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ISO 13485:2003 is underpinned by the ISO9001 quality standard, which Accutronics has had in place for several years. However, it is significantly more specialised and dedicated to the medical device manufacturing sector.
The new standard specifies requirements for a quality management system in which manufacturers have to demonstrate the provision of medical components that satisfy customer and regulatory requirements.
ISO 13485:2003 details additional commitment to continual improvement, above and beyond the requirements of ISO 9001. The major differences are the design and traceability procedures as well as an additional focus on supplier audits.
“We’ve been working tirelessly to develop new and improved batteries for medical devices that help save lives in hospitals across the globe,” explained Matt Simcock, quality manager at Accutronics. “However, for some of the OEMs we work with, this stamp of approval is essential for building trust.
“This caused us to start working towards ISO 13845: 2003 twelve months ago. It was new to us in the beginning, but thanks to the strong and supportive team we have here, we achieved the accreditation in a very short period of time.
“As quality manager I had the task of creating procedures for the design and manufacturing teams and looking at traceability and sustainability issues. The end result is remarkable and I couldn’t be happier,” he enthused.
“Gaining the ISO 13845: 2003 stamp for the quality of our designs, manufacturing and testing procedures was a huge boost for everyone in the company,” said Rob Phillips managing director of Accutronics. “The new procedures and internal audits have made us a leaner manufacturer and we’re starting to see the results on the bottom line. What’s more, we are now in an even better position during tenders and sales meetings,” he concluded.