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ISO 15189 Medical Laboratories:
Understanding the Four Components of a Quality Management System

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White Paper ISO 15189 Medical LaboratoriesMedical laboratories are a critical part of the healthcare system. A patient’s diagnosis and treatment are often based on test results, and an incorrect test result could lead to a misdiagnosis — which could have potentially fatal consequences. This is why accurate test results are critical — each and every time a test is conducted. In order to improve the accuracy of results, medical labs around the world have begun adopting ISO 15189: Medical laboratories—particular requirements for quality and competence. The standard requires medical labs to implement a quality management system. This requires them to document all their processes and procedures to ensure lab technologists always understand and follow the correct method when conducting a test.

This white paper provides an overview of the four main components of a quality management system:

  • 1. Management Responsibility
  • 2. Resource Management
  • 3. Service Realization
  • 4. Measurement, Analysis & Improvement

PLUS! Learn all about The Deming Cycle:
The white paper also examines the Deming Cycle, which organizations can use to achieve continual improvement for their quality management system. The Deming Cycle has four phases which organizations should constantly loop through.  Learn More Now!

The Dark Report is happy to offer our readers a chance to download our recently published FREE White Paper “ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System” at absolutely no charge. This free download will provide readers with a detailed overview of current legal challenges that your lab may encounter in the near future.

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Here is just some of what you will take away…

  1. Committing to Quality and Effective Strategic Planning
  2. Service Realization: Identifying and Managing Activities
  3. Measurement, Analysis and Improvement: Checking on Progress
  4. For more about a Quality Management System, please CLICK HERE

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Table of Contents

Preface – Page 3

Chapter 1. Executive Overview — Page 3
Chapter 2. Introducing the Four Components of a Quality Management System — Page 5
Chapter 3. Management Responsibility: Committing to Quality  — Page 8
Chapter 4. Resource Management: Applying Established Plans — Page 15
Chapter 5. Service Realization: Identifying and Managing Activities — Page 17
Chapter 6. Measurement, Analysis and Improvement: Checking on Progress — Page 21
Chapter 7. Understanding the Deming Cycle — Page 24
Chapter 8. Case Study:  Implemented ISO 15189 and the Deming Cycle — Page 29
Chapter 9. Conclusion— Page 36


A-1 About Gregory J. Flynn, B.Sc., MD, FRCPC — Page 39
A-2 About Julie Coffey, MLT, ART, CQA, CMQ/OE (ASQ) — Page 40
A-3 About Institute for Quality Management in Healthcare — Page 41
A-4 About DARK DAILY — Page 42
A-5 About The Dark Intelligence Group, Inc., and The Dark Report— Page 43
A-6 About Executive War College on Laboratory and Pathology Management — Page 44
A-7 About Robert Michel — Page 46
A-8 About the Poonam Khanna — Page 49

Terms of Use — Page 52

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