OSHAA 30-Hours ISO 15189:2022 – Medical Laboratories Quality Assurance & Competence

OSHAA 30-Hours ISO 15189:2022 - Medical Laboratories Quality Assurance & Competence

The OSHAA 30-Hours ISO 15189:2022 – Medical Laboratories Quality Assurance & Competence programme is designed for professionals seeking practical knowledge of the international requirements for medical laboratory quality and competence. It provides a structured understanding of how laboratories can establish effective quality management practices, support reliable laboratory services and maintain a strong focus on patient safety.

ISO 15189:2022 provides requirements for quality and competence in medical laboratories, covering both management and technical aspects of laboratory operations. Understanding these requirements is increasingly important for laboratory professionals involved in quality assurance, quality control, laboratory management, compliance and accreditation preparation.

The programme explores key areas including quality management systems, risk management, personnel competence, laboratory processes, documentation, internal auditing, quality assurance programmes, nonconformity management and continual improvement. It also helps Learners understand how quality requirements can be applied across pre-examination, examination and post-examination laboratory activities.

The course is relevant to medical laboratory professionals, laboratory managers, quality officers, biomedical scientists, technicians, healthcare quality professionals and personnel responsible for laboratory compliance.

By developing knowledge of ISO 15189:2022 principles, the programme helps Learners understand how effective quality systems and competent laboratory practices can support accurate, reliable and patient-focused laboratory services while strengthening organisational quality and continual improvement.


All About OSHAA 30-Hours ISO 15189:2022 – Medical Laboratories Quality Assurance & Competence

Course Overview

The OSHAA 30-Hours ISO 15189:2022 – Medical Laboratories Quality Assurance & Competence is a specialised professional training programme focused on the principles and requirements of ISO 15189:2022 for medical laboratory quality and competence.

This 30-hour ISO 15189:2022 training course provides Learners with practical knowledge of how quality management principles can be applied within medical laboratory environments. It connects laboratory quality assurance with competence, risk management, patient safety and continual improvement.

Key learning areas include ISO 15189:2022 requirements, medical laboratory quality management systems, quality assurance, quality control, risk-based thinking, personnel competence, laboratory documentation, internal audits, nonconformity management and corrective actions.

The course also helps Learners understand quality across the laboratory workflow, including pre-examination, examination and post-examination processes, while highlighting the importance of reliable results and patient-focused laboratory services.

The programme is relevant to medical laboratory scientists, laboratory technicians, quality officers, laboratory managers, biomedical professionals, healthcare quality personnel and professionals involved in laboratory compliance or accreditation preparation.

By completing the OSHAA 30-Hours ISO 15189:2022 programme, Learners can strengthen their understanding of laboratory quality and competence and apply relevant principles to support consistent, reliable and effective medical laboratory practices.

Entry Requirement:

The OSHAA 30-Hours ISO 15189:2022 – Medical Laboratories Quality Assurance & Competence programme is suitable for professionals and Learners interested in medical laboratory quality, competence and quality management systems.

  • Age: Learners should normally be 18 years or above.
  • Experience: Previous experience in a medical laboratory, healthcare or quality-related environment is beneficial but not essential.
  • Educational Background: A background in medical laboratory science, biomedical science, healthcare, quality management or a related field is recommended.
  • Language Proficiency: Learners should have sufficient English language skills to understand technical terminology, course materials and assessment activities.
  • Technical Knowledge: Basic awareness of laboratory operations or quality management can be helpful, but specialist ISO 15189 experience is not normally required.

Study Units

The OSHAA 30-Hours ISO 15189:2022 – Medical Laboratories Quality Assurance & Competence programme covers the following key study units:

  1. Introduction to ISO 15189:2022 and its Importance in Medical Laboratories (3 Hours)
  2. Key Clauses of ISO 15189:2022 and Their Application in Medical Laboratories (4 Hours)
  3. Quality Management Systems (QMS) in Medical Laboratories (4 Hours)
  4. Developing and Implementing Laboratory Quality Assurance Programs (5 Hours)
  5. Competency Management for Laboratory Personnel (4 Hours)
  6. Documentation and Record-Keeping for ISO 15189:2022 Compliance (3 Hours)
  7. Internal Auditing and Laboratory Inspections for ISO 15189:2022 (4 Hours)
  8. Risk Management and Mitigation in Medical Laboratories (3 Hours)

Learning Outcomes:

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

Introduction to ISO 15189:2022 and its Importance in Medical Laboratories (3 Hours)

  • Understand the purpose and scope of ISO 15189:2022 in the context of medical laboratories.
  • Recognise the significance of ISO 15189:2022 in ensuring quality, accuracy, and patient safety.
  • Identify the key benefits of implementing ISO 15189:2022 in laboratory operations.
  • Appreciate the global relevance of ISO 15189:2022 for laboratories seeking accreditation and compliance.

