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!

A well-established quality management system (QMS) aims to implement quite the opposite effect. Quality assurance boosts customer confidence and as a result, grants a good reputation which inevitably translates into loyalty. Customer feedback is welcomed and acted upon to ensure products and services are continually improved. Consistency is maintained, ensuring the customers’ standards are met every time. If quality assurance is at the foundation of a business’s work culture, the drive for quality is infused at every level and everyone feels responsible for the part they have to play.

ISO 9001 may be a voluntary QMS, but accreditation to it demonstrates a company’s commitment to meeting the requirements of customers, regulators and other stakeholders. Establishing a robust QMS protects a company against risks, increases efficiency and positions it to continue growing. From a design and development perspective, section 8 of ISO 9001 lays out a series of design controls which ensure the necessary activities and processes are being carried out, whilst also being flexible enough to enable an agile, waterfall or hybrid model process. All of the previously discussed benefits of a well-established QMS result from conformance to ISO 9001 design.

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.

Luke Brown - Design development Engineer at Haughton Design Luke Brown 31 August 2022

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Get in Touch with Luke Brown

Design Development Engineer

Luke graduated from Staffordshire University with a degree in Product Design and has since developed a broad range of skills from working in the HVAC & refrigeration industries to designing for sheet metal & fabrication. Luke has a keen interest in FEA and 3D CAD modelling as well as a strong knowledge of standards and patents – he is keen to contribute this experience to HD. Outside of work, Luke enjoys being creative be it through music or home improvements.

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