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ISO 17025 - Expert Advice Community



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  • Intermediate checks Testing Lab

    We are independent mechanical testing lab.

    Recently we got intiial audit for 17025 and major concern had been raised on IMC.

    as testing lab i bought one large quality control material and make my own samples and

    Based on repeatability of final reading in MPA for (UTM) i made 1.5x expanded uncertainty as my UCL/LCL.

    auditor told me that I should check in primary unit like here its KN and acceptance should be of machine error range.

    2nd observation :
    I m using slip gauge as master instrument for doing IMC for vernier calipers m, gauge block have only OEM
    verification no traceability , he insisted to have calibration of slip gauge.

    Need your inputs on this.

  • SOP

    Do risks need to be highlighted within an SOP or can you refer to them in a separate document?

  • ISO 17025 and 22716

    We are a manufacturer of OTC Drugs that has undergone FDA inspections. We are considering using in-house stability data to set the expiration date of products. Currently, we are referring to outsourced stability data from an external lab(ISO 17025) for checking product stability and active potency. To ensure the acceptability of our in-house data, is it necessary to have an ISO 17025 certificate?

    We are complying with CGMP.

  • Identifying the method and scope of audit

    "I  want to conduct internal audit and would like  to ask that how we will identify the method and scope of audit  for our to be accredited lab of petroleum chemistry

  • Fulfilling ISO/IEC 17025:2017 8.9.3

    As a lab accredited under ISO/IEC 17025:2017, what ways can clause 8.9.3 (Outputs of Management Reviews) be fulfilled? Clause 8.9.2 is fully implemented.

  • Sampling in coal mine

    what are the basics i need to know to successfully do sampling in a coal mine

  • Writing standard operating procedure

    How to write a standard operating procedure specific for an analytical toxicology laboratory?

  • Food Packaging Testing

    We are a Transport Packaging Testing Laboratory. We are looking to grow our business in the Medical Device Packaging Testing portion of our industry. We see that SIO standards are geared towards manufacturing and product based businesses. We are looking to adapt a current Medical Device Manufacturer's QM to ours as a service based QM. Mainly need to know how deep do we need to go with process and procedure from the quality side. there's only 2 of us

  • Annual calibration

    we have a laboratory equipment's such as viscometer and we need to do an annual calibration to certify it , and i am wondering if the third party can do that and can the supplier certify with IS09001 AND IS017020\.

  • Risk Management Requirements

    What are the missing requirements may be reported during auditing as major Non Conformity and minor Non conformity?
    How we can cover risk management?

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