Quality management

Challenges

Quality is an increasing concern for the life sciences sector. Companies and research institutes are facing stricter European and global regulations which limit the advances of R&D whilst increasing costs. The main challenges are:

  • Implementation of legislative requirements (certifications and norms; ISO 9000, EFQM)
  • Managing complicated and complex processes in R&D (clinical trials, production sites, research process and security requirements)
  • Aligning projects and priorities
  • Performance evaluation

These changes create an increasingly competitive environment that requires Luxembourg’s life sciences industry to have a well-defined two- to three-year strategic plan and underlying roadmap in order to be able to adapt to the changes enforced by the regulators.

Quality is becoming a key differentiator and full compliance with the ISO 9000 and EFQM standards is increasingly important, as is the need for a well-considered and comprehensive performance management and monitoring strategy, and the need for integrating qualitative and quantitative indicators.

Deloitte service offering

We assist life sciences with a service offering that will support them in improving the quality of their services. This service offering spans from (cross-border) benchmarking, optimisation of functional and operational processes and procedures, governance, automation, performance management and dashboard definition to employee and customer surveys, ISO and EFQM audits and EFQM certifications:

  • Benchmarking analysis on different aspects (client and personnel satisfaction, process efficiency and effectiveness)
  • Development of strategies, implementation of roadmaps and assistance in implementation
  • Design of employee and patient surveys, results analysis and development of recommendations/action plans
  • Optimisation of resources, processes and costs, including analytical accounting, shared service centres, selective outsourcing, dashboards/business intelligence and activity-based costing
  • Design and implementation of quality programmes covering the different dimensions of quality: effectiveness, efficiency, technical competence appropriateness, acceptability and safety
  • Guidance with ensuring that the organisation meets the new legislative requirements (e.g. cost analysis) on elements such as IT systems, governance and skill sets