ISO 13485:2016vsISO 19011:2018
See exactly how ISO 13485:2016 controls map to ISO 19011:2018. 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 19011:2018 with 26% coverage across 20 directly mapped controls. Analysis of 78 ISO 13485:2016 controls identifies 63 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 38 mapped controls across 5 domains. Sign up to explore all 310K+ mappings across 686 frameworks.
Quality management system – ISO 13485:2016(8 mappings)
Management responsibility – ISO 13485:2016(7 mappings)
Resource management – ISO 13485:2016(1 mappings)
Product realization – ISO 13485:2016(4 mappings)
+18 more mappings
Plus AI-powered gap analysis, compliance advisory, PDF exports, and cross-mapping for all 686 frameworks.
Create Free Account →Free forever, no credit card required
A ISO 13485:2016 to ISO 19011:2018 crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which ISO 19011:2018 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 26% 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 19011:2018 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 19011:2018 comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 686 frameworks, at a fraction of consulting costs.
Free
- ✓ 686 framework browser
- ✓ Cross-framework mappings (310K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between ISO 13485:2016 and ISO 19011:2018?
ISO 13485:2016 has 78 controls across its framework, while ISO 19011:2018 covers 55 controls. Direct mapping analysis identifies 20 overlapping controls (26% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 25 ISO 13485:2016 controls have no direct ISO 19011:2018 equivalent.
How many controls map between ISO 13485:2016 and ISO 19011:2018?
Of 78 total ISO 13485:2016 controls, 20 map directly to ISO 19011:2018 controls, representing 26% coverage. The remaining 63 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 19011:2018?
63 ISO 13485:2016 controls have no direct equivalent in ISO 19011:2018. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 25 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 19011:2018?
The domain with the highest gap count is Product realization – ISO 13485:2016 (25 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.