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ISO 17025 - Expert Advice Community

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  • Technical Manager - role, responsibilities and qualification

    We are working with a water laboratory on implementing a ISO 17025 Laboratory Management System. During our pre-assessment, *** highlighted that we needed to appoint a Technical Manager and highlighted that he needed to have specific qualification (including CPD, chartership etc.) So I am looking for the definition of technical manager under ISO 17025 or any other relevant Laboratory guidance/regulation, his role and responsibilities and competency required. Could you kindly advise?
  • Impartiality

    *** will be needing the standard for one operation only which is a mobile testing facility for pallets, for which they will charge their customers.  Commercially they want to demonstrate whether the material their customer is using (probably not bought from ***) is adequate and secondly to demonstrate that their own brand does meet the particular standard that they are testing against.

    To help me in pricing this, could you help with the following:

    1. How will what they are doing affect impartiality?
    2. As the testing will only be for one type of test, is it likely that all 58 forms are needed.

  • Do I need ISO 17025 certification in order to audit laboratories?

    I am a molecular diagnostics lab expert with decades worth of experience. I am also well versed in ISO17025.I am interested in ISO9001 lead auditor certification. My question is, as a lab expert, do I also need ISO17025 certification in order to audit laboratories? Or is 9001 is sufficient? Thank you

  • Can one person be lab director and quality manager at the same time?

    I want to let you know that I enjoyed last week’s webinar very much.  But I wanted to follow up on a question….We are currently a small organization and I’m currently wearing multiple hats including lab director and quality manager, among other things.  As we plan for ISO 7025 accreditation, is that something I will continue to do…can 1 person continue doing both or does the quality manager need to be a different person or report to a different group?

  • ISO 17025 accreditation

    Generally, what is the cost and how long it takes for certification?

  • Is ISO 17025 designed and intended to be implemented on individual, test-by-test basis?

    Is it true that ISO 17025 is designed and intended to be implemented on an individual, test-by-test basis, specifying requirements for the competence to carry out tests and /or calibrations,including sampling?

  • Importance of change controls

    I  just have a quick question regarding ISO 17025:2017. How important are change controls? since this is a technical accreditation, how much importance is laid on change controls?

  • Documents needed in term of testing methods

    If we are trying to get ISO 17025 certification with a scope of testing methods....what all documents would we need in term of testing for the said methods? for example, do I need to validate/ verify these methods? If so how? what documents/records do I need for this.

  • ISO 17025 requirements for Pharmaceutical organization

    What are ISO 17025 requirements for Pharmaceutical organization?

  • Lab activities

    Plz define list of lab activities and and what is range of lab activities?

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