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Duration: 180 Days

Fees: 350 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:

  • Quality Manager
  • QMS Lead Auditor
  • Subcontractor Lead Auditor
  • QA Lead
  • QA Head

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


Lead Auditor - ISO 15189:2012

  • In today’s hyper competitive landscape, it is imperative for Medical Laboratories to function effectively; and deliver the most reliable results that guarantee the accurate diagnosis & treatment of patients. This course is designed to help professionals build the capability to initiate & spearhead an audit for ISO 15189, to assist medical laboratories in maintaining the highest level of quality & integrity through all their processes.
  • You will grasp the key concepts, techniques & procedures for successfully executing an ISO 15189 audit in the capacity of a Lead Auditor. Build the competence to plan for an ISO 15189 audit, propel team towards goal fulfillment, monitor, evaluate, interpret key audit findings, communicate results to clients & maintain compliance to the ISO 15189 standard, while constantly improving the medical laboratory’s management system.
  • 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, appear for the exam and qualify for Credentials Global’s ISO 15189 Lead Auditor certification.
  • This course is open to all professionals, health specialists, quality managers, compliance executives, experts, who intend to lead audits conforming to the ISO 15189 standard.

Key Outcomes:

  • Acknowledge the objective and value of an ISO 15189 audit
  • Understand how ISO 15189 correlates to other international regulatory frameworks
  • Appreciate how conforming to ISO 15189 can improve the reliability, validity & accuracy of test results & positively impact patient health & safety
  • Interpret the requirements of ISO 15189 that need to be fulfilled for successful accreditation
  • Develop confidence to lead & manage an ISO 15189 audit successfully
  • Gain the skill set to initiate, execute, monitor, evaluate, draft audit reports & carry out improvements to achieve excellence in operation & management of Medical Laboratories
  • Assist the medical laboratory to maintain compliance to ISO 15189

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 Guidelines For Auditing Management Systems
Chapter 23 Audit Excellence

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