SOPs and the NELAC Standard

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SOPs and the NELAC Standard

Postby sreed » Mon Oct 21, 2013 8:18 am

I need to update my SOPs, both administrative and technical, and I would like to know which standard I am to follow. In Florida, we haven't adopted the 2009 TNI Standard as law, but I have been told I can use either standard when updating my Quality manual or SOPs. I recently received information from Steve Arms, FDOH, concerning the contracting of certification assessments in which he writes the following:

What will be the providers’ responsibilities?
They will conduct the biennial on-site assessment of your laboratory, evaluating it against the 2003 National Environmental Laboratory Accreditation Conference (NELAC) standards (with simultaneous comparison to the 2009 TNI Standards),

My question: Do I rewrite my SOPs to he 2009 Standard, or leave them as they are which is based on the 2003 NELAC Standard?

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Re: SOPs and the NELAC Standard

Postby sarms » Fri Dec 12, 2014 8:45 am

Hi Susan - Sorry you haven't gotten any response on this question. I would suggest that your SOPs for now could include updates that reflect the TNI standard, at least for Quality Systems. However, until Florida rules are formally changed, you should carefully consider including something that violates the 2003 NELAC standard. Since the "2012" TNI PT standards make some significant changes in how labs can report results compared to their LODs, I would not deviate from the NELAC standard yet.
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