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  QS9000 Section 4.10.6.5

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Author Topic:   QS9000 Section 4.10.6.5
Miriam
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From:Orlando, FL, USA
Registered: Jul 1999

posted 14 March 2000 11:00 AM     Click Here to See the Profile for Miriam   Click Here to Email Miriam     Edit/Delete Message   Reply w/Quote
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"?

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Marc Smith
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From:West Chester, OH, USA
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posted 17 March 2000 02:27 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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.

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Christian Lupo
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From:Auburn, NY
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posted 17 March 2000 03:04 PM     Click Here to See the Profile for Christian Lupo   Click Here to Email Christian Lupo     Edit/Delete Message   Reply w/Quote
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?

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Miriam
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From:Orlando, FL, USA
Registered: Jul 1999

posted 17 March 2000 04:30 PM     Click Here to See the Profile for Miriam   Click Here to Email Miriam     Edit/Delete Message   Reply w/Quote
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?

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Christian Lupo
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posted 20 March 2000 09:22 AM     Click Here to See the Profile for Christian Lupo   Click Here to Email Christian Lupo     Edit/Delete Message   Reply w/Quote
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.

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