Transitions Optical manufactures photochromic plastic lenses at its premises in Tuam, Co. Galway and employs approximately 200 people. The company is certified to ISO 13485:2016 – the medical device management system standard. Clause 7.6 of this standard addresses the control of monitoring and measuring equipment, which relates to the calibration and verification of measuring equipment used by the company. A footnote to this clause states that further information can be found in ISO 10012:2003 Measurement management systems – requirements for measurement processes and measuring equipment.
Antaris developed and delivered a customised training course on ISO 10012 for engineering & scientific personnel involved in the R&D and QC laboratories in the company. This explored the synergy between ISO 13485 and ISO 10012 and the benefits of implementing a measurement management system based on ISO 10012.