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Award-winning plastics injection moulding manufacturer, Boddingtons is currently processing enquiries for its services, following a successful exhibiting presence at Compamed, Düsseldorf, November 12-15th.

A key part of the company’s appeal is in its handling of med-tech red tape, international standards and product introductions.

At Compamed 2018 Boddingtons was able to report, for example, that the company has successfully transitioned its Quality Management System to ISO 13485:2016 and to ISO 9001:2015, thereby achieving continued certification with BSI. The company’s new certificates were received in August.

Jay Cheema, Boddingtons Quality Manager notes that ‘our QA team collaborated extremely well during a 12 month period in order to identify the new and amended requirements of both standards and thereby to significantly improve the features our Quality Management System now current.

All changes to our procedures were risk assessed,’ adds Cheema, ‘as part of our change control process prior to implementation. The implementation included updating of our existing procedures, implementing new procedures and rolling out training. The effectiveness of these measures was then assessed by challenging the processes and procedures during internal audits.

The qualifications of ISO9001:2015 and ISO13485:2016 now enable Boddingtons to further improve technical leadership and risk management and other improvements in the service of the customer – ‘helping them realise their products to the required standard of quality, and in accordance with directives and legislation, whether domestic or global,’ says Cheema.

Boddingtons is also site registered with the FDA, this is not a certification but as we manufacture Medical Devices that are exported to the US we comply with QSR 21 CFR Part 820 requirements. In the coming months, says Cheema, ‘we will be focussing heavily on the Medical Device Regulation requirements. Our Quality Management System (QMS) never stands still, there are always challenges to be met and improvements to be embraced here.’

The company’s Class 7 cleanrooms and the expert testing and inspection services at the company are in high demand, in the UK and abroad.

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