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Cross-Framework Mapping

ISO 13485:2016vsISO 37002:2021 - Whistleblowing Management Systems

See exactly how ISO 13485:2016 controls map to ISO 37002:2021 - Whistleblowing Management Systems. Pre-computed mappings, identified gaps, and coverage analysis.

15
Controls Mapped
45
Gaps Found
2%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485:2016 maps to ISO 37002:2021 - Whistleblowing Management Systems with 2% coverage across 3 directly mapped controls. Analysis of 60 ISO 13485:2016 controls identifies 80 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.

Source: TheArtOfService Knowledge Graph | 60 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 15 of 15 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Quality management system – ISO 13485:2016(1 mappings)

iso-13485-2016::4.1General requirements
→ISO-56002-10.1General

Management responsibility – ISO 13485:2016(7 mappings)

iso-13485-2016::5.6Management review7 targets
→ISO-22313-9.3Management review
→ISO-37002-9.3Management review
→ISO-39001-9.3Management review
→ISO-41001-9.3Management review
→ISO-50001-9.4Management review
→ISO-56002-9.3Management review
→ISO37002-9.3Management Review

Measurement, analysis and improvement – ISO 13485:2016(7 mappings)

iso-13485-2016::8.2.4Internal audit7 targets
→ISO-22313-9.2Internal audit
→ISO-37002-9.2Internal audit
→ISO-39001-9.2Internal audit
→ISO-41001-9.2Internal audit
→ISO-50001-9.3Internal audit
→ISO-56002-9.2Internal audit
→ISO37002-9.2Internal Audit

Related Comparisons

Other ISO 13485:2016 comparisons

ISO 13485:2016 vs PIC/S Guide to Good Manufacturing Practice for Medicinal Products4 mappingsISO 13485:2016 vs ICH E6(R3) - Good Clinical Practice4 mappingsISO 13485:2016 vs FDA Quality Management System Regulation (QMSR)4 mappingsISO 13485:2016 vs ISO 45001:20184 mappingsISO 13485:2016 vs ISO 20000-14 mappingsISO 13485:2016 vs ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence4 mappingsISO 13485:2016 vs ISO 140014 mappingsISO 13485:2016 vs ASIS SPC.1-2009 - Organizational Resilience Standard4 mappings

Other ISO 37002:2021 - Whistleblowing Management Systems comparisons

ISO 9001:2015 vs ISO 37002:2021 - Whistleblowing Management Systems78 mappingsISO 14001:2015 vs ISO 37002:2021 - Whistleblowing Management Systems76 mappingsISO 14004:2016 vs ISO 37002:2021 - Whistleblowing Management Systems62 mappingsISO 10006:2003 vs ISO 37002:2021 - Whistleblowing Management Systems14 mappingsISO 56002 vs ISO 37002:2021 - Whistleblowing Management Systems12 mappingsISO 41001:2018 - Facility Management Systems vs ISO 37002:2021 - Whistleblowing Management Systems12 mappingsISO 39001:2012 - Road Traffic Safety Management vs ISO 37002:2021 - Whistleblowing Management Systems12 mappingsISO 50001:2018 - Energy Management Systems vs ISO 37002:2021 - Whistleblowing Management Systems12 mappings

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What are the key differences between ISO 13485:2016 and ISO 37002:2021 - Whistleblowing Management Systems?

ISO 13485:2016 has 60 controls across its framework, while ISO 37002:2021 - Whistleblowing Management Systems covers 159 controls. Direct mapping analysis identifies 3 overlapping controls (2% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 33 ISO 13485:2016 controls have no direct ISO 37002:2021 - Whistleblowing Management Systems equivalent.

How many controls map between ISO 13485:2016 and ISO 37002:2021 - Whistleblowing Management Systems?

Of 60 total ISO 13485:2016 controls, 3 map directly to ISO 37002:2021 - Whistleblowing Management Systems controls — representing 2% coverage. The remaining 80 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 37002:2021 - Whistleblowing Management Systems?

80 ISO 13485:2016 controls have no direct equivalent in ISO 37002:2021 - Whistleblowing Management Systems. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 33 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 37002:2021 - Whistleblowing Management Systems?

The domain with the highest gap count is Product realization – ISO 13485:2016 (33 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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.