Since ISO 13485 has five main sections, our conformance audit tool (AB) has
five questionnaires. Similarly, our audit assessment tool (BB) has four sets of
questions because the ISO 19011 auditing standard has four main sections.

For each question, three answers are possible: YES, NO, or N/A. A YES answer
means you’re in compliance with the standard, a NO answer means you’re not in
compliance, while an N/A answer means that a question is not applicable in your
situation. NO answers identify gaps that exist between each standard and your
organization's practices and processes while N/A answers point to items
that aren’t applicable in your case.

All ISO 13485 2016 gaps must be filled and all N/A answers must be justified
and explained before you can say that your organization’s quality management
system complies with the new ISO 13485 2016 standard. You may exclude any
requirement in sections 6, 7, or 8 if you can justify doing so because of the
nature of your activities or products and if doing so does not undermine
regulatory compliance.

Once you’ve completed all five questionnaires, study your NO answers,
your own comments and observations, and our questions and then use this
information to formulate actions or steps that need to be taken in order to bring
your practices and processes into compliance with the new standard. Use this
information to develop your own unique ISO 13485 2016 Quality Management
Conformance Plan.

You can also summarize your internal audit results quantitatively if you wish.
The idea here is to measure how compliant your quality management practices
and processes actually are. If you carry out regular audits, you can also use our
approach to measure whether or not your quality management practices and
processes are improving over time.

Our ISO 19011 audit assessment tool works much the same way. A YES answer
means you’re in compliance with the standard, a NO answer means you’re not in
compliance, while an N/A answer means that a question is not applicable in your
circumstances. NO answers reveal gaps that exist between the ISO 19011 2011
standard and your organization's internal audit practices and processes.

Once you’ve completed our ISO 19011 audit assessment questionnaires, study
your NO answers and use the associated questions to formulate remedial actions.
Once you've done this for all gaps, you will have four detailed plans which, taken
together, will make up a complete Internal Audit Improvement Plan. And once all
plans have been implemented and all remedial actions have been taken, you
will have improved the overall effectiveness of your organization's internal
audit practices and processes.