Cross-Framework Mapping

ASIS SPC.1-2009 - Organizational Resilience StandardvsISO 13485:2016

See exactly how ASIS SPC.1-2009 - Organizational Resilience Standard controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.

14
Controls Mapped
28
Gaps Found
29%
Coverage

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:

ASIS SPC.1-2009 - Organizational Resilience Standard maps to ISO 13485:2016 with 29% coverage across 12 directly mapped controls. Analysis of 42 ASIS SPC.1-2009 - Organizational Resilience Standard controls identifies 30 compliance gaps, primarily concentrated in Check.

Source: TheArtOfService Knowledge Graph | 42 controls analysed | 686 frameworks | 310K+ cross-framework mappings

Control Mappings

Showing 14 of 14 mapped controls across 6 domains. Sign up to explore all 310K+ mappings across 686 frameworks.

Implementation and Operation(2 mappings)

4.4.3Communication and Warning
iso-13485-2016::7.2.3Communication
4.4.4Documentation
iso-13485-2016::4.2Documentation requirements

Checking and Corrective Action(2 mappings)

4.5.4Control of Records
iso-13485-2016::4.2.5Control of records
4.5.5Internal Audit
iso-13485-2016::8.2.4Internal audit

Management Review(2 mappings)

4.6.2Review Input
iso-13485-2016::5.6.2Review input
4.6.3Review Output
iso-13485-2016::5.6.3Review output

Support(3 mappings)

SPC1-4.4.3Communication and Warning
iso-13485-2016::7.2.3Communication
SPC1-4.4.4Documentation
iso-13485-2016::4.2Documentation requirements
SPC1-4.4.5Control of Documents
iso-13485-2016::4.2.4Control of documents

Check(4 mappings)

SPC1-4.5.1Monitoring and Measurement3 targets
iso-13485-2016::8.2Monitoring and measurement
iso-13485-2016::8.2.5Monitoring and measurement of processes
iso-13485-2016::8.2.6Monitoring and measurement of product
SPC1-4.5.6Internal Audit
iso-13485-2016::8.2.4Internal audit

Act(1 mappings)

SPC1-4.6Management Review
iso-13485-2016::5.6Management review
Coverage crosswalk

A ASIS SPC.1-2009 - Organizational Resilience Standard to ISO 13485:2016 crosswalk, built to order

The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which ISO 13485:2016 controls your existing ASIS SPC.1-2009 - Organizational Resilience Standard work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.

ASIS SPC.1-2009 - Organizational Resilience Standard into ISO 13485:2016
Not published yet

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.

ISO 13485:2016 into ASIS SPC.1-2009 - Organizational Resilience Standard
Not published yet

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.

ASIS SPC.1-2009 - Organizational Resilience Standard to ISO 13485:2016 (built to order)
$299
per framework pair, one time
  • 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 29% in the header counts how many ASIS SPC.1-2009 - Organizational Resilience Standard controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many ISO 13485:2016 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.

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What are the key differences between ASIS SPC.1-2009 - Organizational Resilience Standard and ISO 13485:2016?

ASIS SPC.1-2009 - Organizational Resilience Standard has 42 controls across its framework, while ISO 13485:2016 covers 78 controls. Direct mapping analysis identifies 12 overlapping controls (29% coverage). The frameworks diverge most significantly in Check, where 4 ASIS SPC.1-2009 - Organizational Resilience Standard controls have no direct ISO 13485:2016 equivalent.

How many controls map between ASIS SPC.1-2009 - Organizational Resilience Standard and ISO 13485:2016?

Of 42 total ASIS SPC.1-2009 - Organizational Resilience Standard controls, 12 map directly to ISO 13485:2016 controls, representing 29% coverage. The remaining 30 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ASIS SPC.1-2009 - Organizational Resilience Standard to ISO 13485:2016?

30 ASIS SPC.1-2009 - Organizational Resilience Standard controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Check with 4 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 ASIS SPC.1-2009 - Organizational Resilience Standard and ISO 13485:2016?

The domain with the highest gap count is Check (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.