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ISO 17025 - Expert Advice Community

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  • ISO 17025 lab certification

    I wanted to be certain of the requirement for certification. Does our quality system need to be up and running with 6 months of records before a notified body/registrar will grant certification? I need to clarify this ro ensure the company has the correct timeline for obtaining certification. Thanks for the training you provide, I have joined in on a few of your webinars.

  • QMS requirements

    I have a question about the toolkit we purchased: Procedure #04, section 3.3, fourth bullet point.. Implications of not conforming with QMS requirements. Will you please let me know exactly what this is referring to?

  • ISO/IEC 17025 Certificate duration

    I'd like to ask how long ISO/IEC 17025 certificates are valid for?

  • Common challenges in accreditation process

    What are the common challenges you come across in your accreditation process?

  • Audit Scope

    I have difficulty with the concept of "Scope" of an audit. If for example I have a lab that has multiple departments (Biology, Organic Chemistry, Physical Chemistry, Product Development etc.), each performing a different array of tests, could you provide some general examples of what the scope of an internal audit might be? Is it the clauses we intend to audit? Or the specific test/group of tests within a department? I'm just not sure of what Scope exactly is. Thanks for your time.

  • Min number of employees necessary for lab to get 17025

    What is the min number of employees necessary for a lab to get 17025?

  • Numbering system

    I was hoping you could give advice on a numbering system for cross reference between the different documents ? Also do you have experience with 510K application at the FDA ? I have a local manufacturer who is busy the process

  • What are the main areas of ISO 17025 that most Laboratory miss?

    What are the main areas of ISO 17025 that most Laboratory miss?

  • Internal audit on Sampling & Analysis

    I'm currently doing an internal audit on Sampling & Analysis and I noticed we don't have a true "procedure" for 17025:2017 requirement 7.4. We made a procedure for 7.3 and I am now realizing that 7.3 only needs to be a "plan". I was wondering if we should keep these two requirements separate or possibly roll them together into one procedure that covers both 7.3 and 7.4.  What do you think?
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