Rutland Plastics is awarded ISO 13485
17 June 2013
Rutland Plastics has attained the medical standard ISO 13485. Building on the ISO 9001 accreditation that the company already has, it now has additional approval for the manufacture of non-sterile injection and flow moulded products.
These include thermoplastic components for medical devices and the machining, finishing and sub-assembly of mouldings to customers’ requirements. 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 achieving this standard demonstrates proven business credentials in this sector through independent verification. This is the culmination of many months hard work led by QC Inspector Lee Hatton.
“This is a growing market for plastic mouldings due to the high usage of disposables,” says 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 mould shop backed up by effective quality assurance processes.”
Midlands-based Rutland Plastics has been in business for more than 50 years, manufacturing a wide range of products including invalid aids, recycling products and large mouldings on machines up to 1,700t capable of manufacturing parts of up to 48kg in weight.
In addition to injection moulding Rutland Plastics offers design and tool-making to machining and assembly services, including sonic welding and glueing as well as being specialists in gas assisted moulding.
It is also able to offer rapid prototyping in multiple materials using its Objet Connex 350 3D printer, either in conjunction with prospective moulding work or as a standalone service.
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