Quality Control
Our production and assembly of medical moulded products is quality managed to ISO 13485:2016 standards
Here at Amies Innovation we are proud of our quality record. With the four stages of inspection, First Off, In-Process, Last-Off and Final Inspection, quality assurance is always controlled from concept to completion.
Our sister company Amies Plastics operates quality management systems certified to ISO 9001:2015 to meet the requirements of our market sectors. www.amiesplastics.co.uk
RESPECTED STANDARDS
All Amies Innovation production is quality managed to ISO 9001:2015 and ISO 13485:2016.
We are justifiably proud of our quality record and Amies Innovation operates to the same exacting disciplines as our “big sister”.
TRACEABILITY
Amies operates a very thorough system of traceability with document and sample back-up from all production batches.
ACCURATE MEASUREMENTS
With a Mitutoyo Quick Vision 250 Ace (fully CNC) which can measure in either conventional contact or fully optical mode, together with a second Mitutoyo CMM, Amies is at the forefront of accurate component measurement.
HIGHLY TRAINED STAFF
Our quality department produces capability studies and Initial Sample Inspection Reports (ISIR’s) on all newly-tooled medical moulded products and again following any tool modifications. This measuring service is also offered to the toolmaking trade and provides the complete tool trialling and dimensional study service.
Statistical Process Control (SPC) is also applied to critical dimensions when required.
