QMS for Life Sciences
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Lab Requirement 4.10.7

P

Patti

#1
I have been tasked with bringing our labs on site up to speed to the QS-9000 requirements. The internal qualifications are not a problem, the problems lie in accreditation of labs we use in addition to our own. If you could please answer the following questions or direct me to where I could find additional information I would be very grateful.
If I have this correct, QS-9000 requires that all external labs used for analysis and calibration must be Guide 17025 certified or equivalent.
What other National Equivalents. Would EPA, FDA certification be ok?
What can a company do if the external labs they are currently using are not 17025 certified and:
Is the only lab that can perform the required analysis
Is the closest lab to the company and provides the best turnaround time to meet internal/external customer needs
Is the most cost effective choice for the company
What is the protocol for non-certified labs?
Can we perform an audit on their quality systems and approve them for use?
If so, is there a guideline/checklist that we can use that will satisfied QS9000 requirements?
Can we request our customers to waive the accreditation requirement?
Does this include everything sent outside the company or can we define what is required to be sent to accredited labs?
Thanks
 
A

Al Dyer

#2
Originally posted by Patti:
I have been tasked with bringing our labs on site up to speed to the QS-9000 requirements. The internal qualifications are not a problem, the problems lie in accreditation of labs we use in addition to our own. If you could please answer the following questions or direct me to where I could find additional information I would be very grateful.

If I have this correct, QS-9000 requires that all external labs used for analysis and calibration must be Guide 17025 certified or equivalent.

-Yes

What other National Equivalents. Would EPA, FDA certification be ok?

-Do you want the FDA/EPA to calibrate your CMM?

What can a company do if the external labs they are currently using are not 17025 certified and:
Is the only lab that can perform the required analysis

-Don't use them. Tough road, why aren't they certified. You can use the gage supplier to calibrate your gages, under circumstancs outlined in QS-9000 3rd edition.


Is the closest lab to the company and provides the best turnaround time to meet internal/external customer needs Is the most cost effective choice for the company

-Do you think the customer (SQA) really cares cares about your cost?


What is the protocol for non-certified labs?

-Don't use them.


Can we perform an audit on their quality systems and approve them for use?

- Sure, will your customer buy in?????


If so, is there a guideline/checklist that we can use that will satisfied QS9000 requirements?

-Not to my knowledge, try A2LA.

Can we request our customers to waive the accreditation requirement?

-Yes, will you get it? I dont know, I'd like my customer to waive the QS-9000 requirements for customer satisfaction. QS is a set of standards with very few "outs".


Does this include everything sent outside the company or can we define what is required to be sent to accredited labs?

-Why would you (your company) put youself in a position where you are using labs that might not be up to snuff?


Cost?

Thanks
ASD...
 
P

Patti

#3
FDA / EPA certifications would only be used for our chemical analysis. Just wanted to know if a registrar would accept these accreditation.
 
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