2023-2024 / GEST0188-1

Determination and recognition of quality and conformity

Common theory

practice

Duration

Common theory : 15h Th
practice : 15h Pr

Number of credits

 Master in biomedicine (120 ECTS)3 crédits 

Lecturer

Common theory : Pierre Dewallef
practice : Joëlle Widart

Language(s) of instruction

French language

Organisation and examination

Teaching in the first semester, review in January

Schedule

Schedule online

Units courses prerequisite and corequisite

Prerequisite or corequisite units are presented within each program

Learning unit contents

Common theory

  • Goals and definitions of Quality
  • Evolution of Quality (from Quality Control to Quality Management and Intregrated Systems Management (Quality, Security, Hygiene, Environment)
  • Origins of Products and Management Systems Standards
  • Quality level and Quality management differences
  • Quality and national/european legislations/reglementations
  • Quality improvement/Quality progression
  • Interactions between Policy-Objectives-Process and Ressources
  • Process approach and Process risk analysis
  • Documentation : documentation structure, differences between documents and records, drafting techniques
  • Major quality tools: Pareto, Ishikawa, 5S + OPERER, monitoring indicators...
  • Exercises on Quality Approaches
  • Case study
  • Integrated management systems (Quality, Security, Environment, Well-being)
  • Team management and leadership (motivational tools and to obtain the collaboration of others, maturity, strengths, skills and responsibilities of the leader, basics of team management and leadership, concept of excellence and efficiency, developing talent)

practice

Students will be informed about medical devices regulation and technical folder.

Learning outcomes of the learning unit

This course contributes to the learning outcomes V.1, V.2, V.3, VI.1, VI.2, VI.3, VI.4, VII.1, VII.2, VII.3, VII.4, VII.5, VII.6 of the MSc in biomedical engineering.

Common theory

The objective of that course is to familiarize students with quality management in industrial activities and services.
These activities cannot be organised without thorough consideration of the structures to be established in order to ensure optimal efficiency.
The objective of this is to reduce production and operating costs but also, and more specifically, to meet the needs of clients (both external and internal).
That course is intented as a concrete and practical study of management systems, relied on the experiences of experts in that field.
The discovery of basic principles of human management and of leadership fits naturally into thatcourse on management systems.

Prerequisite knowledge and skills

Common theory

None

practice

Quality assurance

Planned learning activities and teaching methods

Common theory

After various lectures introducing management approaches, students will realize :

  • studies of processus (from the process identification to the drafting of procedures)
  • process and product risk analysis
  • a case study of the implementation of a system management approach
 
Special lectures will be devoted to human behavior in the  industrial environment and in society in general. Conflict managment and communication exercices as weel as a leadership case study will be realized.
Video, exercises and case studies will be used to illustrate the theoretical knowledge transferred in the human management and executive leadership course.
Knowledge will be assessed through a written exam.

practice

'Séminaires'

Mode of delivery (face to face, distance learning, hybrid learning)

Common theory

This course will be taught in the first term on Friday afternoon from 13h30 to 17h30 at the room 0/523 (B52).The theoretical part will cover around fifteen hours and reviewed exercises will cover 15 hours.
The first lecture will be given Friday the 29th of September 2017. 

practice

face-to-face (remote depending on sanitary conditions)

Recommended or required readings

Common theory

Written notes are available in the form of PowerPoint files.
Recommended reading (for the « management humain et leadership » course) :

  • Outliers : the Story of Success (Malcolm Gladwell - PENGUIN BOOKS - ISBN : 978-0-141-03625-0)
  • « La maturité de l'esprit » (J.-M. Compère - éditions EDIPRO - ISBN : 978-2-87496-223-3)
  • « Clés pour s'élever » (J.-M. Compère - éditions QUASYS-BEBOOKS- ISBN : 978-2-87569-132-3)

Common theory

Knowledge will be assessed through a written exam.
The appreciation of exercices realized by the students will take place in the global assessment.

practice

Evaluation is based on working during pratical sessions.

Work placement(s)

Organisational remarks and main changes to the course

Contacts

Common theory

Jean-Michel COMPERE : Tel : 04 254 55 88  Email : compere@quasys.com
Pierre DEWALLEF: Tel : 04 366 99 95 Email : p.dewallef@ulg.ac.be

practice

WIDART Joëlle
04/366.44.70
B36 - 2° étage - local 2/1B

Association of one or more MOOCs