Laboratory Management According to ISO 15189 Standards
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
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Course overview
This 2-day course provides an overview of requirements for BoA/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.
Course objectives
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 the standard requirements with laboratory activities, processes, and management systems.
- Identify potential risks to patient safety and the validity of test results.
What you will learn
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:
- Scope
- Normative references
- Terms and definitions
- General requirements: Key ethical concepts including impartiality and confidentiality, and requirements regarding patients
- Structural and governance requirements: How the organisation needs to be structured for effective clinical governance
- Resource requirements: What is needed to competently perform medical laboratory activities
- Process requirements: Laboratory systems, processes and procedures needed for technically valid test results
- Management system requirements: Management of laboratory operations to ensure quality outcomes, patient safety and conformance with Standard requirements
Who should do this 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.
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
Dates and booking
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Benefits of being a BoA accredited organisation
The Bureau of Accreditation (BoA) accredits organizations engaged in activities such as testing and calibration laboratories, inspection bodies, certification bodies, medical laboratories, proficiency testing providers, and reference material producers for their products and services. This provides consumers with the necessary confidence to make safe, healthy, and reliable choices.
Choosing to become an organization accredited by BoA offers several competitive advantages for your business.
Accreditation contributes to the promotion of international trade. Once accredited, the results of conformity assessment activities (certification, testing, inspection) are recognized by other countries, thereby facilitating the import and export of goods.
Accreditation enhances the reliability of products, goods, and services, as they are inspected and assessed by competent organizations.
In order to be accredited, organizations must establish, maintain, and continuously improve their conformity assessment activities in accordance with international standards. Therefore, accreditation helps ensure the competence of conformity assessment bodies.
Accreditation increases the trustworthiness of conformity assessment results, enabling outcomes achieved in one location to be accepted in many others.
Accreditation helps reduce compliance costs for businesses by eliminating the need to repeat testing or assessment activities.