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Expired consumables and reagents
whether blood collection tubes used outside of their manufacturers expiry date can be assumed to be fit for purpose in the absence of validation in a forensic or anti doping analysis? -
The validation of LIMS
After your webinar today, a question came to my mind about the validation of LIMS. Not as easy of verification as spreadsheets, customized LIMS requires validation. Do you have a quick list of the elements that have to be considered for this kind of validation. -
ISO 17025 - Traceability Questions
Our intension is to provide certified values that are traceable to an International Standard. The workflow is the following: 1. External lab is certifying the power of a set of lenses that cover the calibration range. This lab provides (according to their certificate) NIST traceable values 2. We purchase a calibration target another provider that also confirm that this target is NIST Traceable 3. We calibrate our lab metrology device with the certified devices (mentioned above) The questions are as follows: 1. If we measure another set of calibration lenses in house with our now calibrated lab metrology device, can we claim the power of these lenses are NIST Traceable? (no longer requiring the use of another external provider) 2. If so, my assumption here is that we would need to confirm through documentation/audit of the original external lab and target provider to confirm that the chain is unbroken - all certificates/claims are valid etc. Please can you share your thoughts regarding this? -
Questions regarding Impartiality
A laboratory is being established that intends to seek accreditation to ISO/IEC 17025. The laboratory will operate as a separate legal entity but will have a close relationship with a sister company that will act as a critical supplier, providing specialized technical engineering expertise supporting certain laboratory activities. In this structure, the CTO of the sister company would also serve as the CTO of the laboratory. The laboratory would retain full responsibility for testing activities, results, and reporting, but the shared CTO role raises potential questions regarding impartiality and conflicts of interest under ISO/IEC 17025 (particularly clauses related to impartiality and personnel). In such a scenario: Is it acceptable under ISO/IEC 17025 for a laboratory CTO to simultaneously hold the CTO role in a critical supplier organization? What risks to impartiality would an accreditation body likely expect the laboratory to identify and control in this situation? What types of governance or structural controls (e.g., role separation, technical signatory independence, conflict-of-interest documentation, or impartiality risk management) would typically be expected to mitigate this arrangement? Are there examples of acceptable structures where a laboratory shares senior technical leadership with a supplier or related organization? Is full technical independence for method selection, data interpretation, and approval of results generally expected in such cases? -
Client tolerances much wider than standards
Hello everyone, A calibration laboratory states that in its calibration certificates it indicates conformity or non-conformity based on a tolerance specified by the customer. The tolerance values given by the customer are significantly wider than those implied by the relevant standard or industry norms. When questioned about 7.2.1.1 (“the laboratory shall use appropriate methods”), the argument is that the decision rule based on the customer’s tolerance is allowed by ISO/IEC 17025, referring to the note in 7.8.6.1: “Where the decision rule is prescribed by the customer, regulations or normative documents, a further consideration of the level of risk is not necessary.” My concern is that using a much wider customer-specified tolerance may conflict with the requirement to use “appropriate methods”, since the conformity statement could be misleading when compared to the normative expectations. In your interpretation, is relying solely on customer-specified tolerances (even if they are much wider than normative ones) acceptable under ISO/IEC 17025? Or should the laboratory ensure that the method and decision rule remain technically appropriate beyond simply following the customer’s prescription? Thanks in advance for your insights. -
Measurement Uncertainty for 17025 Accreditation
Hello! I just took your Estimating Measurement Uncertainty in ISO 17025 class and wanted to confirm something with you. Our laboratories use a lot of standard published and well recognized methods in our areas of testing (Animal Feed, Fertilizer, etc). I just wanted to make sure that I heard you correctly... is it correct that those specific methods do not need measurement uncertainty calculations? If we have a method that is identical to the published method, just written in our format (giving proper credit and reference to the original published method in the document, of course), we don't need MU? -
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.
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SOP
Do risks need to be highlighted within an SOP or can you refer to them in a separate document?
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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