Maintaining consistent manufacturing quality is not merely a regulatory obligation. It represents a long-term commitment by PT Miconos to deliver safe and precise medical devices for the healthcare industry. Therefore, PT Miconos completed its ISO 13485:2016 Surveillance Audit on September 28–29, 2026, at its internal facility.
Quality Management System Evaluation with TÜV NORD
The evaluation agenda was directly reviewed by Mr. Usman Suwandi. He served as the official auditor from the certification body PT. TÜV NORD Indonesia. Furthermore, the audit aimed to evaluate the effectiveness of the Quality Management System for medical devices. This procedure ensures that all operational processes at PT Miconos align with global regulations.
Comprehensive Cross-Departmental Review
The inspection process was conducted by verifying Standard Operating Procedure (SOP) documents. Additionally, the auditor reviewed technical implementations on the field directly. This thorough evaluation involved all key departments across the company.
The Management Representative division oversaw the quality system governance. Meanwhile, the Research and Development division was audited for product design safety. On the other hand, the Purchasing division was evaluated on raw material quality assurance. Consequently, the Sales, Quality Control, and Production divisions were also assessed to ensure manufacturing consistency and after-sales service quality.
Quality Assurance for Healthcare Facilities
Through the success of this evaluation, PT Miconos strengthens its consistent quality management system. Thus, quality assurance remains the main foundation for the company. This commitment provides safety and confidence for partners and hospitals utilizing PT Miconos medical equipment.