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A summary of ISO Guide 25 and an NVLAB Question

QMS for Medical Device Companies
Elsmar Forum Sponsor
V

Vicki Horner

#2
#2
This isn't a summary, but the entire text of ISO Guide 25 is available on-line as a part of the A2LA Accreditation of Laboratories. This site also includes an assessor checklist for what is essentially ISO Guide 25, and has additional requirements that laboratories must pass before becoming A2LA-certified.
Here is the website:
www.a2la.org.a2la/general.htm
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
#3
I appreciate your response to this. In all honesty I was too lazy (far be it from me to say I've been busy...) to find it.

I checked the document out and it says it's OK to distribute so I'm posting it here as well.

http://Elsmar.com.com/pdf_files/A2LA.pdf - A2LA's General Requirements for Accreditation of Laboratories - [Part A includes all ISO/IEC Guide 25 requirements]

Again, thank you very much!
 
B

barb butrym

Quite Involved in Discussions
#4
#4
Has anyone had any experience with NVLAB? I ran into that while performing an audit of a cal lab using 'guide 25'...and I was not impressed comparing my findings to the NVLAB audit findings. What are youe experiences with NVLAb and their accredited companies?
 
B

barb butrym

Quite Involved in Discussions
#6
#6
Marc..there is money to be made here..to be sure.....a system with all requirements covered is easy to pull together....have been playing with one and its not as tough as it seems. Have 2 cal labs ready to drop it into..soon as I get a bit of free time to finish it. Its generic to be sure, all it needs is the technical stuff for the specality calibrations, but the labs I plan to do are regular stuff...no fluids, pressure or gas so I am Ok.
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#7
#7
I don't have any hands on but part of the reason I pulled together that thread from other 'list' threads is to better understand it all. No - there is no question in my mind that it's just a matter of understanding the requirements and from what I've seen - no bid deal.
 
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