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  • Customer audits - 17025 requirement?

    I have a quick question for the Customer Service Procedure. In your template, you have included a section on "customer requests to monitor laboratory performance". This is basically an audit option for clients to 'come and see for themselves'.

    In our case, there isn't really anything to see - it's all data.

    Are we required to provide this auditing option, or can we leave it out?

    There is also a sentence on demonstrating or explaning in conversation the preparation of items for testing. Again - very relevant if you are a blood sample lab but not for our field work. However, a requirement to explain in conversation how our methods are applied (in this case DFM) and data is treated seems both appropriate and relevant. But this is more to ensure customers understand what we do (how we derive at a result) - and because the methods are new.

    We may include something like that - but that's different from a client audit. 

  • Design & Development

    I communicated earlier with you regarding the implementation of ISO 9001 for our Laboratory. We are accredited ISO 17025. 

    For ISO 9001, do I include Design & Development, since method development is done by our Lab? 

    Your view and insight is highly appreciated

  • Possibility of including more methods on calibration certificate

    our metrology laboratory is accredited according to ISO 17025. I downloaded your guide because I would like to find information, if it is possible to include more methods (from the same scope of accreditation) on the calibration certificate (ar. 7.8.2.1 f) - identification of the method used). I think that is not a problem, but it is not exactly solved anywhere. If you could give me some feedback I would appreciate it.

  • Quality Manual

    Some labs applied to copy the whole ISO Standard as their quality manual, may I know is this acceptable? 

  • Method validation/verification

    Yes, we are in the process of implementing ISO17025 and have almost completed creating our quality management system. I am struggling with method validation/verification for my analyses. One is semi-quantitative while primarily identification (NIOSH 9002) and I am unsure how to verify the method since I can’t order standards and I have previous PT samples I can use but they don’t cover the entire scope and since the method is partially identification I can’t re-use them as blinds. The other method is random by nature so again I can’t order standards. I just want to ensure that the verification that I perform is robust enough.

     

  • How to become good assessor for ISO 17025:2017?

    Good Day! For Your info, I have been involved in assessment of chemical labs for ISO 17025:2017 for 3-4 years. From my own self assessment, I feel that something lacking in my way of carrying out the assessment and maybe you can give some advise /guidance on how I should go about it as I am aiming to be Lead Assessor ( Currently as Technical Assessor).Really appreciate your kind help here.

  • LEEA and ISO 17025

    If a company has gained LEEA. is this covered by ISO17025?

  • How to show impartiality in the QMS?

    My lab I am trying to get certified is within a larger company. I work as the larger company’s Quality Manger and Operations Manager. I can see how this could look as a conflict of interest. How would I go about showing impartiality in the QMS for this situation?

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