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  • How to consistently implement ISO requirements?

    How to consistently implement ISO requirements?

  • GLP and ISO 17025 (Clause Improvement)

    My question is regarding GLP. Are there written requirements of GLP anywhere .which would be fulfilled to by lab . More over in ISO 17025 we have clause of improvements. If the lab will get same results as was in previous year then it means the lab has maintained its success or maintained the implemented rules. Does this would be counted in improvement ? Further to fulfill the clause of improvement what would you suggest to do ?
  • Adapting existing management system

    If you already have a 17020 accreditation and you require a 17025 accreditation would it be best to adapt the existing management system or build a new separate one alongside?

  • Do we need ISO 17025 certification to certify the freezer?

    I am confused. We certify freezers and refrigerators to customers that buy them from us. There is a pharmacy that uses it to store vaccines. They want the certification doc to state that it complies with ISO 17025. I thought that it was not mandatory.
    Do we need that certification to certify the freezer?

  • Addressing and closing nonconformity regarding clause 7.2

    We have an NC regarding clause 7.2, how do I address it and close it?

  • Document control

    When update quality system, if we have a stock of printed forms with a code for example "lab(5) form". In new document we change the coding system for example 6-4-01. Can we use the old form although it has a cod with different system. or it is acceptable to change the code on each form manually?

  • Requirements for temperature, humidity, and room type in house calibration lab

    What are the requirements for temperature, humidity, and room type when it comes to creating an in house calibration lab?
  • Becoming expert in quality of pathology lab

    If you want to be an expert in quality of a pathology lab what are the steps to follow and concentrate on

  • Clause 6.4.3

    "Under clause 6.4.3 within 17025, I have a question regarding a requirement or not if there is a requirement for a test for residual detergents? This is regarding the cleaning of glassware within microbiology.

  • Glassware cleaning within microbiology labs

    Section 6.4.3 - Requirement: The procedure and/or supporting procedures include instructions to ensure that equipment, media, reagents, test organisms, etc. are handled, transported, stored, and used in a manner to ensure proper functioning and to prevent contamination or deterioration.

    Question - When washing and reusing glassware that can impact the recovery of organisms, does the laboratory require a procedure to test for residual detergents ? Is this mandatory or purely a best practice ? for example: Bromthymol Blue Solution (0.04% Aqueous Solution (Caledon #LC 12050-1) or equivalent) is used once a month to verify the complete removal of detergent traces by the rinse cycles and used whenever new detergents are introduced. Should a test such as this be written in to the SOP ?

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