ISO 9001:2015 / ISO 13485:2016 Combined Gap Analysis Checklist

The gap analysis checklist is a very useful tool in evaluating your Quality Management System (QMS) as you transition from ISO 9001:2015 to include ISO 13485:2016. Requirements are expressed as questions for the user (auditor / assessor) to use in determining your QMS capabilities.

While the versions of the standards do not line up when comparing the requirements:

• The right-hand column in green shade is intended to provide reference / comparison / similarities to the ISO 13485:2016 requirements, and to identify and locate where in the former requirements are relevant.
• In the green shaded right-hand column, the ISO 13485:2016 requirements over ISO 9001:2015 are highlighted in yellow.
• The intent of the main clauses of the ISO 9001:2015 standard is shown in bold blue font.

For a complete set of ISO 13485:2016 documentation, visit the 13485 Store, We have designed and documented a Quality Management System for you to use as the foundation of your documentation system. This system addresses all of the requirements of the standard, from setting quality objectives and measurement criteria for your processes to internal audits and continual improvement. All the procedures interrelate to provide you with an efficient, effective quality management system.

• You know where you are (Current Quality Management System).
• You want to be ISO 13485 Compliant.
• The difference between these is your gap. Anytime they differ you need to change your processes to bridge the gap.

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