PharmOut recently developed a free ISO 13485:2016 Gap Analysis tool for identifying the gap between the ISO 13485:2016 and ISO 13485:2003, currently this tool is free to all clients attending our ISO 13485:2016 Medical Device training, or anyone that may have previously purchased our ISO 13485:2003 QMS templates since the 1st January 2016.
The latest ISO 13485:2016 QMS templates can be bought here.
If you would like to read more about what is in the ISO 13485:2016 and why we focused certain elements, read recent FDA citations, so in addition to the recent changes ISO changes, we included common FDA 483 observations.
Is the new ISO 13485:2016 for you now?
Before I continue describing the need for ISO 13485:2016 certification and regulatory approval, PharmOut is experienced in helping many companies establish ISO 13485:2003 Quality Management System (QMS), plus we have already helped a number of companies with upgrading or establishing their ISO 13485:2016 QMS from scratch.
We supply both sets of template, a gap analysis assessment and tracking tool and of course training on ISO 13485 and ISO 14971.
Organizations certified to ISO 13485:2003 are granted a three-year transition period to migrate to the new edition of the standard, after this time, if you wish to obtain third-party validation, you will have to seek certification to the new version. For more details about transitioning to ISO 13485:2016, talk to your notified body or PharmOut.
Whilst there is a 3 grace period, most sensible people will start looking to adopt the ISO 13485:2016 standard straight away.