Avenue Mould enjoys certification success

Published: 6-Oct-2004


Sligo-based Avenue Mould is celebrating its recent success of being one of the first companies in Europe to achieve certification to the new EN ISO 13485:2003 Quality Management System for manufacturers of medical devices.

Although accreditation will not become necessary until 2006, Avenue seized the initiative to put all the required processes in place at the earliest opportunity. With a global value of €137bn each year, currently growing at 7%, medical manufacturing represents a huge market, and one for which Avenue is constantly looking to develop new services. With this in mind the company now offers a single-source option for medical and pharmaceutical OEMs. It provides a complete solution from product design and development support, through tool manufacture, mould trials, optimisation and validation through to launch-stock manufacture, in the company's own Class 100,000 cleanroom. Achieving this latest quality accreditation involved considerable preparatory work, including upgrading certain existing systems to bring them into line with the new standard, implementing new systems where required, re-writing procedures and updating the quality manual. These documents were then forwarded to the accreditation agency for review, after which a site audit was undertaken to review how the procedures were applied in practice and to confirm compliance with the requirements of EN ISO13485. Tel: +353 7191 69510 sales@avenuemould.com

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