Quality management in MR Coils : getting MR mechanics and IE components on their way towards ISO 13485 certification

Abstract

MR Coils is a company that specializes in building prototype coils for MRI scanners. They want to be able to sell their coils independently on the market. To be able to do so, customers require them to be ISO 13485 certified. Since MR Coils consists of and does business with multiple subsidiary companies, these subsidiary companies also require the ISO 13485 certification. Recently, MR Coils was focussed on getting themselves and MR Production & Service (MR P&S) ISO 13485 certified. They achieved this certification in December 2017. Their next step of focus will be on getting MR Mechanics and IE Components certified. Since MR Coils has been busy with the certification of themselves and MR P&S, the team of interns was asked to focus on the first steps of getting MR Mechanics and IE Components towards ISO 13485 certification. The main goal of this project is getting MR Coils a step further to the ISO 13485 certification of MR Mechanics and IE Components. Another goal of this project is for the interns to get used to working in a company and learn about core processes and structure (hierarchy). The interns will also learn how to work in a team and on their own on the topic of quality management with help from the quality manager of MR Coils and the ISO 13485 standard. The main question of this project was “How can MR Mechanics and IE Components be directed to obtaining ISO 13485 certification through quality management?”. This question was answered by first analyzing what the core processes of MR Mechanics and IE Components are. Then, the priorities for each company were examined and defined. Afterwards, the group of interns split in pairs. Each pair of interns worked on the priorities of one of the involved companies. After splitting up, the MR Mechanics pair focussed on maintenance and cleaning, work instructions, safety instructions, documents for the design phase and calibration of machines. The IE Components pair focussed on creating work instructions, measuring labour costs, maintenance and cleaning, work environment, room planning, critical component analysis, failure mode and effects analysis and a product journal. The pairs of interns worked on separate tasks, but exchanged knowledge continuously, as can be seen in some of the similarities. The MR Mechanics interns made the original maintenance and cleaning forms which the IE Components interns used as a basis for theirs. The same goes, but the other way around, for the working instructions, which were originally set up by the IE Components interns. The results mentioned in the previous paragraph are a direct answer to the main question “How can MR Mechanics and IE Components be directed to obtaining ISO 13485 certification through quality management”. They are all required for the ISO 13485 standard. Furthermore, the interns recommended that, after their leave, MR Mechanics focuses on stock management, setting up clear external and administrative processes, improvement of skills and conducting an FMEA and that IE Components focuses on implementing everything in Greenlight Guru, conducting a safety analysis, finishing the measurement of labour times and that the next group of interns focuses on tackling stock management issues in combination with electrostatic discharge dangers and protection.