Key Clauses of ISO 15189:2022 and Their Application in Medical Laboratories (4 Hours)

  • Gain an in-depth understanding of the key clauses within ISO 15189:2022.
  • Learn how to interpret and apply the clauses in day-to-day laboratory operations.
  • Understand the requirements for ensuring technical competence and quality management in medical laboratories.
  • Develop skills to align laboratory practices with international ISO standards.

Quality Management Systems (QMS) in Medical Laboratories (4 Hours)

  • Understand the concept and importance of a Quality Management System (QMS) in medical laboratories.
  • Learn the structure and components of an effective QMS, including documentation, procedures, and processes.
  • Develop the ability to implement a QMS in accordance with ISO 15189:2022 standards.
  • Explore methods for monitoring and improving laboratory processes for continual compliance.

Developing and Implementing Laboratory Quality Assurance Programs (5 Hours)

  • Learn the essential components of a laboratory quality assurance program.
  • Develop the skills to design and implement quality assurance programs that meet ISO 15189:2022 criteria.
  • Understand how to evaluate laboratory performance and ensure continuous improvement.
  • Explore common challenges in quality assurance and strategies for overcoming them in medical laboratories.

Competency Management for Laboratory Personnel (4 Hours)

  • Understand the role of personnel competency in maintaining high standards of laboratory performance.
  • Learn how to assess and manage the competency of laboratory staff in line with ISO 15189:2022.
  • Develop processes for training, evaluating, and maintaining staff competence.
  • Learn how to ensure continuous professional development for laboratory personnel.

Documentation and Record-Keeping for ISO 15189:2022 Compliance (3 Hours)

  • Understand the documentation requirements for ISO 15189:2022 compliance.
  • Learn best practices for record-keeping, ensuring data integrity and traceability.
  • Gain the skills to maintain proper documentation of laboratory activities, procedures, and results.
  • Explore the role of document control in maintaining an effective quality management system.

Internal Auditing and Laboratory Inspections for ISO 15189:2022 (4 Hours)

  • Learn how to conduct internal audits in medical laboratories to assess compliance with ISO 15189:2022.
  • Understand the process of preparing for laboratory inspections and accreditation assessments.
  • Develop the skills to identify areas for improvement during audits and inspections.
  • Explore audit techniques and strategies for ensuring continuous compliance with ISO standards.

Risk Management and Mitigation in Medical Laboratories (3 Hours)

  • Understand the principles of risk management in medical laboratories.
  • Learn how to identify, assess, and mitigate risks to laboratory processes, safety, and compliance.
  • Develop strategies for implementing risk management practices in laboratory operations.
  • Explore common risks in medical laboratories and how to minimise their impact on quality and safety.

Ideal Candidate:

The OSHAA 30-Hours ISO 15189:2022 programme is designed for professionals who want to strengthen their knowledge of medical laboratory quality, competence, compliance and quality assurance practices.

  • Medical Laboratory Scientists: Professionals seeking stronger knowledge of ISO 15189:2022 requirements.
  • Laboratory Technicians: Personnel involved in laboratory testing and quality practices.
  • Laboratory Managers: Managers responsible for laboratory quality and operational performance.
  • Quality Officers: Professionals managing quality assurance and quality control activities.
  • Biomedical Scientists: Healthcare professionals involved in laboratory testing and quality processes.
  • Laboratory Supervisors: Personnel supporting competent and consistent laboratory operations.
  • Healthcare Quality Professionals: Individuals involved in healthcare quality management and compliance.
  • Internal Auditors: Professionals involved in laboratory quality audits and improvement activities.
  • Accreditation Personnel: Staff supporting laboratory compliance and accreditation preparation.
  • Laboratory Consultants: Professionals advising laboratories on quality management and ISO requirements.
  • Healthcare Professionals: Individuals seeking knowledge of medical laboratory quality and competence.

FAQs OSHAA 30-Hours ISO 15189:2022 – Medical Laboratories Quality Assurance & Competence

This training can support professional responsibilities in medical laboratory quality, quality assurance, quality control, laboratory compliance, internal auditing and laboratory management.

It helps professionals understand how quality and competence requirements can be applied to laboratory activities, supporting reliable processes, effective risk management and patient-focused laboratory services.

It is suitable for individuals involved in medical laboratory operations, quality management, laboratory compliance, healthcare quality and accreditation-related activities.

Assessment is designed to evaluate understanding of ISO 15189:2022 principles and their application in medical laboratory environments. Depending on the delivery method, this may involve knowledge questions, assignments, practical activities or other suitable assessment methods.

The standard provides a framework for laboratories to demonstrate competence and manage quality across their activities, with strong attention to reliable processes and patient needs.

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