Hologic (Diagenode)
Four-Week ISO/IEC 17025 Gap Analysis and Quality System Roadmap
Service
Prioritised implementation roadmap with indicative timelines
Scope
ISO/IEC 17025, ISO 13485, service laboratory and manufacturing
Year
2024
Result
Four-week quality systems consultancy
Brief
Hologic’s Diagenode site operated an established ISO 13485-certified quality system and needed to determine what was required to extend its accreditation framework to service laboratory activities. Leadership also needed to understand how to incorporate manufacturing activities within the existing ISO 13485 scope.
Approach
I completed a focused four-week assignment, including an on-site assessment, evaluating the service laboratory against ISO/IEC 17025 and manufacturing activities against the existing ISO 13485-certified framework. I identified the principal quality, documentation and operational gaps, then translated the findings into a practical, prioritised implementation strategy.
Outcome
Within four weeks, I delivered and presented a comprehensive report outlining the gaps, required improvements, and priorities, supported by an implementation roadmap and indicative timelines. This gave senior leadership a structured route towards ISO/IEC 17025 accreditation and a clear basis for incorporating manufacturing into the existing quality system.
Hologic subsequently offered a 12-month extension to support implementation of the recommendations, strongly validating the assessment and roadmap.
Result
Four-week quality systems consultancy
Leadership gained a practical, prioritised improvement strategy spanning laboratory operations and manufacturing. The engagement converted ISO/IEC 17025 and ISO 13485 requirements into an achievable programme of work, enabling informed decisions about accreditation scope, sequencing and implementation.
Client Testimonial
"Ciaran quickly built strong relationships across our teams, enabling him to rapidly understand our operations and conduct a remarkably thorough quality assessment in a very short timeframe. What I appreciated most was his pragmatic approach, balancing quality improvements with the realities of a growing life sciences business and ensuring recommendations were both impactful and sustainable."
RW
Raphael Werding
Head of Life Sciences and Site Lead, Hologic-Liege
Other Testimonials