Overview
This course is a comprehensive 3-day program 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.
What you will learn
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Understand the structure, scope, requirements, and application of ISO 15189:2022
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Develop and implement a laboratory quality management system which can improve their medical laboratory operations to meet the needs of their clients
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Understand the key requirements for accreditation and be familiarize with the laboratory accreditation process
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Acquire the concepts of risk-based approach, plan-do-check-act cycle, validation, verification, CAPA and continual improvement
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Understand the principals of auditing with reference to ISO 15189 and ISO 19011
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Learn the essentials of auditing, which include the techniques in assessing the effectiveness of quality systems and identifying areas for improvement
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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.
Course Facilitation and Duration
This course is run as a 3-day classroom training led by facilitator. Course includes a mix of theory and interactive workshops that address ‘real-world’ scenarios from industry and case studies that are directly applicable to client’s operations. Please contact us for details.