Quality Management System

Quality Management Systems

I support organisations in establishing, implementing, improving and simplifying Quality Management Systems in regulated life science environments.
My experience includes both building new Quality Management Systems and optimising, harmonising and standardising existing systems and processes.

Areas of Support

  • Establishment and implementation of Quality Management Systems
  • Development and implementation of procedures and quality processes
  • Gap assessments and compliance reviews
  • Optimisation and simplification of existing systems and documentation
  • Harmonisation and standardisation across organisations and manufacturing sites
  • Internal audits
  • Supplier Quality Management
  • Supplier audits
  • Quality Agreements
  • Change Control
  • Training and knowledge transfer

Regulatory and Quality Frameworks

My experience includes Quality Management Systems related to:

  • ISO 13485
  • MDR and IVDR
  • ISO 15378
  • GMP
  • Other applicable regulatory and quality requirements

IT Systems Supporting Quality Management

I also have experience with implementation of IT systems supporting Quality Management processes, including electronic document management systems and software validation.
This includes defining requirements, supporting implementation and ensuring that applicable quality and compliance requirements are appropriately addressed.

Practical and Proportionate Quality Management Systems

A Quality Management System should support compliance without creating unnecessary complexity.
I adapt systems and processes to the organisation, its regulatory requirements, products and level of maturity, with focus on solutions that are practical, effective and workable in day-to-day operations.

If you would like to discuss a Quality Management System challenge or a potential assignment, you are welcome to contact me.