Without a robust quality management system, a company runs the risk of lacking continuous improvement, a disengaged workforce, lack of customer satisfaction, lack of document control and ultimately, missed revenue as a result of sub-par quality standards. Design Development Engineer, Luke, discusses the importance of ISO:9001 and ISO:13485 for new product & medical device development.
There have been many historic scandals which could have been avoided with proper deployment of, and conformance to, a quality management system; oil spills in the ocean, horse meat in place of minced meat and falsely recorded emissions data, to name a few!
ISO 13485 builds on the foundation that ISO 9001 lays but is a mandatory requirement for the development of medical devices. Conformance to design controls (ISO 13485:2015 section 7) ensures medical devices are safe, efficient, and meet the indications for use. A design history file (DHF) is created in order to document each of the design control elements, and evidence any decisions taken during medical device development. The DHF ensures traceability in order to demonstrate that ultimately, the user needs have been met and a device is both safe and effective for use.
ISO 13485 offers many enhancements over ISO 9001 as a whole. It places a premium on the isolation of risk factors, requests further clarification of management responsibilities, enhances training of staff and improvement of facilities as well as enhancing the control of suppliers. The design controls have also been streamlined and rationalized to improve the design and development process for medical devices.
Haughton Design are certified to both ISO 9001 and ISO 13485, ensuring we work to the highest of standards across all projects. Please get in touch to discuss how we can help with your new product or medical device development project.