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

Understanding ISO 15189 (2 Days) image

Quicklinks

Course overview

This 2-day course provides an overview of requirements for NATA/RCPA medical laboratory accreditation in the Australian context which incorporates:

  • ISO 15189 (covered in detail)
  • National Pathology Accreditation Standards
  • TGA regulatory framework

The course:

  • explains the requirements so participants can work more knowledgeably and confidently with the relevant Standards
  • identifies how the medical laboratory’s management system needs to align to the requirements to ensure conformance

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

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

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

Learning outcomes

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

  • describe the requirements of ISO 15189 and identify corresponding National Pathology Accreditation Standards
  • align requirements in the Standards to relevant laboratory activities, processes and the laboratory’s management system
  • identify potential risks to patient safety and the validity of test results

The course is designed to:

  • interpret ISO 15189 requirements to enable understanding and practical application in the medical laboratory
  • identify corresponding NPAAC Standards
  • identify any potential risks to patient safety and/or conformance to Standard requirements

This course covers the following ISO 15189 clauses:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. General requirements: Key ethical concepts including impartiality and confidentiality, and requirements regarding patients
  5. Structural and governance requirements: How the organisation needs to be structured for effective clinical governance
  6. Resource requirements: What is needed to competently perform medical laboratory activities
  7. Process requirements: Laboratory systems, processes and procedures needed for technically valid test results
  8. Management system requirements: Management of laboratory operations to ensure quality outcomes, patient safety and conformance with Standard requirements

Who should attend

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.

Delivery

Course delivery:

  • Face-to-Face
  • Virtual

Course content is delivered using engaging learning activities that include:

  • individual and group work
  • activities and scenarios that apply ISO 15189 requirements to real-life laboratory practice
  • opportunities to evaluate understanding as the course progresses

Duration

2  days

Cost

Member Rate:  $1,404.20  (incl. GST)

Non-Member Rate:  $1,652.00  (incl. GST)

Dates & booking

DateTimeLocation
25 & 26 March 202509:00 am - 05:00 pmVirtual Course
3 & 4 June 202509:00 am - 05:00 pmVirtual Course

Sign up for our newsletter

Our newsletter has great information around accreditation news, industry updates and other important information.

Or follow us on social media

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.
Assurance
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.
Competence
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.
Recognition
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.
Training
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.
International
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.
Innovation
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.