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  • 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?
  • ISO 17025:2017 witnessing audit

    During witnessing internal auditing for compliance to ISO 17025 , which clauses do you look at ?
  • Implementation duration

    please tell me the duration to get certification from scratch?
  • Eddy Current Testing or Electromagnetic Testing

    I'm an ET inspector -  does eddy current (Eddy Current Testing or Electromagnetic Testing ) machine flaw detection unit need a third party calibration sticker? I just want to make sure that as approved Testing Facility we need to comply in all particulars that refer to ISO/IEC17025
  • GMP license

    My company doesn’t require this, but I’m trying to understand the difference between being ISO 17025 certified versus having a drug establishment license from Health Canada and letter of Compliance from the FDA.  A third part lab we use does not have ISO 17025  but does have the other 2 items mentioned, they are an approved lab for Pharmaceutical testing and we manufacture for both Pharmaceutical companies and Dietary companies.  Is there anything outside the requirements for a GMP license by Health Canada that ISO 17025 has that would impact the validity of the test results from a lab that doesn’t have ISO 17025.  It is also not a requirement to have ISO 17025 but there can be an equivalent license.  Would the Health Canada license be considered equivalent?
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