QS9000 Section 4.10.6.5

[Miriam]

I'm currently drafting up a lab scope and have questions regarding a sentence in section 4.10.6.5. What does "The laboratory shall verify its capability to perform to the standard specifications before carrying out such work." mean? We follow SAE specs in performing some of our testing. Does this mean that we have to verify that we are capable of doing this? How would we go about performing that "verification"?

 

[Marc]

It depends upon what it is. As an example, if you are doing internal calibration you could send out a sample device to an outside lab to confirm your internal calibration.

I also would like to hear from some of the others on this.

 

[Christian Lupo]

What does "The laboratory shall verify its capability to perform to the standard specifications before carrying out such work." mean? We follow SAE specs in performing some of our testing.

In my Quality Manager days we also did testing to SAE and ASTM requirements, and our lab was A2LA Accredited. Standard specifications (national standards) are written in general language that can be adapatable to any lab. What the standard is saying is that you have to prove/validate that you can perform the testing in your lab with your equipment, using your trained personnel, etc...We did this by documenting the environment, equipment(stability/accuracy/etc..), instrumentation, measurements, personnel, used. Therefore our company ended up writing procedures specific to our lab, based on the standard. Did that make sense?

 

[Miriam]

Christan:
Thanks for your assistance. What you said makes sense. I was kinda hoping that we wouldn't have to do all that. Do you (or anyone else) have any pointers on how to keep this short?

 

[Christian Lupo]

It is a lot of work initially, but its worth it in the end. Just like FMEAs once you have done one or, two the rest go a lot faster. That's not a shortcut, but sometimes it good to know that all the effort you are going through is worth it.