Sligo-based Avenue Mould is celebrating its recent success in being one of the very first companies in Europe to achieve certification to the new EN ISO 13485:2003 Quality Management System.
Sligo-based Avenue Mould is celebrating its recent success in being one of the very 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 extensive experience of supplying products to the medical technology market - over 80% of the company's current workload - and a huge measure of expertise in toolmaking, the company already operated a comprehensive quality policy, but achieving the new standard in such a short period still presented quite a challenge.

With a global value of $169 billion 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 - providing a complete solution, from product design and development support, through tool manufacture, mould trials, optimization and validation through to launch-stock manufacture, in the company's own Class 100,000 clean room.

Avenue's ability to achieve all these activities in-house, in a strictly controlled quality environment, enables its customers to get their products to market, faster and with complete confidence.

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.

To reinforce the company's quality focus a full time Quality Manager has been appointed, to oversee, co-ordinate and document all quality processes, including undertaking the work required for the latest accreditation.

However, the successful achievement of this new accreditation in such a short timescale has been very much a team effort in which all members of staff have been actively involved.