Quality System Management

CVO-EUROPE offers support for setting up quality procedures as well as ISO certifications.

Our consultants possess a rich experience in organisation and management of quality systems and associated documentation.

 

Our offer

Quality System Management(QMS)

  • Defining Quality Policies, the Organization to be implemented and the associated responsibilities.
  • Implementation of a QMS in compliance with GxP regulations (GMP, GLP, GCP, GDP) and/or ISO Norms (ISO 9001, 13485, 17025, 14001…).
  • Integration of ICH Q10 Requirements(Pharmaceutical Quality System) for pharmaceutical operations
  • Evaluation and modeling of processes, followed by suggestions for improvement
  • Setup of a methodology for quality risk management (ICH Q9)
  • Setup of a QA department (CVO-EUROPE) or reinforcement of an internal QA department (client)

 

Documentation

  • Setup and optimization of  document structures
  • Establishment and improvement of Quality Manuals
  • Procedure preparation and up-dating, operating methods and work instructions
  • Evaluation of documentation/ regulations


Quality Continuous Improvement Management Processes

  • Quality improvement, performance improvement and cost reductions
  • Methodologies: 5S, Lean Management, Six Sigma, Waste Terminator, Total Quality