What point does the Accreditation begin in the process? ISO 17025

[JodiB]

Here is the first of a probably long series of questions from me, as I embark down the road of getting 10 labs accredited to ISO/IEC 17025....

Background: Our labs are part of a larger organization that provides products and services. The labs test (mostly) water samples drawn from customer sites. The work is either straight analysis or it's product performance testing.

The water samples are taken by company employees who are not lab personnel. The employee pulling the sample and requesting the analysis is typically doing this to monitor the effectiveness of our products or because he wants to know which of our products would be most effective for the conditions ( to improve our service delivery or win an account, etc.). The lab considers their customer to be the company employee requesting the sample analysis, not the external customer. All results are provided to the company employee. The lab exists to service the internal customer, who exists to service the external customer.

At what point does the lab responsibility start for accreditation purposes? At the sampling point, even when not done by the lab? As a company we recognize that we want to get a grip on proper capture, label, and transport of the samples to make sure that the lab can provide quality data results. So that's not the point. What I need to know is how far back do I have to document competency, sampling plans, etc. for accreditation purposes. At what point does the lab take ownership of this under their quality system? Is it from the receipt of sample?

[Jennifer Kirley]

Hi Jodie,

The lab has a list of processes it is carrying out as its scope, yes? And procedures for each of them? These are subject to accreditation. I doubt that the collection step is part of them; there is no way your lab can control purity or condition of a sample before it reaches you. So yes, you can state your responsibility starts at receipt. You would of course be expected to provide a means to receive that would not compromise the sample. That is, physical damage and temperature extremes sufficient to compromise the sample are avoided via design of the collection drop off area or receiving process.

[Hershal]

In Reply to Parent Post by JodiB

Here is the first of a probably long series of questions from me, as I embark down the road of getting 10 labs accredited to ISO/IEC 17025....

Background: Our labs are part of a larger organization that provides products and services. The labs test (mostly) water samples drawn from customer sites. The work is either straight analysis or it's product performance testing.

The water samples are taken by company employees who are not lab personnel. The employee pulling the sample and requesting the analysis is typically doing this to monitor the effectiveness of our products or because he wants to know which of our products would be most effective for the conditions ( to improve our service delivery or win an account, etc.). The lab considers their customer to be the company employee requesting the sample analysis, not the external customer. All results are provided to the company employee. The lab exists to service the internal customer, who exists to service the external customer.

At what point does the lab responsibility start for accreditation purposes? At the sampling point, even when not done by the lab? As a company we recognize that we want to get a grip on proper capture, label, and transport of the samples to make sure that the lab can provide quality data results. So that's not the point. What I need to know is how far back do I have to document competency, sampling plans, etc. for accreditation purposes. At what point does the lab take ownership of this under their quality system? Is it from the receipt of sample?

First question, given the obvious regulatory issue is: What is/are the criteria to comply with?

Only AFTER that should the subject of an AB come up.

If this is for something like CARB or more likely, Water Sense, then there are specified ABs. Otherwise, look to ILAC and get all the ABs that accredit labs.

Now then, the REAL work begins. You have to have procedures and policies in place and implmented. Uncertainties, calibration, training, proficiency testing, internal audit, management review, on and on.

The true effort and true cost is internal.

Some things you can and should discuss with your AB.

[JodiB]

Thanks to both of you.
Jennifer hit the right spot of what I was asking. I was specifically asking about how far back in the process I have to go. If receipt of the sample is "good enough" and I don't have to try to control / document/ etc. the sample collection activities that's what I needed to know.

If the field guys carry a sample around in their trucks for a week, the results that the lab delivers will be "accurate" as far as results that the lab reports but not necessarily "accurate" in real life. The sample could have degraded. Does that make sense? So we don't want the field guys to carry those samples around for a week, but if this is out of scope of our accrediation, then I don't know if I have a big enough stick to make them send them in promptly.

We're standardizing our field test methods (for those tests that the field engineers conduct on their own - again, these are not lab personnel) and that will include the proper sampling conditions, labeling, transport, etc. but since these are not conducted by the lab personnel and are not part of the lab services per se, I wasn't sure if they had to be covered under our accreditation. In limited situations, the lab will use some of the data that is provided by the field engineer in order to make a final interpretation, .... maybe in those situations we would need to include it? What do you think?

[Jennifer Kirley]

If you are using data supplied by field engineer, that field engineer has become part of the process and might be considered part of the scope.

When approaching this subject I am thinking of a lab I take my well water sample to when transferring property ownership or after work of some kind is done on the well. The lab provides instructions and the sampling container plus ziplock plastic bag for the sample for transport and transfer from me to the lab - as I remember it even included a light-blocking bag. This kit would be part of the scope, which covers the testing processes and not the supplied condition of the sample - the outcome bacteria count for example is not something taken into consideration for accreditation. As long as the transfer point you provide is reasonably controlled you have done your part to the extent you are able and it's assumed the bacteria count has not been affected by collection, handling and transport. As a lab your responsibility doesn't include that and a notice of some type could say as much.

To summarize, your accreditation is not presented based on test results, but on your internal controls and processes.

[JodiB]

Thanks so much for the very clearly written guidance!

[Hershal]

I had a beautifully written contribution, but am on a hotel computer in China so I should have copied as it must periodically reset.

Try tomorrow evening.