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Duration: 180 Days

Fees: 280 US$

Course duration is the Learning Management System (LMS) access available to the student. However, the student can complete the course early or whenever within 180 days and appear for the exam as per the individual learning goals.

Eligibility criteria:

  • Knowledge of ISO 15189 - Quality Management System for Medical Laboratories.

Course material:

  • PowerPoint Presentations
  • Reference material
  • Articles
  • Case Studies
  • Case Reference Material
  • Management System Documentation Templates
  • Videos

Assessment method:

  • Assignments
  • Examination

Career Prospects:

  • Laboratory/Quality Manager
  • QM/QA Specialist
  • Analyst
  • Operations Manager
  • Laboratory Director
  • Medical Laboratory Mangement System Consultant

Certified Lead Implementer - ISO 15189 Medical Laboratories - Quality Management System

Lead Implementer - ISO 15189:2012

  • This course is designed to enable professionals to build capability to initiate and spearhead the Implementation of ISO 15189 in medical laboratories. A robust quality management system will boost the medical laboratory’s credibility rating; opening up new business avenues & propelling it towards greater success.
  • You will attain the skills to evaluate a laboratory’s current processes, equipment, personnel & service quality. You will establish an effective quality management system compliant to ISO 15189 in the laboratory, conduct audits, review audit data, communicate results & propose corrective actions. You will be responsible in ensuring that the laboratory renders accurate & valid medical test results in a timely manner. You will further ensure that the laboratory maintains its compliance to ISO 15189.
  • Empirical approach to coaching will include detailed training material, assignments, case studies and presentations to assist students in analysis and synthesis of body of knowledge and to develop required skills.
  • On course completion, you can appear for the exam to qualify for Credentials Global’s ISO 15189 Lead Implementer certification.
  • This course is open to all professionals, operation managers, compliance executives, health specialists, and senior management that wish to lead the implementation of and establish conformity with the ISO 15189 framework.

Key Outcomes:

  • Appreciate the significance of an ISO 15189 audit
  • Acknowledge that ISO 15189 standard provides a structured approach to streamline key laboratory processes like inquiries, registrations, & requests, managing patients, collecting samples, safeguarding patient information, transport, storage, reviews
  • Understand key implementation techniques & requirements for assisting the laboratory in achieving compliance with ISO 15189
  • Identify the correlations between ISO 15189& other regulatory & legal frameworks
  • Develop competence to lead the implementation of a ISO 15189 audit
  • Review audit discoveries and suggest remedial measures to upgrade a laboratory’s quality management system
  • Guide clients to achieve& maintain compliance with ISO 15189 framework

Course Chapters:

Chapter 1 Introduction to Course
Chapter 2 Introduction to Standard & Terms and Definition
Chapter 3 Quality Related Concepts
Chapter 4 Process Mapping
Chapter 5 Conformity Assessment
Chapter 6 Organization & Management Responsibility
Chapter 7 Quality Management system and Document Control
Chapter 8 Service Agreements & Examination by referral laboratories
Chapter 9 External Services & Suppliers
Chapter 10 Advisory Services & Resolution of Complaint
Chapter 11 Non conformities & CAPA
Chapter 12 Continual Improvement and Control of Records
Chapter 13 Evaluation & Audits
Chapter 14 Management Review
Chapter 15 Personnel
Chapter 16 Accommodation & Environment
Chapter 17 Equipments Reagents & Consumables
Chapter 18 Process Control
Chapter 19 Quality Control
Chapter 20 EQA
Chapter 21 Laboratory Information Management System
Chapter 22 Managing Management System Implementation Project
Chapter 23 Consulting Skills for Management System Implementation

Certified Lead Implementer - ISO 15189 Medical Laboratories - Quality Management System etraining online Course