Cold formers pass medical test
ISO 13485:2003 will help Dawson Medical develop its presence in the medical and healthcare sectors
Dawson Shanahan’s medical division has been accredited to the ISO 13485:2003 standard for the cold-forming and precision manufacture of components for the medical industry.
This complements its existing approval to ISO 9001:2008 and will help the company develop its presence in the medical and healthcare sectors.
The ISO 13485 standard has been introduced as a method of specifying requirements for quality management planning, monitoring and control systems in organisations manufacturing components or products for medical applications. It is therefore an essential requirement for companies such as Dawson Medical with a long term commitment to engineering parts for medical devices.
The company’s managing director, Les Reeves, says, “We are already actively involved in the production of components for customers in the medical and healthcare sectors; for example, we’ve been closely involved in the development of needle-free injection devices, where we manufacture key parts for the drug delivery mechanism.”
The company has also recently expanded its manufacturing facilities. “We’ve invested heavily in advanced precision machine tools at our factory in Potters Bar”, explains Les Reeves. “In particular, we have established a dedicated grinding cell with custom built high speed slot, groove and centreless grinding machines, plus new component finishing and cleaning systems.”
Although the company was already manufacturing to the standards demanded by the medical sector, and employing processes such as cGMP (current good manufacturing processes), the new ISO 13485 accreditation will play an important role in its future development in this area.
“The new ISO 13485 accreditation provides our customers and prospects with a further guarantee of our consistent approach and commitment to the development of precision solutions for cutting edge medical applications,” says Les Reeves.
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