An ultra-Hi-Tech Laboratory – Nano technology cancer research
A gap / needs analysis and thereafter support for an integrated ISO 17025 laboratory and ISO 13485 medical devices management system.
The problem & the prize
An embryonic management system had been developed by the internal compliance team who required both additional knowledge and resource to successfully complete and register the integrated ISO 17025 & 13485 system. Concerns arose around several issues, for instance:
• How to sensibly combine the requirements of both standards
• The documentation relating to:
o Batch reporting
• The robustness of the uncertainty calculations
• The fact that the company were not yet validating key components of the SOP’s
The rationale for gaining certification to these standards; the prize, was that it would:
1. Eliminate an external testing cost – circa £150k
2. Open additional income streams estimated at £40-£80k pa
Following the completion of eight years of animal research and moving towards human trials, the company had been spun out of Oxford University to develop and commercialise a pioneering nano-technology which improves the effectiveness of conventional radiotherapy whilst minimising side-effects.
The nanoparticle approach employed offers the ability to improve treatment of a wide range of solid tumours.
The approach, the solution and the outcome
The objective was to provide a full assessment of the company’s management systems against both ISO13485 and ISO17025. A gap analysis was developed for both standards with the identification of both common and individual requirements.
The management team worked with Statius systematically analysing each requirement against the draft system, providing evidence of compliance where applicable. Where gaps were identified Statius delivered additional support to eliminate them whilst at the same time raising the standard of compliance.
A detailed analysis and report was provided with agreed actions, responsibilities and timeframes prior to supporting the onward journey to assessment.