About Us

Trefor Mitchell  BSc., FCQI

Bringing the experience of more than 40 years in quality management and business process development

Following 20 years as a quality engineer and quality manager in a laboratory instrumentation company I have been an independent practitioner since 1995.

I have held quality management roles responsible for the design and implementation of quality management systems since they were first developed in the 1970’s, initially as British Standard BS 5750 followed by the introduction of ISO 9001. I have worked with life science, biotechnology and laboratory organisations developing Quality Management Systems that meet ISO 13485 Medical Device requirements.

My formative years were spent with businesses that operated company-wide Total Quality philosophies. Product quality, process improvement and operational discipline were major business drivers in the achievement of customer satisfaction, business efficiency & profitability.

I have continued to apply these principles throughout my career.

For more details of my experience please visit my profile in LinkedIn: -


More Than Just Quality

Company-wide Business Processes

In more than 25 years as an independent practitioner, together with my earlier employed career, I have worked with well over 20 different organisations ranging from large multi-nationals to small start-ups.

As a result I have a comprehensive understanding of most of the processes that need to be in place in a mature business, and a broad view of how they should work.

I have developed a company-wide business process model that can be adapted to most technology-based organisations.

In young, developing organisations I can apply this knowledge to help you develop processes that are not yet mature, and to introduce processes that are missing.

This approach goes beyond the boundaries of what is required by a formal quality management system and can support the evolution from a start-up, to a scale-up, to a mature commercial operation.

Quality Management Projects

Typical Project Scopes

New Start-Ups and Developing Organisations
Development & implementation of new Quality Management Systems leading to certification.
Establishing business processes and operational discipline to provide a sustainable foundation for meeting quality, regulatory and business objectives.

Established Organisations
Process development and improvement of existing Quality Systems

Business we have supported
Technology; instrumentation; medical devices; life sciences; biotech


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