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I recently bought the ISO 17025 toolkit and I am a bit overwhelmed by everything we need to do and I could use some guidance. While most of the stuff is pretty straightforward I am super lost when it comes to the validation and verification process. I am trying to design the protocol for my lab techs so we can start working our way through the various testing we need to validate/verify but I don't know where to start. I personally don't have much experience with method validation and what I have been reading has thoroughly confused me. Everyone here is very technically skilled in the sciences but none of us are very experienced in the regulatory side of things.
The lab I am managing tests mainly dietary supplements, nutraceuticals, and ready-to-drink beverages. I am trying to understand how to categorize everything because the reference methods all list their validations on different food products. I have looked through the FDA validation/verification guidelines, AOAC, and ISO 16140-3 and they all say different things. The first thing that is stumping me is how to categorize the materials we test. There is no category listed in AOAC or ISO guidelines that our samples would fit into. For instance, we test lots of dried botanicals, vitamins, mineral salts, and proteins. How would we categorize these? I know of many contract labs that test dietary supplements and have their accreditation but when I look at their scopes of accreditation I see the categories as "Dietary Supplements and Neutraceuticals and Food" so I am trying to understand how we determine what does and does not need a validation/verification study. Because we are attached to a manufacturing company we test a lot of different stuff. We have around 3000 SKUs when we consider raw ingredients and finished goods. I dont think it will be possible to ever do a full on validation study on all of them. So my question is do we need to prove we can test all of them? Or can we consider lets say spinich powder to be more or less the same as broccoli powder and crandberry powder? I am nervous that the assessor will want to see records for any possible matrix we test.
My other question that is really giving me anziety is how do we do these validation studies and verifications? Do we really need to do interlaberotory validations on every method? If we are using an AOAC or USP or FDA-BAM method, to what extent do we need to prove those methods work seeing as they are already validated and considered Standard Methods?
I am sure that I will have many more questions along the way, but for now I feel paralyzed by the sheer volume of testing we would need to do to validatye every matrix.
Any guidance you can offer would be extremenly helpful.
I have reviewed the sample copy of Quality Manual and it seems that QM is not covering each sub-clauses.
I am looking for QM where its mentions the requirement of cl. 4.1.1, 4.1.2, 4.1.3, 4.1.4 separately.
1. I have a question about achieving ISO 17025 accreditation for a specific lab at fixed premises. Once you attain accreditation for a lab can you also expand the accreditation to another premises? Would the lab tests being performed in the new premises have to be re-validated etc?
2. Another question regarding calibration due dates. Is it ok to write a calibration due date on a calibration cert for a device we have calibrated? Do we need to write a disclaimer saying the calibration interval is determined by the customer? I've seen this on a number of ISO17025-accredited certificates.
3. One last question, we use a subfraction of an ISO 12103-1 standard dust for calibrating our dust monitors. Does this material need to be tested (particle distribution) by an ISO 17025 accredited laboratory? we have a particle distribution from a non-accredited lab for the material. I am concerned that as we are using it as a reference material we would need to have an accredited certificate of the particle distribution.
I was wondering if you could assist. I’m looking for a check list of sorts to be able to determine what I would need to do in my department to see if we should become ISO17025. Is that something that exists? I’m not looking to go on a course to find that out. I’m more on a fact finding mission at the moment.
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Can a process be ISO17025 certified but the lab where the process was done is not iso17025 certified?