ISO 9001 and ISO 13485 for rapid digital manufacturing platform.
Geomiq’s digital manufacturing platform makes rapid prototype and production manufacturing easy. They develop and work with top performing suppliers to provide top-notch, on-demand manufacturing services.
We were introduced by referral from another satisfied client, RPD, themselves being in the rapid design, prototyping and digital manufacturing sector. Both clients were active in medical devices and required ISO 13485 certification for regulatory compliance. In both cases we threw in ISO 9001 to provide a leg-up in other sectors (there being very little addition required as ISO 13485 is effectively ISO 9001 on steroids).
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standards.
1
system.
QFactorial Service offering
Implementation
We always say we are in it for the long haul. Our oldest client has been with us since 2016. Some projects take longer than others. Priorities change, funding gets diverted, all hell breaks loose with a giant new project, organisations re-organise, people come and go. We get it. We’ve been there enough times. We can work to almost any timeline, adjusting as we go. There’s no rush. Our work with the folks at Geomiq really put this to the test. But we passed the test with our trade-mark combination of professionalism, perseverance and flexibility. From initial contact in September 2021, to Stage 2 certification success in April 2024, it was great working with the Geomiq team. Starting with our well-proven Gap & Synergy Assessment with Action Plan (GSAAP) our consultant Alistair steered the project through the QMS design, documentation and implementation phases, with additional support on key topics such as selecting a UKAS accredited certification body, risk management and training/mentoring. Together we established a robust quality management system with all the documentation and verification confirmed. Processes were honed, people were trained, evidence was gathered, audits were passed with flying colours.
Customer satisfaction gets talked about and this is one of the best ways of generating new business. This project was a great example of lead generation by ‘word of mouth’ followed by a successful execution incorporating lessons learned from work done with the referring client. Continuity between consultants and projects is one of the big benefits of working with QFactorial.
We think Sam said it all with the testimonial below. Nothing for us to add.
Hi Kevin, Recommended pass with only two OFI’s! Great stuff!! Awaiting certificate now! Thanks for your support and also Alistair!! Sam.
