Good news! We are now very proud of our most recent certification -  ISO 13485:2003 & EN ISO 13485:2012: the internationally recognised quality management standard specifically designed to support medical device manufacture.




Flying med-tech colours for WHP

Oxfordshire-based White Horse Plastics (WHP) passes another milestone in its servicing of the medical manufacturing market

Following WHP’s successful accreditation last year to the medical industry manufacturing standard ISO 13485 the business has just passed its first surveillance audit.

Colin Voller, QA manager says that ‘there was a mix up with the administration of our account at BSI resulting in the originally booked date being aborted, and no revised date possible within the necessary time frame. The upshot was that an ISO assessor travelled from Sweden to do the work. WHP was none the worse for an international flavour!’

WHP made the decision at the start of the audit to start the transition from ISO13485:2003 / 2012 to ISO 13485:2016. Says Voller, ‘this should put us in a very good position going forward, especially when the deadline hits in about a year’s time.’

As for the audit proper, all corrective actions were closed out successfully and only three minor non-conformities being raised, as a consequence of the transition process.

All told, and by any standard, this was a successful audit, and also enabled WHP to introduce Steve Allen, Quality Co-ordinator, to the various ISO procedures and protocols.

Many months into the process and WHP is firmly satisfied that the ISO 13485 accreditation is very worthwhile. Says Voller, ‘It gives our current customers and potential new ones the confidence that our systems are robust enough to cope with all the challenges that the medical industry requires.

Our visit last month, for example, to Med-Tech Innovation EXPO in Coventry was all the more fruitful for us being fully conversant with all relevant ISO 13485 matters. We hope to pursue some new lines of business as a result.’