Redditch Medical facility passes the ISO 9001:2008 Surveillance Audit

Published: 6-Nov-2014

For the third consecutive year, Redditch Medical facility excels in ISO 9001:2008 Surveillance Audit

For the third consecutive year, Redditch Medical's Durham facility has excelled in ISO 9001:2008 Surveillance Audit. The audit, which covers all internal processes (from product design to product release and all core quality management systems), showed Redditch Medical’s facilities to be fully compliant with industry regulatory standards. No non-conformances were highlighted in the ISO 9001:2008 surveillance audit reports – which also covered all Redditch Medical facilities – including manufacturing and distribution centres.

This is the third consecutive audit of the facility where no non-conformances have been identified in the audit process. The integrity of Redditch Medical’s focus on high standards is supported by positive audit results.

A message from Redditch Medical Facility Operators

'We ensured full conformance from the offest when our Durham facility opened in 2012. The 2012 audit results were very positive. We maintained this positive result in 2013, achieving a Fully Conformant status. As we continue to develop our InSpec range in 2014, with our unique Burstable Pouch Wipes and Mops, the standard of our facilities remain second to none as shown by our present outstanding audit results in 2014.'

Redditch Medical’s Durham facility contains a 100m2 EN ISO 6 GMP cleanroom together with an EN ISO 5 GMP localised air shower facility for assembly and contract packing of pharmaceutical products. While industry only requires ISO 9001:2008, Redditch Medical’s Durham facility boasts a superior Quality Management System that is approved to EU GMP and is ISO 13485/US FDA compliant.

This facility is where the iconic InSpec brand cleanroom contamination control products are developed. Solutions delievered by experience in this facility include alcohol disinfectants, rotational biocides and sporicides. New Burstable Pouch Wipes are manufactured at  Redditch Medical’s Durham facility to GMP under the prestigious ISO quality system.

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