Micronclean awarded ISO13485:2016 and ISO 14001:2015


Micronclean are delighted to announce that they have successfully transitioned to ISO13485:2016 and ISO14001:2015.

The transition to the 2016 version of the ISO 13485 quality management system for our MicronDevices sterile packs range followed a recent two-day site surveillance audit by our Notified Body, BSi. This follows on from the building last year of our own medical devices cleanroom and it subsequent approval by BSi.

The transition to ISO 14001:2015 followed a separate three days surveillance audit again conducted by BSi which also renewed our approval to ISO 50001:2001.

Robert Parker, Micronclean Managing Director, said: “This represents a significant achievement for us. In under 3 months we have successfully transitioned to ISO 9001:2015, ISO 14001:2015 and ISO13485:2016 as well renewing our approval to ISO 50001:2011. These new versions of the standards require businesses to bring the standards to the centre of everything they do”

“The ease with which we achieved the new standards demonstrates that as a business we are not only have quality alongside innovation in our Business Purpose statement but we are bringing it to life not only in terms of expanding knowledge and increasing awareness within Micronclean but also in the way we provide quality and efficiency to our customers backed by outstanding customer care”.

Micronclean now have plans in place for the transition to the new Medical Device Regulation for the MicronDevices cleanroom by the deadline date in 2020.