AACE were contracted by an organization who specialised in the through life asset management, repair and overhaul (R&O) of medical devices throughout the world. They recognized that their methods of operation could be improved using an internal governance system.
AACE designed and developed a bespoke framework which defined the governance of the processes required to control integrated support of medical device maintenance including equipment maintenance, logistic control, spares procurement, repair approval, and product release procedures.
Within the first 3 weeks, AACE undertook a series of audits undertaken by a team of support specialists to determine the effectiveness of the current system and developed an outline of how the AACE team would produce a bespoke governance framework matched to the organization’s business and future aspirations.
The AACE proposal for a governance framework was presented and accepted by the organizations international stakeholders. A key aspect of the agreed framework was an enhanced QMS that met the requirements of ISO9001 and the medical device focussed ISO13485:2016.
AACE developed a structured governance regime grouped into:
• Organisation, Policy and Governance
• Training, Employment and Authorisation
• Supply Chain
• Engineering and Maintenance Organisation
• Logistic Information Systems
These elements were developed in a 3 tier system covering integrated support. The highest level documentation was a governance statement which also included a justification on how the governance would improve efficiency and therefore business benefit. The second tier was how the company would comply with the governance including assigning compliance roles and responsibilities.
The AACE team produced the tier 1 governance documentation that would allow International Group implementation and the tier 2 documentation bespoke to the UK company. This work required AACE to gain experience of the customer’s operations and control arrangements. AACE also provided the organization with consultancy advice on how to implement the tier 3 working level processes.
As part of this 4 month contract AACE delivered 78 governance processes and 101 supporting policies which provide the framework for the organization to implement their own working level documents. This met the UK company business need and more importantly that of the wider organization for a bespoke governance arrangement that has the potential to greatly increase business efficiency and control.
Throughout the whole of the contracted period AACE have been proactive and added value consistently. The staff utilised in the execution of the work were well suited and committed individuals who delivered quality work. Their integrity and ability to work direct with the OEM reduced the administrative burden to us the customer. A big well done all round.