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Understanding ISO 15189

Take an in-depth look at the requirements for human pathology testing in ISO 15189:2022 – Medical Laboratories – Requirements for quality and competence in the Australian accreditation context.

Pre-Requisites

Recommended Experience

2 days

Duration

Virtual, Face-to-Face

Delivery Mode

$1652.00 (incl. GST)

Cost

Overview

This course explores the requirements in the international standard ISO 15189 and provides an overview of the requirements for NATA/RCPA medical laboratory accreditation in the Australian context which incorporates: ISO 15189, NPAAC Standards, and the TGA regulatory framework. The course explains the requirements so participants can work more knowledgeably and confidently with the relevant Standards and identifies how the medical laboratory’s management system needs to align to the requirements to ensure conformance.

Outcomes

Describe the requirements of ISO 15189 and identify corresponding National Pathology Accreditation Standards.
Align relevant laboratory systems, processes and management system to these requirements to ensure conformance.
Identify and address risks to, and opportunities for patient care, associated with medical laboratory procedures.

Audience

Learner Image
This course is for anyone who:
  • would like to become familiar with ISO 15189:2022
  • needs to understand the requirements for NATA/RCPA accreditation which includes the National Pathology Accreditation Standards and TGA regulatory framework
  • works in a human pathology or medical laboratory or service
  • is involved in establishing, implementing and maintaining medical laboratory quality and technical systems
Medical laboratory roles that would benefit from attending this course include:
  • Quality managers
  • Quality officers
  • Laboratory directors
  • Laboratory managers
  • Laboratory pathologists and scientists
  • Internal auditors or audit programme managers
  • Hospital pathology testing personnel
  • Point of Care Testing (POCT) personnel.
The course may also be of interest to medical laboratories who are considering, or are in the process of gaining, accreditation in the NATA/RCPA human pathology program.

Delivery

Course content is delivered using engaging learning activities that may include:

  • individual and group work
  • case study scenarios that apply the learning to real-life practice
  • opportunities to evaluate understanding as the course progresses.

Learning through individual and group activities and discussions

Activities and scenarios that apply to real life practice

Opportunities to evaluate understanding as the course progresses

Training is delivered from 9:00 am – 5.00 pm.

Locations.

Dates & Booking

Understanding ISO 15189

Course Date
26 Aug 2025 – 27 Aug 2025
Location
Virtual Course

“Excellent course! Practical activities helped cement information and kept me engaged."

Rebecca Whidborne – Medical Scientist in Charge – Clinical Immunology, Pathwest