Celebrating a Milestone: Congratulations to SleepNet|BreatheNet - ISO 13485 certification

At DQS, we are proud to have partnered with SleepNet|BreatheNet on their ISO 13485 certification journey. This achievement reflects their unwavering commitment to excellence and their dedication to delivering safe and effective medical devices. As SleepNet|BreatheNet joins the esteemed community of ISO 13485 certified organisations, we are confident that their certification will unlock new avenues for growth and success.

SleepNet-BreatheNet’s journey to obtaining ISO 13485 certification.

"SleepNet|BreatheNet is well known as market leaders in the supply of medical equipment and skilled aftercare to patients requiring respiratory support at home and in hospital. Once again, SleepNet-BreatheNet lead the field by becoming one of the first in South Africa to obtain ISO 13485 certification. This is their story. 

Over the course of two years, our medical device company embarked on a transformative journey to achieve ISO 13485 certification. This rigorous and comprehensive standard, specifically tailored for the medical device industry, demanded unwavering commitment and meticulous attention to detail. 

Our journey began with a thorough evaluation of our existing processes and procedures, as we embarked on building our Quality Management System. We identified gaps and areas for improvement, setting clear goals and milestones. An internal team was formed, comprising middle and top management, and under the invaluable council of our external consultant, we collaborated closely to implement necessary changes. 

We initiated a series of robust measures, including process optimisation, staff training, and the establishment of stringent quality control procedures. We scrutinised every aspect of our operations, from design and development to production, installation, and servicing. We invested in advanced technologies and infrastructure to meet the stringent requirements of ISO 13485. 

Internal and then finally external audits were conducted by external certification bodies, providing invaluable feedback and guidance. This iterative process allowed us to fine-tune our practices, rectify any non-conformities, and continually enhance our Quality Management System. 

Finally, after two years of tireless effort and dedication, we achieved ISO 13485 certification. This milestone not only validates our commitment to quality and patient safety but also opens doors to new market opportunities and strengthens customer confidence in our products. Our journey to ISO 13485 certification has been a transformative experience that has positioned us as a trusted and compliant player in the medical device industry. "

 ^{SleepNet|BreatheNet Top Management} 

The Power of ISO 13485

ISO 13485 is an internationally recognized standard that sets the framework for quality management systems in the medical device industry. By achieving this certification, SleepNet|BreatheNet has demonstrated their dedication to maintaining the highest standards in product quality, regulatory compliance, and customer satisfaction. ISO 13485 provides a solid foundation for organizations to streamline their processes, enhance risk management, and ensure the consistent delivery of safe and effective medical devices.

Benefits of ISO 13485

• Enhanced Regulatory Compliance: ISO 13485 aligns organisations with global regulatory requirements, allowing them to navigate complex and evolving regulatory landscapes with ease.
• Improved Product Quality: By implementing robust quality management systems, organisations can optimize their production processes, minimize defects, and deliver superior products that meet or exceed customer expectations.
• Strengthened Customer Confidence: ISO 13485 certification instills trust in customers, partners, and stakeholders, assuring them of SleepNet|BreatheNet's commitment to delivering safe and reliable medical devices.

Benefits of Choosing DQS as Your Certification Partner

• Extensive Expertise: With years of experience in the certification industry, DQS brings deep knowledge and understanding of the medical device sector, ensuring a smooth certification process tailored to your unique needs.
• Global Recognition: DQS certifications are internationally recognized, providing credibility and market acceptance that can open doors to new opportunities and collaborations worldwide.
• Integrated Services: DQS offers a holistic approach by combining certification and training services, allowing organisations to optimize their quality management systems comprehensively.