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IS0 17025:2017 Section 5.1 to 5.7

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by Jithu Bastin, Jul 14, 2021.

  1. Jithu Bastin

    Jithu Bastin New Member

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    We have been audited for ISO 17025 recently and were asked to add a section for Structural requirements(Section 5.1 to 5.7) in our internal audits. We are a dimensional measurement laboratory.
    How can I accommodate a question from these sections in my audit?
    Any help would be appreciated. Thank you.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome, Jithu. Before I can answer, can I ask who made this request? How have you been auditing your Lab Management System in the past? Do you audit to ISO/IEC 17025? or to your lab processes and activities?
     
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  3. Jithu Bastin

    Jithu Bastin New Member

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    Appreciate the reply.
    We had an annual ISO/IEC 17025:2017 surveillance audit and this was one of the NC's that the ANAB auditor found.
    The auditor wanted us to include Sections 5.1 to 5.7 in our internal audits and I wasn't sure how to frame this as a question.
    Audits have been an ongoing process in our facility since its inception decades ago.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    OK, so that begs a couple of questions, like "Why now?"

    However, what I'd like to know is what are your internal audits using as audit criteria? Do you audit the 17025 requirements each time, or what? How have you been missing this aspect of 17025?
     
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  5. Jithu Bastin

    Jithu Bastin New Member

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    We audit 17025 twice a year and the rest of the internal audits are under 9001.
    We usually include questions from 4,6 & 7 and all the previous auditors did not have an issue with this.

    This year an auditor decided to make this an issue and asked us to include section 5 in our audits.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    OK, so there's a huge opportunity to improve this. Internal audits, once the lab system has been established, should move away from only considering elements/clauses of the standards. You should be looking at auditing processes (especially since you have chosen to base your Lab System on ISO 9001). I'm a little surprised that it took the AB auditor so long to report this, but it is what it is. I'd play devil's advocate and ask why it's not been an issue with other auditors, but that's just me. The implications are that one of them is wrong!

    What does your lab do, in it's Lab Management System to comply with section 5?
     
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  7. Jithu Bastin

    Jithu Bastin New Member

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    So we are a fixture manufacturing facility and the QC lab takes care of CMM inspection.
    We are accredited by ANAB for Dimensional Measurement.
    All our departments are audited by 9001 and QC lab by 9001 and 17025.
    As far as complying with section 5 we have organizational charts, policies, guidelines, etc.
    I would like to know how else can we include Section 5 in our system.
    Appreciate all the advice.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I can tell you how you COULD audit it, but it will require work by the organization, so that you can do the audit. Unless your top management are made responsible for the organization's processes as "Process Owners", then they cannot reasonably demonstrate compliance to section 5.

    I have a separate question about how you comply with section 5 in your ISO 9001 certification, too. Because it would be easy enough to simply replicate that. However, in reality, I know ISO 9001 auditors don't know HOW to audit management.
     
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