controlled in any case. But what about, for example, a document that is given externally (to the customer)? For example, an order sheet, which we then receive from the customer again and file in the order documents.

    Thanks in advance!
    Lorin
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Lorin B. and welcome to the site.

    There are two areas within 17025 that refer to or imply "external" documents...

    6.4.13 Records shall be retained for equipment which
    documentation of reference materials, results, acceptance criteria, relevant dates and the period of
    validity;

    8.3.1 The laboratory shall control the documents (internal and external) that relate to the fulfilment of
    this document.


    And of course, if your organization is claiming compliance via "Option B", then ISO 9001 verbiage directly applies as follows..
    7.5.3.2
    Documented information of external origin determined by the organization to be necessary for the planning
    and operation of the quality management system shall be identified as appropriate, and be controlled.


    As you can see from my underlined references above, much is left to your organization to determine.
    I developed and have taught my teams and clients to consider the following "wrong or gone" term.

    In other words, if the information is WRONG or if it is GONE (missing), can the result lead to a non-conformance? If the answer is 'yes" then how would your organization justify not 'controlling' that information?

    Hope this helps.
    Be well.
     
    Andy Nichols likes this.
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome Lorin:

    For clarification, when you say
    Who is doing the "giving"? Or is it a typo?

    Yes, is the short answer. ISO/IEC 17025 (or ISO 9001 if you chose that option for the way the lab complies) both require documents related to the QMS (of internal or external origin) are controlled.
     
  4. Enghabashy

    Enghabashy Member

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    beside the documents above' the external documents should cover ILAC or accreditation party " UKAS/A2L----etc. " -- you should refer to the procedures & regulations also in theirr web, , you should refer to relevant regulation " i.e.: uncertainty of calibration/testing, rules of use the accredit logo ,--etc. -- all of this are formally published