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which clause in ISO 17025:2017 does talk about any exclusion?
hi am about to start implementing my lab quality system. New in the field. am struggling to understand what is the first document to have as a starting point. I established the LMS myself, successfully so. I also need to know if or do I have the option to implement the LMS manually or can I buy or get the software to implement it because it looks like too much work. Please advise.
For initial first gap assessment by Certification body what is the requirements for proficiency testing / ILC and repeatability & repeatability?
Which is the definition of validity of a method? Is validity synonym of accuracy?
can aflatoxin be accredited using ELISA? for an ISO17025 accredited lab
I want to know what the requirements to implementation of ISO /IEC 17025/2017 in quality control lab
Do we need to maintain improvement list?
What if, because of the lockdown, the authorized signatory and alternate authorized signatory cannot visit work place and/or reached to obtain their signature on test reports which need to be sent to customers?
The question is about the applicability of 17025 to our operations. We are a GMP analytical laboratory that conducts lot release testing for pharmaceutical and/or biological products used in clinical trials and eventually for commercial. We abide by 21CFR11.
We only test these medicines. We do not manufacture.
Does ISO 17025 apply to our operations?