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  • Are there any things in ISO 9001 not covered by ISO 17025?

    Hi, I am looking at ISO 9001. We are currently 17025 but due to spiraling costs have decided to lose the accreditation and apply for 9001. All will remain the same as to working under 17025 but we will no longer carry the badge.  I am trying to source the information for changing to iso 9001 as we are giving up our UKAS accreditation 17025. Are there any things in 9001 not covered by 17025?
  • Reporting

    1. 7.8.2.1  i) The date of the test or calibration. For geology/mineral reports, is this necessary? I know there have been some changes in reporting requirements, but if the date of testing does not affect the validity of the results, is 7.8.2.1 i) necessary? 2. If deviations and abnormalities of sample on receipt are sorted out before the person delivering sample/s goes, other than saying this is done.is this sufficient? 7.4.3 states 'Upon receipt, does the laboratory have a system to identify and record abnormalities or deviations from specified conditions?' so I'm confused
  • Mass pieces for verification of balance

    1. In another post on this subject, you say "This means you should have mass pieces that cover the range of use of the balance and have calibration certificates for the mass pieces." Does this mean that if you have mass pieces that are verified on a balance right after calibration of the balance, this is insufficient to prove 'fit for purpose'? 2. 7.8.2.1 e)  The name and contact information of the customer. Is this necessary if only one client - laboratory is on mine property 7.8.2.1 o) Identification of the person authorizing the report. If the report is simplified and emailed from a password protected computer, is this necessary? And finally 7.8.1.3 Is any information that is not reported to the customer readily available? Does this mean that a report with above information must be available as well?
  • ISO17025 Stage 1 Application- Covid Testing

    Tested began as a Research project looking at the detection of SARS-CoV-2 in *** via qPCR using a hypecube pooling method. We would like to become an accredited facility offering Covid-Testing to the University. However our method is not CE Marked and potentially need to apply for derogation. Is this something you have encountered before and can provide advise on how to go about this. Secondly any advise on what is required for Stage 1 Declaration Application.
  • Resource Requirements

    1. I have a question about Resource Requirements, 5.5 Metrological Traceability.  As we are testing laboratory and not offering any calibration services does 5.5 need to stay in our Quality Manual or can I delete this? 2. Next question 17025 clause 8.1.3 Option B, our lab complies with option B so does that mean I can delete 7.2-7.9 from my Quality manual?
  • Section 2 Normative references

    I have been asked to review the quality manual for accuracy before the owner reprints it. I never noticed this before, but under section 2 normative references, the owner of the laboratory listed reference such as textbooks and guides like: Bam, ISO/IEC guide to general terms in the definitions, and many other ISO guides like 7218, ISO guide 8402:1986. Do all of these references have to be put on a list of controlled external documents? Our lab has a list of internal and external controlled documents. These textbooks and guides listed in Section 2 of the QM are not of the list of external controlled documents. Isn't this a non-conformance?
  • Proficiency testing  and PT provider in pesticide formulation

    I need you help regarding Proficiency testing  and PT provider in pesticide formulation" i need your help with regard to PT testing as we couldn't find any in our scope .is there any alternative?
  • Question about clause 4 of ISO17025:2017

    I want to ask a question about the impartiality clause in the ISO17025:2017 standard. I understand all the requirements about the impartiality, but as an auditor of the laboratory i want to ask you, How should i audit this clause of the standard? Which document or information should i be looking for to make a decision if the laboratory is compliant to this clause. The same goes with confidentiality.
  • Customer Service Procedure

    Can you give me an idea of how the CS Procedure needs to change if service mine only - i.e. mine is only client of lab
  • Implementing verification and validation of method in microbiology lab

    How can I implement verification and validation of method in microbiology lab. If I creat standard operation procedure (SOP) for each clause is that enough or not required
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