PT Chageur Medikal Industri (CMI) officially received ISO 13485 certification for the quality management system of medical devices from PT TÜV NORD Indonesia. The certificate handover was held on Monday, April 6, 2026, at the PT Chageur Medikal Industri facility, Bizpark 3, Bekasi.
This certification is one of the company's important steps in strengthening the quality management system, consistency of the production process, and commitment to the safety and quality of the resulting medical device products.
ISO 13485 is an international standard for medical device industry-specific quality management systems that emphasizes process control, risk management, traceability, documentation, and compliance with applicable regulatory requirements. The implementation of this standard is an important foundation for medical device manufacturing companies in maintaining product quality in a sustainable manner.
The ISO 13485 certificate was issued by PT TÜV NORD Indonesia as a certification body that carries out the audit and certification process according to the applicable mechanism and is accredited by the National Accreditation Committee (KAN). The certification process is carried out through the stages of a thorough audit of the quality system, documentation, process implementation, and operational readiness of the company.
Director of PT Chageur Medikal Industri, Tubagus Mualif, said that this achievement was the result of the joint commitment of all company teams in building a culture of quality and continuous improvement.
“ISO 13485 certification is not only an administrative achievement, but part of our commitment to continuously improve the quality of the systems, processes, and products we produce. We believe that the medical device industry requires strong, consistent, and safety-oriented quality standards for users,” he said.
The journey towards ISO 13485 certification is carried out through an intensive system preparation and strengthening process, including the improvement of quality documentation, improvement of process control, implementation of risk management, and strengthening of human resource competencies.
The implementation of an ISO 13485-based quality management system is also expected to increase the trust of customers, business partners, health institutions, and support the company's readiness to meet the needs of the growing medical device market.
In addition to strengthening the aspects of quality and regulatory compliance, this certification is part of PT Chageur Medikal Industri's strategic steps in building a national medical device manufacturing company that is competitive, professional, and competitive.
When handing over the certificate, PT TÜV NORD Indonesia also appreciated the company's commitment in building a structured and sustainable quality system as part of the development of the medical device industry in Indonesia.
With the achievement of ISO 13485 certification, PT Chageur Medikal Industri affirms its commitment to continue to deliver quality, safe, and reliable products and systems, while contributing to the strengthening of the national medical device industry.
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