Understanding ISO 15189

This course provides detailed information about the requirements in the ISO 15189:2022 Standard; how these requirements are applied in practice; the controls required to manage patient risk; and the tools and management system needed to support successful medical laboratory operation.

This comprehensive course covers all aspects of the recently revised Standard and is not primarily intended to identify or focus on the differences between the old and revised versions of ISO 15189.


Course overview

This course develops understanding of the requirements of the international standard ISO 15189 and an overview of the requirements for NATA/RCPA medical laboratory accreditation in the Australian context which incorporates:

  • ISO 15189
  • the National Pathology Accreditation Standards, and
  • the TGA regulatory framework

This course:

  • is designed to develop understanding of the accreditation and regulatory requirements for medical laboratories in Australia
  • explains the requirements in detail so participants can work more knowledgeably and confidently with the relevant Standards
  • identifies how the laboratory’s management system needs to align to the requirements to ensure conformance

“In depth coverage of specific clauses within the standard and engaging problem-solving exercise.

Oliver Van Wageningen – IH MEDR SA Pathology 1

Course objectives

By the end of this course, participants will be able to:

  • describe the requirements of ISO 15189 and corresponding National Pathology Accreditation Standards
  • align these requirements to relevant laboratory systems and processes and the laboratory’s management system
  • identify and address patient risks associated with medical laboratory procedures

What you will learn

The course examines the purpose and application of ISO 15189 in-depth, introduces the corresponding National Pathology Accreditation Standards and is focused on identifying any potential risks associated with each requirement.

As the latest version of ISO 15189 has a higher focus on risk, the course integrates risk identification into each requirement and the elements of the quality management system that need to be addressed.

Ultimately you will learn how conforming to ISO 15189 will ensure your pathology service works effectively and consistently to ensure valid laboratory results.

By the end of the 2-day course, you will be able to:

  • Describe the requirements of ISO 15189:2022 and corresponding National Pathology Accreditation Standards
  • Align these requirements to relevant laboratory systems and processes and the laboratory’s management system
  • Identify and address risks associated with medical laboratory procedures

Specific learning areas:

  • General requirements: Key ethical and patient related concepts
  • Structural requirements: How the organisation needs to be structured and the governance framework that needs to be in place
  • Resource requirements: What is needed to competently perform medical laboratory activities
  • Process requirements: Laboratory systems, processes and procedures that ensure technically valid results
  • Management system requirements: How to manage quality in the laboratory’s operations and the key management system processes that fulfil the Standard requirements

The content is delivered using engaging course activities which includes individual and group work. There are relevant scenarios to apply the requirements into real-life practice, and opportunities to assess your understanding along the way.

Who should do the course?

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 may be considering, or are in the process of becoming, accredited in the NATA/RCPA human pathology program.

Course dates and booking

Date Time Location Available Spaces
11 & 12 September 2024 09:00 am - 05:00 pm Virtual Course 14
6 & 7 November 2024 09:00 am - 05:00 pm Brisbane 14
6 & 7 November 2024 09:00 am - 05:00 pm Melbourne 20
13 & 14 November 2024 09:00 am - 05:00 pm Virtual Course 16
4 & 5 December 2024 09:00 am - 05:00 pm Sydney 20

Become a member

Benefits of being a NATA accredited organisation

NATA accredits organisations to perform testing and inspection activities for their products and services. This gives consumers the assurance they need to make safe, healthy and reliable choices. When you choose to become NATA accredited, you can be sure of a number of competitive advantages for your business.
NATA members receive a globally-recognised, peer-reviewed and government endorsed accreditation that provides a unique level of assurance to members, their clients and the community.
Our accreditation provides an independent benchmark for technical competence. Receiving NATA accreditation demonstrates to customers your organisation’s commitment to quality, safety and reliability of products and services.
NATA accreditation is both nationally and internationally recognised. This provides a competitive advantage when compared to non-accredited organisations and ensures you are market-ready to capitalise on trade opportunities.
NATA has been training individuals and teams both nationally and internationally for over 20 years and enjoys a global reputation for the quality of its courses and programs. Our active role in international accreditation education has seen us conduct training in over 20 countries.
NATA’s long standing and active involvement with international groups enables our members to gain international recognition for their accreditation and minimises the need for multiple assessments from different suppliers.
NATA provides innovative and timely business solutions that meet the needs of our members and fulfil the expectations of the community. We have the experience and resources to ensure your accreditation provides you and your organisation with unique advantages.