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View Full Version : ISO 17025 Validation Procedure - Need Example


ThomasMichael
7th September 2006, 07:11 AM
Anybody has an example/sample method validation procedure compliant to ISO 17025:2005?
Thank you in advance.

Hershal
8th September 2006, 05:12 PM
Validation under ISO/IEC 17025:2005 is not as well defined as perhaps it could be.....I would begin by stating what the procedure is, what it is for, consummables, equipment, etc......and what you expect it to accomplish.....have management buy off on it.....

Run the procedure or software or whatever.....record and report all the bugs and glitches you find.....fix the important ones.....run a regression analysis to make sure the fixes did not make anything else go bad.....

Provide a report to management clearly identifying what the expected outcome was and what the actual outcome was, and the two must be relevent to each other.....

You will need a statement that the procedure or software that you are validating is acceptable for intended use.....and again have management buy off on it.....

Keep those records, and hopefully you will be OK.....

HOWEVER, check with your accrediting body to make sure that the approach is acceptable to them.....

Hope this helps.

Hershal