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Hi,
I was hoping someone in the community who has had to go through ISO 9001:2008 and ISO 1345:2003 certification could give us some feedback on what was required by their auditors to verify/validate the widefield microscopes in your facility. We have an IX83 scope with an LED. I assume we can use calibration slides, but which parameters are required? Intensity, chromatic aberrations, spherical, etc?? How many parameters are enough to call an instrument "verified"? We also have questions about how often you are required to calibrate and/or validate the scope? Monthly, quarterly, yearly? Is there anything about instrument validation for ISO compliance that we are overlooking? Very open to experienced input.
Anybody out there in industry that can help?
Thanks,
Kelly
Kelly Lundsten
Business Segment Manager, Advanced Cytometry
Email: [log in to unmask]
Telephone: 773.633.4774
Website: www.biolegend.com
BioLegend
9727 Pacific Heights Blvd., San Diego, CA 92121, USA
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