The problem

In order to gain access to new and lucrative markets the company’s existing ISO 9001 approved management system required:

• Adapting to meet the additional requirements of ISO13485

• An overhaul to make it reflect the way in which the work worked

The client

The client company has been manufacturing scientific instruments for over 100 years and is now a global leader in the design and manufacture of precision positioning devices, optical systems, automation solutions and components.

The approach and the solution

The initial objective of the project was to adapt the company’s existing written “procedure based” ISO9001 management system to include the additional requirements of ISO13485.

A needs analysis was developed against both standards with identification of both individual and common requirements.

Following the needs analysis an action plan was developed and agreed. The plan included timescales, responsibilities and milestones. Thereafter, Statius facilitated the re-development and integration of the two systems, managing the project and offering support and guidance to the internal team as the project progressed. The project being controlled with regular meetings where actions were agreed and closed out against the original plan.

Part way through the project it became apparent that it would actually be more beneficial to completely re-engineer the existing written procedures into an, easier to manage and interpret, “flowchart” format. This “change of tack” required a number training sessions which were developed and delivered by Statius allowing the processes to be completely re-engineered by the people “at the coal face”.

The outcome

• The new processes are now written in the sequence of the activities undertaken by the company and in their language

• The processes have been developed by the staff undertaking the work, so they are both owned & adhered to

• Certification to ISO 13485 has, as expected, opened new commercial doors


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