SleepNet / BreatheNet

Good to Better: SleepNet-BreatheNet’s Journey to Obtaining ISO 13485 Certification

SleepNet-BreatheNet, a renowned market leader in providing medical equipment and comprehensive aftercare to patients requiring respiratory support, has once again set a new benchmark. They have become one of the first companies in South Africa to achieve ISO 13485 certification, solidifying their position at the forefront of the industry.

This is our remarkable journey.

For a span of two years, our esteemed medical device company embarked on a transformative path with the sole objective of obtaining ISO 13485 certification. This internationally recognized standard, designed specifically 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. We were determined to build a robust Quality Management System that would meet the rigorous standards of ISO 13485. Through this evaluation, we identified areas for improvement and set clear goals and milestones. To ensure the success of our endeavour, we formed an internal team comprising middle and top management. Additionally, we sought the guidance of an external consultant, whose invaluable counsel played a pivotal role in our success.

We initiated a series of robust measures, including process optimization, staff training, and the establishment of stringent quality control procedures. Every facet of our operations underwent scrutiny, ranging from design and development to production, installation, and servicing. In our relentless pursuit of excellence, we invested in advanced technologies and infrastructure to meet the stringent requirements of ISO 13485.

We conducted both internal and external audits facilitated by external certification bodies. These audits provided us with invaluable feedback and guidance, allowing us to fine-tune our practices, rectify any non-conformities, and continually enhance our Quality Management System. The iterative nature of this process ensured that we left no stone unturned in our quest for perfection.

Finally, after two years of tireless effort and unwavering dedication, we proudly achieved ISO 13485 certification. This remarkable milestone not only validates our unwavering commitment to quality and patient safety but also unlocks new market opportunities and strengthens customer confidence in our products. Our journey to ISO 13485 certification has been nothing short of transformative, positioning us as a trusted and compliant player in the medical device industry.

We extend our heartfelt gratitude to Mark Banfield of Mark Banfield Consulting, whose unwavering support and tireless work have been instrumental in our achievement. We would also like to thank the audit team at DQS for their professional and composed approach during the challenging formal audit process. Lastly, we express our appreciation to all the staff at SleepNet-BreatheNet for their buy in and continued commitment to the success of the company.

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