Stefan Book, Phd

Quality Management Systems Experience

Responsible for quality management systems

Engaged since mid-1990´s in projects with a variety of scopes, among others focusing on management systems in Medical Device Sector and Supply Chain to this sector.
From 2006 engaged in ISO Certified (9001, 14001) consultancy firm as owner, CEO, senior management consultant and mentor.

Responsible for quality management systems development

Facilitation and project management in a variety of companies with the aim to develop the organizational structures, roles, processes and documentation.
Always applying in depth systems analysis, to find best possible solutions, using my key knowledge.

Regulatory Compliance

Analysis and advice relating to regulations on quality management systems in the healthcare and medical device sectors.
Development of two-year programme in quality management and process development within life science, regulative requirements applied.
In depth analysis and structuring of Medtech regulation.
Responsible for Compliance at Sahlgrenska Science Park Incubator CO-AX.

Responsible for management systems development in world leading stainless steel company

Ensured compliance with demanding requirements on Quality Management.
Requirements oriented towards Automotive, Medtech and other industries.

Facilitating the design and development of risk management system

Trainer and workshop leader in risk management complying with ISO 14971 and ISO 13485 in Medtech company acting on the global market.

Development of corporate sustainability strategy and governance

Cooperated with global quality manager and prepared process for global governance of sustainability within international Medtech company, in the context of regulative requirements.

Maintaining and developing QMS in international Medtech company

Facilitation and speaking partner in assignment to maintain and develop quality management system (QMS) within international Medtech company.

Selected Work Experience

Senior Advisor and Consultant

TheVision Partner AB + Structura MedTech Partner AB

2020 – Now

Focus on functional management systems, business driven sustainability and situation analysis, including internal audits and management reviews.

Specific focus on how to translate and use regulations such as MDR, IVDR and regulations under FDA, and standards such as ISO 13485 and 14971.

Business Advisor responsible for compliance and sustainability at CO-AX, the Accelerator at Sahlgrenska Science Park. Founded Structura with Jenny Fäldt, December 2025.

CEO and Senior Management Consultant

Effort Consulting AB

2006 – 2019

Combined the roles as senior consultant, trainer, project manager and CEO. For global world leading companies, medium sized and small companies.

Applied and developed knowledge from prior work and research, including internal audits and management reviews.

Facilitated and managed projects related to management systems and sustainable development. Supervised research at Chalmers University of Technology.

PhD work

Chalmers University of Technology

2000 – 2006

Research leading to PhD thesis 2006 in Quality Management. In depth knowledge in quality management systems development.

Responsible for courses and lectures related to quality management systems, including internal audits and management reviews.

Training in pedagogics, research methodology, and supervision. Functioned as advisor in industry and healthcare while conducting the research.

Responsible for maintaining and developing the quality management system

Fagersta Stainless AB

1997 – 2000

Responsible for the development of quality management and integrated management system fulfilling advanced quality requirements from variety of industries, among those the Medtech industry.

Responsible for internal audits, management reviews, process development and development of ERP system.

Change leader involved with top management in designing, planning and implementing leadership and team development program.

Mix of work experience and military training

1987 – 1997

Prior to Master of Science studies at Chalmers, military training and responsibility for platoon with six group chiefs and twenty-four soldiers.

Assembly of cars at Saab and material handler at Volvo Cars.

Worked as teacher and started a consultancy firm focusing on process analysis and development as a consequence of master thesis.