# ISO 42001 Certified AI Governance for Hearing Care | Auditdata
> Auditdata is the first PMS vendor globally certified to ISO/IEC 42001 for AI management — responsible, audited AI governance for hearing care.
ISO/IEC 42001 Certified
# **Responsible AI** Starts **With The Company Behind** Your Software.
Auditdata's AI Management System is certified to ISO/IEC 42001 — the first international standard for AI management. Every use of AI across our business is governed with human oversight, privacy protection, and structured risk management.
Last updated: April 21, 2026 · Certified to ISO/IEC 42001:2023
## 1st
PMS vendor globally certified to ISO/IEC 42001 for AI management.
## 10+
Years of adherence to ISO 27001, ISO 13485, and EU MDR standards.
## Aug 2026
EU AI Act enforcement deadline — Auditdata is already aligned.
## 100%
Of AI outputs subject to human review under the certified framework.
ISO
What ISO 42001 Actually Means
## A ***Governance Framework*** for Every Use of AI, Not A Badge On A Product
[**ISO/IEC 42001:2023**](https://www.auditdata.com/media/e0tdiwmb/auditdata_42001_enf49_45100057_web_v1_08c91417-1cec-4a04-84b8-704db6c2dafc_en-16.pdf "Auditdata_42001_ENF49_45100057_web_v1_08c91417-1cec-4a04-84b8-704db6c2dafc_en[16].pdf")**is the first international standard for Artificial Intelligence Management Systems (AIMS).** Published by the International Organization for Standardization, it defines how organizations should develop, provide, and use AI responsibly — with risk assessment, human oversight, privacy protection, and continuous improvement.
## Human Oversight, Always
AI-generated outputs require human review. No "AI on autopilot", every output is checked before it reaches your software or your patients.
## Privacy & GDPR, by Design
The certified system explicitly covers protection of individuals' privacy and safety, GDPR compliance, and applicable legal and ethical requirements.
## Third-Party AI Risk Managed
Every external AI tool we use goes through structured risk and impact assessment; identified, treated, and monitored, not reviewed once and forgotten.
## Annual Audits, Continuous Review
The certification is subject to annual surveillance audits and a full recertification cycle every three years, so governance keeps pace with how fast AI evolves.
## EU AI Act Ready
Controls aligned with the EU AI Act, ahead of the August 2026 enforcement deadline. Work with a vendor that's ahead of the regulatory timeline, not behind it.
## AI-Governance by Design
AI governance is integrated into how Auditdata designs, builds, and maintains its products,not a separate policy document stored in a drawer.
For Auditdata, ISO 42001 certification covers every AI tool our developers use to build your software, every AI that supports our operations, and every AI-driven process that touches your clinic.
Built on a decade of compliance
## ISO 42001 Is the ***Next Logical Step***, Not a Stand-Alone Badge
Auditdata didn't start from zero. The AI governance framework is built on management systems we've maintained for over a decade — including the most stringent standards for information security, medical device quality, and regulatory compliance.
Trust earned over a decade is now extended to AI. Auditdata is the first [practice management software](https://www.auditdata.com/ "Auditdata.com") vendor globally to hold ISO 42001 certification — and when your hearing enterprise works with a certified vendor, it strengthens your own compliance posture too.
## ISO 27001
**Information Security**
Protecting your data, devices, and networks for more than a decade.
## ISO 42001
**AI Management System**
Governance of AI tools and processes is managed within our ISO/IEC 42001-certified AI Management System.
The four pillars of our AI governance
## How Every Use of AI at Auditdata is **Governed and Audited**
## Risk & impact assessment
Every AI tool and process goes through structured risk and impact assessments before and during use.
## Human-in-the-loop review
AI outputs are reviewed by people. Transparency and accountability are built into the workflow.
## Privacy & safety protection
GDPR-aligned, with explicit protection of individuals' privacy, safety, and applicable legal requirements.
## Continuous monitoring
Risks are identified, treated, and monitored, backed by annual surveillance audits and a 3-year recertification cycle.
What this means for your clinic
## Vendor Governance You Can ***Point To*** and Stand Behind
As AI reshapes hearing care, Auditdata is setting the standard for responsible adoption. Here's what certified AI governance looks like for each team in your organization.
Clinic owners & managers
## Audited Documentation You Can Share Upward
Feel reassured that the company building the software for your hearing care network governs AI to an international standard. When group leadership or regulators ask about your vendors' AI governance, you have answers, backed by independent audit.
Heads of Audiology
## AI that Supports Clinicians, Doesn't Replace Them
The software audiologists rely on is developed and maintained under the strictest governance framework — requiring human oversight of AI outputs, privacy protection, and structured risk management. AI supports clinical work in a way that's proven to be governed, transparent, and accountable.
IT & Compliance
## One Less Vendor Risk to Manage
Third-party AI tools are risk-assessed. GDPR compliance is baked in. EU AI Act alignment means you're working with a vendor that's ahead of the regulatory timeline — so your own compliance posture is stronger the day you start working with us.
Operations Leaders
## Scaling AI with Confidence
As AI evolves rapidly, Auditdata has a certified framework to adopt new AI capabilities responsibly across the organization. The AI used to develop, improve, and deliver your hearing care tools is governed from day one, not retrofitted later.
## **The Details Behind the Certification**
## Is ISO 42001 about the AI in your products, or the AI your company uses?
Both. Our certified management system covers every use of AI across Auditdata. The AI tools our developers use to write and review code, the AI that supports our operations and consulting services, and AI in internal processes. Governance is woven into how we operate, not just stamped onto our products.
## How does ISO 42001 relate to the EU AI Act?
Auditdata has implemented controls aligned with the EU AI Act ahead of its August 2026 enforcement deadline. While ISO 42001 and the EU AI Act are separate instruments, our certified framework materially overlaps with the Act's requirements — so clinics working with us have a partner who is already operating to the standard the regulation will enforce.
## How is the certification maintained over time?
ISO 42001 is not a one-time effort. The certification is subject to annual surveillance audits and a full recertification cycle every three years, allowing governance to keep pace with how AI evolves.
## How does this build on Auditdata's other certifications?
ISO 42001 integrates with 10+ years of adherence to ISO 27001 (information security), ISO 13485 (medical device quality), and EU MDR (regulatory compliance). AI governance is the next logical step, and Auditdata is the first PMS vendor globally to hold this certification. See all [certifications](https://www.auditdata.com/company/certifications/ "Certifications") here.
## What does "human oversight" actually mean in practice?
Every AI-generated output used inside Auditdata requires human review before it's acted upon. Third-party AI tools are formally risk-assessed. Risks are identified, treated, and monitored, not reviewed once and forgotten. This isn't AI on autopilot; it's AI with accountability built in.