ISO 13485:2016

‘ISO 13485:2016 Medical devices ­– Quality management systems – Requirements for regulatory purposes’ is a standard that manufacturers and service providers in the medical device industry can comply with to demonstrate their control and commitment to quality of their products and processes.

Rebus Medical is proud of its ISO 13485:2016 certification, which it has held for three years. Although we don’t manufacture medical devices ourselves, certification provides our clients with confidence that we operate to the same high internal standards as their own businesses when it comes to quality.

What can clients expect?

Clients that select a human factors consultancy which has this certification can expect to partner with an organisation that:

  • has implemented and maintains a quality management system (QMS) that is effective in delivering an efficient, high-quality service
  • puts client requirements and satisfaction at the forefront of everything it does
  • takes a data-driven, risk-based approach to operations and processes helping to proactively reduce risk to our client projects
  • ensures that competency is managed throughout the organisation
  • invests in continual improvement and professional development across the team
  • evaluates and monitors the performance and quality of suppliers, helping to minimise downstream risk to client projects
  • provides credibility in its business operations
  • ensures compliance with relevant regulatory requirements and industry standards

Rebus’ quality policy states that: “We are committed to providing the highest possible standards of quality in relation to human factors engineering consulting services to medical device developers, manufacturers and pharmaceutical companies.” ISO 13485:2016 requires quality objectives are developed to make sure that this statement can be achieved. Through the implementation of a robust QMS it is possible to accomplish these objectives through continual improvement of each process.

If you have any questions about ISO 13485:2016 certification, please do get in touch.