Introduction
Continual demonstration of technical competence is key in provision of quality healthcare services. At RANQUAL CONSULTING GROUP, we have a wide array of continuous development trainings in the various areas of Quality Management System.
The trainings have been designed for institutions desirous of quality improvement, those pursuing initial accreditation or certification as well as institutions interested in sustenance of achieved accreditation or certification.
Below are our course for QMS;
Course Description
This course is designed to impart valuable insights and tools for the effective documentation, establishment, execution and monitoring of an ISO 15189:2012 Quality Management System for clinical laboratories.Course Outline
- Value of ISO 15189 Laboratory accreditation
- ISO 15189 Management requirements (Clauses 4.0 – 4.15)
- ISO 15189 Technical requirements (Clauses 5.1 – 5.10)
- Mandatory 15189:2012 QMS documentations
- Essentials of achieving and sustaining ISO 15189 Laboratory accreditation
- Overview of ISO 15189 internal quality auditing
- Value of ISO 15189 Laboratory accreditation
- ISO 15189 Management requirements (Clauses 4.0 – 4.15)
Course Description
The course is designed for auditing ISO 15189, ISO 17025, ISO 17043 or ISO 9001 Quality Management Systems based on the guidelines of ISO 19011.
Course Outline
- Introduction to Audits
- Overview of ISO 15189:2012 Management Requirements
- Overview of ISO 15189:2012 Technical Requirements
- Terminologies & definitions
- Principles of auditing
- Audit programme and planning
- Conducting audits
- Generation of audit findings (conformities & nonconformities)
- Audit Reporting
- Competence and evaluation of auditors
- Competence & Evaluation of Auditors
- Documenting procedure for internal audit
- Introduction to root cause analysis, corrective actions, and preventive actions
Course Description
The course is designed to impart skills necessary for systematic investigation of the root cause of non-conformities to avert their recurrence (corrective action) or to prevent their occurrence (preventive action).Course Outline
- Introduction to root cause analysis
- Purpose of root cause analysis
- Elements of root cause analysis
- Steps in root cause analysis
- Problem definition
- Root cause analysis approaches & techniques
- Challenges to root cause analysis
- Corrections/ immediate actions
- Corrective actions
- Preventive actions
- Documenting procedure for identification and management of nonconformities
Course Description
This course is designed to equip clinical laboratory personnel with necessary skills for performance confirmation of laboratory equipment, reagents, and procedures before being introduced into routine use. The training is based on ISO 15189, ISO 5725, ISO/TS 21749, and Westgard guidelines.Course Outline
- Introduction to validation & verification
- Basic statistics
- Precision
- Accuracy
- Linearity
- Diagnostic and analytical Sensitivity
- Diagnostic and analytical Specificity
- Biological intervals
- Uncertainty of measurements
- Documenting procedure for Method validation and measurement uncertainty
Course Description
To provide knowledge on risk assessment, identification and management in clinical laboratories.Course Outline
- Overview of ISO 15189:2012
- Risk identification
- Risk analysis tools & methods
- Risk estimation
- Risk control & Monitoring
- Documentation and implementation of procedure for risk management
Course Description
This course is designed to describe the application of globally recommended principles in pre-examination, examination and post examination phases of clinical laboratories.
COurse Objective
To provide knowledge on the 12 quality management essentials and their application in clinical laboratories.Course Outline
- Introduction to GCLP
- Organization & Personnel
- Facilities, Equipment, Materials & Reagents
- Standard operating procedures & analytical plan
- Method and system validation
- Quality Management
- Sample Management
- Records
Course Description
The course is designed to impart skills necessary for handling, analysis, review and interpretation of internal Quality controls in a clinical laboratory.
Course Outline
- Introduction to IQC
- Handling IQC materials
- Levey-Jenning Quality Control charts
- Westgard Quality Control Rules
- Troubleshooting failed IQC results
- Documentation and implementation of Procedure for Internal Quality Control
This course is designed to equip participants with skills necessary for maintaining clinical laboratories in a safe and healthy working condition and prevent unnecessary harm to patients, staff, visitors, and the environment.
Course Outline
- Introduction to Biosafety & Biosecurity
- Policies and Regulations in Biorisk management
- Laboratory Biosecurity
- Field Biosafety and Biosecurity
- Biosecurity Management
- Bio-containment and Facility Design
- Waste management
- Shipping and transport of biological materials
- Incident management & emergency response
- Occupational safety and health
- Roles & responsibilities of key players in Bio-risk management
This course is designed to impart valuable insights and tools for the effective documentation, establishment, execution and monitoring of an ISO 17043:2010 Quality Management System for proficiency testing providers.
Course Outline
- Value of ISO 17043 accreditation
- ISO 17043 Management requirements (Clauses 4.0 – 4.15)
- ISO 17043 Technical requirements (Clauses 5.1 – 5.10)
- Mandatory 17043:2010 QMS documentations
- Essentials of achieving and sustaining ISO 17043 Laboratory accreditation
- Overview of ISO 17043 internal quality auditing
The course is designed to describe the statistical procedures necessary for analysis, evaluation, review, and interpretation of proficiency testing reports.
Course Outline
- Introduction about ISO 13528:2015 and process approach
- Inter laboratory Management System Principles
- Guidelines for statistical design of proficiency testing
- Guidelines for initial review of proficiency testing items
- Determination of the assigned values and its standards uncertainty
- Determination of criteria for evaluation of performance
This course is designed to impart valuable insights and tools for the effective documentation, establishment, execution, and monitoring of an ISO 9001 Quality Management System.
course Outline
- Foundations of Quality Management system
- History of ISO 9001 revisions
- Process approach and PDCA cycle
- Context of organization and risk-based thinking
- Foundations of Quality Management System
- Auditable clauses in ISO 9001:2005
The course is designed for auditing ISO 9001 Quality Management Systems based on the guidelines of ISO 19011.
Course Outline
- Introduction to Audits
- Overview of ISO 9001 Requirements
- Terminologies & definitions
- Principles of auditing
- Audit programme and planning
- Conducting audits
- Generation of audit findings (conformities & nonconformities)
- Audit Reporting
- Competence and evaluation of auditors
This course is designed to impart valuable insights and tools for the effective documentation, establishment, execution and monitoring of an ISO 17025 Quality Management System for calibration and testing laboratories.
Course Outline
- Introduction to ISO 17025 Quality Management system
- History of ISO 17025 revisions
- General Requirements
- Resource Requirements
- Process Requirements
- Management System Requirements
- Metrological traceability
- Management system options
- Competency assessment