ISO 13485:2016vsISO 9001:2015
See exactly how ISO 13485:2016 controls map to ISO 9001:2015. Pre-computed mappings, identified gaps, and coverage analysis.
Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485:2016 maps to ISO 9001:2015 with 19% coverage across 16 directly mapped controls. Analysis of 78 ISO 13485:2016 controls identifies 67 compliance gaps, primarily concentrated in Product realization – ISO 13485:2016.
Source: TheArtOfService Knowledge Graph | 78 controls analysed | 686 frameworks | 310K+ cross-framework mappings
Control Mappings
Showing 20 of 34 mapped controls across 5 domains. Sign up to explore all 310K+ mappings across 686 frameworks.
Clause 0 – ISO 13485:2016(1 mappings)
Quality management system – ISO 13485:2016(10 mappings)
Management responsibility – ISO 13485:2016(6 mappings)
Product realization – ISO 13485:2016(3 mappings)
+14 more mappings
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A ISO 13485:2016 to ISO 9001:2015 crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which ISO 9001:2015 controls your existing ISO 13485:2016 work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
- Every evidenced control, with the reasoning behind it
- Every gap, with what it requires
- Its level of review stated plainly, not a bare number
Why this page shows two different percentages. The 19% in the header counts how many ISO 13485:2016 controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many ISO 9001:2015 controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.
A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.
Related Comparisons
Other ISO 13485:2016 comparisons
Other ISO 9001:2015 comparisons
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What are the key differences between ISO 13485:2016 and ISO 9001:2015?
ISO 13485:2016 has 78 controls across its framework, while ISO 9001:2015 covers 66 controls. Direct mapping analysis identifies 16 overlapping controls (19% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 24 ISO 13485:2016 controls have no direct ISO 9001:2015 equivalent.
How many controls map between ISO 13485:2016 and ISO 9001:2015?
Of 78 total ISO 13485:2016 controls, 16 map directly to ISO 9001:2015 controls, representing 19% coverage. The remaining 67 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485:2016 to ISO 9001:2015?
67 ISO 13485:2016 controls have no direct equivalent in ISO 9001:2015. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 24 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between ISO 13485:2016 and ISO 9001:2015?
The domain with the highest gap count is Product realization – ISO 13485:2016 (24 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.