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New system application for ISO 17025

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by New World 2021, Jan 21, 2021.

  1. New World 2021

    New World 2021 New Member

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    I am about to start the gap analysis of our current lab practises which are against ISO 13485 and as a result the EU IVD directive against the, new to us, ISO 17025.
    This may be a quick review as i may fall at the first block ... Can anyone provide me with a bit of info or guidance regarding qualifications required.

    To comply with the ISO 17025 standard, does a company require a registered medical practitioner as part of their company to be on site who is registered with the General Medical Council - is this a strict requirement?

    Is there a work around for this whereby justifications can be made against the performance of the product or is the requirement held in the standard set in stone that the requirement of the practitioner is required?

    I would appreciate any held or information on this matter

    thank you
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome. It's worth buying a copy of the standard, so that you can become knowledgeable of the requirements.

    Since ISO/IEC 17025 is about labs/testing and calibration in general, it is agnostic to specific industry application. Hence your answer is "no". I'd commend you to obtaining a copy of the document from your country standards provider to assist with an accurate gap analysis.
     
    John C. Abnet likes this.