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I have a qeustion and I hope if you could give me the solution
In my organization we have Two systems the first is a laboratory system that has been established in accordance with International ISO /IEC 17025: 2017 and is applied and maintained ,this system have a guide to policies and procedures ,and this guide were mention that the laboratory implements the clause 8.1.2 option A in ISO 17025 , and this guide approved by the General Director of the organization and the Director of the Laboratories , this guide prepared by the quality manager in the Laboratories and after we implement the internal audit and the managemet review ,the lab will request the accredation .
The second system in the organization were applied ISO 9001: 2008 ,and the certificate has been expired , now the presentitive of the management want to transfere to ISO 9001 :2015 , and he request the quality manger of the laboratories to give him all the procedures and forms to make the code of ISO 9001 , is that true or the lab have to refuse to give the management representitive the procedures and forms (template) .and complete implemented the ISO 17025
Dear Ms/ Mr, Hi. I want to know about the risk of the corrective action form and corrective action procedure. An audit tell me that I should consider the risk when I want to write the corrective action? And also I should consider it in the corrective action procedure. Could you please help me?
What would the standard requires when the laboratory wants to use expired reagents, as management is placing it under clause 6. 4.9 but as Quality commander I do not think it is allowed
I'm a new Quality Manager and we are outsourcing IT. Since they will have remote access to our servers/computers do I need to have them sign a NDA/Confidentiality agreement? If so, do you guys have an example of one?
Are CRM certificates considered external documents even though you can get them online?
I have a very barebones understanding of what an audit needs to cover but I lack the experience of knowing how to conduct an audit.
For example, I know that an ISO 17025 audit needs to look for up to date equipment calibrations, but I do not know the reference guidelines set out in ISO 17025 (clause 7.4 I believe) for this and what would need to be presented as evidence, how to get this evidence or from who.
In other words I know "what" to look out for, but not "how" to or "who" to.
I'm the Quality Manager at a testing lab, and I'm working on a training presentation for staff on 'risks to impartiality'. I will be asking them to report any identified risks to their supervisor and one of the examples of a risk to impartiality I'm giving as one that is likely to occur is 'pressure on lab staff due to an unforeseen event (e.g. equipment failure, delay in receiving supplies etc.) I believe that these are risks to impartiality as they do put the staff under stress which can lead to cutting corners if they aren't properly mitigated. I'm just wondering if I'm correct or if these types of pressures are not exactly what is meant by risks to impartiality. If they are considered risks, is there a good way to communicate these? I feel like these ones are not what most expect as a risk to impartiality as most think of Conflicts of Interest. Thanks for any information you can provide.
Is it required that proficiency testing be completed using an outside lab? If the SME, for instance, verifies their performance with an outside lab, then we have the SME run a test side by side with each technician, can we document that as their proof of proficiency/competency?
i work for *** and we are trying to decide if the ISO 17025 certification of our 3rd party labs in Ukraine is still valid and full scope and what the ISO requirements are for situations like this for labs operating in warzones?
I'd have a tricky question.
For the controlled room monitoring, we have an agreement with the lab measuring the contamination of air and surfaces (bioburden). This lab has a GMP certificate focused on: 1 Manufacturing operation (Batch certification and Quality control testing) 2 Importation of medicinal products, etc.
For the measurement of the material contamination (bioburden), we have an agreement with the lab which is 17025 certified (for determination of endotoxins, bioburden etc).
And for the measurement of the particle count, we have an agreement with the lab which is also 17025 certified.
My question is, shouldn't we require the same certification from all labs or is this attitude correct? How can we prove the auditor the correctness of this choice (if it is correct). Still, it does'nt seem to be clear for the companies how to choose the testing lab based on the certification.
Thanks a lot!