Internal SOP for a validated (ISO) method?

[LabCat]

Our lab is accredited for internal methods only. We are considering extending the scope to some ISO methods. The actual text of the ISO methods is quite dense and confusing, so we would like to create internal SOPs that capture the directions in a more user friendly manner. Is this a bad idea? If we want to be accredited to perform ISO XYZ, do we have to simply use ISO XYZ as our SOP?

In addition, the ISO methods we are considering are for specific strains of bacteria. Would we have to get separate accreditation for each strain of bacteria that we want to perform the method with?

Thanks

 

[dwperron]

I am in the 17025 world, but certainly not in the biologics field, so this will be a generic response.

The problem you will face using an outside procedure, whether it be ISO, ANSI, ASME, IEC, etc., is that since you claim to be using that procedure you must use it as is, in it's entirety. If you deviate from the procedure then you must document the deviations, and validate your "modified" procedure:

7.2.2 Validation of methods
7.2.2.1 The laboratory shall validate non-standard methods, laboratory-developed methods and
standard methods used outside their intended scope or otherwise modified.

 

[LabCat]

I am in the 17025 world, but certainly not in the biologics field, so this will be a generic response.

The problem you will face using an outside procedure, whether it be ISO, ANSI, ASME, IEC, etc., is that since you claim to be using that procedure you must use it as is, in it's entirety. If you deviate from the procedure then you must document the deviations, and validate your "modified" procedure:

7.2.2 Validation of methods
7.2.2.1 The laboratory shall validate non-standard methods, laboratory-developed methods and
standard methods used outside their intended scope or otherwise modified.

Thanks so much for your response.

I want to be able to tell our customers that we are accredited to perform the particular ISO. But we have made some modifications (allowed for in the ISO when "suitably validated"). So I am just weighing up the best way to approach it.