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ISO 17025 - Expert Advice Community

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  • Project Plan in ISO 17025 toolkit

    Hello - I purchased the ISO 17025 toolkit with extended support and have come across my first item for which I need help :) I am working on implementing the ISO 17025 documentation provided in the tool kit and am unsure if my company needs the project plan. We already have an ISO 13485 management system in place so I'm unsure if this applies.

  • Calibration program

    I have one question, that is if the lab has the calibration program for all the equipment, that enough for valid the result? Or they have to do for example PT ?

  • Is ISO 17025 accreditation needed?

    I would like to ask if an OEM company is ISO9001:2015 certified is it mandatory that they will get certification for ISO IEC 17025:2017 accreditation? if answer is No, does it affects company's accreditation to  IATF 16949?
    appreciate the help. . if you can provide other reference I would be gladly to receive it.   Thanks much.

  • Changing calibration frequency

    I have a question regarding changing the calibration frequency of my field test instrument.

    In the process of obtaining ISO 17025 I came to realise the external supplier I used to calibrate our field test instruments were not accurate enough which in turn was making my uncertainty of measurement for temperature calibration too high.

    Due to this I have used another external supplier to carry out the field test instrument calibrations and the results have come back much better.  Due to this finding I need to build up a calibration history quickly to help with my measurement uncertainty calculations, so instead of having my calibrators calibrated every 3 months I now have changed it to monthly, and will continue to do this for the next 4 months after which time I will change the calibration frequency back to 3 monthly.

    How best do I document these findings and changes using your 17025 toolkit paperwork to show the auditors what I have done.  Your help would be appreciated.

  • What is the acceptable range of RH for a laboratory? 

    I would like to ask you a question. The ISO17025 standard has a clause that explains how important environmental conditions are for a lab. What is the acceptable range of RH for a laboratory?

  • Measurement uncertainty and lab validation

    If tests come with accepted tolerance ranges do you still do measurement uncertainty? Also if you use international standards which are validated already do you still need to validate the method in the lab?

  • Documents and clauses

    We attended the 12 steps webinar today and are thinking about buying your template package. After the seminar we discussed what we learned and decided to write up our  notes. We think these notes (and others we will create as we progress) should be part of the records but cannot figure out which clause they fit under. Any advise for us?

  • What is EQA Test in ISO17025

    Our lab is a petrol and diesel lab, and our lab says we need to do an EQA Test to get iso 17025. I did not understand the EQA Test.

  • Requlatory Requirements for a DNA testing lab

    Hi, I am in the process of starting a DNA testing lab in Canada, but I’m unsure of the regulatory requirements for offering my testing services to other businesses in Canada. Specifically, I am interested in offering microbial identification services to GMP pharmaceutical companies. I have worked for a pharmaceutical company in the regulatory side of the business (QA) and in QC (microbiology) and I am well versed in GMP requirements for the pharmaceutical industry. However, I have very little knowledge of what is required of outsourced labs that process samples that they receive from GMP pharmaceutical companies. I assume accreditation is mandatory for outsourced testing labs. Is ISO 17025 the relevant accreditation? Is it possible to speak to you or send follow up questions to better understand the regulatory framework for a DNA testing lab in Canada?

  • Pre audit visit by our assessment organization

    Do you recommend that we request a pre audit visit by our assessment organization?
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