Understanding ISO 15189 (1-day)

This course explores key requirements in the international standard ISO 15189, relevant for human pathology testing, to support the delivery of quality outcomes, valid test results, and conformance with the Standard.

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

• describe the requirements of ISO 15189
• align the medical laboratory’s processes, procedures and management system to these requirements

This course covers the following ISO 15189 clauses:

1. Scope
2. Normative references
3. Terms and definitions
4. General requirements
5. Structural and governance requirements
6. Resource requirements
7. Process requirements
8. Management system requirements

The course is ideal for individuals who:

• need to understand the requirements in ISO 15189:
• to use as a stand-alone quality management Standard, or
• as they relate to NATA/RCPA accreditation
• interact with, or work in, a human pathology or medical laboratory or service
• establish, implement or maintain medical laboratory quality and technical systems

Medical laboratory roles that would benefit from attending this course include:

• Quality managers and officers
• Laboratory directors, managers, pathologists and scientists
• 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.

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 the Standard requirements to real-life practice
• opportunities to evaluate understanding as the course progresses

1 day

Member Rate:  $781.15 (incl. GST)

Non-Member Rate:  $919.00 (incl. GST)