ISO 15189:2022 – Medical Laboratory Quality & Accreditation
ISO 15189:2022 – Medical Laboratory Quality & Accreditation Program
SPEA Approved Certificate
Overview
From Quality Requirements to Accreditation Readiness
- This practical training program provides a comprehensive understanding of the requirements of ISO 15189:2022 – Medical laboratories — Requirements for quality and competence.
- It is designed to help medical laboratory professionals understand, implement, maintain, and improve a quality management system aligned with ISO 15189:2022 and prepare effectively for accreditation assessments.
- The program covers key requirements related to impartiality, confidentiality, governance, personnel competence, facilities and equipment, examination processes, quality assurance, risk management, nonconformities, corrective actions, internal audits, management review, and continual improvement.
- Through practical examples, exercises, and laboratory-based scenarios, participants will develop the skills needed to apply ISO 15189:2022 requirements in real medical laboratory environments.
- This program is designed to equip medical laboratory professionals with the knowledge and practical skills required to understand, implement, and sustain the requirements of ISO 15189:2022.
- The course focuses on bridging the gap between standard requirements and real laboratory operations, ensuring participants can confidently apply quality practices in clinical and diagnostic environments.
Who Should Attend
- Medical Laboratory Managers and Supervisors
- Medical Laboratory Technologists and Technicians
- Quality Managers and Quality Officers
- Laboratory Quality Coordinators
- Accreditation and Compliance Officers
- Healthcare and Laboratory Professionals involved in ISO 15189 implementation or accreditation
Learning Outcomes
- By the end of the program, participants will be able to Interpret and apply the key requirements of ISO 15189:2022.
- Implement quality and competence requirements within medical laboratory operations.
- Apply requirements related to personnel, equipment, examination processes, and quality assurance.
- Manage laboratory risks, nonconformities, and corrective actions.
- Plan and support internal audits, management reviews, and continual improvement.
- Assess laboratory readiness for accreditation and identify improvement actions.
Course Outline
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Introduction to ISO 15189:2022
Purpose, scope, structure, terminology, and accreditation context.
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General, Structural & Resource Requirements
Impartiality, confidentiality, governance, personnel competence, facilities, equipment, reagents, and externally provided services.
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Examination Process & Quality Assurance
Pre-examination, examination, and post-examination requirements, method verification and validation, quality control, and proficiency testing
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Risk, Nonconformity & Corrective Action
Risk-based thinking, patient safety, identification and management of nonconformities, root-cause analysis, and corrective actions.
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Internal Audit, Management Review & Improvement
Audit planning, audit findings, management review, quality indicators, performance monitoring, and continual improvement.
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Accreditation Readiness & Practical Application
Gap analysis, evidence preparation, assessment readiness, case studies, implementation exercises, and improvement planning
Assessment
1. Knowledge checks and short quizzes 2. Practical exercises 3. Case studies 4. Identification of nonconformities 5. ISO 15189 requirement interpretation exercises 6. Final knowledge assessment