Fabrinet are a leading global contract electronics manufacturing solutions provider dedicated to delivering innovation and service excellence to the global electronics industry by adding value in the design, build and test of printed circuit board assemblies for use in aerospace and defence, oil and gas, automotive and transportation, communications, semi-conductor testing, green energy, LED lighting and medical technology.
Fabrinet UK had made a strategic decision to seek ISO 13485 certification to support expansion in the medical device sector. QFactorial were selected as their consultancy partner to carry out a gap and synergy assessment, develop an action plan and help drive the plan to completion with a combination of mentoring, progressing, hands on document development and progressive auditing.
New product introduction
QFactorial Service offering
Starting with our trademark Gap & Synergy Assessment, we worked closely with Fabrinet to create and implement an action plan, closing the gaps and absorbing the synergies from the existing, mature business management system. With several other approvals already in place, we were able to provide focused and detailed support in the areas where ISO 13485 differs from other standards such as ISO 9001 and AS9100. This included validation of production processes and software, risk management and the medical device file. We created a progressive audit process to continuously monitor gap closure as the new product was being introduced alongside ISO 13485. This enabled us to gradually close the gaps as the product was introduced into the factory from prototyping through to production.
With a mature and detailed management system and multiple approvals already in place, the challenge for QFactorial was to embed the additional requirements of ISO 13485 in the most efficient way. This is where the ‘synergy’ part of our Gap & Synergy assessment really paid dividends. Examples of this included adopting the existing PFMEA process to cover the risk management requirements of ISO 13485 and using the existing First Article Inspection Report (FAIR) as part of the solution for production process validation.
Working at the pace set by the client and the NPI programme, BSI certification to ISO 13485 was achieved within 12 months of our engagement, setting up the client for this and future medical device production.
“We have worked with QFactorial for the past year to help us implement the ISO 13485 Medical Devices standard. Although we have experience with several standards the ISO 13845 documentation requirements are much more thorough than that of ISO 9001 for example and also the terminology differs greatly and this set a significant challenge. QFactorial were able to offer a robust gap analysis and synergy tool that helped guide us through the early part of the project, and with Kevin’s auditing of our internal processes we were able to identify and improve any weak areas within our system. Working closely with Kevin Brown has been a real pleasure and with his experience and advice we have been successful in implementing the ISO 13485 standard.”
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