Procedures from recognized standards or specifications

itsbiodiversity

Involved In Discussions
#1
Would love some opinions and/or interpretations to ISO/IEC 17025 Section 5.4.1

"NOTE International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform the tests and/or calibrations do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used as published by the operating staff in a laboratory. It may be necessary to provide additional documentation for optional steps in the method or additional details."

I would venture to say that ASTM, NIST, etc. would be included in the type of procedures that DO NOT require supplementation or rewritten as internal procedures.

What about GIDEP based procedures? I have been told different viewpoints by different auditors, but I love a good discussion.

I have some history with this and will be glad to share how I have worked with this in the past, if anyone is interested.
 
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dwperron

Trusted Information Resource
#2
My training as an assessor, and my experiences as a calibration lab lead to the same point:

"Deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer."

What is a deviation? Anything that is not as written in the procedure. So if you substitute equipment, delete a step, add a step, etc. you must document this, justify this (validation), get it approved by your defined policy, and notify the customer that you are using an altered procedure.

I've tried the argument that we use the GIDEP procedure as a guide only, and that our datasheets are the actual test document, but never won with that.

Unfortunately, the new revision of 17025 contains the same language.
 

itsbiodiversity

Involved In Discussions
#3
My experience aligns exactly with what you have stated. I have worked around it in the past by placing a "foreword" type of cover page describing the distillations of the procedure that are acceptable, such as "customer requested data points, or using appropriate standards of qualified accuracy and uncertainty, etc".

Thank you for chiming in. Do you have any thoughts on the workaround I stated above? I do not mind criticism whatsoever - we are here to grow and learn.
 

dwperron

Trusted Information Resource
#4
To me, your cover page method should work.

The direction here is:
"5.4.5.2 The laboratory shall validate non-standard methods, laboratory-designed/developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the intended use. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application. The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use."

"Extensive as is necessary" gives some wiggle room. Your cover page can supply the required information.

However, I had an assessor hit me with findings because the validation I performed and documented did not have "a statement as to whether the method is fit for the
intended use" on it. I added "This method is fit for the intended use" and everything was good. That really added value, right?
 
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