ISO 13485vsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
See exactly how ISO 13485 controls map to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 21% coverage across 6 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 23 compliance gaps — primarily concentrated in ISO 13485: Administrative Safeguards.
Source: TheArtOfService Knowledge Graph | 29 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 11 of 11 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Resource Management(1 mappings)
Improvement(3 mappings)
ISO 13485: Patient Data Protection(3 mappings)
ISO 13485: Technical Safeguards(4 mappings)
Related Comparisons
Other ISO 13485 comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.
Free
- ✓ 718 framework browser
- ✓ Cross-framework mappings (332K+)
- ✓ 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 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
ISO 13485 has 29 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 77 controls. Direct mapping analysis identifies 6 overlapping controls (21% coverage). The frameworks diverge most significantly in ISO 13485: Administrative Safeguards, where 6 ISO 13485 controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between ISO 13485 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
Of 29 total ISO 13485 controls, 6 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 21% coverage. The remaining 23 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485 to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
23 ISO 13485 controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in ISO 13485: Administrative Safeguards with 6 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 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is ISO 13485: Administrative Safeguards (6 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.