Quality Management in Healthcare

Garant předmětu:

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

As part of the subject Quality Management in Healthcare, the student will learn about basic terms such as: product, its characteristics and definition, quality, management, requirement, customer satisfaction, eligibility. They will also familiarize themselves with the relevant standards. Within the course, the issues of the following areas are addressed: Basic concepts and principles in quality management systems. Technical standards in the field of quality control. Quality management of medical devices and evaluation of the quality and safety of health services.

Requirements:

Mandatory participation in 80% of the exercises. Completion of assignments for independent work at seminars - max. 10 points per seminar. In total, the student can get a maximum of 100 points from the exercise. Written examination test for 50 points, the student must write the test for at least 50% of the points to be admitted to the oral examination (possibility of earning up to 50 points).

The overall assessment is a combination of points for the written test and the oral examination. In total, the student has the opportunity to obtain 100 points, a minimum of 50 points is required to complete the course. Evaluation according to the ECTS scale.

Syllabus of lectures:

• Basic concepts and principles in quality management systems.

• Basic legislation in the field of quality. Overview of approaches (ISO 9001, TQM, Six sigma)

• Principles of quality management. Tools and methods in the field of quality management.

• Quality management system in the field of medical devices.

• Quality management system audit. Principles of conformity assessment

• Quality assessment in medical laboratories

• Measurement and standards management.

• Principles of evaluating the quality and safety of health services.

• Creation and evaluation of standards in the area of ​​quality and safety evaluation of health services.

• Audit options as part of an external assessment of the quality and safety of healthcare services.

Syllabus of tutorials:

• Creation of process maps.

• Old and new quality management tools.

• Application of the FMEA and FTA methods.

• Creation of a quality manual for the needs of the quality system for medical devices.

• Audit investigation and audit outputs. Audit investigation as part of conformity assessment.

• Application of ISO 15 189, ISO 17 025, ISO 13485 standards.

• Metrological assurance system in the hospital, metrological confirmation.

• Processes of internal assessment of the quality and safety of health services.

• Evaluation of standards as part of an external evaluation of the quality and safety of healthcare services – inpatient care.

• Proposal for an audit investigation as part of an external evaluation of the quality and safety of health services.

Study Objective:

Study materials:

[1]TAGUE, Nancy R. The quality toolbox. 2nd ed. Milwaukee, Wis.: ASQ Quality Press, 2005. ISBN 978-0-87389-639-9.

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans:

• Systematic Integration of Prosesses of Healthcare (compulsory course)