

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
- 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
- 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.
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.
- Virtual training is at AEST (or AEDT during daylight savings).
- Face-to-face training is at local time.
Locations.
- We schedule public courses in all capital cities.
- Regional and in-house training at your preferred location are available upon request.
Dates & Booking
Understanding ISO 15189
“Excellent course! Practical activities helped cement information and kept me engaged."
Rebecca Whidborne – Medical Scientist in Charge – Clinical Immunology, Pathwest