Royal Ortho attains ISO:13485

Royal Ortho Achieves Inaugural ISO 13485 Certification from DQS

Royal Ortho is proud to announce that it has successfully achieved its inaugural ISO 13485 certification from DQS, a leading certification body. This significant milestone underscores the company's commitment to maintaining the highest standards of quality management in the design and manufacture of orthopedic devices.

What is ISO 13485?

ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system (QMS) specific to the medical device industry. It ensures that organizations consistently meet regulatory requirements and demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Key Steps to Achieving Certification

The journey to obtaining the ISO 13485 certification involved several critical steps:

• Gap Analysis: Royal Ortho conducted a thorough gap analysis to identify areas of improvement in their existing quality management practices.

• Implementation of QMS: A robust quality management system was developed and implemented, aligning with ISO 13485 requirements.

• Training and Awareness: Employees underwent extensive training to ensure understanding and adherence to the new processes and standards.

• Internal Audits: Regular internal audits were conducted to assess compliance and identify opportunities for further enhancement.

• Management Review: Top management was actively involved in reviewing the QMS, ensuring alignment with organizational goals.

• Certification Audit: The final step involved a comprehensive audit by DQS, which confirmed that Royal Ortho met all ISO 13485 requirements.

Impact of Certification

Achieving ISO 13485 certification is a testament to Royal Ortho's dedication to quality and excellence. The certification will:

• Enhance customer confidence in the quality and reliability of Royal Ortho's products.

• Facilitate access to global markets by meeting international regulatory requirements.

• Improve operational efficiency through streamlined processes and continuous improvement initiatives.

• Provide a framework for ongoing compliance and risk management in product development.

Looking Ahead

Royal Ortho is committed to maintaining its ISO 13485 certification and continually improving its quality management system. The company aims to leverage this achievement to drive innovation and deliver superior orthopedic solutions to its customers. In conclusion, the successful acquisition of the ISO 13485 certification from DQS marks a significant achievement for Royal Ortho, reinforcing its position as a leader in the orthopedic device industry dedicated to quality and customer satisfaction.