Quality Specialized Training Courses with certification are scheduled for Pathologists and other Laboratory Scientists.  See the schedule below. To book, contact Temitope on 0816 205 7563, 0806 846 6957 or email: tenolone@tenol-alpha.com

 

Laboratory Training 1

 

ISO 15189 Medical Laboratory Quality Management System Standard Training for Laboratory Scientists

OVERVIEW:

ISO 15189 is an international quality management system standard designed specifically for medical laboratories. It outlines the controls required to manage risks that may have an impact on the validity of examination results, and tools to help the laboratory to improve its operations and customer satisfaction.

ISO 15189's requirements are designed to apply to all types of human pathology testing and therefore often need to be interpreted with respect to the type of testing concerned, and the techniques involved.

The requirements in the ISO 15189 standard covers management and technical requirements that will ensure an efficient and efficient laboratory producing reliable results. The requirements also cover staff, management, physical laboratory, quality of samples and analytical methods, customers, process management, equipment quality, competence, complaint management, error prevention etc.

This training will help you understand the key concepts in ISO 15189 for implementing a quality management system, a prerequisite for clinical laboratory accreditation.

The delegates will be able to understand and interpret the requirements of ISO 15189, including its QMS. Identify required documents and understand a risk management plan. This course is delivered in such a way that delegates will be able to apply the concepts, methods, and principles in their daily professional lines.

 

  • Clinical Microbiologists,
  • Clinical Biochemists and Technicians
  • Those working in Medical labs with a need to understand ISO 15189
  • Consultants
  • Pathologists
  • Laboratory scientists
  • Internal Assessors
  • Companies seeking ISO 15189 accreditation
  • Certification / Registrar / Accreditation body auditors
  • Laboratory managers
  • Quality managers and frontline staff responsible for implementing the quality system of Laboratories
  • Existing internal auditors who are looking to expand their skills in laboratory practices
  • Supplier Quality Auditors who need to evaluate clinical laboratory services

 

  • Purposes of the standard, and the history of accreditation requirements.
  • How the standard applies to the laboratory process.
  • Structure of the standard.
  • ISO 15189 Standard Requirements
  • Competence Management
  • Understanding the organization and its context
  • Context of the organization
  • Management and technical clauses of ISO 15189 (a facilitated discussion will occur with each clause 
  • Internal Audits & Management Reviews
  • Risk Management
  • Process development and formulation
  • Clinical Testing Criteria
  • Complaint Handling Processes
  • Corrective Actions and Preventative Actions
  • Training
  • Confidence Region for Clinical Results
  • Process model for an effective laboratory management
  • Traceability of Measurement
  • Report standardisation
  • Internal audit essentials
  • Accreditation process
   
 

 

  • Ability to apply the requirements of ISO 15189 standard to a laboratory and manage a process leading to accreditation of the laboratory
  • Learn tools that will support you in project managing the process delivering a standardized laboratory delivering consistently to the aspirations of clients
  • Identify the purpose and interaction of the management system and technical requirements.
  • Implement these requirements to ensure added service to customers and enhanced confidence in the facility's results.
  • Initial information necessary to initiate accreditation process for the laboratory
  • An understanding of the medical testing accreditation requirements.

 

3 days

 

N200,000

 

22nd -24th July ,2020

 

Lagos, Nigeria

 

please email: training@tenol-alpha.com or contact:
  • Tope: 0816 205 7563 OR 0806 846 6957
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