We have awarded ISO/IEC 42001 certification to Sorsix, making it North Macedonia’s first certified company and Europe’s first with a national health system in production to meet the global AI management system (AIMS) standard. Sorsix – the company behind Pinga®, a health operating system deployed across Australia, New Zealand, Canada and Europe – has demonstrated its commitment to safe, accountable and transparent AI in healthcare.
Setting a regional benchmark for AI governance in healthcare
The certification recognizes Sorsix's structured approach to governing AI across one of the most sensitive sectors in which the technology is deployed. As AI adoption accelerates in healthcare, the need for transparent, accountable and risk-aware governance has become a regulatory and operational priority. ISO/IEC 42001 provides the framework against which this can be independently verified.
Certifying responsible AI in healthcare
The scope covered the governance of Sorsix's AIMS, including the design, deployment, monitoring and continual improvement of AI-driven capabilities embedded across Pinga's clinical workflows.
Pinga powers healthcare delivery across five continents, from single private clinics to entire national health systems. The technology integrates electronic health records, clinical workflows, radiology, laboratory and practice management into a single platform. AI is embedded throughout – clinical voice recognition, report dictation, document processing and intelligent pathway automation. Among its deployments, Sorsix operates national digital health systems, including Moj Termin in North Macedonia and Moj Doktor in Serbia, among other clients.
A global benchmark for responsible AI
ISO/IEC 42001 provides a certifiable framework for responsible AI. Organizations that achieve certification demonstrate that their AI systems are developed and operated within a structured, accountable and risk-aware governance framework.
With the EU AI Act now in force and AI governance requirements tightening globally, ISO/IEC 42001 is increasingly recognized as the benchmark for deploying AI in sensitive sectors, particularly healthcare, where AI-supported processes can affect patient outcomes, clinical workflows and safety.
The certification process
Sorsix pursued ISO/IEC 42001 certification to provide its health system partners, government clients and regulators with independent assurance that its AIMS for Pinga is governed in line with internationally recognized requirements.
Preparation included gap analysis, readiness assessment and framework and documentation review, followed by our formal audit. We assessed whether Sorsix's AIMS was not only documented but also implemented, monitored and continuously improved across the in-scope AI governance processes supporting Pinga.
Angela Vasovska, Head of Implementation at Sorsix, said: “We chose SGS for its global reputation for rigorous, independent assessment and its expertise in AI assurance.
“As a health technology company supporting government, public and private healthcare organizations across multiple markets, it was essential our ISO/IEC 42001 certification was delivered by a certification body recognized and trusted internationally.”
This certification forms part of our SGS DIGITAL TRUST services, designed to help organizations strengthen confidence in digital technologies through cybersecurity, privacy protection, AI governance and digital compliance across the technology life cycle.
The benefits of certification
Dalibor Frtunik, CEO of Sorsix, said: “Technology is the easy part. Digital transformation takes partnership – and partnerships are built on trust. Achieving ISO/IEC 42001 certification is how we demonstrate to every health system, clinician and patient we serve that our use of AI is governed responsibly, transparently and to the highest international standards.”
The certification provides Sorsix a demonstrable foundation for regulatory compliance, particularly relevant as EU AI Act obligations begin to apply. It also provides government and health network clients with confidence that AI-enabled capabilities within Pinga are governed responsibly.
Whatever your industry, size, location and AI technology, our comprehensive ISO/IEC 42001 services are ready to support your mission.
About Sorsix
Sorsix is a global health technology company that builds Pinga® – a health operating system deployed across Australia, New Zealand, Canada and Europe, and the technology behind national digital health platforms in North Macedonia and Serbia. Pinga powers clinical workflows for private clinics, public hospitals, diagnostic networks and national health programs, serving 10 million-plus patients, 75,000-plus daily users and 330-plus clinical centers.
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW).
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