B. Braun Indonesia Achieves ISO 13485:2016 Certification with Zero Findings, Reinforcing Excellence in Quality Management and Patient Safety

B. Braun Indonesia has successfully achieved ISO 13485:2016 certification with zero findings for its medical device manufacturing facility, reaffirming the company's commitment to world class quality and compliance standards to ensure the safety, quality, and reliability of products delivered to healthcare professionals and patients across Indonesia. This achievement demonstrates the effectiveness of the company's Quality Management System in meeting internationally recognized standards for the medical device industry.

ISO 13485:2016 is the internationally recognized quality management system standard for the medical device industry, designed to ensure consistent product quality, patient safety, and compliance with applicable regulatory requirements. The certification serves as recognition of an organization's ability to effectively manage its processes and consistently deliver products that meet established quality and safety standards.

The certification was awarded following an Initial Certification Audit conducted by TÜV SÜD. The comprehensive assessment evaluated the effectiveness of the company's Quality Management System, including management processes, operational controls, regulatory compliance, risk management, process validation, document control, and the readiness of its medical device manufacturing facility. Auditors also conducted on site inspections of production areas, quality control laboratories, and warehouse operations to verify the implementation of documented procedures and controls throughout the facility.

The audit concluded with no nonconformities identified across all evaluated areas. Achieving zero findings reflects the maturity of B. Braun Indonesia's quality management practices and demonstrates the consistent implementation of a strong quality culture across the organization.

“ISO 13485 certification demonstrates B. Braun's commitment to operating under a strong and internationally recognized compliance framework that ensures the quality of products manufactured and marketed by the company,” said Eko Peryatno, Senior General Manager Plant of B. Braun Indonesia.

This achievement further strengthens B. Braun Indonesia's position as a trusted partner for healthcare professionals, healthcare institutions, and stakeholders across the healthcare sector. Through the implementation of a Quality Management System aligned with global standards, the company continues to ensure that every product it delivers meets the highest principles of quality, safety, and compliance that are essential to supporting optimal healthcare outcomes.

More than a certification milestone, achieving ISO 13485:2016 with zero findings reflects a culture of quality embedded throughout every aspect of the organization's operations. By making quality and compliance an integral part of its business processes, B. Braun Indonesia continues to strengthen its role in delivering safe, reliable, and value driven healthcare solutions for customers, healthcare professionals, and patients throughout Indonesia.