Course Title: Medical Laboratory Quality Systems and Accreditation

Part A: Course Overview

Course Title: Medical Laboratory Quality Systems and Accreditation

Credit Points: 12.00


Course Code




Learning Mode

Teaching Period(s)


City Campus


160H Medical Sciences


Sem 2 2006,
Sem 1 2007,
Sem 2 2007,
Sem 2 2008,
Sem 2 2009,
Sem 1 2010,
Sem 1 2011


Bundoora Campus


160H Medical Sciences

Distance / Correspondence

Sem 1 2015,
Sem 1 2016


Bundoora Campus


160H Medical Sciences


Sem 1 2012,
Sem 1 2013,
Sem 1 2014


Bundoora Campus


173H School of Health and Biomed


Sem 2 2017

Course Coordinator: Associate Professor Andrew Wootton

Course Coordinator Phone: 0481 392 798

Course Coordinator Email:

Course Coordinator Availability: By email

Pre-requisite Courses and Assumed Knowledge and Capabilities

Assumed knowledge:  You must be familiar with the operation of a diagnostic or medical research laboratory and have had work experience in either of these laboratory settings.

Course Description

This course will provide you with knowledge and understanding of quality systems and the accreditation processes undertaken in medical laboratories. The course will draw on your laboratory experience and provide you with 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.

Objectives/Learning Outcomes/Capability Development


This course contributes to the following Program Learning Outcomes for MC158 Master of Laboratory Medicine and MC112 Master of Applied Science (Medical Science) programs:

PLO1. Knowledge capability (of quality control, quality assurance, quality management systems in laboratory medicine, accreditation, internal audits, document control and ISO15189).

PLO2. Technical and management capability (in applying of QC, QA, quality systems, accreditation and ISO15189 into work practice).

PLO3. Professional work practices (by participating in workplace QC, QA, quality systems, NATA accreditation visits).

PLO5. Reflective capability (through development of a learning journal thoroughout the course).


On completion of this course you should be able to:

CLO1. Apply the concepts and processes that underpin quality control, quality assurance and quality systems to your practice within a medical laboratory environment
CLO2. Design and implement a continuous quality improvement program in a medical laboratory environment
CLO3. Articulate the basis of Six Sigma and evaluate the impact of implementing Six Sigma in a medical laboratory environment
CLO4. Apply knowledge of medical laboratory accreditation systems that have been put in place to accredit laboratories
CLO5. Prepare standard operation procedures that conform to the requirements of the ISO15198:2003 standards
CLO6. Implement a quality system within a laboratory that would meet the accreditation requirements undertaken according to the ISO15189:2003 standards.

Overview of Learning Activities

Independent web-based learning, synchronous and asynchronous online conferences, reflective learning journal. Blackboard collaborate sessions are run each week for 1.5 hours in duration for interaction with students on line.

Total study hours: 36 hours.   1.5 hours per week BB collaborate session.  You are expected to spend 1.5 hours per week on independent study to cover modules and prepare assessments.

Overview of Learning Resources

Three independent learning modules will guide you through the course content. Extensive use will be made of web-based resources and the RMIT library electronic databases. You will be presented with case-studies and problem-based learning exercises to enhance their learning experiences.

Overview of Assessment


☒This course has no hurdle requirements.

Assessment tasks


Early Assessment Task 1: Module test one

Weighting 5%

This assessment task supports CLOs 1, 3, 4.

Assessment Task 2:  Module one assignment

Weighting 25%

This assessment task supports CLOs 1,2 and 3.


Assessment Task 3: Module two assignment

Weighting 30%

This assessment task supports CLOs 4, 5 and 6.

Assessment Task 4: On line discussion

Weighting 20% 

This assessment supports CLOs 1-6.

Assessment Task 5: Learning Journal.

Weighting 20%

This assessment task supports CLOs 1-6.

Marking rubrics are available for module one and two assignments.