Laboratory Testing as a "Special Process" - element 7.5.2

[ccochran]

Howdy,

Here is an interesting issue I've been mulling over recently. Should lab testing be considered a "special process" within the framework of section 7.5.2 of ISO 9001? Very few ISO 9001-certified organizations consider lab testing a special process, but there is often no way to verify the outcome of the process (i.e., the test data). This is especially the case with destructive lab testing: once the test has been run, that's it; there's no way to verify it. If you accept the notion that at least some lab tests are special processes, then additional requirements come into play. Namely, that the testing process be validated. Validation of test methods would be a new horizon for many ISO 9001-certified organizations. What are your thoughts?

Craig

 

[Hershal]

Best approach is to have an accredited test lab do your testing.....or if the testing is in-house have it accredited as an internal lab.....then move on, no other validation is necessary.....

Hope this helps.

 

[Hershal]

Oh, I forgot to mention.....accreditation is to ANS/ISO/IEC 17025:2005.....

 

[ccochran]

Hershal,

Those are effective options, but not all organizations can use outside labs, and not everyone can become ISO 17025 certified (which is what I suppose you mean by becoming accredited).

So, if an organization does not pursue these 2 avenues, the question remains: is lab testing a special process?

Craig

 

[Hershal]

Good question.....given the options, and depending on the test, one can make the argument either way I believe.....