Celesticas kidsgrove facility accredited to medical devices standard ISO13488:1996 and compliant to ISO13485:2003
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(2004), "Celesticas kidsgrove facility accredited to medical devices standard ISO13488:1996 and compliant to ISO13485:2003", Soldering & Surface Mount Technology, Vol. 16 No. 1. https://doi.org/10.1108/ssmt.2004.21916aab.004
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:Emerald Group Publishing Limited
Copyright © 2004, Emerald Group Publishing Limited
Celesticas kidsgrove facility accredited to medical devices standard ISO13488:1996 and compliant to ISO13485:2003
Celesticas kidsgrove facility accredited to medical devices standard ISO13488:1996 and compliant to ISO13485:2003
Keywords: Celestica, Medical
Celesticas UK manufacturing facility at Kidsgrove, near Stoke-on-Trent, has been accredited by the British Standards Institute to the medical devices standard ISO 13488: 1996. It has also been confirmed as compliant to the latest and soon to be released ISO 13485: 2003 standard – one of the first company globally to achieve this certification.
The ISO 13485: 2003 standard is expected to become mandatory for companies designing, developing, manufacturing and distributing electro-mechanical assemblies, devices and systems for the medical device industry. The ISO standards embrace all the principles of the FDAs good manufacturing practise (GMP) and are designed to ensure that device manufacturers have the quality management systems in place to consistently deliver products that are safe and effective.
The medical device market is growing rapidly as is the trend by OEMs in this sector to outsource the design, development and manufacture of their products to electronics manufacturing services (EMS) companies, such as Celestica. According to Technology Forecasters Inc., of Almeda, California, the medical device sector is forecast to grow to US$54.5 billion by 2005 and generate US$7.1 billion in revenue for EMS providers.
Accreditation to the ISO standards demonstrates Celesticas ongoing commitment and capability to service OEMs in the medical device and pharmaceutical markets, commented Julie Davies, Market Development Director – Medical at Celestica. Our Kidsgrove operation focuses on a broad range of services, such as design, prototyping, NPI, low volume, high technology, high mix manufacturing, attractive services to customers in these markets.
She added, This certification demonstrates that we have the processes and systems in place to consistently deliver high quality products. Importantly, because of our sophisticated IT capabilities and supply chain, we also provide medical device OEMs with fully automated real- time component traceability, obsolescence mitigation, risk management and software validation. Rob Paton, General Manager at Celestica, Kidsgrove, summed up the position. Medical device OEMs are driven towards outsourcing in order to speed new product development, reduce overall costs and improve time-to-market. However, they also want to build long term relationships with outsourcing partners as product lifecycles can be up to 15 years. With these latest accreditations, and our global capability and reputation for quality, Celestica is in a strong position to form partnerships with OEMs in this dynamic market.
For further information, please contact: Celestica Limited, Westfields House, West Avenue, Kidsgrove, Stoke-on-Trent, Staffs ST7 1TL. Tel: 01782 771000; E-mail: sales@celestica.com; Web site: www.celestica.com