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Duration: 90 Days

Fees: 250 US$

<p>Course duration is the Learning Management System (LMS) access available to the student. However, the student can complete the course early or whenever within 90 days and appear for the exam as per the individual learning goals.</p><p><strong>Eligibility criteria:</strong></p><ul><li>Knowledge of ISO 15189 - Quality Management System for Medical Laboratories.</li></ul><p><strong>Course material:</strong></p><ul><li>PowerPoint Presentations</li><li>Reference material</li><li>Articles</li><li>Case Studies</li><li>Case Reference Material</li><li>Management System Documentation Templates</li><li>Videos</li></ul><p><strong>Assessment method:</strong></p><ul><li>Assignments</li><li>Examination</li></ul><p><strong>Career Prospects:</strong></p><ul><li>QMS Internal Auditor</li><li>Audit Team Member</li></ul>

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

Internal Auditor - ISO 15189:2012

  • This course is designed to help professionals build the confidence to participate in & contribute to an ISO 15189 complaint internal audit. As an Internal auditor for ISO 15189 you will engage in initiating and maintaining an efficient quality management system for your medical laboratory. By attaining compliance with ISO 15189, your laboratory will have a structured framework to streamline its processes, personnel, equipment, operations & service offerings. You can ensure that patient safety and ethical practices are prioritized.
  • Gain the skills to plan for and initiate an ISO 15189 audit internally, assess audit findings, draft audit reports, propose corrective measures & evaluate effectiveness of the audit. As an Internal Auditor, you will work towards maintaining conformity to ISO 15189 & updating the laboratory’s quality management system.
  • Build a strong foundation for auditing for ISO 15189 though lectures, workshops, discussions, group activities, role plays and case study analysis.
  • On completion of training, appear for the exam and qualify for Credentials Global’s ISO 15189 Internal Auditor certificate.
  • This course is open to professionals engaging in or monitoring internal audits for ISO 15189.

Key Outcomes:

  • Gain understanding of the ISO 15189 standard
  • Acknowledge the objective & significance of an ISO 15189 audit
  • Appreciate the role and accountability of an ISO 15189 Internal Auditor
  • Interpret the requirements to establish conformity to ISO 15189
  • Plan for and engage in an internal audit for ISO 15189, review audit data, communicate results, propose recommendations and initiate follow up audits
  • Formulate strategy to boost the effectiveness of laboratory procedures, equipment & personnel
  • Assist the laboratory to achieve conformity with ISO 15189

Course Chapters:

Chapter 1 Introduction to Course
Chapter 2 Introduction to standard & Terms & Definition
Chapter 3 Quality related concepts
Chapter 4 Process Mapping
Chapter 5 Conformity Assessment
Chapter 6 Management Requirements
Chapter 7 Technical Requirements I
Chapter 8 Technical Requirements II
Chapter 9 Understanding the terms and Definition of Auditing
Chapter 10 Guidelines for auditing management system

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