17025 Flexible Scopes of Accreditation - Laboratory to 'self-assess' new test method

[Simon123456]

Hi

First posting so wish me luck!

I'm a Continuous Improvement Manager ( ) who looks after our 9k and 17025 approvals (Mainly Testing with some limited Calibration approval) as well as working on the procedural side of going for 14k and 18k so I'm a busy boy!

What I am trying to get my head around is 17025 and flexible scopes of accreditation which in my understanding allow a 17025 Accredited lab to 'self-assess' new test methods and add them to their scope of accreditation.

We are a Test and Development house in the UK for many Tier 1 companies who are accredited to QS9000, 16949, etc. The new 16949 states that they must use suppliers accredited to 17025.

That’s us!

Seems easy to follow so far, but, we carry out hundreds of different types of test for many customers and the cost implications alone of adding all of that to our 17025 approval are scary to say the least, especially as the Tier 1 marketplace cannot stand the extra costs.

From my limited 2-year exposure to UKAS, firstly it seems like a very good technical standard, which ensures that a test or calibration is carried out correctly, but to me, at the moment it seems restrictive due to the cost implications, which smaller companies cannot easily afford.

Now that we have been informed about Flexible Scopes (Certainly here in the UK anyway - UKAS Website - Publication LAB 39) it seems to allow us a way out in terms of the costs to add tests. Obviously we still have the internal costs of doing it.

Has anyone had any experience of working with Flexible Scopes of Accreditation? and any guidance on where to start?



Simon

 

[Hershal]

Hello Simon,

Welcome to posting in the Cove.

Flexible scopes are one of the really hot topics in accreditation right now, especially in the testing world, and to a lesser degree in calibration and inspection accreditations.

The basic concept runs something along the lines of a lab is accredited for some given TYPE of test (e.g. compression force) and specific methods may well be mentioned. In the U.S. that could be the ASTM methods for example.

The lab is then considered (in general) competent to perform any test which uses the same equipment and basic test methods, even if the specific test is different than ones listed on the scope. An example is a lab that can do calibration of force compression machines, and then uses that capability to calibrate a weight lift machine at the gym.

Accrediting bodies are working through it, and some are using it now. Of those, UKAS is one of the leading groups.

There are obvious potentials for issues. One is that some tests may actually be beyond the lab's true ability to carry out, but the flexible scope would allow the lab to proceed. Most labs would not knowingly exceed their scope, but a few may try and get into trouble because they discover the test is beyond what they can do. That brings up contract review of course, but also the question of how much oversight the accrediting body really has in a flexible scope.

The best thing for you to do is to have a discussion with UKAS and find out EXACTLY how they work the flexible scope approach, including the required oversight and any limitations on your lab.

Hope this helps.

Hershal

 

[Simon123456]

Hello Hershall

Thanks for the reply. I am trying the UKAS route with my assessment manager but there is confusion there as well at the moment in terms of interpreting it and also how to police it.

New things take time!

Thanks for the help.

Simon