As of Jul 7th 2014, "ISO 11135:2014 cancels and replaces ISO 11135-1:2007 and ISO/TS 11135-2:2008, both of which have been technically revised and condensed into a single standard.", the foreword of ISO 11135:2014 says.
How big are the technical changes (other than consolidating the two -n standards)? A consultant wants to charge us $2000 to do a gap analysis with our validation. If there are significant changes, it's worth it. If the changes are simply updated references (like the recent ISO 11607 changes) I can probably figure it out myself. Thoughts?
Since you should be in control of your sterilization processes, I would suggest you take also the ownership of this gap analysis by comparing the documents side by side and evaluate the impact on your sterilization programme.
I am not yet completely through with my gap analysis yet, but once I am done I can post my 2 cents.
sorry - no free lunch. My gap analysis is the property of the company I am working for and cannot be shared. And as I pointed out previously, in the end only you can really evaluate the impact of the standard changes to your sterilization programme - therefore, I would suggest you take also the ownership of this gap analysis tailored to your specific process.
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