HMA Medical Limited completed the initial audit for UAF-accredited ISO 13485:2016 Certification for Medical Devices – Quality Management System (MD-QMS).
The scope of the certification includes the Manufacturing and Distribution of Medical Devices (Disposable Syringes and Needles and Auto-Disable Syringes and Needles).
Along with this, HMA Medical Limited can also apply for ISO 14001:2015 Certification for Environmental Management System (EMS) to adopt environmental conscious processes and procedures to reduce carbon emission and waste generation. The organization can apply for ISO 41001:2018 Certification for Facility Management – Management System to implement best facility practices.
What is ISO 13485:2016 Certification?
The International Organization for Standardization (ISO) has published ISO 13485:2016 Certification defines the regulatory requirements for medical devices. The standard works on the lines of ISO 9001 certification for Quality Management System (QMS); and is known as Medical Devices – Quality Management System (MD-QMS). ISO 13485 standard is specifically designed for the Medical Devices Industry.
ISO 13485 is a process-based standard that helps organizations streamline various manufacturing processes and procedures to identify and eliminate possible threats and elements that might hamper the quality of medical devices during their lifespan.
Benefits of ISO 13485 for HMA Medical Limited
ISO 13485 certification offers the following benefits for HMA Medical Limited. These are:-
- ISO 13485 is a process-oriented certification that enhances product quality. Moreover, it helps HMA Medical Limited reduce waste and lower costs. The standard also improves overall efficiency by giving the organization a competitive edge in the medical device industry.
- ISO 13485 ensures that HMA Medical Limited implements a robust quality management system to ensure the production of safe and effective medical devices.
- HMA Medical Limited can reduce the likelihood of product errors or defects by adhering to ISO 13485 standards. Hence, it protects patient safety and enhances the organization’s reputation for quality.
Conclusion
HMA Medical Limited obtained ISO 13485:2016 certification to show its commitment to producing high-quality, safe and effective medical devices. Moreover, the certification enhances the organization’s credibility and solidifies its position in the global market.
