Now is the time to make any necessary changes. By accessing your gap analysis report, you can discover and put right any problems found, what non-conformities need to be addressed before our consultant visits you again.

To make this as straightforward as possible, you can contact your consultant, help guides, and editable templates given to you by Aequalis.  If more help is needed, our consultants are on telephone, email, text or Watts App support during office hours, Monday to Friday.

While ISO 13485:2016 remains a stand-alone document, it aligns with ISO 9001:2008. (Yes, 2008, not 2015.)  This is because it does not follow the high-level structure (Annex L) of the latest version of ISO 9001 (which is 9001:2015). In addition, the documentation and safety requirements are much greater under ISO 13485:2016, whereas ISO 9001:2015 puts focus on customer satisfaction and continuous improvement.

To gain certification, our auditor will visit your organisation to check that all the required processes and procedures are in place and, more importantly, are being followed correctly. If any non-conformities were identified during the gap analysis, the auditor will need to see evidence that these have been addressed.

Providing everything is in place, our auditor will recommend you for certification and you will shortly receive your ISO certificate. Congratulations!