About This Course
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Course
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ISO 15189 Training Course
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D
INSTRUCTOR
Dr. Adel Osama
What You'll Learn
1‐ Introduction to ISO 15189:2022
* Overview of ISO Standards
* Benefits of implementing ISO 15189:2022.
* Key changes from the previous version (ISO 15189:2012)
* Road Map for ISO 15189:2022
* How to start?
2‐ GENERAL REQUIREMENTS
* Understanding Impartiality
* How do you monitor impartiality threats
* Management & Release of information
* Requirements regarding patients
3‐ PERSONNEL
* Personnel competency requirements
* Authorization process
* Continuing education and professional development
* Personnel records
4‐ FACILITIES AND ENVIRONMENTAL CONDITIONS
* The requirements for facilities and environmental conditions
* Facility controls
* Storage facilities
* Personnel facilities
* Sample collection facilities
5‐ EQUIPMENTS
* Equipment requirements
* Equipment acceptance procedure
* Equipment maintenance and repair
* Equipment adverse incident reporting
* Equipment calibration and metrological traceability
* Equipment records
6‐ REAGENTS AND CONSUMABLES
* Receipt and storage
* Acceptance testing
* Inventory management
* Adverse incident reporting
7‐ EXTERNALLY PROVIDED PRODUCTS AND SERVICES
* Referral laboratories and consultants
* Review and approval of externally provided products and services
* Evaluations of the performance of external providers
8‐ PRE‐EXAMINATION PROCESSES
* Laboratory information for patients and users
* Requests for providing laboratory examinations
* Oral requests
* Primary sample collection and handling
* Information for pre‐collection activities
* Patient consent
* Instructions for collection activities
* Sample transportation
* Sample acceptance exceptions
* Pre‐examination handling, preparation, and storage
9‐ EXAMINATION PROCESSES
* Verification of examination methods
* Understand the difference between validation & verification
* Verification of quantitative methods according to ISO 15189:2022 requirements
* Verification of qualitative methods according to ISO 15189:2022 requirements
* Method Verification calculation and performance criteria
* Comparability of examination results
10‐ UNCERTAINTY MEASUREMENTS
* Identify Sources of Uncertainty
* Quantify Uncertainty Components
* Combine Uncertainty Components
* Calculate Expanded Uncertainty
* Report Uncertainty
11‐ UNDERSTANDING RISK ASSESSMENT
* Define the scope of the risk assessment
* Identify Risks
* Analyze Risks
* Evaluate Risks
* Mitigate Risks
* Monitor and Review risks and controls to ensure effectiveness
* Integrating Risk Assessment into the quality management system
12‐ ENSURING THE VALIDITY OF EXAMINATION RESULTS
* Internal quality control (IQC)
* External quality assessment (EQA)
* POST‐EXAMINATION PROCESSES
13‐ MANAGEMENT SYSTEM REQUIREMENTS
* Define key elements of a quality management system (QMS)
* Management system documentation
* Management system awareness
* Control of management system documents
* Control of records
* Retention of records
14‐ EVALUATIONS OF QUALITY MANAGEMENT SYSTEM
* Quality indicators
* Internal audits
* Management reviews