ISO 15189 Lead Assessor

Plan and conduct assessments of medical laboratory quality, evaluate evidence and follow up findings on patient-focused processes, laboratory competence and reliable examination results.

Work through patient-focused processes, laboratory competence and reliable examination results and connect them to the responsibilities of your audit or assessment role. The detailed programme explains the methods and activities covered.

Upon completion of the course, participants will be able to:

1. Understand the structure and requirements of the ISO 15189:2022 standard.
2. Apply quality management principles to medical laboratories.
3. Develop the skills to conduct thorough assessments and audits of medical laboratories.
4. Assess laboratory operations, including quality control, risk management, and technical performance.
5. Lead and manage an assessment team effectively.
6. Interpret and evaluate the evidence collected during laboratory assessments.
7. Prepare audit reports and identify non-conformities.
8. Provide recommendations for improvements based on audit findings.
9. Understand the role of accreditation bodies and regulatory requirements related to ISO 15189:2022.

After completing the course, participants will:

1. Be proficient in assessing medical laboratories' compliance with ISO 15189:2022 standards.
2. Have the ability to lead a team of assessors and manage the auditing process.
3. Be capable of identifying areas of improvement within laboratory operations and ensuring compliance with international standards.
4. Understand the principles of risk management, quality control, and technical processes in medical laboratories.
5. Have a comprehensive understanding of the roles and responsibilities of an assessor in the accreditation process.

• Quality managers and laboratory managers in medical laboratories.
• Lead assessors and auditors who wish to specialize in medical laboratory accreditation.
• Healthcare professionals involved in laboratory operations and quality management.
• Accreditation body professionals and regulatory authorities involved in laboratory assessments.
• Consultants advising medical laboratories on quality management and accreditation.

• ISO 15189:2022 - Medical laboratories — Requirements for quality and competence

1. Introduction to ISO 15189:2022
   • Overview of ISO 15189 and its relevance to medical laboratories.
   • Structure and clauses of the ISO 15189:2022 standard.
   • Key concepts: quality management system, technical competence, and risk management.
2. Quality Management System for Medical Laboratories
   • Establishing a quality management system in a laboratory setting.
   • Document control, internal audits, and corrective actions.
   • Continuous improvement processes.
3. Assessment and Auditing Principles
   • Principles of auditing and assessment.
   • Preparation for conducting assessments and audits.
   • Developing an audit plan and audit schedule.
   • Roles and responsibilities of the lead assessor.
4. Technical Competence of Medical Laboratories
   • Evaluation of laboratory equipment, procedures, and techniques.
   • Sampling and testing requirements.
   • Calibration, maintenance, and equipment verification.
5. Risk Management and Corrective Action
   • Identifying and assessing risks in laboratory operations.
   • Implementing preventive actions and corrective actions.
   • Managing non-conformities and audit findings.
6. Assessment Process and Audit Tools
   • Conducting interviews, inspections, and evidence collection.
   • Documenting findings and preparing audit reports.
   • Communicating findings and providing recommendations.
7. Leading an Assessment Team
   • Managing the assessment team and ensuring effective collaboration.
   • Ensuring consistency and objectivity in assessment activities.
   • Dealing with conflicts and ensuring impartiality.
8. Accreditation Process and Follow-up
   • Understanding the laboratory accreditation process.
   • Role of the assessor in the accreditation process.
   • Preparing for and managing surveillance audits.

• Instructor-led Training (ILT): Delivered through interactive presentations by qualified instructors with real-world experience in ISO 15189 assessments.
• Case Studies: Real-life examples to analyze challenges and solutions in laboratory audits.
• Group Discussions: Encourage sharing of experiences and knowledge among participants.
• Role-playing Exercises: Simulated audit scenarios for hands-on learning and practice.
• Workshops: Practical exercises on developing audit plans, assessing laboratory procedures, and preparing audit reports.
• Quizzes and Assessments: To evaluate participants’ understanding of the ISO 15189:2022 standard and assessment techniques.

5 days

• Assessment and Qualification

Learning is assessed through:

• one-hour examination. Passing the exams qualifies the candidate for Cognicert ISO 15189 Lead Assessor (Provisional Auditor Certificate)
• Practical experience of 20 days with activity log qualifies participants for our Cognicert ISO 15189 Lead Assessor (Auditor Category) I.D Card and Certificate
• Practical experience of 40 days with activity log qualifies participants for our Cognicert ISO 15189 Lead Assessor (Lead Auditor Category) I.D Card and Certificate

Self-Study Material, Exam and Certification 

Online Training, Material, Exam and Certification 

Classroom Training, Material, Exam and Certification – Locations here