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Laboratory Quality Systems and Accreditation G (10079.2)

Level: Graduate Level
Credit Points: 3
HECS Bands: 2, 4
Faculty: Faculty of Health
Discipline: Discipline of Diagnostic Pathology


Unit Outlines

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  • Semester 1, 2020, INTENSIVE, BRUCE (193885) - View
  • Semester 1, 2019, INTENSIVE, BRUCE (189277) - View
  • Semester 1, 2018, INTENSIVE, BRUCE (182953) - View
  • Semester 1, 2017, ONLINE, BRUCE (164152) - View
  • Semester 1, 2016, ONLINE, BRUCE (156702) - View

If a link to your Unit Outline is not displayed, please check back later. Unit Outlines are generally published by Week One of the relevant teaching period.


This unit will provide students with knowledge and understanding of quality systems and the accreditation processes undertaken in medical laboratories. The unit will draw on students' laboratory experience and provide them the skills and ability to evaluate the quality systems in their laboratory and how to implement improvement processes. The ISO15189 standards for medical laboratory accreditation will be examined and approaches to the conduct of internal audits, establishing error logs, training records and accreditation documentation etc. will be explored.

Learning Outcomes

On successful completion of this unit, students will be able to:

1. Discuss the concepts and processes that underpin quality control, quality assurance and quality systems within a medical laboratory environment;

2. Design and implement a continuous quality improvement program in a medical laboratory environment;

3. Understand the basis of Six Sigma and LEAN processes in a medical laboratory environment;

4. Discuss the background of medical laboratory accreditation and the systems that have been put in place to accredit laboratories;

5. Describe the features and discuss the strengths and weaknesses of the ISO15189:2003 standards for the accreditation of Medical Laboratories; and

6. Prepare standard operation procedures that conform to the requirements of the ISO15198:2003 standards.

Assessment Items

Contact Hours

3 hours per week.





Assumed Knowledge

Undergraduate Biochemistry.

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