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ISO 17025 - Expert Advice Community

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  • Auditing impartiality

    How do you audit impartiality, how do you ensure impartiality in a testing laboratory according to ISO17025:2017?

  • SOP and authority record

    1. When they say the procedure can that be guideline or does it have to be an SOP? Also I thought in the std when it specifies that procedure then you need an SOP? But for audit and management review i have a record template and not SOP.

    2. For the authority record is it a list of staff, names, employee ID#, with list required authority and do they sign the form? Or is it a general document with all the information such as technician ,specialist, manager, Director, etc

  • Laboratory activity - where to draw the line

    If a laboratory is accredited ISO 17025 for testing, but in order to perform the tests it has to verify his equipments and calibrate them according to ISO 17025 requirement procedure before executing the tests, my question is: if the laboratory can perform calibration to prove it’s tests adequacy why can it do calibration activity (offer calibration service and provide calibration certificate for clients) as well besides the testing?

  • New measurement system

    Which standard defines how a new measurement system (CMM for example) should be run off and proven OK for use?

  • Procedures listed in equipment's manual

    1. 6.4.3 The laboratory shall have a procedure for handling, transport, storage, and use and planned maintenance of equipment, these procedures could they be the ones that listed in the equipment's manual? Or a procedure must be created according to the manual and the laboratory's policy? 2. If the laboratory has a code of ethics and conducts, to which every employee signed his agreement to respect, does that prove the company's impartiality and confidentiality?

  • How to become ISO/IEC 17025 certified and cost associated

    I am looking to become ICO/IEC 17025 certified. I understand the written part of the certification, but I do not know who can and how much it is to become certified and how often we will need to be re-certified.

  • ISO 17025 Quality Manual Option B

    I am working on the Quality Manual for ISO 17025 using the ISO 17025 Academy templates. Section 8 regarding Management Requirements. We are ISO 9001:2015 accredited so we are Option B. My question is do I delete sections 8.2-8.9? or do I just changed "8.1 Unitherm Furnace Complies with "Option B"?

  • Test validity for the regulatory bodies

    We have purchased two of the advisera kits to implement ISO 9001 and 17025. We are in the process of implementation, and in a couple of months, we hope to be ready to get accredited. In the meanwhile, we are performing several experiments following some of the ISO protocols. For example, to test the antiviral properties of certain products, we follow ISO 21702:2019. With our customers, we always make it very clear that we are not yet ISO accredited. Some have told us that this is no problem for them (they have been working with us in the past and are happy with our performance), as long as they can state that the product has been tested following that particular ISO. Now, my question is: will the tests that we perform (strictly following the ISO protocols) be valid for the regulatory bodies, even if we are not yet accredited?

  • Writing quality manual and nominating quality manager when we implement ISO 17025:2017

    Good evening As the previous standard there mentioned about the Quality Manager and Quality manual, but in the new version even 9001 and 17025, no mentioned about QM and Q. manual I saw new quality manuals for some companies and institutes according to 9001:2015 or 17025:2017. Can we write a quality manual and nominate a quality manager for our institute, when we implement ISO 17025:2017?

  • ISO/IEC 17025:2017 accreditation timeline

    We are vetting an opportunity to expand our lab for Heavy Metal testing and pathogen testing (salmonella). What type of timeline would you suggest after a lab is fully operational including ISO/IEC 17025:2017 accreditation? Best guess in getting a lab certification set up? I’m assuming some amount of time before lab is operational to get application data submitted and then some amount of time after lab is operational to validate procedures, processes, etc. and then finally third party validation. Is this a fair assessment? Any help would be much appreciated. Other recommendations? I noticed that the site mentions familiarity training. Are you all an approved certified body for ISO17025 audits?
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