Should QS/TS certified internal test/calibration labs be required to be ISO17025

[Ken K]

Just wondering how you all feel about this. Especially looking for replies from auto suppliers.

 

[D.Scott]

I see no reason why an internal lab shouldn't be 17025 compliant, but registration carries it too far. We ran into all sorts of problems when we were both A2LA and QS-9000. There are 2 seperate audits with 2 sets of opinions on how they want to interpret the standard. QS-9000 even states that 17025 would not satisfy all the requirements of QS-9000 requirements for a lab. This sets up the old "2 book system" we lived by before QS (I still don't think it is dead yet).

Just my opinion.

Dave

 

[Ryan Wilde]

Hi all,

I'm of the 'other opinion'. I've been in internal QS labs that did exceptional work, with the added bonus of being able to tailor their calibrations and testing to their company's needs. I've also been in QS labs where the lead person was a machinist that got a 'promotion to this cushy job'. The problem is that I've met a number of QS auditors, and the majority that I've met know very little about the operations of a laboratory on a technical level, and these labs pass audits.

Herein lies my problem with the whole thing. QS9000 registration is not enough for a laboratory unless more auditors are drawn from a technical background, and that isn't going to happen.

Do I think that internal labs should be required to be 17025 accredited? Not in the least. From a metrologist point of view, it is a great idea, but from a business stance, it is pure folly. Companies are expected to do more with less, cut costs, improve quality, and dropping $100k (112.4k EUROs as of this morning) to improve quality while reducing unit prices is not a good way to stay in business.

I've seen '17025 compliant' labs, and usually, they are anything BUT 17025 compliant. If they were, they might as well spend the extra $5k and be accredited and be done with it, after all, to be compliant means that you could pass muster on an accreditation assessment. BUT, many make great measurements, which leads to great quality, even though 17025 compliance isn't met.

So what needs to be done? Something in between accreditation and QS9000 needs to be done. 17025 has a lot of measurement assurances, but also a lot of extra things that may not be necessary to ensure quality product. Internal labs need to understand and adhere to the measurement assurances that are practical (a rare term in ISO/QS lingo) and apply to their process. Such things as technically valid procedures (many aren't), uncertainty calculations (I've now seen an MSA study and I could shoot them so full of holes it is pitiful), and proficiency tests to prove a lab's abilities are necessary parts of the metrology world. The rest of 17025 is probably over the top for an internal lab, because the scope of an internal lab is much more focused. The problem is that so far, anything short of a true 17025 assessor doesn't seem to work. The assessor needs to understand the technical aspects of the lab, and be able to assess their abilities to make quality measurements. QS9000 doesn't provide that, and 17025 provides that, but also provides a lot of out-of-scope hassles.

So who wants to form a committee that can write a practical standard for internal labs?

Just some thoughts,
Ryan

 

[Roger Eastin]

I agree with Dave above. ISO17025 compliant, fine. ISO17025 registration, no.

 

[barb butrym]

I agree with Roger and Dave........

where did the $5K figure come from for registration cost? I see a heavier hit.

 

[Ryan Wilde]

barb butrym said:

I agree with Roger and Dave........

where did the $5K figure come from for registration cost? I see a heavier hit.

The actual ACCREDITATION cost is about $5k. That pays for the assessment and accreditation body paperwork, nothing more. What I was saying is that if a lab claims that they are fully compliant with 17025, then the only cost they should have left is the accreditation body fee. What I've seen, however, is that most of the actual work involved in accreditation that adds to cost has not been done by labs claiming compliance. Time for validation of procedures and software, time and resources for uncertainty studies, interlaboratory comparisons, and check standards for in-process checks are the major costs of accreditation. In order to be truely compliant with ISO 17025, all of these things must be done, and done regularly.

What I meant was that all of those things may (or are) not necessary for an internal laboratory. You may not need true interlaboratory comparisons because of the tolerance the test equipment is used to measure (proving that a lab can calibrate a micrometer with an uncertainty of 2 µm makes no sense when your company makes products that have a dimensional tolerance of ±50 µm). Uncertainties may be able to be calculated with less detailed studies for the same reason. These are major costs that have no return on investment, and make no difference to product quality in such cases. Somewhere there needs to be a common sense approach, one that ensures quality without going over the top.

At this time, there is no common sense approach to laboratory quality. ISO 17025 is great for those of us that are strictly calibration and testing suppliers because we do not have a set group of measurements to temper what needs to be done. We have to be ready for everything from low accuracy and resolution needs to high-end laboratory standards. On the other hand, ISO and QS 9000 do absolutely nothing to ensure laboratory data validity or competence. What is in between? Nothing, nada, zilch. Do we need something? Yes, but it needs to be more tailored to application than ISO 17025, which is very minute in its requirements, regardless of application.

Ryan

 

[Ken K]

When I originally started this, my vote was going to be a resounding NO. But, I changed to the 3rd choice mainly because if I was an OEM and receiving parts with tight tolerances and critical applications, I would want to make sure they absolutely meet the specification as measured by a competent lab.

However, being a supplier of acoustical and interior flooring applications, our company is really having a hard time finding a justification for being required to be ISO17025 accredited.
Most of our test specifications only require us to meet a minimum for physical properties with weight and thickness having a tolerance of +/- 10%. Rocket science it is not.

After all, I have never, ever read about someone being injured or killed because the carpeting in their vehicle failed causing them to lose control.

 

[metrologyguy]

I feel the cost of managing an accredited lab in a manufacturing enviornment would add more to the cost of the product than the benifit received, unless you are gage manufacture.

With OSHA, EPA, Taxes, and worst of all the Lawyers, American manufactures have a tough enough time trying to compete with other Countries that have little or none of the above.

At one time we allmost had ISO 10012 become the standard to have internal labs work to. In most companies this would be more than adaquate.

 

[Randy Stewart]

Where's the Payback?

We just went through a surveillance and were hit on 4.10.6.1 because we didn't have our "scope" as a controlled document. Once again, we are a prototype shop, we have a very large tolerance that our CMM's can easily maintain. We don't have to be concerned with "soak time", our facility is not environmentally controlled, our equipment is calibrated by the OEM and each facility has a set of gage blocks that are calibrated by a certified lab. There is no added value to being certified to another standard and it would be a great expense to be bring our inspection area into compliance. Since we have never had an issue with the customer due to tolerances, we follow the MSA and our equipment is able to measure way above what is required by the customer standards, where would the company or the customer see benefit????
As for the non-conformance; we will generate a quality record showing that we understand the limitations of our equipment (we already have the personnel trained, equipment listed and the processes documented) that will only be used for audits. Totally Useless!!

 

[JRKH]

Competent = Accredited?

Ken K said:

When I originally started this, my vote was going to be a resounding NO. But, I changed to the 3rd choice mainly because if I was an OEM and receiving parts with tight tolerances and critical applications, I would want to make sure they absolutely meet the specification as measured by a competent lab.

Ken,
I agree wholeheartedly. Where in a situation with critical tolerances I want my lab to be competent to make the measurments. But the origional question was not about competance or compliance, but accreditation.
If we take the time and expense to set up a competent lab, and we have no complaints from customers re: measurements what is the point of getting certified?
Before being forced to become certified to QS, we had a system in place based (somewhat loosely) on ISO-9000. In the preamble of the Quality Manual I stated that the system is ....."Designed to comply with the intent of ISO 9000....."
This both indicated a what we were shooting for and an out for anything we felt was superfluous. This system was just fine with our customers.
It strikes me that a similar statement in regards your internal lab should be sufficient.

James