Quality Management
System
To ensure a consistent and reliable product supply throughout the globe, Healthium employs a central Quality Management System (QMS) across all business processes.
Owing to the quality systems we set in place as well as the data we generated for product realisation over the past few years, we have received various certifications and approvals such as:
- 510(K)
- EUMDR CE
- TGA
- EN ISO 13485
- ISO 9001
- BIS Mark
- WHO-GMP
- CDSCO Medical Device License
At Healthium, quality by design remains the mindset across the organisation, with special focus on innovative and robust product design, strong risk management processes as well as manufacturing process controls, leading our products to be well received in the market.
Healthium’s facilities are integrated into the QMS with Level 1 and Level 2 documentation consistent across all facilities, allowing for ease of execution of the QMS system across the organisation. What’s more, in order to complete registration, our plants have also been through multiple audits from various countries’ health authorities, serving as a testimony for Healthium’s audit-ready mindset.
Our state-of-the-art manufacturing plants are designed as per international clean room standards & GMP standards. We have also deployed the latest technologies as part of our continual improvement journey.
We believe that having a matured quality system has helped us meet customer and compliance needs, thereby allowing us to sustain Healthium’s product quality over the years.