Andel Plastics

intelligent engineering

20 February 2017

Andel Plastics ISO13485:2003 Achievement

Andel Plastics ISO13485:2003 Achievement

ISO13485 Certification

ISO13485 Quality certfication

Andel Plastics are very pleased to announce that we have been recommended for Certifcation to the ISO13485:2003 Medical Devices Quality System.  Demonstrating the procedures and policies for the Class 7 Cleanroom are inline with Industry Standards. 

Andel invested in the Cleanroom, with the aide of a Business Innovation Programme grant from the Birmingham LEP in September 2015.  From January 2016 procedures packs and small test devices have been assembled with the strict procedures and traceability in place from the start.  With the aim of acquiring enough evidence of best practise to be able to achieve the ISO certification early this year.

Managing Director Graham Robinson was 'pleased that the plan had come together on target, just in time to release this news before this years Southern Manufacturing Exhibition in Farnborough.'  "We will have plenty of examples of product to demonstrate to people what our Medical device capabilities are, so even people we have met there before will have something new to see from us

Andel Plastics prides itself on being one of the only businesses in the UK to have an in-house tool design and toolmaking facility, on the same manufacturing site for injection moulding and Cleanroom facilities.  The next stage of the Companies expansion plans, are to invest in cleanroom moulding plant and equipment. 

Winners of the 2015 Plastics Industry Awards

Winners of the 2015 Plastics Industry Awards

UKAS Management Systems

Class 7 Cleanroom

Class 7 Cleanroom