INTERNATIONAL BURCH UNIVERSITY
Graduate Study - Faculty of Engineering and Natural Sciences
3+2 Genetics and Bioengineering
2017-2018

SYLLABUS
Code Name Level Year Semester
GBE 525 Laboratory Quality Management System Graduate 1 Spring
Status Number of ECTS Credits Class Hours Per Week Total Hours Per Semester Language
Area Elective 6 3 120 English

Instructor Assistant Coordinator
Almir Badnjević, Assist. Prof. Dr. Assist. Prof. Dr. Almir Badnjević Almir Badnjević, Assist. Prof. Dr.
[email protected] [email protected] no email

This course will provide the students with knowledge and understanding of quality systems and the accreditation processes undertaken in laboratories. The course will focus on skills and abilities to evaluate the quality systems in laboratory and how to implement improvement processes. The ISO 9001, ISO 17020, ISO 17025, ISO 15189 standards will be examined and approaches to the conduct of internal audits, establishing error logs, training records and accreditation documentation etc. will be explored.

COURSE OBJECTIVE
The aim of this course is to provide students with an understanding of quality and its role in the organisation together with techniques to enable them to make a significant contribution to an organisation’s strategic vision for success. It will also prvoide students with knowledge for effective implementation of procedures of process in laboratory.

COURSE CONTENT
Week
Topic
  1. Introduction to Quality Management
  2. International Standards Terms and Definitions
  3. General requirements and Structural requirements
  4. Resource and process requirements
  5. Management system documentation and Management review
  6. Independence requirements - Working procedures
  7. Mid-Term Exam
  8. Developing documentation according to ISO17025 or ISO17020 for chosen laboratory
  9. Developing documentation according to ISO17025 or ISO17020 for chosen laboratory
  10. Developing documentation according to ISO17025 or ISO17020 for chosen laboratory
  11. Developing documentation according to ISO17025 or ISO17020 for chosen laboratory
  12. Developing documentation according to ISO17025 or ISO17020 for chosen laboratory
  13. Presentation of student projects
  14. Presentation of student projects
  15. Final Presentation of student projects

LABORATORY/PRACTICE PLAN
Week
Topic
  1. Introduction to Quality Management
  2. International Standards Terms and Definitions
  3. General requirements
  4. Structural requirements
  5. Structural requirements
  6. Resource requirements
  7. Mid-Term Exam Preparation Week
  8. Mid-Term Exam
  9. Resource requirements

  1. Process requirements
  2. Management system documentation
  3. Management review
  4. Independence requirements – Working procedures
  5. Final Exam Preparation Week
  6. Final Exam

TEACHING/ASSESSMENT
Description
  • Interactive Lectures
  • Discussions and group work
  • Other:Consultations
Description (%)
Method Quantity Percentage (%)
Midterm Exam(s)120
Term Paper140
Final Exam140
Total: 100
Learning outcomes
  • to have understanding of scientific concepts and procedures according to quality management
  • to have understanding of application specific International standards and meeting all the requirements
  • to develop management skills related to inventory, personnel and operations in quality management system
TEXTBOOK(S)
  • Barrie G. Dale, Ton van der Wiele, Jos van Iwaarden , Managing Quality, 5th Edition, BlackWell Publishing, 2007
  • International Standard ISO/IEC 17020:2012,
  • International Standard ISO 9001:2008,
  • 2015 Handbook of International Quality Control, Auditing, Review, Other Assurance, and Related Services Pronouncements

ECTS (Allocated based on student) WORKLOAD
Activities Quantity Duration (Hour) Total Work Load
Lecture (14 weeks x Lecture hours per week)14228
Laboratory / Practice (14 weeks x Laboratory/Practice hours per week)14228
Midterm Examination (1 week)122
Final Examination(1 week)122
Preparation for Midterm Examination11010
Preparation for Final Examination12020
Assignment / Homework/ Project11010
Seminar / Presentation12020
Total Workload: 120
ECTS Credit (Total workload/25): 5