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ISO 17025 - Expert Advice Community

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  • ISO 9001 and ISO 17025 certification

    If a company has a lab, does laboratory testing and the lab is ISO 9001 certified, does that mean they are also ISO 17025 certified?

  • Working Instructions for testers under accreditation

    1. Working Instructions for testers under accreditation – is there recommended form and will we receive it?
    2. Is it possible to receive support for the structure of the Lab and it place in our organization chart – to be acceptable for accreditation body?
  • Should we go for ISO 17025 compliance?

    One question: we want to offer testing from our laboratory facility to, for example, the retail pharmacy sector (a previous clinical laboratory I ran was CPA- compliant (now UKAS of course).

    I went through the ISO options and determined we need to go for ISO 17025 compliance. Do you agree ?

  • LIMS validation

    Please let me know if you have templates for LIMS validation (Computer System Validation) as par with USFDA part 11

  • LIMS validation record

    Does this validation record apply for pharmaceutical industry. Actually we are planning to do a LIMS validation , can you help us with the same

     

  • 17025 accreditation: cost benefit

    What about higher income for 17025 accredited Cal's compared to non-accredited?  
    I am trying to justify accreditation to an electrical test equipment rental company. They have not been needing accreditation for most customers, who are small electrical test companies. Occasionally, they have to pass when government customers need accredited cals. 
    Do you happen to have a rough % of additional price that a lab can charge for an accredited calibration, compared to just a straight commercial cal with NIST traceability?
    Just a rough estimate would be great.

  • Clause 7.2.2.2, Changes to a validated Method.

    If a validated and published method (e.g. FDA, EPA, etc.) says that we can adjust parameters as necessary, e.g. column conditions, and we do choose to alter those parameters, is that considered a change to a validated method despite the method stating that we can indeed alter those parameters?

  • Statement of conformity

    we are into calibration Lab, is it possible to give statement of conformity in our calibration certificates without considering the Measurement uncertainty on a request note of the customer.

  • Forms meet AIAG standards

    Can you verify that the forms meet AIAG standards? 

     

  • Test Report Validity

    Need help in validity of any test report [from date of issue]. Is there any standard practice to be followed for considering the validity of the Test Report?

    As i have not seen any test report mentioning Validity. What should a certification body consider if the historical test report submitted by the client is more than 5 to 8 years?

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