Midlands-based injection moulder, Rutland Plastics, has attained the medical standard ISO13485.
Building on the ISO9001 accreditation that the company already has, it now has additional approval for the manufacture of non-sterile injection and flow moulded thermoplastic components for medical devices and the machining, finishing and sub-assembly of mouldings to customers’ requirement. Of particular importance in this standard are risk management and maintaining effective processes specific to the safe manufacture of medical devices.
Rutland Plastics already manufactures a number of products for the medical sector and says that achieving this standard demonstrates proven business credentials in this sector through independent verification.
“This is a growing market for plastic mouldings due to the high usage of disposables,” commented Rutland Plastics’ Managing Director, Steve Ayre. “Medical is a market we would like to develop further. This standard not only demonstrates our commitment but also the level of service we can provide due to our focus on maintaining a clean mouldshop backed up by effective quality assurance processes.”