ISO 13485:2016 Gap Analysis with Changes Identified

Hi everyone, glad to see we're back in business, i was wondering if anyone had carried out a gap analysis for the new 13485? And what have been your major changes identified? I'm about to start this process and i'd be grateful for any tips.

Re: ISO 13485:2016 Gap Analysis with changes identified wanted

Emergo and UL have pretty informative free white papers for download. Not sure if I am allowed to attach them here?!

Re: ISO 13485:2016 Gap Analysis with changes identified wanted

paulag said:

Emergo and UL have pretty informative free white papers for download. Not sure if I am allowed to attach them here?!

Click to expand...

You can provide a hyperlink / URL. Thank you.

Re: ISO 13485:2016 Gap Analysis with changes identified wanted

I find that the white papers referenced provide a clear overview, but still require you to do the real assessment your self.
In our training for all, we provide a document, but yes, we also need to make a living
Suggestion: Create a table which for all sections identifies the standards section number. Open both the 2003/2012 version and the 2016 version and check any differences. Then document where in your QMS these new requirements are covered. In case of gaps: define your action(s).

NB's and certifiers will determine the additional day(s) onsite, taking into account your gap analysis (and of course size of company, complexity etc).

Have the NB's perform this "upgrade" audit in addition to one of your surveillance audits already planned, as early as possible. In case major NC's are found against the new standard, you have time to fix them without loosing your current certification.
If your next audit (this or next year) is a renewal, discuss with your NB.

And: Not all are yet accredited for ISO 13485:2016!!!

Re: ISO 13485:2016 Gap Analysis with changes identified wanted

The new ISO13485:2016 has a comparison table to the 2003 version in the appendix A.
I took that table, added two more columns, one for the gaps within my processes/procedures and the other for the actions I plan to take to address the gaps.

I then attached this table to my CAPA.


General comment. If your company followed all the latest guidance documents, other standards, and/or best industry practices, and also complied with FDA's QSR and CMDR, then you shouldn't have many changes to your processes or procedures as a result of the updated standard.
My changes were mostly clarifications or changes to the wording to better align it with the new standard.

I took this opportunity to update most of my procedures as part of the periodic review/update.

Re: ISO 13485:2016 Gap Analysis with changes identified wanted

Hi there,

I came across a numbering gap analysis a few weeks ago to help me get started. I added a comments section to help with my assessment against our own procedures. This might help you get started. Its something still in the works for us but the good news is we have some time available.

Regards,

Bryan

Re: ISO 13485:2016 Gap Analysis with changes identified wanted

Hi Bryan

Thank you so much, very useful, and much appreciated.

Tracy

Re: ISO 13485:2016 Gap Analysis with changes identified wanted

Thank you Bryan; this is definitely helpful to many Covers.

Re: ISO 13485:2016 Gap Analysis with changes identified wanted

Thank you

Re: ISO 13485:2016 Gap Analysis with changes identified wanted

BSi now have white papers featuring an expert commentary on the new 13485 and another that compares and contrasts ISO 13485:2016 with ISO 9001:2015.

Registration required:
http://www.bsigroup.com/en-GB/medical-devices/resources/whitepapers/