How reliable are published methods ie) ASTM, FDA When a published method is referenced in a lab method ... does the lab need to be accredited for the published method?

I am not aware of any possible accreditations for published methods (procedures)

You should check with your accreditation body to see what organizations they recognize as publishing "validated" procedures. If you do adopt a procedure from an organization such as ASTM you need to be aware of any updates or revisions.

How reliable are published methods ie) ASTM, FDA When a published method is referenced in a lab method ... does the lab need to be accredited for the published method?

I don't understand this question.

How reliable are published methods ie) ASTM, FDA When a published method is referenced in a lab method ... does the lab need to be accredited for the published method?

Be aware that a test method, as published, is still subject to interpretation and differences in lab instrumentation and equipment. They are not the "be all, end all".

How reliable are published methods ie) ASTM, FDA When a published method is referenced in a lab method ... does the lab need to be accredited for the published method?

If I understand your question right, are you saying if a non accreditated lab cab can use published methods from ASTM or FDA ?

If this was your question, YES, any lab can use these methods. In fact the classic example is of the various Pharmacopeia like United States Pharmacopeia, European Pharmacopeia, British Pharmacopeia and various similar documents which mention monographs for testing each materials.

These monographs including their test methods are to be used for testing the materials for showing compliance.

Hope this clarifies.

I believe my question was not clear enough ... so I'm going to try again.

Lets say that you are an accredited lab ... and you are being audited to maintain your accreditation. You seek to add a couple of methods to your scope which are developed by the lab based on a published method. You reference this published method in the references section of the method ... would you need to be accredited for the published method aswell as the lab method ... or do you only seek accreditation for the lab method because the published method is considered to be scientifically sound by industry and regulating bodies ?

Thank you.

If your testing procedure meets all the requirements of the controlling specification (ASTM or other) then you only need be accreditted to the standard test method.

If, however, you are deviating from the ASTM specification and performing a test "method" that is entirely home brewed you will need to show significant data to validate the method used. If this is the case, I would contact your AB for further guidance as you wouldn't want to commit significant resources to validating a method only to have your AB reject it in audit.

I hope I've interpretted the question correctly...I believe you're asking if you produce an internal laboratory "procedure" based on an ASTM test "method" would you only need accreditation to the ASTM method. If this is the correct interpretation of the question then the answer is yes. ;)

How reliable are published methods ie) ASTM, FDA When a published method is referenced in a lab method ... does the lab need to be accredited for the published method?

Susiepmt,
I don't know how generic your test methods are but I suppose in some specialised areas an AB might allow accreditation of the simplest published methods exactly as written, but why not write your in-house version with citation and just accredit that. It can be brief as long as you show the deviations are valid. Otherwise are you really going to use the published method as a local work instruction ? Our scope is full of "in-house SOPxxx based on ISOxxxx, ASTMxxxx" etc.

I have written a published test procedure for a UK regulatory agency which became an ISO standard, then later an ASTM method was based on it, but even I as original author have my own accredited in-house version.

I'm curious as to why you needed to write your own method and not use the published one.

I believe my question was not clear enough ... so I'm going to try again.

Lets say that you are an accredited lab ... and you are being audited to maintain your accreditation. You seek to add a couple of methods to your scope which are developed by the lab based on a published method. You reference this published method in the references section of the method ... would you need to be accredited for the published method aswell as the lab method ... or do you only seek accreditation for the lab method because the published method is considered to be scientifically sound by industry and regulating bodies ?

Thank you.

Given this scenario, the scope of accreditation will likely reference the published method, not the distilled method.....

Incidentially, taking the published method (e.g., ASTM), referencing that method and only distilling it in order to add specific detail like "Use this fixture" or "Turn this switch" is usually not considered "lab developed" and usually does not require separate validation, except for the specific detail added for your specific lab and equipment.

Of course, double-check with your AB, as they may have specific rules for such distilled procedures.

Hope this helps.

From personal experience we base our procedures on published test methods but are accredited (ISO17025:2005) to our procedures and not the published test method.

Merric65 - my experience though somewhat dated, as it was in the time frame 1995 to 2000 and was Guide 25 rather than its successor ISO 17025 was the exact opposite of yours. Where there was an ASTM method, such as E8 for tensile testing, we were accredited to E8 not our lab distilled method. Where we were performing tests that were not supported by an ASTM method, we were accredited either back to the manufacturer's method, for example the modul-r test currently sold by Tinius Olsen, or to our own internal methods an example of which was "ridging" an internally developed test to gauge the formability of stainless steel sheet.

Our accreditation agency was A2LA, and the better assessors did a thorough comparison of our internally developed work instructions to the requirements of the ASTM methods.

the better assessors did a thorough comparison of our internally developed work instructions to the requirements of the ASTM methods

We experienced the same thing. Very thorough comparison and in some instances we just went back to the original ASTM method. There is less questions because precision and bias are usually addressed within the method.

We are also accredited to gems like the example below. Our first auditor was a 37 year veteran of GM and he just chuckled and said whatever after he read the method:

5.3.4 Adhesion. As received and after 72 h @ 55°C the foam
must be adequately bonded to the carpet backing and shall display
no curling or lifting. When peeled at an angle of 180° and
at a rate of 300 mm/minute, resistance to peeling must be an
average minimum of 50 N/m width of the carpet backing or
show a cohesive failure of the foam. Size of the tested sample
is 2.54 x 25.4 cm. Allow at least 24 h recovery after environment
exposure prior to testing.

Gotta love the OEM's:rolleyes: