Overview
This course provides comprehensive training for medical laboratory personnel to build their knowledge and competency in implementing and maintaining their ISO/IEC 15189:2022 laboratory management system and establish effective auditing skills to evaluate the effectiveness of the laboratory quality management system in their organization.
Learning Objective
Understand the structure, scope, requirements, and application of ISO 15189:2022.
Develop and implement a laboratory quality management system which can improve their medical laboratory operations to meet the needs of their clients.
Understand the key requirements for accreditation and be familiarize with the laboratory accreditation process Acquire the concepts of risk-based approach, plan-do-check-act cycle, validation, verification, CAPA and continual improvement.
Understand the principals of auditing with reference to ISO 15189 and ISO 19011.
Learn the essentials of auditing, which include the techniques in assessing the effectiveness of quality systems and identifying areas for improvement
Gain competency as internal auditor to plan, conduct, report and follow up an audit of a Laboratory Management System to assess conformity with ISO 15189.
Target Audience
This course is suitable for personnel of medical or clinical laboratories who have been tasked to develop and implement a laboratory management system in accordance to ISO/IEC 15189:2022 as well as laboratory personnel responsible for the technical or quality management of the tests or calibrations performed.
Facilitation
This course can be run as a live classroom or virtual (synchronous) instructor-led training.
Certificates
Please contact us for details.