“QFactorial worked with us to achieve ISO 9001 and ISO 55001 certification in 2023. We were impressed by their professionalism, knowledge, and competitive pricing, which prompted us to engage their services again in 2024 when seeking further ISO certification. QFactorial did not disappoint, ultimately helping us gain ISO 14001 and ISO 45001 certification. Thank you QFactorial for your expertise and support in guiding us through the certification process.”
Fabrinet UK
ISO 13485 certification for manufacture of electronic medical devices
Fabrinet UK builds printed circuit board assemblies for aerospace, defence, automotive and medical technology clients around the world.
When they set their sights on the medical device sector, they needed ISO 13485 certification, and needed it to slot into an already mature management system without disrupting a live new product introduction.
“Working closely with Kevin has been a real pleasure, and with his experience and advice we have been successful in implementing the ISO 13485 standard.”
Key challenges included:
Approach taken
We ran our trademark Gap and Synergy Assessment to find where ISO 13485 could reuse what already existed, adopting Fabrinet’s PFMEA process for risk management and their First Article Inspection Report for production process validation, rather than building fresh documents from scratch. A progressive audit process tracked gap closure continuously as the new product moved from prototype through to full production, closing the gaps gradually rather than all at once at the finish line.
Services used:
Outcomes achieved
Gosh, you shouldn’t have…
Kind words from our clients
Commercial Asset Manager
–
Elgin
“I am incredibly impressed with the professionalism and expertise shown by QFactorial in guiding us through the ISO27001 certification process. Their support and guidance were invaluable in ensuring that our company’s information security management system met the required standards. Thanks to QFactorial, we now have the confidence to assure our clients that we take the security of their data seriously. I would highly recommend their services to any business looking to achieve ISO27001 certification.”
Chief Operating Officer
–
Eseye
Aside from a delighted client, we also elicited this comment from the auditor: “That’s the best legal register and compliance process I’ve seen, I’m recording it as best practice.”
Certification Body Auditor
–
“We passed in the UK with no nonconformities. It was a fantastic result. The audit in Hong Kong also went well. We passed with no nonconformities and just 2 recommendations for improvements – both minor things which we will implement. I thank you for the help and support to get the process documented.”
Group Quality Compliance Manager
–
Rebound Electronics
“I knew I needed someone who could work with me on creating a business transformational management system, I didn’t want to just tick some boxes to pass an audit I wanted to set the business up for change and in the process of doing that achieve certification because we were actually doing it.
So when it came to needing to get someone in to help us achieve all of that I knew exactly who to call in, having worked with Q! previously in a different company at a very different time I knew what they could do for me and they absolutely delivered.
I’m really proud of what we’ve all achieved as a team, but I’m also excited about what we’ll carry on to deliver together as we really embed and socialise the way of working into the bones of the business.”
MD
–
OPRL
“We used QFactorial to support us in preparing for certification to IATF 16949. QFactorial dealt with all of our project’s challenges in a competent and professional manner. With the support of their knowledgeable team, we were able to complete a comprehensive gap analysis, develop and implement processes and documentation, set up and carry out internal audits. All to plan and on budget. The overall project management was invaluable.”
Quality & Continuous Improvement Director
–
Fabrinet
“Working with Q-Factorial has been very pleasant and productive, right from the beginning. In the first meetings they put great emphasis on understanding the business, before helping to build the management system around it.Throughout the whole journey it always felt that rolling out the management system was value adding, rather than just a tick box exercise to get through the audit. Internal audits and Management reviews were scheduled at the right time to leave us fully prepared for the stage 1 and 2 external audits. With QFactorial’s help, including comprehensive staff training, quality and environmental considerations have become key pillars of our business operations and set us upwell for continued growth. In terms of consultants, they were simply a perfect fit for us, cannot recommend them highly enough.”
CEO
–
SWS
