amanbhai
24th March 2009, 03:40 AM
I will be thankful to anyone who describes the clause 4.2.7 of ISO 17025:2005 which states that " Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented."
How do we audit this clause? When we audit and verify this one in the document control (clause 4.3) audit?
Help is appriciated!.
:thanks:
Hershal
25th March 2009, 01:21 AM
Excellent question!
In my opinion, once changes are made then there needs to be some objective evidence that the integrity of the management system has not been compromised.....
To me, I would say that once a change has been made, it needs to be implemented.....given a little time.....then internal audit of the changes.....other evidence may also be acceptable instead of internal audit.....
On the other hand, if the change compromises the integrity of the management system, then write that as a non-conformance. It may seem political suicide, but any AB that is doing its job reviews the internal audit, management review, and similar records. Such a corrective action will typically get th AB's notice who will almost certainly look at it also.
Now, simple changes like printing on green instead of blue do not qualify.....but a true change does.....like changing the whole purchasing system for example.....
Hope this helps.